# Symposium Biostimulanzien 2022 / Teil 2 ## Metadata - Entity type: YouTube item (`iva_youtube_video`) - URL: https://www.iva.de/videos/symposium-biostimulanzien-2022-teil-2 - Language: de - Created: 2026-06-23T08:14:01+00:00 - Updated: 2026-07-17T08:00:01+00:00 - Published: true ## Content Titel Symposium Biostimulanzien 2022 / Teil 2 YouTube video ID lGZa2qHMEWg Video ![youtube](https://www.iva.de/sites/default/files/oembed_thumbnails/2026-06/th8OjaOEZFtL-n_37AYMl0eVXVBVP4OCxAOnLf-RUng.jpg) [Watch on YouTube: Symposium Biostimulanzien 2022 / Teil 2](https://www.youtube.com/watch?v=lGZa2qHMEWg) Videotyp Video Beschreibung Am 21. September 2022 fand zum 4. Mal das Symposium Biostimulanzien statt. Erneut informierte sich ein breites Fachpublikum über die innovative Produktgruppe der Biostimulanzien. Duration in seconds 3093 Published date Do. 3 Nov 2022 - 16:07 Thumbnail URL YouTube channel ID UCfsfFP1-x-HHUYMI4BDkaBA Imported from YouTube Ja Last synced Fr. 17 Jul 2026 - 10:00 Sync status Synced YouTube category [Science & Technology](https://www.iva.de/youtube-categories/science-technology) View count 333 YouTube topics [Health](https://www.iva.de/youtube-topics/health) Like count 4 Anzahl an Kommentaren 0 YouTube playlists [Veranstaltungen](https://www.iva.de/youtube-playlists/veranstaltungen) Favorite count 0 Statistics synced at Fr. 17 Jul 2026 - 10:00 Last synced payload { "kind": "youtube#video", "etag": "vgiWI_Dc8a2vgk5RQEXLKB7dnBk", "id": "lGZa2qHMEWg", "snippet": { "publishedAt": "2022-11-03T15:07:17Z", "channelId": "UCfsfFP1-x-HHUYMI4BDkaBA", "title": "Symposium Biostimulanzien 2022 / Teil 2", "description": "Am 21. September 2022 fand zum 4. Mal das Symposium Biostimulanzien statt. Erneut informierte sich ein breites Fachpublikum über die innovative Produktgruppe der Biostimulanzien.", "thumbnails": { "default": { "url": "https://i.ytimg.com/vi/lGZa2qHMEWg/default.jpg", "width": 120, "height": 90 }, "medium": { "url": "https://i.ytimg.com/vi/lGZa2qHMEWg/mqdefault.jpg", "width": 320, "height": 180 }, "high": { "url": "https://i.ytimg.com/vi/lGZa2qHMEWg/hqdefault.jpg", "width": 480, "height": 360 }, "standard": { "url": "https://i.ytimg.com/vi/lGZa2qHMEWg/sddefault.jpg", "width": 640, "height": 480 }, "maxres": { "url": "https://i.ytimg.com/vi/lGZa2qHMEWg/maxresdefault.jpg", "width": 1280, "height": 720 } }, "channelTitle": "Industrieverband Agrar e. V. (IVA)", "categoryId": "28", "liveBroadcastContent": "none", "defaultLanguage": "de", "localized": { "title": "Symposium Biostimulanzien 2022 / Teil 2", "description": "Am 21. September 2022 fand zum 4. Mal das Symposium Biostimulanzien statt. Erneut informierte sich ein breites Fachpublikum über die innovative Produktgruppe der Biostimulanzien." } }, "contentDetails": { "duration": "PT51M33S", "dimension": "2d", "definition": "hd", "caption": "false", "licensedContent": false, "contentRating": [], "projection": "rectangular" }, "status": { "uploadStatus": "processed", "privacyStatus": "public", "license": "youtube", "embeddable": true, "publicStatsViewable": true, "madeForKids": false }, "statistics": { "viewCount": "333", "likeCount": "4", "favoriteCount": "0", "commentCount": "0" }, "topicDetails": { "topicCategories": [ "https://en.wikipedia.org/wiki/Health" ] } } Transcript (with timestamps) WEBVTT Kind: captions Language: en 00:00:00.000 --> 00:00:01.250 align:start position:0% check 00:00:01.250 --> 00:00:01.260 align:start position:0% check 00:00:01.260 --> 00:00:01.910 align:start position:0% check um 00:00:01.910 --> 00:00:01.920 align:start position:0% um 00:00:01.920 --> 00:00:04.970 align:start position:0% um yeah<00:00:02.460><c> so</c><00:00:03.060><c> good</c><00:00:03.419><c> morning</c><00:00:03.659><c> everyone</c><00:00:04.500><c> thank</c><00:00:04.920><c> you</c> 00:00:04.970 --> 00:00:04.980 align:start position:0% yeah so good morning everyone thank you 00:00:04.980 --> 00:00:07.190 align:start position:0% yeah so good morning everyone thank you all<00:00:05.100><c> for</c><00:00:05.279><c> for</c><00:00:05.400><c> being</c><00:00:05.580><c> here</c><00:00:05.759><c> firstly</c> 00:00:07.190 --> 00:00:07.200 align:start position:0% all for for being here firstly 00:00:07.200 --> 00:00:09.230 align:start position:0% all for for being here firstly um let<00:00:07.859><c> me</c><00:00:07.980><c> just</c><00:00:08.099><c> say</c><00:00:08.220><c> apologies</c><00:00:08.700><c> this</c> 00:00:09.230 --> 00:00:09.240 align:start position:0% um let me just say apologies this 00:00:09.240 --> 00:00:10.850 align:start position:0% um let me just say apologies this presentation<00:00:09.720><c> will</c><00:00:09.900><c> be</c><00:00:10.019><c> in</c><00:00:10.139><c> English</c><00:00:10.320><c> not</c><00:00:10.620><c> in</c> 00:00:10.850 --> 00:00:10.860 align:start position:0% presentation will be in English not in 00:00:10.860 --> 00:00:13.789 align:start position:0% presentation will be in English not in German<00:00:10.980><c> uh</c><00:00:11.760><c> the</c><00:00:12.300><c> fpr</c><00:00:12.719><c> is</c><00:00:12.900><c> let's</c><00:00:13.440><c> say</c><00:00:13.559><c> a</c><00:00:13.740><c> little</c> 00:00:13.789 --> 00:00:13.799 align:start position:0% German uh the fpr is let's say a little 00:00:13.799 --> 00:00:15.650 align:start position:0% German uh the fpr is let's say a little bit<00:00:13.980><c> complicated</c><00:00:14.400><c> and</c><00:00:14.759><c> if</c><00:00:15.240><c> I</c><00:00:15.420><c> do</c><00:00:15.540><c> the</c> 00:00:15.650 --> 00:00:15.660 align:start position:0% bit complicated and if I do the 00:00:15.660 --> 00:00:16.910 align:start position:0% bit complicated and if I do the presentation<00:00:16.020><c> in</c><00:00:16.199><c> German</c><00:00:16.379><c> it</c><00:00:16.619><c> might</c><00:00:16.800><c> raise</c> 00:00:16.910 --> 00:00:16.920 align:start position:0% presentation in German it might raise 00:00:16.920 --> 00:00:19.970 align:start position:0% presentation in German it might raise more<00:00:17.220><c> questions</c><00:00:17.460><c> than</c><00:00:17.880><c> that</c><00:00:18.359><c> it</c><00:00:18.480><c> might</c><00:00:18.600><c> answer</c> 00:00:19.970 --> 00:00:19.980 align:start position:0% more questions than that it might answer 00:00:19.980 --> 00:00:20.630 align:start position:0% more questions than that it might answer um 00:00:20.630 --> 00:00:20.640 align:start position:0% um 00:00:20.640 --> 00:00:22.609 align:start position:0% um my<00:00:21.000><c> name</c><00:00:21.119><c> is</c><00:00:21.180><c> Phil</c><00:00:21.300><c> tetler</c><00:00:21.779><c> I'm</c><00:00:22.080><c> the</c><00:00:22.320><c> chairman</c> 00:00:22.609 --> 00:00:22.619 align:start position:0% my name is Phil tetler I'm the chairman 00:00:22.619 --> 00:00:25.970 align:start position:0% my name is Phil tetler I'm the chairman of<00:00:22.800><c> the</c><00:00:23.340><c> efci</c><00:00:24.119><c> register</c><00:00:24.539><c> uh</c><00:00:25.380><c> we</c><00:00:25.560><c> are</c><00:00:25.680><c> one</c><00:00:25.859><c> of</c> 00:00:25.970 --> 00:00:25.980 align:start position:0% of the efci register uh we are one of 00:00:25.980 --> 00:00:29.929 align:start position:0% of the efci register uh we are one of the<00:00:26.100><c> now</c><00:00:26.359><c> five</c><00:00:27.359><c> actually</c><00:00:28.140><c> uh</c><00:00:29.099><c> notified</c><00:00:29.460><c> bodies</c> 00:00:29.929 --> 00:00:29.939 align:start position:0% the now five actually uh notified bodies 00:00:29.939 --> 00:00:31.970 align:start position:0% the now five actually uh notified bodies that<00:00:30.240><c> are</c><00:00:30.359><c> appointed</c><00:00:30.779><c> and</c><00:00:30.960><c> accredited</c><00:00:31.560><c> to</c><00:00:31.740><c> do</c> 00:00:31.970 --> 00:00:31.980 align:start position:0% that are appointed and accredited to do 00:00:31.980 --> 00:00:34.850 align:start position:0% that are appointed and accredited to do certification<00:00:32.880><c> for</c><00:00:33.120><c> biostimulus</c> 00:00:34.850 --> 00:00:34.860 align:start position:0% certification for biostimulus 00:00:34.860 --> 00:00:37.050 align:start position:0% certification for biostimulus um<00:00:34.980><c> we're</c><00:00:35.399><c> based</c><00:00:35.640><c> in</c><00:00:35.700><c> the</c><00:00:35.820><c> Netherlands</c> 00:00:37.050 --> 00:00:37.060 align:start position:0% um we're based in the Netherlands 00:00:37.060 --> 00:00:37.790 align:start position:0% um we're based in the Netherlands [Music] 00:00:37.790 --> 00:00:37.800 align:start position:0% [Music] 00:00:37.800 --> 00:00:39.889 align:start position:0% [Music] um 00:00:39.889 --> 00:00:39.899 align:start position:0% 00:00:39.899 --> 00:00:42.049 align:start position:0% what<00:00:40.440><c> I</c><00:00:40.559><c> want</c><00:00:40.739><c> to</c><00:00:40.920><c> talk</c><00:00:41.219><c> to</c><00:00:41.399><c> you</c><00:00:41.399><c> about</c><00:00:41.700><c> today</c> 00:00:42.049 --> 00:00:42.059 align:start position:0% what I want to talk to you about today 00:00:42.059 --> 00:00:44.330 align:start position:0% what I want to talk to you about today is<00:00:42.360><c> is</c><00:00:42.719><c> obviously</c><00:00:43.379><c> the</c><00:00:43.500><c> fpr</c><00:00:43.920><c> but</c><00:00:44.100><c> very</c> 00:00:44.330 --> 00:00:44.340 align:start position:0% is is obviously the fpr but very 00:00:44.340 --> 00:00:46.250 align:start position:0% is is obviously the fpr but very specifically<00:00:44.820><c> how</c><00:00:45.480><c> can</c><00:00:45.660><c> you</c><00:00:45.780><c> actually</c><00:00:45.899><c> get</c><00:00:46.079><c> a</c> 00:00:46.250 --> 00:00:46.260 align:start position:0% specifically how can you actually get a 00:00:46.260 --> 00:00:47.750 align:start position:0% specifically how can you actually get a product<00:00:46.379><c> certified</c> 00:00:47.750 --> 00:00:47.760 align:start position:0% product certified 00:00:47.760 --> 00:00:49.430 align:start position:0% product certified um<00:00:47.879><c> so</c><00:00:48.180><c> very</c><00:00:48.360><c> briefly</c><00:00:48.660><c> because</c><00:00:48.899><c> the</c><00:00:49.320><c> other</c> 00:00:49.430 --> 00:00:49.440 align:start position:0% um so very briefly because the other 00:00:49.440 --> 00:00:51.770 align:start position:0% um so very briefly because the other speakers<00:00:49.680><c> spoke</c><00:00:50.520><c> on</c><00:00:50.640><c> it</c><00:00:50.760><c> as</c><00:00:50.879><c> well</c><00:00:51.000><c> just</c> 00:00:51.770 --> 00:00:51.780 align:start position:0% speakers spoke on it as well just 00:00:51.780 --> 00:00:53.750 align:start position:0% speakers spoke on it as well just shortly<00:00:52.020><c> about</c><00:00:52.140><c> the</c><00:00:52.320><c> fpr</c> 00:00:53.750 --> 00:00:53.760 align:start position:0% shortly about the fpr 00:00:53.760 --> 00:00:55.549 align:start position:0% shortly about the fpr um the<00:00:54.059><c> goal</c><00:00:54.239><c> of</c><00:00:54.300><c> the</c><00:00:54.420><c> regulation</c><00:00:54.899><c> is</c><00:00:55.320><c> to</c> 00:00:55.549 --> 00:00:55.559 align:start position:0% um the goal of the regulation is to 00:00:55.559 --> 00:00:57.889 align:start position:0% um the goal of the regulation is to create<00:00:55.739><c> a</c><00:00:56.039><c> single</c><00:00:56.280><c> market</c><00:00:56.460><c> for</c><00:00:57.120><c> fertilizing</c> 00:00:57.889 --> 00:00:57.899 align:start position:0% create a single market for fertilizing 00:00:57.899 --> 00:01:01.310 align:start position:0% create a single market for fertilizing products<00:00:58.699><c> and</c><00:00:59.699><c> biostimulants</c><00:01:00.480><c> is</c><00:01:00.780><c> one</c><00:01:00.960><c> of</c><00:01:01.079><c> the</c> 00:01:01.310 --> 00:01:01.320 align:start position:0% products and biostimulants is one of the 00:01:01.320 --> 00:01:03.529 align:start position:0% products and biostimulants is one of the types<00:01:01.739><c> of</c><00:01:01.860><c> products</c><00:01:02.160><c> that</c><00:01:02.399><c> is</c><00:01:02.520><c> now</c><00:01:02.760><c> included</c> 00:01:03.529 --> 00:01:03.539 align:start position:0% types of products that is now included 00:01:03.539 --> 00:01:06.170 align:start position:0% types of products that is now included in<00:01:03.719><c> that</c><00:01:03.840><c> regulation</c><00:01:04.700><c> the</c><00:01:05.700><c> regulation</c><00:01:06.060><c> is</c> 00:01:06.170 --> 00:01:06.180 align:start position:0% in that regulation the regulation is 00:01:06.180 --> 00:01:08.510 align:start position:0% in that regulation the regulation is optional<00:01:06.659><c> which</c><00:01:07.080><c> is</c><00:01:07.260><c> quite</c><00:01:07.500><c> unique</c><00:01:07.860><c> it</c><00:01:08.220><c> means</c> 00:01:08.510 --> 00:01:08.520 align:start position:0% optional which is quite unique it means 00:01:08.520 --> 00:01:10.550 align:start position:0% optional which is quite unique it means if<00:01:09.060><c> you're</c><00:01:09.180><c> selling</c><00:01:09.540><c> a</c><00:01:09.600><c> biostimulant</c><00:01:10.260><c> at</c><00:01:10.439><c> the</c> 00:01:10.550 --> 00:01:10.560 align:start position:0% if you're selling a biostimulant at the 00:01:10.560 --> 00:01:12.109 align:start position:0% if you're selling a biostimulant at the moment 00:01:12.109 --> 00:01:12.119 align:start position:0% moment 00:01:12.119 --> 00:01:13.789 align:start position:0% moment um<00:01:12.180><c> under</c><00:01:12.659><c> for</c><00:01:12.960><c> example</c><00:01:13.200><c> a</c><00:01:13.500><c> national</c> 00:01:13.789 --> 00:01:13.799 align:start position:0% um under for example a national 00:01:13.799 --> 00:01:16.070 align:start position:0% um under for example a national registration<00:01:14.400><c> in</c><00:01:14.640><c> France</c><00:01:14.820><c> or</c><00:01:15.060><c> in</c><00:01:15.240><c> Spain</c><00:01:15.479><c> you</c> 00:01:16.070 --> 00:01:16.080 align:start position:0% registration in France or in Spain you 00:01:16.080 --> 00:01:18.410 align:start position:0% registration in France or in Spain you can<00:01:16.140><c> keep</c><00:01:16.320><c> doing</c><00:01:16.560><c> that</c><00:01:17.280><c> but</c><00:01:17.760><c> on</c><00:01:18.000><c> top</c><00:01:18.119><c> of</c><00:01:18.240><c> this</c> 00:01:18.410 --> 00:01:18.420 align:start position:0% can keep doing that but on top of this 00:01:18.420 --> 00:01:20.570 align:start position:0% can keep doing that but on top of this from<00:01:18.720><c> the</c><00:01:18.840><c> 16th</c><00:01:19.200><c> of</c><00:01:19.320><c> July</c><00:01:19.619><c> you</c><00:01:20.100><c> can</c><00:01:20.220><c> choose</c><00:01:20.400><c> to</c> 00:01:20.570 --> 00:01:20.580 align:start position:0% from the 16th of July you can choose to 00:01:20.580 --> 00:01:24.289 align:start position:0% from the 16th of July you can choose to use<00:01:20.759><c> the</c><00:01:21.000><c> fpr</c><00:01:21.420><c> to</c><00:01:22.200><c> sell</c><00:01:22.380><c> a</c><00:01:22.560><c> biosity</c><00:01:22.920><c> Amendment</c> 00:01:24.289 --> 00:01:24.299 align:start position:0% use the fpr to sell a biosity Amendment 00:01:24.299 --> 00:01:25.969 align:start position:0% use the fpr to sell a biosity Amendment um<00:01:24.420><c> so</c><00:01:24.659><c> it</c><00:01:24.780><c> doesn't</c><00:01:24.900><c> replace</c><00:01:25.200><c> National</c><00:01:25.500><c> rules</c> 00:01:25.969 --> 00:01:25.979 align:start position:0% um so it doesn't replace National rules 00:01:25.979 --> 00:01:27.710 align:start position:0% um so it doesn't replace National rules it<00:01:26.220><c> just</c><00:01:26.400><c> provides</c><00:01:26.820><c> an</c><00:01:27.000><c> additional</c><00:01:27.299><c> framework</c> 00:01:27.710 --> 00:01:27.720 align:start position:0% it just provides an additional framework 00:01:27.720 --> 00:01:30.350 align:start position:0% it just provides an additional framework that<00:01:28.080><c> you</c><00:01:28.200><c> can</c><00:01:28.259><c> work</c><00:01:28.439><c> under</c> 00:01:30.350 --> 00:01:30.360 align:start position:0% that you can work under 00:01:30.360 --> 00:01:32.510 align:start position:0% that you can work under um<00:01:30.420><c> like</c><00:01:30.840><c> Theresa</c><00:01:31.259><c> mentioned</c><00:01:31.500><c> earlier</c><00:01:31.740><c> the</c> 00:01:32.510 --> 00:01:32.520 align:start position:0% um like Theresa mentioned earlier the 00:01:32.520 --> 00:01:33.730 align:start position:0% um like Theresa mentioned earlier the regulation 00:01:33.730 --> 00:01:33.740 align:start position:0% regulation 00:01:33.740 --> 00:01:36.530 align:start position:0% regulation splits<00:01:34.740><c> products</c><00:01:35.040><c> up</c><00:01:35.220><c> into</c><00:01:35.400><c> a</c><00:01:35.579><c> PFC</c><00:01:36.000><c> there</c><00:01:36.420><c> are</c> 00:01:36.530 --> 00:01:36.540 align:start position:0% splits products up into a PFC there are 00:01:36.540 --> 00:01:38.390 align:start position:0% splits products up into a PFC there are seven<00:01:36.659><c> of</c><00:01:36.900><c> these</c><00:01:37.140><c> obviously</c><00:01:37.920><c> interesting</c><00:01:38.220><c> for</c> 00:01:38.390 --> 00:01:38.400 align:start position:0% seven of these obviously interesting for 00:01:38.400 --> 00:01:40.190 align:start position:0% seven of these obviously interesting for today<00:01:38.520><c> is</c><00:01:38.700><c> we</c><00:01:38.820><c> have</c><00:01:38.939><c> pfc6</c><00:01:39.600><c> which</c><00:01:40.140><c> is</c> 00:01:40.190 --> 00:01:40.200 align:start position:0% today is we have pfc6 which is 00:01:40.200 --> 00:01:42.230 align:start position:0% today is we have pfc6 which is biostimulants<00:01:40.979><c> and</c><00:01:41.460><c> there</c><00:01:41.640><c> are</c><00:01:41.759><c> two</c> 00:01:42.230 --> 00:01:42.240 align:start position:0% biostimulants and there are two 00:01:42.240 --> 00:01:44.030 align:start position:0% biostimulants and there are two categories<00:01:43.079><c> that</c><00:01:43.259><c> you</c><00:01:43.380><c> can</c><00:01:43.439><c> choose</c><00:01:43.619><c> you</c><00:01:43.979><c> can</c> 00:01:44.030 --> 00:01:44.040 align:start position:0% categories that you can choose you can 00:01:44.040 --> 00:01:46.670 align:start position:0% categories that you can choose you can have<00:01:44.220><c> a</c><00:01:44.340><c> microbial</c><00:01:44.759><c> biostimulant</c><00:01:45.900><c> or</c><00:01:46.500><c> a</c> 00:01:46.670 --> 00:01:46.680 align:start position:0% have a microbial biostimulant or a 00:01:46.680 --> 00:01:48.410 align:start position:0% have a microbial biostimulant or a non-microbial<00:01:47.220><c> biostimulant</c><00:01:47.880><c> you</c><00:01:48.180><c> have</c><00:01:48.299><c> to</c> 00:01:48.410 --> 00:01:48.420 align:start position:0% non-microbial biostimulant you have to 00:01:48.420 --> 00:01:50.330 align:start position:0% non-microbial biostimulant you have to have<00:01:48.600><c> one</c><00:01:48.960><c> or</c><00:01:49.200><c> the</c><00:01:49.380><c> other</c><00:01:49.439><c> and</c><00:01:49.740><c> then</c><00:01:49.860><c> and</c><00:01:50.280><c> then</c> 00:01:50.330 --> 00:01:50.340 align:start position:0% have one or the other and then and then 00:01:50.340 --> 00:01:52.249 align:start position:0% have one or the other and then and then you<00:01:50.460><c> have</c><00:01:50.640><c> to</c><00:01:50.759><c> meet</c><00:01:50.880><c> those</c><00:01:51.119><c> requirements</c><00:01:51.720><c> and</c> 00:01:52.249 --> 00:01:52.259 align:start position:0% you have to meet those requirements and 00:01:52.259 --> 00:01:53.870 align:start position:0% you have to meet those requirements and there<00:01:52.380><c> are</c><00:01:52.500><c> of</c><00:01:52.619><c> course</c><00:01:52.680><c> cmcs</c><00:01:53.340><c> so</c><00:01:53.640><c> the</c> 00:01:53.870 --> 00:01:53.880 align:start position:0% there are of course cmcs so the 00:01:53.880 --> 00:01:56.210 align:start position:0% there are of course cmcs so the ingredients<00:01:54.420><c> that</c><00:01:55.259><c> you</c><00:01:55.439><c> use</c><00:01:55.560><c> to</c><00:01:55.860><c> formulate</c> 00:01:56.210 --> 00:01:56.220 align:start position:0% ingredients that you use to formulate 00:01:56.220 --> 00:01:57.950 align:start position:0% ingredients that you use to formulate your<00:01:56.460><c> product</c><00:01:56.640><c> have</c><00:01:57.299><c> to</c><00:01:57.479><c> meet</c><00:01:57.659><c> certain</c> 00:01:57.950 --> 00:01:57.960 align:start position:0% your product have to meet certain 00:01:57.960 --> 00:02:00.530 align:start position:0% your product have to meet certain requirements 00:02:00.530 --> 00:02:00.540 align:start position:0% requirements 00:02:00.540 --> 00:02:03.289 align:start position:0% requirements um<00:02:00.600><c> important</c><00:02:01.380><c> for</c><00:02:01.560><c> the</c><00:02:01.680><c> day</c><00:02:01.860><c> there's</c><00:02:02.820><c> no</c><00:02:03.119><c> form</c> 00:02:03.289 --> 00:02:03.299 align:start position:0% um important for the day there's no form 00:02:03.299 --> 00:02:05.510 align:start position:0% um important for the day there's no form of<00:02:03.600><c> national</c><00:02:03.960><c> registration</c><00:02:04.680><c> instead</c><00:02:05.340><c> there's</c> 00:02:05.510 --> 00:02:05.520 align:start position:0% of national registration instead there's 00:02:05.520 --> 00:02:07.670 align:start position:0% of national registration instead there's a<00:02:05.759><c> system</c><00:02:05.880><c> of</c><00:02:06.119><c> certification</c><00:02:06.600><c> there's</c><00:02:07.259><c> CE</c> 00:02:07.670 --> 00:02:07.680 align:start position:0% a system of certification there's CE 00:02:07.680 --> 00:02:10.010 align:start position:0% a system of certification there's CE marking<00:02:07.979><c> but</c><00:02:08.399><c> there</c><00:02:08.580><c> are</c><00:02:08.700><c> also</c><00:02:08.940><c> modules</c><00:02:09.360><c> and</c> 00:02:10.010 --> 00:02:10.020 align:start position:0% marking but there are also modules and 00:02:10.020 --> 00:02:12.050 align:start position:0% marking but there are also modules and the<00:02:10.140><c> modules</c><00:02:10.440><c> Define</c><00:02:10.679><c> how</c><00:02:11.580><c> you</c><00:02:11.640><c> get</c><00:02:11.819><c> a</c><00:02:11.940><c> product</c> 00:02:12.050 --> 00:02:12.060 align:start position:0% the modules Define how you get a product 00:02:12.060 --> 00:02:13.970 align:start position:0% the modules Define how you get a product certified<00:02:12.480><c> what</c><00:02:13.140><c> requirements</c><00:02:13.620><c> you</c><00:02:13.739><c> have</c><00:02:13.860><c> to</c> 00:02:13.970 --> 00:02:13.980 align:start position:0% certified what requirements you have to 00:02:13.980 --> 00:02:15.650 align:start position:0% certified what requirements you have to meet<00:02:14.160><c> and</c><00:02:14.879><c> how</c><00:02:15.120><c> you</c><00:02:15.180><c> can</c><00:02:15.300><c> actually</c><00:02:15.420><c> start</c> 00:02:15.650 --> 00:02:15.660 align:start position:0% meet and how you can actually start 00:02:15.660 --> 00:02:17.330 align:start position:0% meet and how you can actually start selling<00:02:16.020><c> the</c><00:02:16.140><c> product</c><00:02:16.319><c> in</c><00:02:17.040><c> the</c><00:02:17.099><c> case</c><00:02:17.220><c> of</c> 00:02:17.330 --> 00:02:17.340 align:start position:0% selling the product in the case of 00:02:17.340 --> 00:02:18.589 align:start position:0% selling the product in the case of biostimulants<00:02:18.060><c> you</c><00:02:18.239><c> have</c><00:02:18.360><c> to</c><00:02:18.480><c> get</c> 00:02:18.589 --> 00:02:18.599 align:start position:0% biostimulants you have to get 00:02:18.599 --> 00:02:20.210 align:start position:0% biostimulants you have to get certification<00:02:19.140><c> and</c><00:02:19.440><c> you</c><00:02:19.560><c> have</c><00:02:19.680><c> to</c><00:02:19.860><c> choose</c> 00:02:20.210 --> 00:02:20.220 align:start position:0% certification and you have to choose 00:02:20.220 --> 00:02:23.890 align:start position:0% certification and you have to choose either<00:02:20.760><c> module</c><00:02:21.180><c> b</c><00:02:21.360><c> or</c><00:02:22.140><c> module</c><00:02:22.500><c> D1</c> 00:02:23.890 --> 00:02:23.900 align:start position:0% either module b or module D1 00:02:23.900 --> 00:02:27.050 align:start position:0% either module b or module D1 the<00:02:24.900><c> difference</c><00:02:25.020><c> is</c><00:02:25.319><c> module</c><00:02:25.920><c> B</c><00:02:26.099><c> just</c><00:02:26.700><c> looks</c><00:02:27.000><c> at</c> 00:02:27.050 --> 00:02:27.060 align:start position:0% the difference is module B just looks at 00:02:27.060 --> 00:02:28.910 align:start position:0% the difference is module B just looks at the<00:02:27.239><c> technical</c><00:02:27.480><c> design</c><00:02:27.720><c> of</c><00:02:28.020><c> a</c><00:02:28.140><c> product</c><00:02:28.319><c> so</c> 00:02:28.910 --> 00:02:28.920 align:start position:0% the technical design of a product so 00:02:28.920 --> 00:02:31.010 align:start position:0% the technical design of a product so it's<00:02:29.040><c> a</c><00:02:29.220><c> remote</c><00:02:29.400><c> and</c><00:02:29.819><c> document</c><00:02:30.180><c> based</c><00:02:30.780><c> audit</c> 00:02:31.010 --> 00:02:31.020 align:start position:0% it's a remote and document based audit 00:02:31.020 --> 00:02:32.690 align:start position:0% it's a remote and document based audit it's<00:02:31.560><c> a</c><00:02:31.680><c> bit</c><00:02:31.800><c> simpler</c> 00:02:32.690 --> 00:02:32.700 align:start position:0% it's a bit simpler 00:02:32.700 --> 00:02:34.790 align:start position:0% it's a bit simpler but<00:02:33.360><c> module</c><00:02:33.840><c> D1</c><00:02:34.140><c> looks</c><00:02:34.500><c> at</c><00:02:34.560><c> the</c><00:02:34.680><c> management</c> 00:02:34.790 --> 00:02:34.800 align:start position:0% but module D1 looks at the management 00:02:34.800 --> 00:02:37.210 align:start position:0% but module D1 looks at the management system<00:02:35.280><c> that</c><00:02:35.940><c> means</c><00:02:36.180><c> that</c><00:02:36.360><c> a</c><00:02:36.480><c> notified</c><00:02:36.780><c> body</c> 00:02:37.210 --> 00:02:37.220 align:start position:0% system that means that a notified body 00:02:37.220 --> 00:02:39.350 align:start position:0% system that means that a notified body visits<00:02:38.220><c> your</c><00:02:38.280><c> company</c><00:02:38.459><c> once</c><00:02:38.879><c> every</c><00:02:39.000><c> year</c><00:02:39.180><c> and</c> 00:02:39.350 --> 00:02:39.360 align:start position:0% visits your company once every year and 00:02:39.360 --> 00:02:42.229 align:start position:0% visits your company once every year and audits<00:02:39.720><c> all</c><00:02:39.780><c> the</c><00:02:39.959><c> production</c><00:02:40.140><c> locations</c><00:02:41.220><c> it</c> 00:02:42.229 --> 00:02:42.239 align:start position:0% audits all the production locations it 00:02:42.239 --> 00:02:44.509 align:start position:0% audits all the production locations it typically<00:02:42.840><c> for</c><00:02:43.140><c> a</c><00:02:43.260><c> biostimulant</c><00:02:44.040><c> company</c> 00:02:44.509 --> 00:02:44.519 align:start position:0% typically for a biostimulant company 00:02:44.519 --> 00:02:47.270 align:start position:0% typically for a biostimulant company module<00:02:45.000><c> B</c><00:02:45.180><c> is</c><00:02:45.420><c> more</c><00:02:45.720><c> efficient</c><00:02:46.040><c> uh</c><00:02:47.040><c> it's</c><00:02:47.220><c> an</c> 00:02:47.270 --> 00:02:47.280 align:start position:0% module B is more efficient uh it's an 00:02:47.280 --> 00:02:49.250 align:start position:0% module B is more efficient uh it's an easier<00:02:47.519><c> module</c><00:02:47.819><c> to</c><00:02:47.940><c> choose</c><00:02:48.180><c> because</c><00:02:48.420><c> we</c><00:02:49.080><c> do</c> 00:02:49.250 --> 00:02:49.260 align:start position:0% easier module to choose because we do 00:02:49.260 --> 00:02:50.570 align:start position:0% easier module to choose because we do the<00:02:49.379><c> audit</c><00:02:49.680><c> once</c><00:02:49.980><c> and</c><00:02:50.220><c> then</c><00:02:50.280><c> you</c><00:02:50.400><c> get</c><00:02:50.519><c> a</c> 00:02:50.570 --> 00:02:50.580 align:start position:0% the audit once and then you get a 00:02:50.580 --> 00:02:52.130 align:start position:0% the audit once and then you get a certificate<00:02:51.060><c> and</c><00:02:51.420><c> there's</c><00:02:51.599><c> no</c><00:02:51.780><c> form</c><00:02:51.959><c> of</c> 00:02:52.130 --> 00:02:52.140 align:start position:0% certificate and there's no form of 00:02:52.140 --> 00:02:55.070 align:start position:0% certificate and there's no form of reassessment<00:02:52.920><c> for</c><00:02:53.400><c> at</c><00:02:53.519><c> least</c><00:02:53.640><c> five</c><00:02:53.819><c> years</c><00:02:54.080><c> but</c> 00:02:55.070 --> 00:02:55.080 align:start position:0% reassessment for at least five years but 00:02:55.080 --> 00:02:56.809 align:start position:0% reassessment for at least five years but of<00:02:55.140><c> course</c><00:02:55.260><c> if</c><00:02:55.440><c> you</c><00:02:55.560><c> have</c><00:02:55.680><c> a</c><00:02:55.920><c> large</c><00:02:56.099><c> portfolio</c> 00:02:56.809 --> 00:02:56.819 align:start position:0% of course if you have a large portfolio 00:02:56.819 --> 00:02:59.690 align:start position:0% of course if you have a large portfolio of<00:02:56.940><c> products</c><00:02:57.360><c> D1</c><00:02:58.260><c> could</c><00:02:58.739><c> potentially</c><00:02:59.280><c> be</c> 00:02:59.690 --> 00:02:59.700 align:start position:0% of products D1 could potentially be 00:02:59.700 --> 00:03:01.910 align:start position:0% of products D1 could potentially be economically<00:03:00.599><c> more</c><00:03:00.840><c> interesting</c> 00:03:01.910 --> 00:03:01.920 align:start position:0% economically more interesting 00:03:01.920 --> 00:03:04.610 align:start position:0% economically more interesting in<00:03:02.580><c> some</c><00:03:02.700><c> cases</c><00:03:03.200><c> depending</c><00:03:04.200><c> on</c><00:03:04.440><c> the</c> 00:03:04.610 --> 00:03:04.620 align:start position:0% in some cases depending on the 00:03:04.620 --> 00:03:06.830 align:start position:0% in some cases depending on the ingredients<00:03:05.040><c> that</c><00:03:05.280><c> you</c><00:03:05.400><c> use</c><00:03:05.580><c> it</c><00:03:06.540><c> will</c><00:03:06.660><c> be</c> 00:03:06.830 --> 00:03:06.840 align:start position:0% ingredients that you use it will be 00:03:06.840 --> 00:03:10.729 align:start position:0% ingredients that you use it will be required<00:03:07.879><c> to</c><00:03:08.879><c> choose</c><00:03:09.060><c> module</c><00:03:09.420><c> D1</c><00:03:09.780><c> to</c><00:03:10.620><c> sell</c> 00:03:10.729 --> 00:03:10.739 align:start position:0% required to choose module D1 to sell 00:03:10.739 --> 00:03:12.770 align:start position:0% required to choose module D1 to sell your<00:03:10.920><c> product</c><00:03:11.099><c> in</c><00:03:11.580><c> both</c><00:03:11.700><c> cases</c><00:03:12.060><c> you</c><00:03:12.480><c> will</c><00:03:12.599><c> have</c> 00:03:12.770 --> 00:03:12.780 align:start position:0% your product in both cases you will have 00:03:12.780 --> 00:03:15.649 align:start position:0% your product in both cases you will have to<00:03:12.840><c> employ</c><00:03:13.019><c> a</c><00:03:13.260><c> notified</c><00:03:13.560><c> body</c> 00:03:15.649 --> 00:03:15.659 align:start position:0% to employ a notified body 00:03:15.659 --> 00:03:17.330 align:start position:0% to employ a notified body um<00:03:15.720><c> the</c><00:03:15.959><c> fpr</c><00:03:16.379><c> is</c><00:03:16.500><c> of</c><00:03:16.620><c> course</c><00:03:16.739><c> the</c><00:03:16.920><c> first</c><00:03:17.099><c> time</c> 00:03:17.330 --> 00:03:17.340 align:start position:0% um the fpr is of course the first time 00:03:17.340 --> 00:03:19.610 align:start position:0% um the fpr is of course the first time that<00:03:17.940><c> a</c><00:03:18.180><c> truly</c><00:03:18.540><c> comprehensive</c><00:03:19.019><c> framework</c><00:03:19.440><c> for</c> 00:03:19.610 --> 00:03:19.620 align:start position:0% that a truly comprehensive framework for 00:03:19.620 --> 00:03:21.410 align:start position:0% that a truly comprehensive framework for biostimulants<00:03:20.340><c> has</c><00:03:20.459><c> been</c><00:03:20.640><c> defined</c><00:03:20.879><c> at</c><00:03:21.180><c> EU</c> 00:03:21.410 --> 00:03:21.420 align:start position:0% biostimulants has been defined at EU 00:03:21.420 --> 00:03:22.790 align:start position:0% biostimulants has been defined at EU level 00:03:22.790 --> 00:03:22.800 align:start position:0% level 00:03:22.800 --> 00:03:24.229 align:start position:0% level um<00:03:22.860><c> it</c><00:03:23.099><c> provides</c><00:03:23.400><c> a</c><00:03:23.459><c> system</c><00:03:23.640><c> of</c><00:03:23.819><c> certification</c> 00:03:24.229 --> 00:03:24.239 align:start position:0% um it provides a system of certification 00:03:24.239 --> 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position:0% thus there are of course a lot of 00:03:30.480 --> 00:03:32.750 align:start position:0% thus there are of course a lot of questions<00:03:30.800><c> uh</c><00:03:31.800><c> and</c><00:03:31.980><c> we're</c><00:03:32.099><c> happy</c><00:03:32.280><c> to</c><00:03:32.459><c> help</c><00:03:32.580><c> in</c> 00:03:32.750 --> 00:03:32.760 align:start position:0% questions uh and we're happy to help in 00:03:32.760 --> 00:03:35.270 align:start position:0% questions uh and we're happy to help in that<00:03:32.879><c> regard</c><00:03:33.180><c> what</c><00:03:34.019><c> the</c><00:03:34.140><c> fpr</c><00:03:34.560><c> also</c><00:03:34.860><c> introduces</c> 00:03:35.270 --> 00:03:35.280 align:start position:0% that regard what the fpr also introduces 00:03:35.280 --> 00:03:37.250 align:start position:0% that regard what the fpr also introduces is<00:03:35.580><c> C</c><00:03:35.819><c> marking</c><00:03:36.300><c> there</c><00:03:36.720><c> is</c><00:03:36.900><c> also</c><00:03:37.200><c> already</c> 00:03:37.250 --> 00:03:37.260 align:start position:0% is C marking there is also already 00:03:37.260 --> 00:03:39.110 align:start position:0% is C marking there is also already mentioned<00:03:37.680><c> it</c><00:03:38.159><c> allows</c><00:03:38.400><c> you</c><00:03:38.459><c> to</c><00:03:38.700><c> if</c><00:03:38.879><c> you</c><00:03:39.000><c> sell</c> 00:03:39.110 --> 00:03:39.120 align:start position:0% mentioned it allows you to if you sell 00:03:39.120 --> 00:03:40.729 align:start position:0% mentioned it allows you to if you sell under<00:03:39.300><c> fpr</c><00:03:39.780><c> and</c><00:03:39.900><c> you</c><00:03:40.019><c> have</c><00:03:40.140><c> the</c><00:03:40.260><c> certification</c> 00:03:40.729 --> 00:03:40.739 align:start position:0% under fpr and you have the certification 00:03:40.739 --> 00:03:43.070 align:start position:0% under fpr and you have the certification you<00:03:41.400><c> can</c><00:03:41.519><c> affix</c><00:03:41.879><c> the</c><00:03:42.000><c> CE</c><00:03:42.299><c> marking</c><00:03:42.599><c> to</c><00:03:42.900><c> your</c> 00:03:43.070 --> 00:03:43.080 align:start position:0% you can affix the CE marking to your 00:03:43.080 --> 00:03:45.110 align:start position:0% you can affix the CE marking to your product 00:03:45.110 --> 00:03:45.120 align:start position:0% product 00:03:45.120 --> 00:03:47.030 align:start position:0% product so 00:03:47.030 --> 00:03:47.040 align:start position:0% so 00:03:47.040 --> 00:03:49.130 align:start position:0% so um<00:03:47.099><c> if</c><00:03:47.519><c> we</c><00:03:47.640><c> look</c><00:03:47.819><c> specifically</c><00:03:48.299><c> about</c><00:03:48.599><c> getting</c> 00:03:49.130 --> 00:03:49.140 align:start position:0% um if we look specifically about getting 00:03:49.140 --> 00:03:50.930 align:start position:0% um if we look specifically about getting to<00:03:49.379><c> Market</c> 00:03:50.930 --> 00:03:50.940 align:start position:0% to Market 00:03:50.940 --> 00:03:52.430 align:start position:0% to Market um a<00:03:51.420><c> lot</c><00:03:51.540><c> of</c><00:03:51.599><c> you</c><00:03:51.720><c> might</c><00:03:51.900><c> be</c><00:03:52.080><c> used</c><00:03:52.260><c> to</c> 00:03:52.430 --> 00:03:52.440 align:start position:0% um a lot of you might be used to 00:03:52.440 --> 00:03:54.830 align:start position:0% um a lot of you might be used to National<00:03:52.799><c> registration</c><00:03:53.459><c> authorities</c><00:03:53.940><c> uh</c><00:03:54.599><c> to</c> 00:03:54.830 --> 00:03:54.840 align:start position:0% National registration authorities uh to 00:03:54.840 --> 00:03:57.350 align:start position:0% National registration authorities uh to do<00:03:54.900><c> approval</c><00:03:55.379><c> either</c><00:03:55.620><c> for</c><00:03:56.180><c> biostiminants</c><00:03:57.180><c> in</c> 00:03:57.350 --> 00:03:57.360 align:start position:0% do approval either for biostiminants in 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position:0% you can see notified bodies as the new 00:04:03.540 --> 00:04:06.170 align:start position:0% you can see notified bodies as the new type<00:04:03.780><c> of</c><00:04:03.959><c> registration</c><00:04:04.379><c> Authority</c> 00:04:06.170 --> 00:04:06.180 align:start position:0% type of registration Authority 00:04:06.180 --> 00:04:08.390 align:start position:0% type of registration Authority um<00:04:06.299><c> they</c><00:04:06.659><c> are</c><00:04:06.780><c> private</c><00:04:07.140><c> so</c><00:04:07.560><c> like</c><00:04:07.799><c> I</c><00:04:07.920><c> said</c><00:04:08.040><c> we</c> 00:04:08.390 --> 00:04:08.400 align:start position:0% um they are private so like I said we 00:04:08.400 --> 00:04:10.130 align:start position:0% um they are private so like I said we are<00:04:08.519><c> one</c><00:04:08.700><c> of</c><00:04:08.819><c> the</c><00:04:09.000><c> five</c><00:04:09.180><c> if</c><00:04:09.900><c> you</c><00:04:10.019><c> want</c> 00:04:10.130 --> 00:04:10.140 align:start position:0% are one of the five if you want 00:04:10.140 --> 00:04:11.750 align:start position:0% are one of the five if you want certification<00:04:10.620><c> for</c><00:04:10.860><c> bios</c><00:04:11.159><c> gaming</c><00:04:11.519><c> you</c><00:04:11.700><c> can</c> 00:04:11.750 --> 00:04:11.760 align:start position:0% certification for bios gaming you can 00:04:11.760 --> 00:04:13.309 align:start position:0% certification for bios gaming you can work<00:04:11.939><c> with</c><00:04:12.060><c> us</c><00:04:12.239><c> or</c><00:04:12.659><c> you</c><00:04:12.840><c> can</c><00:04:12.900><c> choose</c><00:04:13.080><c> one</c><00:04:13.260><c> of</c> 00:04:13.309 --> 00:04:13.319 align:start position:0% work with us or you can choose one of 00:04:13.319 --> 00:04:15.830 align:start position:0% work with us or you can choose one of the<00:04:13.439><c> other</c><00:04:13.560><c> five</c><00:04:13.739><c> companies</c><00:04:14.220><c> and</c> 00:04:15.830 --> 00:04:15.840 align:start position:0% the other five companies and 00:04:15.840 --> 00:04:17.870 align:start position:0% the other five companies and we<00:04:16.500><c> expect</c><00:04:16.680><c> during</c><00:04:17.040><c> the</c><00:04:17.220><c> course</c><00:04:17.340><c> of</c><00:04:17.519><c> next</c><00:04:17.760><c> year</c> 00:04:17.870 --> 00:04:17.880 align:start position:0% we expect during the course of next year 00:04:17.880 --> 00:04:19.789 align:start position:0% we expect during the course of next year that<00:04:18.120><c> more</c><00:04:18.299><c> notified</c><00:04:18.660><c> bodies</c><00:04:19.079><c> including</c><00:04:19.620><c> some</c> 00:04:19.789 --> 00:04:19.799 align:start position:0% that more notified bodies including some 00:04:19.799 --> 00:04:21.770 align:start position:0% that more notified bodies including some from<00:04:20.040><c> Germany</c><00:04:20.459><c> will</c><00:04:20.880><c> become</c><00:04:21.180><c> listed</c><00:04:21.540><c> on</c><00:04:21.660><c> the</c> 00:04:21.770 --> 00:04:21.780 align:start position:0% from Germany will become listed on the 00:04:21.780 --> 00:04:23.510 align:start position:0% from Germany will become listed on the Nando<00:04:22.079><c> list</c> 00:04:23.510 --> 00:04:23.520 align:start position:0% Nando list 00:04:23.520 --> 00:04:25.490 align:start position:0% Nando list um<00:04:23.580><c> so</c><00:04:23.880><c> you</c><00:04:24.000><c> can</c><00:04:24.120><c> choose</c><00:04:24.180><c> the</c><00:04:24.419><c> notified</c><00:04:24.660><c> body</c> 00:04:25.490 --> 00:04:25.500 align:start position:0% um so you can choose the notified body 00:04:25.500 --> 00:04:27.950 align:start position:0% um so you can choose the notified body in<00:04:26.100><c> theory</c><00:04:26.460><c> and</c><00:04:27.000><c> what</c><00:04:27.180><c> we</c><00:04:27.300><c> see</c><00:04:27.419><c> in</c><00:04:27.540><c> practice</c><00:04:27.720><c> as</c> 00:04:27.950 --> 00:04:27.960 align:start position:0% in theory and what we see in practice as 00:04:27.960 --> 00:04:29.749 align:start position:0% in theory and what we see in practice as well<00:04:28.139><c> is</c><00:04:28.680><c> that</c><00:04:28.800><c> is</c><00:04:28.979><c> quite</c><00:04:29.160><c> a</c><00:04:29.280><c> pragmatic</c> 00:04:29.749 --> 00:04:29.759 align:start position:0% well is that is quite a pragmatic 00:04:29.759 --> 00:04:32.450 align:start position:0% well is that is quite a pragmatic approach<00:04:30.060><c> it</c><00:04:30.600><c> means</c><00:04:30.900><c> you</c><00:04:31.139><c> can</c><00:04:31.259><c> find</c><00:04:31.680><c> an</c> 00:04:32.450 --> 00:04:32.460 align:start position:0% approach it means you can find an 00:04:32.460 --> 00:04:33.590 align:start position:0% approach it means you can find an authority<00:04:32.759><c> that</c><00:04:32.940><c> you</c><00:04:33.060><c> like</c><00:04:33.240><c> to</c><00:04:33.360><c> work</c><00:04:33.479><c> with</c> 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another sharp and 00:04:39.780 --> 00:04:42.050 align:start position:0% on another sharp and it<00:04:40.440><c> means</c><00:04:40.740><c> notified</c><00:04:41.100><c> bodies</c><00:04:41.460><c> inherently</c><00:04:41.880><c> have</c> 00:04:42.050 --> 00:04:42.060 align:start position:0% it means notified bodies inherently have 00:04:42.060 --> 00:04:44.510 align:start position:0% it means notified bodies inherently have to<00:04:42.180><c> be</c><00:04:42.240><c> approachable</c><00:04:42.860><c> so</c><00:04:43.860><c> if</c><00:04:43.979><c> you</c><00:04:44.100><c> send</c><00:04:44.220><c> us</c><00:04:44.340><c> a</c> 00:04:44.510 --> 00:04:44.520 align:start position:0% to be approachable so if you send us a 00:04:44.520 --> 00:04:46.189 align:start position:0% to be approachable so if you send us a question<00:04:44.639><c> you</c><00:04:45.360><c> know</c><00:04:45.419><c> you'll</c><00:04:45.660><c> get</c><00:04:45.780><c> a</c><00:04:45.900><c> response</c> 00:04:46.189 --> 00:04:46.199 align:start position:0% question you know you'll get a response 00:04:46.199 --> 00:04:47.870 align:start position:0% question you know you'll get a response within<00:04:46.440><c> a</c><00:04:46.620><c> few</c><00:04:46.680><c> days</c><00:04:46.800><c> rather</c><00:04:47.160><c> than</c><00:04:47.340><c> you</c><00:04:47.820><c> know</c> 00:04:47.870 --> 00:04:47.880 align:start position:0% within a few days rather than you know 00:04:47.880 --> 00:04:51.290 align:start position:0% within a few days rather than you know weeks<00:04:48.300><c> or</c><00:04:48.360><c> months</c><00:04:48.660><c> and</c><00:04:49.259><c> we</c><00:04:49.560><c> do</c><00:04:49.680><c> want</c><00:04:49.800><c> to</c><00:04:49.979><c> help</c> 00:04:51.290 --> 00:04:51.300 align:start position:0% weeks or months and we do want to help 00:04:51.300 --> 00:04:52.670 align:start position:0% weeks or months and we do want to help um 00:04:52.670 --> 00:04:52.680 align:start position:0% um 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00:05:01.189 --> 00:05:01.199 align:start position:0% you submit a dossier to a notified body 00:05:01.199 --> 00:05:03.350 align:start position:0% you submit a dossier to a notified body if<00:05:01.800><c> they</c><00:05:01.979><c> approve</c><00:05:02.340><c> the</c><00:05:02.460><c> file</c><00:05:02.639><c> you</c><00:05:03.120><c> get</c><00:05:03.240><c> a</c> 00:05:03.350 --> 00:05:03.360 align:start position:0% if they approve the file you get a 00:05:03.360 --> 00:05:05.270 align:start position:0% if they approve the file you get a certificate<00:05:03.840><c> and</c><00:05:04.440><c> that</c><00:05:04.560><c> allows</c><00:05:04.860><c> you</c><00:05:04.919><c> to</c><00:05:05.100><c> sell</c> 00:05:05.270 --> 00:05:05.280 align:start position:0% certificate and that allows you to sell 00:05:05.280 --> 00:05:07.969 align:start position:0% certificate and that allows you to sell in<00:05:05.639><c> the</c><00:05:05.759><c> entire</c><00:05:06.000><c> in</c><00:05:06.540><c> the</c><00:05:06.660><c> entirety</c><00:05:07.020><c> of</c><00:05:07.139><c> the</c><00:05:07.259><c> EU</c> 00:05:07.969 --> 00:05:07.979 align:start position:0% in the entire in the entirety of the EU 00:05:07.979 --> 00:05:10.730 align:start position:0% in the entire in the entirety of the EU so<00:05:08.340><c> there's</c><00:05:08.580><c> no</c><00:05:08.940><c> specific</c><00:05:09.479><c> National</c><00:05:09.900><c> rules</c> 00:05:10.730 --> 00:05:10.740 align:start position:0% so there's no specific National rules 00:05:10.740 --> 00:05:12.950 align:start position:0% so there's no specific National rules that<00:05:10.919><c> you</c><00:05:11.040><c> have</c><00:05:11.160><c> to</c><00:05:11.220><c> meet</c><00:05:11.400><c> you</c><00:05:11.820><c> do</c><00:05:12.000><c> it</c><00:05:12.120><c> once</c><00:05:12.360><c> you</c> 00:05:12.950 --> 00:05:12.960 align:start position:0% that you have to meet you do it once you 00:05:12.960 --> 00:05:14.450 align:start position:0% that you have to meet you do it once you get<00:05:13.080><c> the</c><00:05:13.199><c> certificate</c> 00:05:14.450 --> 00:05:14.460 align:start position:0% get the certificate 00:05:14.460 --> 00:05:16.730 align:start position:0% get the certificate and<00:05:14.759><c> you're</c><00:05:14.880><c> done</c> 00:05:16.730 --> 00:05:16.740 align:start position:0% and you're done 00:05:16.740 --> 00:05:18.530 align:start position:0% and you're done um<00:05:16.860><c> the</c><00:05:17.220><c> Civic</c><00:05:17.520><c> will</c><00:05:17.639><c> be</c><00:05:17.820><c> valid</c><00:05:18.060><c> for</c><00:05:18.180><c> three</c><00:05:18.419><c> to</c> 00:05:18.530 --> 00:05:18.540 align:start position:0% um the Civic will be valid for three to 00:05:18.540 --> 00:05:20.030 align:start position:0% um the Civic will be valid for three to five<00:05:18.720><c> years</c><00:05:18.900><c> depending</c><00:05:19.380><c> on</c><00:05:19.620><c> both</c><00:05:19.860><c> the</c> 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doesn't</c><00:05:27.419><c> make</c><00:05:27.600><c> a</c><00:05:27.780><c> difference</c> 00:05:27.890 --> 00:05:27.900 align:start position:0% you choose it doesn't make a difference 00:05:27.900 --> 00:05:29.689 align:start position:0% you choose it doesn't make a difference for<00:05:28.320><c> the</c><00:05:28.500><c> the</c><00:05:28.680><c> acceptance</c><00:05:29.100><c> whether</c><00:05:29.400><c> you</c><00:05:29.580><c> have</c> 00:05:29.689 --> 00:05:29.699 align:start position:0% for the the acceptance whether you have 00:05:29.699 --> 00:05:32.090 align:start position:0% for the the acceptance whether you have a<00:05:29.759><c> certificate</c><00:05:30.120><c> for</c><00:05:30.300><c> b</c><00:05:30.479><c> or</c><00:05:30.720><c> D1</c><00:05:31.080><c> either</c><00:05:31.740><c> one</c><00:05:31.919><c> is</c> 00:05:32.090 --> 00:05:32.100 align:start position:0% a certificate for b or D1 either one is 00:05:32.100 --> 00:05:33.770 align:start position:0% a certificate for b or D1 either one is valid<00:05:32.400><c> either</c><00:05:32.820><c> one</c><00:05:33.000><c> allows</c><00:05:33.300><c> you</c><00:05:33.360><c> to</c><00:05:33.479><c> sell</c><00:05:33.600><c> the</c> 00:05:33.770 --> 00:05:33.780 align:start position:0% valid either one allows you to sell the 00:05:33.780 --> 00:05:35.210 align:start position:0% valid either one allows you to sell the product<00:05:33.900><c> and</c><00:05:34.380><c> it</c><00:05:34.500><c> allows</c><00:05:34.740><c> you</c><00:05:34.800><c> to</c><00:05:34.979><c> sell</c><00:05:35.100><c> the</c> 00:05:35.210 --> 00:05:35.220 align:start position:0% product and it allows you to sell the 00:05:35.220 --> 00:05:38.090 align:start position:0% product and it allows you to sell the product<00:05:35.400><c> in</c><00:05:35.880><c> every</c><00:05:36.060><c> European</c><00:05:36.479><c> country</c> 00:05:38.090 --> 00:05:38.100 align:start position:0% product in every European country 00:05:38.100 --> 00:05:39.710 align:start position:0% product in every European country um<00:05:38.160><c> the</c><00:05:38.520><c> potential</c><00:05:38.820><c> of</c><00:05:39.000><c> that</c><00:05:39.120><c> is</c><00:05:39.360><c> obviously</c> 00:05:39.710 --> 00:05:39.720 align:start position:0% um the potential of that is obviously 00:05:39.720 --> 00:05:43.189 align:start position:0% um the potential of that is obviously that<00:05:39.960><c> it</c><00:05:40.199><c> could</c><00:05:40.919><c> possibly</c><00:05:41.820><c> uh</c><00:05:42.780><c> through</c><00:05:42.960><c> a</c> 00:05:43.189 --> 00:05:43.199 align:start position:0% that it could possibly uh through a 00:05:43.199 --> 00:05:45.590 align:start position:0% that it could possibly uh through a single<00:05:43.500><c> system</c><00:05:43.680><c> of</c><00:05:43.979><c> approval</c><00:05:44.580><c> greatly</c><00:05:45.180><c> expand</c> 00:05:45.590 --> 00:05:45.600 align:start position:0% single system of approval greatly expand 00:05:45.600 --> 00:05:47.570 align:start position:0% single system of approval greatly expand the<00:05:46.320><c> market</c><00:05:46.500><c> potential</c><00:05:46.979><c> for</c><00:05:47.160><c> for</c><00:05:47.400><c> your</c> 00:05:47.570 --> 00:05:47.580 align:start position:0% the market potential for for your 00:05:47.580 --> 00:05:49.370 align:start position:0% the market potential for for your products 00:05:49.370 --> 00:05:49.380 align:start position:0% products 00:05:49.380 --> 00:05:50.090 align:start position:0% products um 00:05:50.090 --> 00:05:50.100 align:start position:0% um 00:05:50.100 --> 00:05:53.210 align:start position:0% um what's<00:05:50.639><c> important</c><00:05:51.000><c> to</c><00:05:51.180><c> note</c><00:05:51.360><c> is</c><00:05:52.259><c> once</c><00:05:53.100><c> you're</c> 00:05:53.210 --> 00:05:53.220 align:start position:0% what's important to note is once you're 00:05:53.220 --> 00:05:55.610 align:start position:0% what's important to note is once you're certified<00:05:53.580><c> the</c><00:05:54.360><c> obligations</c><00:05:54.780><c> don't</c><00:05:55.259><c> stop</c> 00:05:55.610 --> 00:05:55.620 align:start position:0% certified the obligations don't stop 00:05:55.620 --> 00:05:56.629 align:start position:0% certified the obligations don't stop there 00:05:56.629 --> 00:05:56.639 align:start position:0% there 00:05:56.639 --> 00:05:59.150 align:start position:0% there Market<00:05:57.360><c> surveillance</c><00:05:57.960><c> is</c><00:05:58.080><c> a</c><00:05:58.199><c> big</c><00:05:58.320><c> part</c><00:05:58.500><c> of</c><00:05:58.680><c> fpr</c> 00:05:59.150 --> 00:05:59.160 align:start position:0% Market surveillance is a big part of fpr 00:05:59.160 --> 00:06:01.310 align:start position:0% Market surveillance is a big part of fpr and<00:05:59.460><c> National</c><00:05:59.699><c> governments</c><00:06:00.300><c> will</c><00:06:00.660><c> be</c><00:06:00.840><c> testing</c> 00:06:01.310 --> 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--> 00:06:06.660 align:start position:0% meet the requirements and they can do 00:06:06.660 --> 00:06:08.629 align:start position:0% meet the requirements and they can do that<00:06:06.840><c> a</c><00:06:07.560><c> year</c><00:06:07.680><c> after</c><00:06:07.860><c> you've</c><00:06:08.100><c> sold</c><00:06:08.280><c> a</c><00:06:08.460><c> product</c> 00:06:08.629 --> 00:06:08.639 align:start position:0% that a year after you've sold a product 00:06:08.639 --> 00:06:10.610 align:start position:0% that a year after you've sold a product two<00:06:09.300><c> years</c><00:06:09.479><c> three</c><00:06:09.720><c> years</c> 00:06:10.610 --> 00:06:10.620 align:start position:0% two years three years 00:06:10.620 --> 00:06:12.529 align:start position:0% two years three years doesn't<00:06:11.100><c> matter</c><00:06:11.340><c> they</c><00:06:11.880><c> can</c><00:06:12.060><c> come</c><00:06:12.180><c> up</c><00:06:12.300><c> with</c><00:06:12.419><c> a</c> 00:06:12.529 --> 00:06:12.539 align:start position:0% doesn't matter they can come up with a 00:06:12.539 --> 00:06:14.210 align:start position:0% doesn't matter they can come up with a plan<00:06:12.720><c> they</c><00:06:13.320><c> can</c><00:06:13.440><c> take</c><00:06:13.560><c> one</c><00:06:13.740><c> of</c><00:06:13.860><c> your</c><00:06:13.979><c> products</c> 00:06:14.210 --> 00:06:14.220 align:start position:0% plan they can take one of your products 00:06:14.220 --> 00:06:15.830 align:start position:0% plan they can take one of your products off<00:06:14.340><c> the</c><00:06:14.520><c> shelf</c><00:06:14.639><c> and</c><00:06:14.880><c> if</c><00:06:15.000><c> you</c><00:06:15.120><c> then</c><00:06:15.360><c> if</c><00:06:15.660><c> that</c> 00:06:15.830 --> 00:06:15.840 align:start position:0% off the shelf and if you then if that 00:06:15.840 --> 00:06:17.090 align:start position:0% off the shelf and if you then if that product<00:06:16.020><c> doesn't</c><00:06:16.259><c> meet</c><00:06:16.500><c> their</c><00:06:16.800><c> the</c> 00:06:17.090 --> 00:06:17.100 align:start position:0% product doesn't meet their the 00:06:17.100 --> 00:06:18.650 align:start position:0% product doesn't meet their the requirements<00:06:17.520><c> of</c><00:06:17.639><c> the</c><00:06:17.759><c> FBR</c> 00:06:18.650 --> 00:06:18.660 align:start position:0% requirements of the FBR 00:06:18.660 --> 00:06:20.510 align:start position:0% requirements of the FBR you<00:06:18.840><c> could</c><00:06:19.139><c> possibly</c><00:06:19.440><c> have</c><00:06:19.560><c> a</c><00:06:19.680><c> problem</c><00:06:19.860><c> so</c> 00:06:20.510 --> 00:06:20.520 align:start position:0% you could possibly have a problem so 00:06:20.520 --> 00:06:22.550 align:start position:0% you could possibly have a problem so it's<00:06:20.699><c> an</c><00:06:20.820><c> ongoing</c><00:06:21.180><c> obligation</c><00:06:21.600><c> there's</c><00:06:22.259><c> also</c> 00:06:22.550 --> 00:06:22.560 align:start position:0% it's an ongoing obligation there's also 00:06:22.560 --> 00:06:24.110 align:start position:0% it's an ongoing obligation there's also requirements<00:06:23.039><c> to</c><00:06:23.160><c> hold</c><00:06:23.400><c> the</c><00:06:23.819><c> technical</c> 00:06:24.110 --> 00:06:24.120 align:start position:0% requirements to hold the technical 00:06:24.120 --> 00:06:25.610 align:start position:0% requirements to hold the technical information<00:06:24.360><c> for</c><00:06:24.900><c> at</c><00:06:25.020><c> least</c><00:06:25.139><c> five</c><00:06:25.380><c> years</c> 00:06:25.610 --> 00:06:25.620 align:start position:0% information for at least five years 00:06:25.620 --> 00:06:27.650 align:start position:0% information for at least five years after<00:06:25.919><c> a</c><00:06:26.160><c> sale</c><00:06:26.340><c> so</c><00:06:27.000><c> you</c><00:06:27.060><c> have</c><00:06:27.240><c> to</c><00:06:27.300><c> be</c><00:06:27.419><c> aware</c> 00:06:27.650 --> 00:06:27.660 align:start position:0% after a sale so you have to be aware 00:06:27.660 --> 00:06:29.870 align:start position:0% after a sale so you have to be aware that<00:06:27.840><c> there</c><00:06:28.139><c> are</c><00:06:28.319><c> specific</c><00:06:29.039><c> obligations</c><00:06:29.520><c> not</c> 00:06:29.870 --> 00:06:29.880 align:start position:0% that there are specific obligations not 00:06:29.880 --> 00:06:31.670 align:start position:0% that there are specific obligations not just<00:06:30.000><c> to</c><00:06:30.180><c> get</c><00:06:30.300><c> certified</c><00:06:30.660><c> but</c><00:06:31.199><c> also</c><00:06:31.380><c> to</c><00:06:31.500><c> hold</c> 00:06:31.670 --> 00:06:31.680 align:start position:0% just to get certified but also to hold 00:06:31.680 --> 00:06:33.770 align:start position:0% just to get certified but also to hold records 00:06:33.770 --> 00:06:33.780 align:start position:0% records 00:06:33.780 --> 00:06:34.550 align:start position:0% records um 00:06:34.550 --> 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an</c><00:06:39.900><c> ingredient</c><00:06:40.020><c> you</c> 00:06:40.670 --> 00:06:40.680 align:start position:0% formulation if you add an ingredient you 00:06:40.680 --> 00:06:42.110 align:start position:0% formulation if you add an ingredient you have<00:06:40.800><c> to</c><00:06:40.919><c> report</c><00:06:41.039><c> that</c><00:06:41.340><c> to</c><00:06:41.520><c> the</c><00:06:41.580><c> notified</c><00:06:41.880><c> body</c> 00:06:42.110 --> 00:06:42.120 align:start position:0% have to report that to the notified body 00:06:42.120 --> 00:06:44.270 align:start position:0% have to report that to the notified body and<00:06:42.900><c> you</c><00:06:43.080><c> have</c><00:06:43.259><c> to</c><00:06:43.380><c> have</c><00:06:43.620><c> the</c><00:06:43.800><c> notified</c><00:06:44.039><c> body</c> 00:06:44.270 --> 00:06:44.280 align:start position:0% and you have to have the notified body 00:06:44.280 --> 00:06:45.710 align:start position:0% and you have to have the notified body assess<00:06:44.759><c> that</c><00:06:44.940><c> change</c> 00:06:45.710 --> 00:06:45.720 align:start position:0% assess that change 00:06:45.720 --> 00:06:49.550 align:start position:0% assess that change if<00:06:46.500><c> you</c><00:06:47.340><c> um</c><00:06:47.400><c> if</c><00:06:48.060><c> you</c><00:06:48.240><c> just</c><00:06:48.479><c> for</c><00:06:48.840><c> example</c><00:06:49.080><c> open</c><00:06:49.319><c> a</c> 00:06:49.550 --> 00:06:49.560 align:start position:0% if you um if you just for example open a 00:06:49.560 --> 00:06:51.230 align:start position:0% if you um if you just for example open a new<00:06:49.680><c> production</c><00:06:49.919><c> location</c><00:06:50.220><c> especially</c><00:06:51.060><c> under</c> 00:06:51.230 --> 00:06:51.240 align:start position:0% new production location especially under 00:06:51.240 --> 00:06:53.390 align:start position:0% new production location especially under module<00:06:51.600><c> B</c><00:06:51.780><c> that</c><00:06:52.500><c> won't</c><00:06:52.680><c> be</c><00:06:52.800><c> required</c><00:06:53.160><c> to</c><00:06:53.280><c> be</c> 00:06:53.390 --> 00:06:53.400 align:start position:0% module B that won't be required to be 00:06:53.400 --> 00:06:54.710 align:start position:0% module B that won't be required to be reported<00:06:53.819><c> but</c><00:06:54.120><c> if</c><00:06:54.240><c> you</c><00:06:54.360><c> change</c><00:06:54.539><c> the</c> 00:06:54.710 --> 00:06:54.720 align:start position:0% reported but if you change the 00:06:54.720 --> 00:06:56.510 align:start position:0% reported but if you change the formulation<00:06:55.199><c> you</c><00:06:56.100><c> have</c><00:06:56.220><c> to</c><00:06:56.280><c> have</c><00:06:56.400><c> it</c> 00:06:56.510 --> 00:06:56.520 align:start position:0% formulation you have to have it 00:06:56.520 --> 00:06:58.550 align:start position:0% formulation you have to have it reassessed 00:06:58.550 --> 00:06:58.560 align:start position:0% reassessed 00:06:58.560 --> 00:06:59.689 align:start position:0% reassessed um 00:06:59.689 --> 00:06:59.699 align:start position:0% um 00:06:59.699 --> 00:07:03.409 align:start position:0% um the<00:07:00.120><c> fpr</c><00:07:00.600><c> and</c><00:07:01.319><c> because</c><00:07:01.560><c> it's</c><00:07:01.800><c> part</c><00:07:02.039><c> of</c><00:07:02.280><c> the</c> 00:07:03.409 --> 00:07:03.419 align:start position:0% the fpr and because it's part of the 00:07:03.419 --> 00:07:05.689 align:start position:0% the fpr and because it's part of the legal<00:07:04.020><c> framework</c><00:07:04.259><c> for</c><00:07:04.440><c> CE</c><00:07:04.800><c> marking</c><00:07:05.160><c> means</c> 00:07:05.689 --> 00:07:05.699 align:start position:0% legal framework for CE marking means 00:07:05.699 --> 00:07:07.430 align:start position:0% legal framework for CE marking means there<00:07:05.880><c> is</c><00:07:06.000><c> a</c><00:07:06.180><c> lot</c><00:07:06.300><c> of</c><00:07:06.479><c> responsibility</c><00:07:06.960><c> for</c><00:07:07.259><c> the</c> 00:07:07.430 --> 00:07:07.440 align:start position:0% there is a lot of responsibility for the 00:07:07.440 --> 00:07:09.529 align:start position:0% there is a lot of responsibility for the manufacturer<00:07:07.979><c> Thomas</c><00:07:08.759><c> already</c><00:07:09.000><c> said</c><00:07:09.300><c> there's</c> 00:07:09.529 --> 00:07:09.539 align:start position:0% manufacturer Thomas already said there's 00:07:09.539 --> 00:07:11.210 align:start position:0% manufacturer Thomas already said there's technical<00:07:09.960><c> specifications</c> 00:07:11.210 --> 00:07:11.220 align:start position:0% technical specifications 00:07:11.220 --> 00:07:12.950 align:start position:0% technical specifications but<00:07:11.699><c> in</c><00:07:11.819><c> truth</c><00:07:12.060><c> you</c><00:07:12.300><c> don't</c><00:07:12.419><c> even</c><00:07:12.539><c> have</c><00:07:12.720><c> to</c><00:07:12.840><c> use</c> 00:07:12.950 --> 00:07:12.960 align:start position:0% but in truth you don't even have to use 00:07:12.960 --> 00:07:14.749 align:start position:0% but in truth you don't even have to use those<00:07:13.199><c> specifications</c><00:07:13.740><c> if</c><00:07:14.340><c> you</c><00:07:14.460><c> want</c><00:07:14.580><c> to</c><00:07:14.699><c> use</c> 00:07:14.749 --> 00:07:14.759 align:start position:0% those specifications if you want to use 00:07:14.759 --> 00:07:16.790 align:start position:0% those specifications if you want to use other<00:07:15.000><c> standards</c><00:07:15.479><c> or</c><00:07:15.900><c> different</c><00:07:16.319><c> standards</c> 00:07:16.790 --> 00:07:16.800 align:start position:0% other standards or different standards 00:07:16.800 --> 00:07:19.790 align:start position:0% other standards or different standards for<00:07:17.100><c> analysis</c><00:07:18.000><c> for</c><00:07:18.240><c> proving</c><00:07:18.660><c> claims</c><00:07:19.020><c> all</c><00:07:19.620><c> of</c> 00:07:19.790 --> 00:07:19.800 align:start position:0% for analysis for proving claims all of 00:07:19.800 --> 00:07:21.409 align:start position:0% for analysis for proving claims all of that<00:07:19.919><c> is</c><00:07:20.160><c> in</c><00:07:20.340><c> the</c><00:07:20.400><c> hands</c><00:07:20.639><c> of</c><00:07:20.759><c> the</c><00:07:20.880><c> manufacturer</c> 00:07:21.409 --> 00:07:21.419 align:start position:0% that is in the hands of the manufacturer 00:07:21.419 --> 00:07:23.870 align:start position:0% that is in the hands of the manufacturer and<00:07:22.020><c> a</c><00:07:22.139><c> lot</c><00:07:22.259><c> of</c><00:07:22.380><c> the</c><00:07:22.440><c> legal</c><00:07:22.740><c> responsibility</c><00:07:23.280><c> is</c> 00:07:23.870 --> 00:07:23.880 align:start position:0% and a lot of the legal responsibility is 00:07:23.880 --> 00:07:25.249 align:start position:0% and a lot of the legal responsibility is also<00:07:24.120><c> in</c><00:07:24.180><c> the</c><00:07:24.300><c> hands</c><00:07:24.539><c> of</c><00:07:24.599><c> the</c><00:07:24.720><c> manufacturer</c><00:07:25.080><c> so</c> 00:07:25.249 --> 00:07:25.259 align:start position:0% also in the hands of the manufacturer so 00:07:25.259 --> 00:07:27.230 align:start position:0% also in the hands of the manufacturer so something<00:07:25.500><c> goes</c><00:07:25.800><c> wrong</c><00:07:25.940><c> it's</c><00:07:26.940><c> not</c><00:07:27.060><c> the</c> 00:07:27.230 --> 00:07:27.240 align:start position:0% something goes wrong it's not the 00:07:27.240 --> 00:07:28.490 align:start position:0% something goes wrong it's not the notified<00:07:27.479><c> bodies</c> 00:07:28.490 --> 00:07:28.500 align:start position:0% notified bodies 00:07:28.500 --> 00:07:31.490 align:start position:0% notified bodies problem<00:07:29.039><c> per</c><00:07:29.400><c> se</c><00:07:29.580><c> or</c><00:07:30.419><c> it's</c><00:07:30.780><c> still</c><00:07:31.020><c> your</c> 00:07:31.490 --> 00:07:31.500 align:start position:0% problem per se or it's still your 00:07:31.500 --> 00:07:33.529 align:start position:0% problem per se or it's still your responsibility<00:07:31.919><c> as</c><00:07:32.220><c> a</c><00:07:32.400><c> manufacturer</c><00:07:32.940><c> that's</c> 00:07:33.529 --> 00:07:33.539 align:start position:0% responsibility as a manufacturer that's 00:07:33.539 --> 00:07:38.390 align:start position:0% responsibility as a manufacturer that's something<00:07:33.720><c> definitely</c><00:07:34.080><c> to</c><00:07:34.259><c> watch</c><00:07:34.380><c> out</c><00:07:34.560><c> for</c> 00:07:38.390 --> 00:07:38.400 align:start position:0% 00:07:38.400 --> 00:07:40.010 align:start position:0% obviously 00:07:40.010 --> 00:07:40.020 align:start position:0% obviously 00:07:40.020 --> 00:07:41.029 align:start position:0% obviously um 00:07:41.029 --> 00:07:41.039 align:start position:0% um 00:07:41.039 --> 00:07:43.850 align:start position:0% um in<00:07:41.699><c> the</c><00:07:41.940><c> uh</c><00:07:42.720><c> in</c><00:07:43.199><c> this</c><00:07:43.259><c> sector</c><00:07:43.500><c> if</c><00:07:43.740><c> someone</c> 00:07:43.850 --> 00:07:43.860 align:start position:0% in the uh in this sector if someone 00:07:43.860 --> 00:07:45.110 align:start position:0% in the uh in this sector if someone comes<00:07:44.220><c> in</c><00:07:44.280><c> and</c><00:07:44.460><c> says</c><00:07:44.699><c> there's</c><00:07:44.819><c> a</c><00:07:45.000><c> simple</c> 00:07:45.110 --> 00:07:45.120 align:start position:0% comes in and says there's a simple 00:07:45.120 --> 00:07:47.270 align:start position:0% comes in and says there's a simple system<00:07:45.419><c> of</c><00:07:45.780><c> registration</c><00:07:46.500><c> there's</c><00:07:47.160><c> always</c> 00:07:47.270 --> 00:07:47.280 align:start position:0% system of registration there's always 00:07:47.280 --> 00:07:49.969 align:start position:0% system of registration there's always the<00:07:47.520><c> question</c><00:07:47.759><c> what's</c><00:07:48.539><c> the</c><00:07:48.780><c> catch</c><00:07:49.139><c> and</c><00:07:49.800><c> in</c> 00:07:49.969 --> 00:07:49.979 align:start position:0% the question what's the catch and in 00:07:49.979 --> 00:07:51.350 align:start position:0% the question what's the catch and in truth 00:07:51.350 --> 00:07:51.360 align:start position:0% truth 00:07:51.360 --> 00:07:52.969 align:start position:0% truth um<00:07:51.419><c> the</c><00:07:51.900><c> system</c> 00:07:52.969 --> 00:07:52.979 align:start position:0% um the system 00:07:52.979 --> 00:07:54.890 align:start position:0% um the system if<00:07:53.460><c> it</c><00:07:53.580><c> works</c><00:07:53.819><c> efficiently</c><00:07:54.240><c> and</c><00:07:54.539><c> if</c><00:07:54.660><c> you</c><00:07:54.780><c> have</c> 00:07:54.890 --> 00:07:54.900 align:start position:0% if it works efficiently and if you have 00:07:54.900 --> 00:07:56.809 align:start position:0% if it works efficiently and if you have all<00:07:55.080><c> the</c><00:07:55.199><c> documentation</c> 00:07:56.809 --> 00:07:56.819 align:start position:0% all the documentation 00:07:56.819 --> 00:07:57.469 align:start position:0% all the documentation um 00:07:57.469 --> 00:07:57.479 align:start position:0% um 00:07:57.479 --> 00:07:59.870 align:start position:0% um is<00:07:58.259><c> as</c><00:07:58.440><c> pragmatic</c><00:07:59.099><c> as</c><00:07:59.160><c> I</c><00:07:59.340><c> just</c><00:07:59.460><c> described</c><00:07:59.759><c> it</c> 00:07:59.870 --> 00:07:59.880 align:start position:0% is as pragmatic as I just described it 00:07:59.880 --> 00:08:02.029 align:start position:0% is as pragmatic as I just described it there<00:08:00.120><c> is</c><00:08:00.240><c> no</c><00:08:00.419><c> catch</c><00:08:00.780><c> getting</c><00:08:01.380><c> a</c><00:08:01.560><c> certificate</c> 00:08:02.029 --> 00:08:02.039 align:start position:0% there is no catch getting a certificate 00:08:02.039 --> 00:08:04.430 align:start position:0% there is no catch getting a certificate in<00:08:02.280><c> essence</c><00:08:02.639><c> is</c><00:08:03.060><c> quite</c><00:08:03.479><c> simple</c><00:08:03.720><c> and</c><00:08:04.319><c> it's</c> 00:08:04.430 --> 00:08:04.440 align:start position:0% in essence is quite simple and it's 00:08:04.440 --> 00:08:06.110 align:start position:0% in essence is quite simple and it's quite<00:08:04.620><c> straight</c><00:08:04.800><c> to</c><00:08:04.979><c> the</c><00:08:05.099><c> point</c><00:08:05.280><c> and</c><00:08:05.880><c> it</c><00:08:06.000><c> can</c> 00:08:06.110 --> 00:08:06.120 align:start position:0% quite straight to the point and it can 00:08:06.120 --> 00:08:07.550 align:start position:0% quite straight to the point and it can be<00:08:06.240><c> done</c><00:08:06.360><c> quite</c><00:08:06.539><c> quickly</c><00:08:06.840><c> and</c><00:08:07.259><c> it</c><00:08:07.440><c> only</c> 00:08:07.550 --> 00:08:07.560 align:start position:0% be done quite quickly and it only 00:08:07.560 --> 00:08:10.610 align:start position:0% be done quite quickly and it only requires<00:08:08.160><c> a</c><00:08:08.639><c> few</c><00:08:08.759><c> uh</c><00:08:09.240><c> documents</c><00:08:09.840><c> so</c><00:08:10.440><c> I</c><00:08:10.560><c> just</c> 00:08:10.610 --> 00:08:10.620 align:start position:0% requires a few uh documents so I just 00:08:10.620 --> 00:08:12.170 align:start position:0% requires a few uh documents so I just want<00:08:10.740><c> to</c><00:08:10.860><c> run</c><00:08:10.919><c> through</c><00:08:11.099><c> them</c><00:08:11.340><c> quickly</c><00:08:11.940><c> to</c><00:08:12.060><c> get</c> 00:08:12.170 --> 00:08:12.180 align:start position:0% want to run through them quickly to get 00:08:12.180 --> 00:08:13.790 align:start position:0% want to run through them quickly to get you<00:08:12.300><c> an</c><00:08:12.419><c> idea</c> 00:08:13.790 --> 00:08:13.800 align:start position:0% you an idea 00:08:13.800 --> 00:08:16.249 align:start position:0% you an idea um<00:08:13.860><c> you</c><00:08:14.460><c> need</c><00:08:14.639><c> a</c><00:08:15.180><c> test</c><00:08:15.360><c> report</c> 00:08:16.249 --> 00:08:16.259 align:start position:0% um you need a test report 00:08:16.259 --> 00:08:18.409 align:start position:0% um you need a test report proving<00:08:16.979><c> that</c><00:08:17.160><c> the</c><00:08:17.340><c> product</c><00:08:17.460><c> contains</c><00:08:18.120><c> or</c> 00:08:18.409 --> 00:08:18.419 align:start position:0% proving that the product contains or 00:08:18.419 --> 00:08:20.390 align:start position:0% proving that the product contains or doesn't<00:08:18.660><c> contain</c><00:08:19.080><c> certain</c><00:08:19.379><c> contaminants</c><00:08:19.979><c> and</c> 00:08:20.390 --> 00:08:20.400 align:start position:0% doesn't contain certain contaminants and 00:08:20.400 --> 00:08:23.270 align:start position:0% doesn't contain certain contaminants and pathogens<00:08:21.440><c> you</c><00:08:22.440><c> need</c><00:08:22.560><c> to</c><00:08:22.740><c> have</c><00:08:22.860><c> information</c> 00:08:23.270 --> 00:08:23.280 align:start position:0% pathogens you need to have information 00:08:23.280 --> 00:08:25.189 align:start position:0% pathogens you need to have information per<00:08:23.879><c> ingredient</c><00:08:24.120><c> that</c><00:08:24.660><c> it</c><00:08:24.780><c> meets</c><00:08:25.080><c> the</c> 00:08:25.189 --> 00:08:25.199 align:start position:0% per ingredient that it meets the 00:08:25.199 --> 00:08:27.730 align:start position:0% per ingredient that it meets the requirements<00:08:25.620><c> of</c><00:08:25.860><c> the</c><00:08:26.280><c> chosen</c><00:08:26.699><c> CMC</c> 00:08:27.730 --> 00:08:27.740 align:start position:0% requirements of the chosen CMC 00:08:27.740 --> 00:08:29.930 align:start position:0% requirements of the chosen CMC you<00:08:28.740><c> need</c><00:08:28.860><c> to</c><00:08:28.979><c> send</c><00:08:29.099><c> us</c><00:08:29.220><c> an</c><00:08:29.400><c> example</c><00:08:29.639><c> of</c><00:08:29.819><c> the</c> 00:08:29.930 --> 00:08:29.940 align:start position:0% you need to send us an example of the 00:08:29.940 --> 00:08:31.129 align:start position:0% you need to send us an example of the label 00:08:31.129 --> 00:08:31.139 align:start position:0% label 00:08:31.139 --> 00:08:33.769 align:start position:0% label you<00:08:31.440><c> need</c><00:08:31.560><c> to</c><00:08:31.620><c> send</c><00:08:31.800><c> us</c><00:08:31.979><c> some</c><00:08:32.159><c> details</c><00:08:32.640><c> on</c><00:08:33.120><c> at</c><00:08:33.599><c> a</c> 00:08:33.769 --> 00:08:33.779 align:start position:0% you need to send us some details on at a 00:08:33.779 --> 00:08:35.329 align:start position:0% you need to send us some details on at a very<00:08:33.839><c> high</c><00:08:34.020><c> level</c><00:08:34.200><c> the</c><00:08:34.740><c> manufacturing</c> 00:08:35.329 --> 00:08:35.339 align:start position:0% very high level the manufacturing 00:08:35.339 --> 00:08:37.850 align:start position:0% very high level the manufacturing process<00:08:35.700><c> and</c><00:08:36.479><c> of</c><00:08:36.599><c> course</c><00:08:36.779><c> for</c><00:08:37.080><c> a</c><00:08:37.200><c> biostiminant</c> 00:08:37.850 --> 00:08:37.860 align:start position:0% process and of course for a biostiminant 00:08:37.860 --> 00:08:40.310 align:start position:0% process and of course for a biostiminant you<00:08:38.459><c> have</c><00:08:38.580><c> to</c><00:08:38.760><c> Define</c><00:08:39.020><c> what</c><00:08:40.020><c> the</c><00:08:40.140><c> product</c> 00:08:40.310 --> 00:08:40.320 align:start position:0% you have to Define what the product 00:08:40.320 --> 00:08:41.930 align:start position:0% you have to Define what the product actually<00:08:40.620><c> does</c><00:08:40.919><c> so</c><00:08:41.399><c> you</c><00:08:41.520><c> have</c><00:08:41.640><c> to</c><00:08:41.760><c> Define</c> 00:08:41.930 --> 00:08:41.940 align:start position:0% actually does so you have to Define 00:08:41.940 --> 00:08:45.829 align:start position:0% actually does so you have to Define claims<00:08:42.959><c> and</c><00:08:43.919><c> you</c><00:08:44.219><c> have</c><00:08:44.339><c> to</c><00:08:44.399><c> prove</c><00:08:44.700><c> them</c><00:08:45.300><c> how</c> 00:08:45.829 --> 00:08:45.839 align:start position:0% claims and you have to prove them how 00:08:45.839 --> 00:08:47.570 align:start position:0% claims and you have to prove them how you<00:08:45.899><c> prove</c><00:08:46.260><c> them</c><00:08:46.320><c> is</c><00:08:46.740><c> somewhat</c><00:08:47.160><c> up</c><00:08:47.339><c> to</c><00:08:47.459><c> you</c> 00:08:47.570 --> 00:08:47.580 align:start position:0% you prove them is somewhat up to you 00:08:47.580 --> 00:08:49.430 align:start position:0% you prove them is somewhat up to you usually<00:08:47.880><c> it'll</c><00:08:48.120><c> be</c><00:08:48.240><c> field</c><00:08:48.360><c> trials</c><00:08:48.779><c> but</c><00:08:49.140><c> if</c><00:08:49.320><c> you</c> 00:08:49.430 --> 00:08:49.440 align:start position:0% usually it'll be field trials but if you 00:08:49.440 --> 00:08:51.710 align:start position:0% usually it'll be field trials but if you want<00:08:49.620><c> to</c><00:08:49.800><c> submit</c><00:08:50.220><c> a</c><00:08:50.399><c> dossier</c><00:08:50.760><c> with</c><00:08:51.060><c> literature</c> 00:08:51.710 --> 00:08:51.720 align:start position:0% want to submit a dossier with literature 00:08:51.720 --> 00:08:53.930 align:start position:0% want to submit a dossier with literature studies<00:08:51.959><c> to</c><00:08:52.080><c> a</c><00:08:52.200><c> notified</c><00:08:52.440><c> body</c><00:08:52.700><c> in</c><00:08:53.700><c> theory</c> 00:08:53.930 --> 00:08:53.940 align:start position:0% studies to a notified body in theory 00:08:53.940 --> 00:08:56.509 align:start position:0% studies to a notified body in theory that's<00:08:54.180><c> also</c><00:08:54.480><c> allowed</c> 00:08:56.509 --> 00:08:56.519 align:start position:0% that's also allowed 00:08:56.519 --> 00:08:57.470 align:start position:0% that's also allowed um 00:08:57.470 --> 00:08:57.480 align:start position:0% um 00:08:57.480 --> 00:08:59.750 align:start position:0% um if<00:08:57.959><c> you</c><00:08:58.080><c> send</c><00:08:58.260><c> us</c><00:08:58.380><c> this</c><00:08:58.620><c> information</c> 00:08:59.750 --> 00:08:59.760 align:start position:0% if you send us this information 00:08:59.760 --> 00:09:01.670 align:start position:0% if you send us this information we<00:09:00.360><c> send</c><00:09:00.480><c> it</c><00:09:00.660><c> to</c><00:09:00.839><c> to</c><00:09:00.959><c> one</c><00:09:01.140><c> of</c><00:09:01.260><c> our</c><00:09:01.320><c> Auditors</c> 00:09:01.670 --> 00:09:01.680 align:start position:0% we send it to to one of our Auditors 00:09:01.680 --> 00:09:03.350 align:start position:0% we send it to to one of our Auditors this<00:09:01.920><c> is</c><00:09:01.980><c> obviously</c><00:09:02.279><c> in</c><00:09:02.399><c> the</c><00:09:02.519><c> case</c><00:09:02.640><c> of</c><00:09:02.760><c> module</c> 00:09:03.350 --> 00:09:03.360 align:start position:0% this is obviously in the case of module 00:09:03.360 --> 00:09:04.490 align:start position:0% this is obviously in the case of module B 00:09:04.490 --> 00:09:04.500 align:start position:0% B 00:09:04.500 --> 00:09:05.150 align:start position:0% B um 00:09:05.150 --> 00:09:05.160 align:start position:0% um 00:09:05.160 --> 00:09:06.949 align:start position:0% um the<00:09:05.580><c> auditor</c><00:09:05.880><c> will</c><00:09:06.060><c> assess</c><00:09:06.240><c> it</c><00:09:06.420><c> and</c><00:09:06.660><c> within</c> 00:09:06.949 --> 00:09:06.959 align:start position:0% the auditor will assess it and within 00:09:06.959 --> 00:09:08.930 align:start position:0% the auditor will assess it and within two<00:09:07.080><c> to</c><00:09:07.260><c> four</c><00:09:07.440><c> weeks</c><00:09:07.680><c> if</c><00:09:07.980><c> the</c><00:09:08.160><c> file</c><00:09:08.459><c> meets</c><00:09:08.880><c> the</c> 00:09:08.930 --> 00:09:08.940 align:start position:0% two to four weeks if the file meets the 00:09:08.940 --> 00:09:10.610 align:start position:0% two to four weeks if the file meets the requirements<00:09:09.420><c> we</c><00:09:09.839><c> can</c><00:09:09.899><c> have</c><00:09:10.019><c> we</c><00:09:10.260><c> can</c><00:09:10.380><c> handle</c> 00:09:10.610 --> 00:09:10.620 align:start position:0% requirements we can have we can handle 00:09:10.620 --> 00:09:12.410 align:start position:0% requirements we can have we can handle the<00:09:10.740><c> paperwork</c><00:09:11.100><c> and</c><00:09:11.519><c> issue</c><00:09:11.820><c> the</c><00:09:11.940><c> certificate</c> 00:09:12.410 --> 00:09:12.420 align:start position:0% the paperwork and issue the certificate 00:09:12.420 --> 00:09:15.410 align:start position:0% the paperwork and issue the certificate so<00:09:13.080><c> the</c><00:09:13.260><c> process</c><00:09:13.560><c> can</c><00:09:14.339><c> be</c><00:09:14.459><c> quite</c><00:09:14.640><c> quick</c><00:09:14.880><c> of</c> 00:09:15.410 --> 00:09:15.420 align:start position:0% so the process can be quite quick of 00:09:15.420 --> 00:09:16.370 align:start position:0% so the process can be quite quick of course<00:09:15.540><c> if</c><00:09:15.720><c> we're</c><00:09:15.899><c> still</c><00:09:16.019><c> waiting</c><00:09:16.320><c> on</c> 00:09:16.370 --> 00:09:16.380 align:start position:0% course if we're still waiting on 00:09:16.380 --> 00:09:17.570 align:start position:0% course if we're still waiting on information<00:09:16.560><c> or</c><00:09:16.980><c> if</c><00:09:17.040><c> you</c><00:09:17.160><c> still</c><00:09:17.279><c> have</c><00:09:17.399><c> to</c><00:09:17.519><c> do</c> 00:09:17.570 --> 00:09:17.580 align:start position:0% information or if you still have to do 00:09:17.580 --> 00:09:20.030 align:start position:0% information or if you still have to do field<00:09:17.700><c> trials</c><00:09:18.120><c> it'll</c><00:09:18.720><c> take</c><00:09:18.839><c> as</c><00:09:19.019><c> long</c><00:09:19.200><c> as</c><00:09:19.320><c> as</c><00:09:19.620><c> it</c> 00:09:20.030 --> 00:09:20.040 align:start position:0% field trials it'll take as long as as it 00:09:20.040 --> 00:09:20.949 align:start position:0% field trials it'll take as long as as it takes 00:09:20.949 --> 00:09:20.959 align:start position:0% takes 00:09:20.959 --> 00:09:25.130 align:start position:0% takes similar<00:09:21.959><c> to</c><00:09:22.140><c> the</c><00:09:22.320><c> costs</c><00:09:22.680><c> so</c> 00:09:25.130 --> 00:09:25.140 align:start position:0% similar to the costs so 00:09:25.140 --> 00:09:26.570 align:start position:0% similar to the costs so um<00:09:25.200><c> it</c><00:09:25.500><c> depends</c><00:09:25.740><c> a</c><00:09:25.860><c> little</c><00:09:25.980><c> bit</c><00:09:26.100><c> obviously</c><00:09:26.399><c> on</c> 00:09:26.570 --> 00:09:26.580 align:start position:0% um it depends a little bit obviously on 00:09:26.580 --> 00:09:27.710 align:start position:0% um it depends a little bit obviously on the<00:09:26.700><c> notified</c><00:09:26.880><c> body</c><00:09:27.120><c> you</c><00:09:27.360><c> choose</c><00:09:27.600><c> because</c> 00:09:27.710 --> 00:09:27.720 align:start position:0% the notified body you choose because 00:09:27.720 --> 00:09:29.329 align:start position:0% the notified body you choose because they're<00:09:28.019><c> they're</c><00:09:28.260><c> private</c><00:09:28.680><c> just</c><00:09:28.920><c> from</c><00:09:29.160><c> our</c> 00:09:29.329 --> 00:09:29.339 align:start position:0% they're they're private just from our 00:09:29.339 --> 00:09:30.710 align:start position:0% they're they're private just from our example 00:09:30.710 --> 00:09:30.720 align:start position:0% example 00:09:30.720 --> 00:09:33.050 align:start position:0% example um<00:09:30.839><c> with</c><00:09:31.200><c> us</c><00:09:31.320><c> you</c><00:09:31.560><c> get</c><00:09:31.740><c> a</c><00:09:32.040><c> price</c><00:09:32.160><c> up</c><00:09:32.459><c> front</c><00:09:32.640><c> and</c> 00:09:33.050 --> 00:09:33.060 align:start position:0% um with us you get a price up front and 00:09:33.060 --> 00:09:35.150 align:start position:0% um with us you get a price up front and that's<00:09:33.240><c> fixed</c><00:09:33.660><c> and</c><00:09:34.140><c> so</c><00:09:34.380><c> for</c><00:09:34.680><c> a</c><00:09:34.920><c> buyer</c> 00:09:35.150 --> 00:09:35.160 align:start position:0% that's fixed and so for a buyer 00:09:35.160 --> 00:09:36.650 align:start position:0% that's fixed and so for a buyer statement<00:09:35.399><c> the</c><00:09:35.700><c> costs</c><00:09:36.060><c> for</c><00:09:36.300><c> getting</c><00:09:36.480><c> a</c> 00:09:36.650 --> 00:09:36.660 align:start position:0% statement the costs for getting a 00:09:36.660 --> 00:09:39.050 align:start position:0% statement the costs for getting a product<00:09:36.839><c> certified</c><00:09:37.260><c> will</c><00:09:37.800><c> be</c><00:09:37.980><c> between</c><00:09:38.160><c> 2</c><00:09:39.000><c> 000</c> 00:09:39.050 --> 00:09:39.060 align:start position:0% product certified will be between 2 000 00:09:39.060 --> 00:09:41.030 align:start position:0% product certified will be between 2 000 and<00:09:39.180><c> 3</c><00:09:39.360><c> 500</c><00:09:39.779><c> euros</c> 00:09:41.030 --> 00:09:41.040 align:start position:0% and 3 500 euros 00:09:41.040 --> 00:09:43.550 align:start position:0% and 3 500 euros the<00:09:41.580><c> 3</c><00:09:41.820><c> 500</c><00:09:42.240><c> euros</c><00:09:42.779><c> is</c><00:09:42.959><c> pretty</c><00:09:43.080><c> much</c><00:09:43.200><c> very</c><00:09:43.380><c> much</c> 00:09:43.550 --> 00:09:43.560 align:start position:0% the 3 500 euros is pretty much very much 00:09:43.560 --> 00:09:47.329 align:start position:0% the 3 500 euros is pretty much very much the<00:09:43.920><c> really</c><00:09:44.700><c> the</c><00:09:44.880><c> the</c><00:09:45.000><c> top</c><00:09:45.480><c> limit</c><00:09:45.720><c> uh</c><00:09:46.800><c> uh</c><00:09:47.160><c> but</c> 00:09:47.329 --> 00:09:47.339 align:start position:0% the really the the top limit uh uh but 00:09:47.339 --> 00:09:49.430 align:start position:0% the really the the top limit uh uh but that's<00:09:47.459><c> for</c><00:09:47.700><c> very</c><00:09:48.000><c> complicated</c><00:09:48.420><c> products</c><00:09:48.959><c> or</c> 00:09:49.430 --> 00:09:49.440 align:start position:0% that's for very complicated products or 00:09:49.440 --> 00:09:51.230 align:start position:0% that's for very complicated products or for<00:09:49.620><c> manufacturers</c><00:09:50.279><c> that</c><00:09:50.459><c> have</c><00:09:50.640><c> not</c><00:09:50.880><c> done</c><00:09:51.060><c> any</c> 00:09:51.230 --> 00:09:51.240 align:start position:0% for manufacturers that have not done any 00:09:51.240 --> 00:09:53.329 align:start position:0% for manufacturers that have not done any form<00:09:51.420><c> of</c><00:09:51.540><c> preparation</c><00:09:51.959><c> usually</c><00:09:52.800><c> the</c><00:09:53.040><c> costs</c> 00:09:53.329 --> 00:09:53.339 align:start position:0% form of preparation usually the costs 00:09:53.339 --> 00:09:55.870 align:start position:0% form of preparation usually the costs are<00:09:53.399><c> about</c><00:09:53.580><c> 2500</c><00:09:54.240><c> Euros</c> 00:09:55.870 --> 00:09:55.880 align:start position:0% are about 2500 Euros 00:09:55.880 --> 00:09:57.949 align:start position:0% are about 2500 Euros that<00:09:56.880><c> of</c><00:09:57.000><c> course</c><00:09:57.060><c> gets</c><00:09:57.360><c> you</c><00:09:57.420><c> a</c><00:09:57.600><c> certificate</c> 00:09:57.949 --> 00:09:57.959 align:start position:0% that of course gets you a certificate 00:09:57.959 --> 00:10:00.470 align:start position:0% that of course gets you a certificate that's<00:09:58.140><c> valid</c><00:09:58.500><c> for</c><00:09:58.680><c> five</c><00:09:58.860><c> years</c><00:09:59.120><c> uh</c><00:10:00.120><c> and</c><00:10:00.300><c> so</c><00:10:00.360><c> if</c> 00:10:00.470 --> 00:10:00.480 align:start position:0% that's valid for five years uh and so if 00:10:00.480 --> 00:10:02.030 align:start position:0% that's valid for five years uh and so if you<00:10:00.600><c> keep</c><00:10:00.720><c> making</c><00:10:00.899><c> that</c><00:10:01.200><c> product</c> 00:10:02.030 --> 00:10:02.040 align:start position:0% you keep making that product 00:10:02.040 --> 00:10:04.490 align:start position:0% you keep making that product you<00:10:02.459><c> don't</c><00:10:02.519><c> have</c><00:10:02.640><c> to</c><00:10:02.760><c> do</c><00:10:02.880><c> a</c><00:10:03.000><c> reassessment</c><00:10:03.500><c> uh</c> 00:10:04.490 --> 00:10:04.500 align:start position:0% you don't have to do a reassessment uh 00:10:04.500 --> 00:10:05.870 align:start position:0% you don't have to do a reassessment uh and<00:10:04.680><c> after</c><00:10:04.860><c> five</c><00:10:05.160><c> years</c><00:10:05.339><c> and</c><00:10:05.580><c> this</c><00:10:05.760><c> is</c> 00:10:05.870 --> 00:10:05.880 align:start position:0% and after five years and this is 00:10:05.880 --> 00:10:08.150 align:start position:0% and after five years and this is something<00:10:06.120><c> specific</c><00:10:06.899><c> to</c><00:10:07.140><c> us</c><00:10:07.260><c> if</c><00:10:07.920><c> you</c><00:10:08.040><c> haven't</c> 00:10:08.150 --> 00:10:08.160 align:start position:0% something specific to us if you haven't 00:10:08.160 --> 00:10:09.490 align:start position:0% something specific to us if you haven't changed<00:10:08.580><c> the</c><00:10:08.700><c> product</c> 00:10:09.490 --> 00:10:09.500 align:start position:0% changed the product 00:10:09.500 --> 00:10:12.470 align:start position:0% changed the product you<00:10:10.500><c> get</c><00:10:10.620><c> a</c><00:10:10.740><c> re-certification</c><00:10:11.279><c> for</c><00:10:11.580><c> free</c><00:10:11.760><c> so</c> 00:10:12.470 --> 00:10:12.480 align:start position:0% you get a re-certification for free so 00:10:12.480 --> 00:10:14.269 align:start position:0% you get a re-certification for free so in<00:10:12.660><c> essence</c><00:10:12.899><c> the</c><00:10:13.080><c> certificate</c><00:10:13.500><c> is</c><00:10:13.620><c> valid</c><00:10:13.920><c> for</c> 00:10:14.269 --> 00:10:14.279 align:start position:0% in essence the certificate is valid for 00:10:14.279 --> 00:10:16.130 align:start position:0% in essence the certificate is valid for as<00:10:14.820><c> long</c><00:10:15.000><c> as</c><00:10:15.060><c> you</c><00:10:15.240><c> keep</c><00:10:15.420><c> making</c><00:10:15.660><c> that</c><00:10:16.019><c> same</c> 00:10:16.130 --> 00:10:16.140 align:start position:0% as long as you keep making that same 00:10:16.140 --> 00:10:18.470 align:start position:0% as long as you keep making that same product<00:10:16.640><c> uh</c><00:10:17.640><c> of</c><00:10:17.760><c> course</c><00:10:17.880><c> if</c><00:10:18.000><c> you</c><00:10:18.120><c> change</c><00:10:18.300><c> the</c> 00:10:18.470 --> 00:10:18.480 align:start position:0% product uh of course if you change the 00:10:18.480 --> 00:10:21.530 align:start position:0% product uh of course if you change the product<00:10:18.660><c> you</c><00:10:19.140><c> have</c><00:10:19.260><c> to</c><00:10:19.320><c> do</c><00:10:19.440><c> a</c><00:10:19.560><c> reassessment</c> 00:10:21.530 --> 00:10:21.540 align:start position:0% product you have to do a reassessment 00:10:21.540 --> 00:10:23.150 align:start position:0% product you have to do a reassessment um in<00:10:22.080><c> that</c><00:10:22.200><c> regard</c> 00:10:23.150 --> 00:10:23.160 align:start position:0% um in that regard 00:10:23.160 --> 00:10:25.310 align:start position:0% um in that regard if<00:10:23.580><c> you</c><00:10:23.640><c> can</c><00:10:23.760><c> spread</c><00:10:24.000><c> the</c><00:10:24.120><c> cost</c><00:10:24.240><c> out</c> 00:10:25.310 --> 00:10:25.320 align:start position:0% if you can spread the cost out 00:10:25.320 --> 00:10:28.130 align:start position:0% if you can spread the cost out it<00:10:26.279><c> is</c><00:10:26.760><c> still</c><00:10:26.880><c> manageable</c><00:10:27.300><c> same</c><00:10:27.839><c> with</c><00:10:28.019><c> the</c> 00:10:28.130 --> 00:10:28.140 align:start position:0% it is still manageable same with the 00:10:28.140 --> 00:10:32.150 align:start position:0% it is still manageable same with the timeline 00:10:32.150 --> 00:10:32.160 align:start position:0% 00:10:32.160 --> 00:10:33.530 align:start position:0% so 00:10:33.530 --> 00:10:33.540 align:start position:0% so 00:10:33.540 --> 00:10:35.990 align:start position:0% so if<00:10:34.019><c> we</c><00:10:34.140><c> look</c><00:10:34.320><c> at</c><00:10:34.560><c> our</c><00:10:34.860><c> specific</c><00:10:35.279><c> company</c> 00:10:35.990 --> 00:10:36.000 align:start position:0% if we look at our specific company 00:10:36.000 --> 00:10:37.550 align:start position:0% if we look at our specific company process<00:10:36.420><c> and</c><00:10:36.660><c> how</c><00:10:36.839><c> we</c><00:10:37.019><c> would</c><00:10:37.140><c> handle</c><00:10:37.440><c> the</c> 00:10:37.550 --> 00:10:37.560 align:start position:0% process and how we would handle the 00:10:37.560 --> 00:10:39.590 align:start position:0% process and how we would handle the certification<00:10:38.040><c> this</c><00:10:38.760><c> is</c><00:10:38.880><c> the</c><00:10:39.060><c> best</c><00:10:39.180><c> way</c><00:10:39.360><c> for</c> 00:10:39.590 --> 00:10:39.600 align:start position:0% certification this is the best way for 00:10:39.600 --> 00:10:41.150 align:start position:0% certification this is the best way for me<00:10:39.720><c> to</c><00:10:39.959><c> explain</c> 00:10:41.150 --> 00:10:41.160 align:start position:0% me to explain 00:10:41.160 --> 00:10:43.009 align:start position:0% me to explain how<00:10:41.580><c> would</c><00:10:41.700><c> it</c><00:10:41.880><c> actually</c><00:10:42.000><c> work</c><00:10:42.240><c> and</c><00:10:42.540><c> how</c><00:10:42.720><c> how</c> 00:10:43.009 --> 00:10:43.019 align:start position:0% how would it actually work and how how 00:10:43.019 --> 00:10:44.509 align:start position:0% how would it actually work and how how straight<00:10:43.260><c> to</c><00:10:43.440><c> the</c><00:10:43.560><c> point</c><00:10:43.740><c> and</c><00:10:44.100><c> simple</c><00:10:44.279><c> this</c> 00:10:44.509 --> 00:10:44.519 align:start position:0% straight to the point and simple this 00:10:44.519 --> 00:10:46.550 align:start position:0% straight to the point and simple this process<00:10:44.820><c> can</c><00:10:45.120><c> in</c><00:10:45.300><c> reality</c><00:10:45.660><c> be</c> 00:10:46.550 --> 00:10:46.560 align:start position:0% process can in reality be 00:10:46.560 --> 00:10:47.870 align:start position:0% process can in reality be let's<00:10:47.040><c> say</c> 00:10:47.870 --> 00:10:47.880 align:start position:0% let's say 00:10:47.880 --> 00:10:50.090 align:start position:0% let's say after<00:10:48.300><c> the</c><00:10:48.540><c> conference</c><00:10:48.899><c> you</c><00:10:49.260><c> want</c><00:10:49.440><c> to</c><00:10:49.620><c> start</c> 00:10:50.090 --> 00:10:50.100 align:start position:0% after the conference you want to start 00:10:50.100 --> 00:10:51.769 align:start position:0% after the conference you want to start with<00:10:50.339><c> one</c><00:10:50.519><c> product</c><00:10:50.700><c> and</c><00:10:51.240><c> that's</c><00:10:51.360><c> that's</c><00:10:51.540><c> your</c> 00:10:51.769 --> 00:10:51.779 align:start position:0% with one product and that's that's your 00:10:51.779 --> 00:10:52.970 align:start position:0% with one product and that's that's your right<00:10:51.959><c> because</c><00:10:52.079><c> it's</c><00:10:52.260><c> optional</c><00:10:52.620><c> you</c><00:10:52.860><c> can</c> 00:10:52.970 --> 00:10:52.980 align:start position:0% right because it's optional you can 00:10:52.980 --> 00:10:55.069 align:start position:0% right because it's optional you can apply<00:10:53.399><c> a</c><00:10:53.579><c> single</c><00:10:53.820><c> product</c><00:10:54.000><c> send</c><00:10:54.660><c> us</c><00:10:54.779><c> a</c><00:10:54.959><c> file</c> 00:10:55.069 --> 00:10:55.079 align:start position:0% apply a single product send us a file 00:10:55.079 --> 00:10:57.410 align:start position:0% apply a single product send us a file and<00:10:55.320><c> then</c><00:10:55.440><c> just</c><00:10:55.620><c> as</c><00:10:55.860><c> a</c><00:10:55.980><c> as</c><00:10:56.220><c> a</c><00:10:56.339><c> trail</c><00:10:56.519><c> what</c><00:10:57.300><c> we</c> 00:10:57.410 --> 00:10:57.420 align:start position:0% and then just as a as a trail what we 00:10:57.420 --> 00:10:58.970 align:start position:0% and then just as a as a trail what we always<00:10:57.540><c> do</c><00:10:57.720><c> with</c><00:10:57.839><c> manufacturers</c><00:10:58.440><c> is</c><00:10:58.560><c> set</c><00:10:58.740><c> up</c><00:10:58.860><c> a</c> 00:10:58.970 --> 00:10:58.980 align:start position:0% always do with manufacturers is set up a 00:10:58.980 --> 00:11:01.850 align:start position:0% always do with manufacturers is set up a teams<00:10:59.220><c> call</c><00:10:59.399><c> just</c><00:11:00.120><c> to</c><00:11:00.300><c> get</c><00:11:00.420><c> an</c><00:11:00.540><c> idea</c><00:11:00.959><c> what</c><00:11:01.740><c> are</c> 00:11:01.850 --> 00:11:01.860 align:start position:0% teams call just to get an idea what are 00:11:01.860 --> 00:11:03.470 align:start position:0% teams call just to get an idea what are your<00:11:01.980><c> questions</c><00:11:02.160><c> uh</c><00:11:03.060><c> what</c><00:11:03.180><c> are</c><00:11:03.300><c> you</c><00:11:03.420><c> running</c> 00:11:03.470 --> 00:11:03.480 align:start position:0% your questions uh what are you running 00:11:03.480 --> 00:11:05.030 align:start position:0% your questions uh what are you running into<00:11:03.720><c> what</c><00:11:03.899><c> are</c><00:11:04.019><c> you</c><00:11:04.079><c> unsure</c><00:11:04.380><c> about</c><00:11:04.500><c> and</c> 00:11:05.030 --> 00:11:05.040 align:start position:0% into what are you unsure about and 00:11:05.040 --> 00:11:06.350 align:start position:0% into what are you unsure about and that's<00:11:05.220><c> where</c><00:11:05.399><c> we</c><00:11:05.519><c> always</c><00:11:05.640><c> help</c><00:11:05.880><c> so</c><00:11:06.240><c> that's</c> 00:11:06.350 --> 00:11:06.360 align:start position:0% that's where we always help so that's 00:11:06.360 --> 00:11:07.610 align:start position:0% that's where we always help so that's typically<00:11:06.660><c> an</c><00:11:06.839><c> hour</c><00:11:06.959><c> and</c><00:11:07.079><c> a</c><00:11:07.200><c> half</c><00:11:07.260><c> where</c><00:11:07.440><c> we</c> 00:11:07.610 --> 00:11:07.620 align:start position:0% typically an hour and a half where we 00:11:07.620 --> 00:11:09.110 align:start position:0% typically an hour and a half where we just<00:11:07.740><c> run</c><00:11:07.860><c> through</c><00:11:08.040><c> what</c><00:11:08.579><c> are</c><00:11:08.760><c> your</c><00:11:08.880><c> specific</c> 00:11:09.110 --> 00:11:09.120 align:start position:0% just run through what are your specific 00:11:09.120 --> 00:11:11.329 align:start position:0% just run through what are your specific products<00:11:09.600><c> what</c><00:11:10.079><c> are</c><00:11:10.200><c> you</c><00:11:10.260><c> worried</c><00:11:10.500><c> about</c><00:11:10.620><c> uh</c> 00:11:11.329 --> 00:11:11.339 align:start position:0% products what are you worried about uh 00:11:11.339 --> 00:11:12.769 align:start position:0% products what are you worried about uh give<00:11:11.519><c> you</c><00:11:11.640><c> the</c><00:11:11.760><c> answers</c><00:11:12.000><c> to</c><00:11:12.480><c> your</c><00:11:12.600><c> questions</c> 00:11:12.769 --> 00:11:12.779 align:start position:0% give you the answers to your questions 00:11:12.779 --> 00:11:14.569 align:start position:0% give you the answers to your questions and<00:11:13.380><c> then</c><00:11:13.500><c> see</c><00:11:13.680><c> if</c><00:11:13.860><c> the</c><00:11:13.980><c> process</c><00:11:14.220><c> is</c><00:11:14.399><c> something</c> 00:11:14.569 --> 00:11:14.579 align:start position:0% and then see if the process is something 00:11:14.579 --> 00:11:17.090 align:start position:0% and then see if the process is something that<00:11:14.940><c> that</c><00:11:15.120><c> you</c><00:11:15.300><c> want</c><00:11:15.420><c> to</c><00:11:15.540><c> pursue</c><00:11:16.200><c> if</c><00:11:16.740><c> it</c><00:11:16.920><c> is</c> 00:11:17.090 --> 00:11:17.100 align:start position:0% that that you want to pursue if it is 00:11:17.100 --> 00:11:18.410 align:start position:0% that that you want to pursue if it is you<00:11:17.579><c> obviously</c><00:11:17.880><c> get</c><00:11:18.000><c> all</c><00:11:18.180><c> the</c><00:11:18.300><c> information</c> 00:11:18.410 --> 00:11:18.420 align:start position:0% you obviously get all the information 00:11:18.420 --> 00:11:20.870 align:start position:0% you obviously get all the information you<00:11:18.720><c> need</c><00:11:18.839><c> to</c><00:11:18.959><c> get</c><00:11:19.140><c> started</c><00:11:19.440><c> so</c><00:11:19.860><c> the</c><00:11:20.519><c> contract</c> 00:11:20.870 --> 00:11:20.880 align:start position:0% you need to get started so the contract 00:11:20.880 --> 00:11:23.210 align:start position:0% you need to get started so the contract that<00:11:21.120><c> we</c><00:11:21.240><c> typically</c><00:11:21.480><c> sign</c><00:11:21.839><c> the</c><00:11:22.560><c> the</c><00:11:22.560><c> pricing</c> 00:11:23.210 --> 00:11:23.220 align:start position:0% that we typically sign the the pricing 00:11:23.220 --> 00:11:25.490 align:start position:0% that we typically sign the the pricing everything<00:11:23.760><c> up</c><00:11:24.060><c> front</c><00:11:24.300><c> and</c><00:11:24.720><c> it's</c><00:11:24.899><c> fixed</c><00:11:25.200><c> so</c> 00:11:25.490 --> 00:11:25.500 align:start position:0% everything up front and it's fixed so 00:11:25.500 --> 00:11:27.110 align:start position:0% everything up front and it's fixed so you<00:11:25.680><c> know</c><00:11:25.860><c> inherently</c><00:11:26.640><c> what</c><00:11:26.820><c> you're</c><00:11:26.940><c> going</c> 00:11:27.110 --> 00:11:27.120 align:start position:0% you know inherently what you're going 00:11:27.120 --> 00:11:28.490 align:start position:0% you know inherently what you're going into 00:11:28.490 --> 00:11:28.500 align:start position:0% into 00:11:28.500 --> 00:11:30.230 align:start position:0% into of<00:11:28.980><c> course</c><00:11:29.160><c> if</c><00:11:29.519><c> it's</c><00:11:29.640><c> something</c><00:11:29.820><c> you</c><00:11:30.000><c> want</c><00:11:30.120><c> to</c> 00:11:30.230 --> 00:11:30.240 align:start position:0% of course if it's something you want to 00:11:30.240 --> 00:11:31.730 align:start position:0% of course if it's something you want to continue<00:11:30.300><c> with</c><00:11:30.600><c> fill</c><00:11:31.140><c> in</c><00:11:31.320><c> the</c><00:11:31.440><c> application</c> 00:11:31.730 --> 00:11:31.740 align:start position:0% continue with fill in the application 00:11:31.740 --> 00:11:34.430 align:start position:0% continue with fill in the application form<00:11:31.980><c> sign</c><00:11:32.279><c> the</c><00:11:32.519><c> contract</c><00:11:32.880><c> that's</c><00:11:33.300><c> step</c><00:11:33.540><c> one</c> 00:11:34.430 --> 00:11:34.440 align:start position:0% form sign the contract that's step one 00:11:34.440 --> 00:11:37.130 align:start position:0% form sign the contract that's step one until<00:11:35.040><c> the</c><00:11:35.399><c> contract</c><00:11:35.700><c> is</c><00:11:35.880><c> signed</c> 00:11:37.130 --> 00:11:37.140 align:start position:0% until the contract is signed 00:11:37.140 --> 00:11:40.730 align:start position:0% until the contract is signed all<00:11:37.560><c> the</c><00:11:37.740><c> information</c><00:11:37.860><c> is</c><00:11:38.579><c> is</c><00:11:39.019><c> non-binding</c><00:11:40.019><c> so</c> 00:11:40.730 --> 00:11:40.740 align:start position:0% all the information is is non-binding so 00:11:40.740 --> 00:11:42.230 align:start position:0% all the information is is non-binding so if<00:11:41.100><c> you</c><00:11:41.220><c> just</c><00:11:41.399><c> want</c><00:11:41.579><c> to</c><00:11:41.700><c> know</c><00:11:41.760><c> something</c><00:11:41.940><c> feel</c> 00:11:42.230 --> 00:11:42.240 align:start position:0% if you just want to know something feel 00:11:42.240 --> 00:11:44.030 align:start position:0% if you just want to know something feel free<00:11:42.360><c> to</c><00:11:42.540><c> send</c><00:11:42.660><c> us</c><00:11:42.779><c> a</c><00:11:42.959><c> question</c><00:11:43.079><c> and</c><00:11:43.620><c> until</c><00:11:43.800><c> the</c> 00:11:44.030 --> 00:11:44.040 align:start position:0% free to send us a question and until the 00:11:44.040 --> 00:11:45.170 align:start position:0% free to send us a question and until the contract<00:11:44.339><c> we</c><00:11:44.519><c> can</c><00:11:44.640><c> give</c><00:11:44.760><c> you</c><00:11:44.880><c> all</c><00:11:45.060><c> the</c> 00:11:45.170 --> 00:11:45.180 align:start position:0% contract we can give you all the 00:11:45.180 --> 00:11:47.569 align:start position:0% contract we can give you all the information<00:11:45.300><c> that</c><00:11:45.720><c> you</c><00:11:45.839><c> need</c><00:11:45.980><c> so</c><00:11:46.980><c> that's</c><00:11:47.220><c> also</c> 00:11:47.569 --> 00:11:47.579 align:start position:0% information that you need so that's also 00:11:47.579 --> 00:11:49.250 align:start position:0% information that you need so that's also an<00:11:47.700><c> open</c><00:11:47.820><c> offer</c><00:11:48.120><c> to</c><00:11:48.300><c> everyone</c><00:11:48.420><c> in</c><00:11:48.839><c> the</c><00:11:48.959><c> in</c><00:11:49.140><c> the</c> 00:11:49.250 --> 00:11:49.260 align:start position:0% an open offer to everyone in the in the 00:11:49.260 --> 00:11:50.269 align:start position:0% an open offer to everyone in the in the room 00:11:50.269 --> 00:11:50.279 align:start position:0% room 00:11:50.279 --> 00:11:52.190 align:start position:0% room once<00:11:50.880><c> we've</c><00:11:51.060><c> signed</c><00:11:51.360><c> the</c><00:11:51.420><c> contract</c><00:11:51.720><c> what</c><00:11:52.019><c> we</c> 00:11:52.190 --> 00:11:52.200 align:start position:0% once we've signed the contract what we 00:11:52.200 --> 00:11:53.569 align:start position:0% once we've signed the contract what we ask<00:11:52.320><c> from</c><00:11:52.500><c> you</c><00:11:52.620><c> is</c><00:11:52.800><c> you</c><00:11:52.920><c> just</c><00:11:53.100><c> send</c><00:11:53.279><c> in</c><00:11:53.459><c> the</c> 00:11:53.569 --> 00:11:53.579 align:start position:0% ask from you is you just send in the 00:11:53.579 --> 00:11:55.009 align:start position:0% ask from you is you just send in the documentation 00:11:55.009 --> 00:11:55.019 align:start position:0% documentation 00:11:55.019 --> 00:11:57.710 align:start position:0% documentation simple<00:11:55.500><c> via</c><00:11:55.980><c> email</c><00:11:56.160><c> or</c><00:11:56.459><c> via</c><00:11:56.700><c> we</c><00:11:56.880><c> transfer</c><00:11:57.300><c> send</c> 00:11:57.710 --> 00:11:57.720 align:start position:0% simple via email or via we transfer send 00:11:57.720 --> 00:11:58.850 align:start position:0% simple via email or via we transfer send in<00:11:57.839><c> all</c><00:11:58.019><c> the</c><00:11:58.140><c> information</c><00:11:58.260><c> that</c><00:11:58.620><c> I</c><00:11:58.740><c> just</c> 00:11:58.850 --> 00:11:58.860 align:start position:0% in all the information that I just 00:11:58.860 --> 00:12:00.470 align:start position:0% in all the information that I just listed<00:11:59.100><c> so</c><00:11:59.279><c> the</c><00:11:59.459><c> test</c><00:11:59.579><c> reports</c><00:12:00.000><c> the</c><00:12:00.300><c> field</c> 00:12:00.470 --> 00:12:00.480 align:start position:0% listed so the test reports the field 00:12:00.480 --> 00:12:03.410 align:start position:0% listed so the test reports the field trial<00:12:00.720><c> reports</c><00:12:01.200><c> the</c><00:12:01.920><c> label</c><00:12:02.459><c> the</c><00:12:02.880><c> dossier</c><00:12:03.240><c> per</c> 00:12:03.410 --> 00:12:03.420 align:start position:0% trial reports the label the dossier per 00:12:03.420 --> 00:12:05.690 align:start position:0% trial reports the label the dossier per CMC<00:12:03.899><c> and</c><00:12:04.320><c> we</c><00:12:04.380><c> evaluate</c><00:12:04.860><c> that</c> 00:12:05.690 --> 00:12:05.700 align:start position:0% CMC and we evaluate that 00:12:05.700 --> 00:12:07.850 align:start position:0% CMC and we evaluate that if<00:12:06.120><c> there</c><00:12:06.300><c> are</c><00:12:06.420><c> any</c><00:12:06.600><c> points</c><00:12:07.019><c> you'll</c><00:12:07.560><c> get</c><00:12:07.680><c> a</c> 00:12:07.850 --> 00:12:07.860 align:start position:0% if there are any points you'll get a 00:12:07.860 --> 00:12:10.550 align:start position:0% if there are any points you'll get a report<00:12:07.980><c> from</c><00:12:08.640><c> the</c><00:12:08.760><c> auditor</c><00:12:09.180><c> uh</c><00:12:10.140><c> on</c><00:12:10.320><c> which</c> 00:12:10.550 --> 00:12:10.560 align:start position:0% report from the auditor uh on which 00:12:10.560 --> 00:12:13.009 align:start position:0% report from the auditor uh on which points<00:12:10.980><c> he</c><00:12:11.220><c> he</c><00:12:11.459><c> or</c><00:12:11.640><c> she</c><00:12:11.820><c> might</c><00:12:12.060><c> not</c><00:12:12.240><c> have</c> 00:12:13.009 --> 00:12:13.019 align:start position:0% points he he or she might not have 00:12:13.019 --> 00:12:14.630 align:start position:0% points he he or she might not have found<00:12:13.380><c> enough</c><00:12:13.620><c> evidence</c><00:12:13.920><c> to</c><00:12:14.220><c> that</c><00:12:14.339><c> you</c><00:12:14.519><c> meet</c> 00:12:14.630 --> 00:12:14.640 align:start position:0% found enough evidence to that you meet 00:12:14.640 --> 00:12:15.829 align:start position:0% found enough evidence to that you meet the<00:12:14.820><c> requirements</c> 00:12:15.829 --> 00:12:15.839 align:start position:0% the requirements 00:12:15.839 --> 00:12:18.170 align:start position:0% the requirements you<00:12:16.320><c> get</c><00:12:16.440><c> that</c><00:12:16.560><c> presented</c><00:12:17.040><c> in</c><00:12:17.220><c> very</c><00:12:18.000><c> simple</c> 00:12:18.170 --> 00:12:18.180 align:start position:0% you get that presented in very simple 00:12:18.180 --> 00:12:21.290 align:start position:0% you get that presented in very simple list<00:12:18.480><c> and</c><00:12:19.200><c> you</c><00:12:19.320><c> can</c><00:12:19.440><c> go</c><00:12:19.680><c> and</c><00:12:20.160><c> fix</c><00:12:20.339><c> that</c> 00:12:21.290 --> 00:12:21.300 align:start position:0% list and you can go and fix that 00:12:21.300 --> 00:12:23.150 align:start position:0% list and you can go and fix that those<00:12:21.959><c> points</c><00:12:22.260><c> those</c><00:12:22.440><c> non-conformities</c> 00:12:23.150 --> 00:12:23.160 align:start position:0% those points those non-conformities 00:12:23.160 --> 00:12:24.889 align:start position:0% those points those non-conformities those<00:12:23.640><c> aren't</c><00:12:23.820><c> concerning</c><00:12:24.360><c> that's</c><00:12:24.600><c> not</c><00:12:24.779><c> an</c> 00:12:24.889 --> 00:12:24.899 align:start position:0% those aren't concerning that's not an 00:12:24.899 --> 00:12:26.090 align:start position:0% those aren't concerning that's not an issue<00:12:25.079><c> you</c><00:12:25.200><c> can</c><00:12:25.320><c> take</c><00:12:25.440><c> as</c><00:12:25.620><c> long</c><00:12:25.740><c> as</c><00:12:25.860><c> you</c><00:12:25.980><c> want</c> 00:12:26.090 --> 00:12:26.100 align:start position:0% issue you can take as long as you want 00:12:26.100 --> 00:12:27.650 align:start position:0% issue you can take as long as you want to<00:12:26.220><c> fix</c><00:12:26.399><c> it</c> 00:12:27.650 --> 00:12:27.660 align:start position:0% to fix it 00:12:27.660 --> 00:12:29.030 align:start position:0% to fix it um<00:12:27.779><c> and</c><00:12:28.019><c> it's</c><00:12:28.140><c> not</c><00:12:28.320><c> something</c><00:12:28.440><c> to</c><00:12:28.680><c> be</c><00:12:28.800><c> worried</c> 00:12:29.030 --> 00:12:29.040 align:start position:0% um and it's not something to be worried 00:12:29.040 --> 00:12:30.230 align:start position:0% um and it's not something to be worried about<00:12:29.100><c> and</c><00:12:29.519><c> of</c><00:12:29.640><c> course</c><00:12:29.760><c> if</c><00:12:29.940><c> the</c><00:12:30.120><c> product</c> 00:12:30.230 --> 00:12:30.240 align:start position:0% about and of course if the product 00:12:30.240 --> 00:12:32.090 align:start position:0% about and of course if the product already<00:12:30.480><c> meets</c><00:12:30.839><c> the</c><00:12:30.899><c> requirements</c><00:12:31.380><c> simple</c> 00:12:32.090 --> 00:12:32.100 align:start position:0% already meets the requirements simple 00:12:32.100 --> 00:12:34.069 align:start position:0% already meets the requirements simple then<00:12:32.459><c> we</c><00:12:32.579><c> go</c><00:12:32.700><c> straight</c><00:12:32.880><c> to</c><00:12:33.000><c> phase</c><00:12:33.180><c> three</c><00:12:33.420><c> uh</c> 00:12:34.069 --> 00:12:34.079 align:start position:0% then we go straight to phase three uh 00:12:34.079 --> 00:12:35.449 align:start position:0% then we go straight to phase three uh which<00:12:34.260><c> is</c><00:12:34.380><c> that</c><00:12:34.500><c> we</c><00:12:34.620><c> review</c><00:12:34.800><c> the</c><00:12:35.040><c> documents</c> 00:12:35.449 --> 00:12:35.459 align:start position:0% which is that we review the documents 00:12:35.459 --> 00:12:38.150 align:start position:0% which is that we review the documents internally<00:12:36.000><c> and</c><00:12:36.420><c> issue</c><00:12:36.779><c> the</c><00:12:36.899><c> certificate</c> 00:12:38.150 --> 00:12:38.160 align:start position:0% internally and issue the certificate 00:12:38.160 --> 00:12:40.069 align:start position:0% internally and issue the certificate obviously<00:12:38.820><c> with</c><00:12:38.940><c> the</c><00:12:39.180><c> first</c><00:12:39.300><c> product</c><00:12:39.540><c> a</c><00:12:39.959><c> lot</c> 00:12:40.069 --> 00:12:40.079 align:start position:0% obviously with the first product a lot 00:12:40.079 --> 00:12:41.449 align:start position:0% obviously with the first product a lot of<00:12:40.140><c> Manufacturers</c><00:12:40.680><c> are</c><00:12:40.800><c> running</c><00:12:40.980><c> into</c><00:12:41.160><c> a</c><00:12:41.339><c> lot</c> 00:12:41.449 --> 00:12:41.459 align:start position:0% of Manufacturers are running into a lot 00:12:41.459 --> 00:12:44.150 align:start position:0% of Manufacturers are running into a lot of<00:12:41.519><c> questions</c><00:12:41.700><c> once</c><00:12:42.660><c> you</c><00:12:42.720><c> get</c><00:12:42.899><c> an</c><00:12:43.079><c> idea</c> 00:12:44.150 --> 00:12:44.160 align:start position:0% of questions once you get an idea 00:12:44.160 --> 00:12:46.129 align:start position:0% of questions once you get an idea what's<00:12:44.579><c> required</c> 00:12:46.129 --> 00:12:46.139 align:start position:0% what's required 00:12:46.139 --> 00:12:47.629 align:start position:0% what's required process<00:12:46.620><c> becomes</c><00:12:46.980><c> very</c><00:12:47.160><c> simple</c><00:12:47.279><c> to</c><00:12:47.519><c> run</c> 00:12:47.629 --> 00:12:47.639 align:start position:0% process becomes very simple to run 00:12:47.639 --> 00:12:49.009 align:start position:0% process becomes very simple to run through<00:12:47.820><c> because</c><00:12:48.420><c> then</c><00:12:48.600><c> it</c><00:12:48.779><c> becomes</c> 00:12:49.009 --> 00:12:49.019 align:start position:0% through because then it becomes 00:12:49.019 --> 00:12:55.730 align:start position:0% through because then it becomes predictable 00:12:55.730 --> 00:12:55.740 align:start position:0% 00:12:55.740 --> 00:12:58.310 align:start position:0% just<00:12:56.579><c> from</c><00:12:57.000><c> from</c><00:12:57.240><c> our</c><00:12:57.480><c> side</c><00:12:57.720><c> some</c><00:12:58.079><c> of</c><00:12:58.200><c> the</c> 00:12:58.310 --> 00:12:58.320 align:start position:0% just from from our side some of the 00:12:58.320 --> 00:13:00.829 align:start position:0% just from from our side some of the questions<00:12:58.500><c> that</c><00:12:58.860><c> we've</c><00:12:59.040><c> already</c><00:12:59.160><c> run</c><00:12:59.399><c> into</c><00:12:59.839><c> uh</c> 00:13:00.829 --> 00:13:00.839 align:start position:0% questions that we've already run into uh 00:13:00.839 --> 00:13:03.410 align:start position:0% questions that we've already run into uh some<00:13:01.019><c> of</c><00:13:01.139><c> the</c><00:13:01.200><c> questions</c><00:13:01.320><c> that</c><00:13:01.560><c> I'm</c><00:13:01.740><c> sure</c><00:13:02.420><c> you</c> 00:13:03.410 --> 00:13:03.420 align:start position:0% some of the questions that I'm sure you 00:13:03.420 --> 00:13:05.449 align:start position:0% some of the questions that I'm sure you have<00:13:03.600><c> as</c><00:13:03.779><c> well</c><00:13:03.959><c> and</c><00:13:04.860><c> that</c><00:13:04.980><c> I</c><00:13:05.160><c> wanted</c><00:13:05.220><c> to</c> 00:13:05.449 --> 00:13:05.459 align:start position:0% have as well and that I wanted to 00:13:05.459 --> 00:13:06.889 align:start position:0% have as well and that I wanted to present<00:13:05.700><c> because</c><00:13:05.940><c> I</c><00:13:06.180><c> think</c><00:13:06.300><c> they</c><00:13:06.480><c> are</c><00:13:06.660><c> they</c> 00:13:06.889 --> 00:13:06.899 align:start position:0% present because I think they are they 00:13:06.899 --> 00:13:10.370 align:start position:0% present because I think they are they are<00:13:07.079><c> important</c><00:13:07.500><c> and</c><00:13:08.160><c> uh</c><00:13:08.820><c> and</c><00:13:09.360><c> and</c> 00:13:10.370 --> 00:13:10.380 align:start position:0% are important and uh and and 00:13:10.380 --> 00:13:12.350 align:start position:0% are important and uh and and if<00:13:10.860><c> I'm</c><00:13:11.040><c> honest</c><00:13:11.279><c> they</c><00:13:11.519><c> make</c><00:13:11.820><c> a</c><00:13:11.940><c> lot</c><00:13:12.060><c> of</c><00:13:12.120><c> they</c> 00:13:12.350 --> 00:13:12.360 align:start position:0% if I'm honest they make a lot of they 00:13:12.360 --> 00:13:13.610 align:start position:0% if I'm honest they make a lot of they make<00:13:12.480><c> a</c><00:13:12.600><c> lot</c><00:13:12.720><c> of</c><00:13:12.779><c> sense</c><00:13:12.899><c> we</c><00:13:13.260><c> see</c><00:13:13.440><c> these</c> 00:13:13.610 --> 00:13:13.620 align:start position:0% make a lot of sense we see these 00:13:13.620 --> 00:13:14.690 align:start position:0% make a lot of sense we see these questions<00:13:13.740><c> from</c><00:13:14.040><c> a</c><00:13:14.160><c> lot</c><00:13:14.220><c> of</c><00:13:14.279><c> Manufacturers</c> 00:13:14.690 --> 00:13:14.700 align:start position:0% questions from a lot of Manufacturers 00:13:14.700 --> 00:13:15.889 align:start position:0% questions from a lot of Manufacturers and<00:13:14.880><c> I'm</c><00:13:14.940><c> sure</c><00:13:15.120><c> you're</c><00:13:15.180><c> running</c><00:13:15.360><c> into</c><00:13:15.540><c> them</c><00:13:15.720><c> as</c> 00:13:15.889 --> 00:13:15.899 align:start position:0% and I'm sure you're running into them as 00:13:15.899 --> 00:13:17.090 align:start position:0% and I'm sure you're running into them as well 00:13:17.090 --> 00:13:17.100 align:start position:0% well 00:13:17.100 --> 00:13:17.870 align:start position:0% well um 00:13:17.870 --> 00:13:17.880 align:start position:0% um 00:13:17.880 --> 00:13:21.050 align:start position:0% um do<00:13:18.240><c> you</c><00:13:18.360><c> have</c><00:13:18.480><c> to</c><00:13:18.600><c> do</c><00:13:18.720><c> field</c><00:13:18.839><c> trials</c> 00:13:21.050 --> 00:13:21.060 align:start position:0% do you have to do field trials 00:13:21.060 --> 00:13:22.550 align:start position:0% do you have to do field trials probably<00:13:21.540><c> yes</c> 00:13:22.550 --> 00:13:22.560 align:start position:0% probably yes 00:13:22.560 --> 00:13:24.710 align:start position:0% probably yes uh<00:13:23.160><c> the</c><00:13:23.339><c> standard</c><00:13:23.639><c> has</c><00:13:23.820><c> a</c><00:13:24.000><c> big</c><00:13:24.120><c> preference</c><00:13:24.480><c> for</c> 00:13:24.710 --> 00:13:24.720 align:start position:0% uh the standard has a big preference for 00:13:24.720 --> 00:13:26.750 align:start position:0% uh the standard has a big preference for field<00:13:24.839><c> trials</c><00:13:25.320><c> but</c><00:13:25.680><c> if</c><00:13:25.860><c> you</c><00:13:25.980><c> have</c><00:13:26.160><c> literature</c> 00:13:26.750 --> 00:13:26.760 align:start position:0% field trials but if you have literature 00:13:26.760 --> 00:13:28.850 align:start position:0% field trials but if you have literature studies<00:13:27.420><c> or</c><00:13:27.779><c> if</c><00:13:27.959><c> you</c><00:13:28.079><c> have</c><00:13:28.200><c> other</c><00:13:28.440><c> forms</c><00:13:28.740><c> of</c> 00:13:28.850 --> 00:13:28.860 align:start position:0% studies or if you have other forms of 00:13:28.860 --> 00:13:31.310 align:start position:0% studies or if you have other forms of evidence<00:13:29.100><c> that</c><00:13:29.700><c> you</c><00:13:29.820><c> say</c><00:13:30.000><c> prove</c><00:13:30.600><c> a</c><00:13:31.079><c> particular</c> 00:13:31.310 --> 00:13:31.320 align:start position:0% evidence that you say prove a particular 00:13:31.320 --> 00:13:33.350 align:start position:0% evidence that you say prove a particular function<00:13:31.620><c> a</c><00:13:31.860><c> particular</c><00:13:32.160><c> claim</c><00:13:33.000><c> that's</c> 00:13:33.350 --> 00:13:33.360 align:start position:0% function a particular claim that's 00:13:33.360 --> 00:13:35.690 align:start position:0% function a particular claim that's allowed<00:13:33.860><c> so</c><00:13:34.860><c> you're</c><00:13:34.980><c> allowed</c><00:13:35.220><c> to</c><00:13:35.279><c> submit</c><00:13:35.579><c> that</c> 00:13:35.690 --> 00:13:35.700 align:start position:0% allowed so you're allowed to submit that 00:13:35.700 --> 00:13:37.129 align:start position:0% allowed so you're allowed to submit that to<00:13:35.820><c> the</c><00:13:35.940><c> notified</c><00:13:36.180><c> body</c><00:13:36.420><c> the</c><00:13:36.660><c> worst</c><00:13:36.839><c> that</c><00:13:37.019><c> will</c> 00:13:37.129 --> 00:13:37.139 align:start position:0% to the notified body the worst that will 00:13:37.139 --> 00:13:38.690 align:start position:0% to the notified body the worst that will happen<00:13:37.320><c> is</c><00:13:37.500><c> that</c><00:13:37.680><c> we</c><00:13:37.800><c> simply</c><00:13:38.040><c> say</c><00:13:38.220><c> we</c><00:13:38.519><c> don't</c> 00:13:38.690 --> 00:13:38.700 align:start position:0% happen is that we simply say we don't 00:13:38.700 --> 00:13:40.370 align:start position:0% happen is that we simply say we don't see<00:13:38.940><c> enough</c><00:13:39.120><c> evidence</c><00:13:39.540><c> so</c><00:13:40.019><c> that's</c><00:13:40.200><c> a</c> 00:13:40.370 --> 00:13:40.380 align:start position:0% see enough evidence so that's a 00:13:40.380 --> 00:13:41.389 align:start position:0% see enough evidence so that's a discussion<00:13:40.680><c> you</c><00:13:40.800><c> have</c><00:13:40.920><c> to</c><00:13:40.980><c> have</c><00:13:41.100><c> with</c><00:13:41.279><c> the</c> 00:13:41.389 --> 00:13:41.399 align:start position:0% discussion you have to have with the 00:13:41.399 --> 00:13:43.850 align:start position:0% discussion you have to have with the auditor<00:13:42.240><c> but</c><00:13:42.720><c> the</c><00:13:42.899><c> room</c><00:13:43.019><c> exists</c><00:13:43.500><c> and</c><00:13:43.740><c> you're</c> 00:13:43.850 --> 00:13:43.860 align:start position:0% auditor but the room exists and you're 00:13:43.860 --> 00:13:45.230 align:start position:0% auditor but the room exists and you're allowed<00:13:44.160><c> to</c><00:13:44.279><c> do</c><00:13:44.399><c> that</c> 00:13:45.230 --> 00:13:45.240 align:start position:0% allowed to do that 00:13:45.240 --> 00:13:47.150 align:start position:0% allowed to do that is<00:13:45.839><c> there</c><00:13:45.959><c> a</c><00:13:46.079><c> standard</c><00:13:46.440><c> that</c><00:13:46.740><c> you</c><00:13:46.860><c> can</c><00:13:46.980><c> test</c> 00:13:47.150 --> 00:13:47.160 align:start position:0% is there a standard that you can test 00:13:47.160 --> 00:13:48.470 align:start position:0% is there a standard that you can test your<00:13:47.339><c> field</c><00:13:47.459><c> trials</c><00:13:47.880><c> maybe</c><00:13:48.060><c> that</c><00:13:48.240><c> you</c><00:13:48.360><c> already</c> 00:13:48.470 --> 00:13:48.480 align:start position:0% your field trials maybe that you already 00:13:48.480 --> 00:13:50.329 align:start position:0% your field trials maybe that you already performed<00:13:48.959><c> against</c><00:13:49.079><c> yes</c><00:13:49.680><c> there</c><00:13:49.860><c> is</c><00:13:50.040><c> I've</c> 00:13:50.329 --> 00:13:50.339 align:start position:0% performed against yes there is I've 00:13:50.339 --> 00:13:51.769 align:start position:0% performed against yes there is I've actually<00:13:50.519><c> put</c><00:13:50.700><c> it</c><00:13:50.820><c> on</c><00:13:50.940><c> on</c><00:13:51.120><c> the</c><00:13:51.300><c> screen</c><00:13:51.420><c> as</c><00:13:51.660><c> well</c> 00:13:51.769 --> 00:13:51.779 align:start position:0% actually put it on on the screen as well 00:13:51.779 --> 00:13:53.810 align:start position:0% actually put it on on the screen as well it's<00:13:52.320><c> this</c><00:13:52.500><c> technical</c><00:13:52.860><c> specification</c><00:13:53.399><c> that</c> 00:13:53.810 --> 00:13:53.820 align:start position:0% it's this technical specification that 00:13:53.820 --> 00:13:55.610 align:start position:0% it's this technical specification that family 00:13:55.610 --> 00:13:55.620 align:start position:0% family 00:13:55.620 --> 00:13:57.650 align:start position:0% family um<00:13:55.680><c> that's</c><00:13:56.040><c> a</c><00:13:56.220><c> family</c><00:13:56.339><c> of</c><00:13:56.700><c> five</c><00:13:57.000><c> standards</c> 00:13:57.650 --> 00:13:57.660 align:start position:0% um that's a family of five standards 00:13:57.660 --> 00:14:00.110 align:start position:0% um that's a family of five standards that<00:13:58.560><c> contain</c><00:13:59.040><c> the</c><00:13:59.220><c> specific</c><00:13:59.459><c> criteria</c><00:13:59.940><c> for</c> 00:14:00.110 --> 00:14:00.120 align:start position:0% that contain the specific criteria for 00:14:00.120 --> 00:14:02.389 align:start position:0% that contain the specific criteria for doing<00:14:00.300><c> field</c><00:14:00.540><c> trials</c><00:14:01.019><c> and</c><00:14:01.740><c> for</c><00:14:01.980><c> proving</c> 00:14:02.389 --> 00:14:02.399 align:start position:0% doing field trials and for proving 00:14:02.399 --> 00:14:05.269 align:start position:0% doing field trials and for proving specific<00:14:02.760><c> claims</c><00:14:03.240><c> so</c><00:14:04.079><c> if</c><00:14:04.320><c> you</c><00:14:04.740><c> want</c><00:14:04.860><c> some</c><00:14:05.100><c> more</c> 00:14:05.269 --> 00:14:05.279 align:start position:0% specific claims so if you want some more 00:14:05.279 --> 00:14:06.650 align:start position:0% specific claims so if you want some more information<00:14:05.459><c> on</c><00:14:05.880><c> you</c><00:14:06.120><c> know</c><00:14:06.180><c> maybe</c><00:14:06.300><c> the</c><00:14:06.540><c> field</c> 00:14:06.650 --> 00:14:06.660 align:start position:0% information on you know maybe the field 00:14:06.660 --> 00:14:07.850 align:start position:0% information on you know maybe the field trials<00:14:06.959><c> you've</c><00:14:07.139><c> already</c><00:14:07.200><c> done</c><00:14:07.440><c> and</c><00:14:07.620><c> do</c><00:14:07.740><c> they</c> 00:14:07.850 --> 00:14:07.860 align:start position:0% trials you've already done and do they 00:14:07.860 --> 00:14:09.889 align:start position:0% trials you've already done and do they meet<00:14:07.980><c> the</c><00:14:08.100><c> requirements</c><00:14:08.579><c> buy</c><00:14:09.300><c> those</c><00:14:09.540><c> specific</c> 00:14:09.889 --> 00:14:09.899 align:start position:0% meet the requirements buy those specific 00:14:09.899 --> 00:14:11.930 align:start position:0% meet the requirements buy those specific standards<00:14:10.320><c> those</c><00:14:10.620><c> five</c><00:14:10.860><c> read</c><00:14:11.519><c> through</c><00:14:11.760><c> them</c> 00:14:11.930 --> 00:14:11.940 align:start position:0% standards those five read through them 00:14:11.940 --> 00:14:13.670 align:start position:0% standards those five read through them and<00:14:12.300><c> see</c><00:14:12.540><c> against</c><00:14:12.959><c> your</c><00:14:13.200><c> own</c><00:14:13.320><c> field</c><00:14:13.440><c> trial</c> 00:14:13.670 --> 00:14:13.680 align:start position:0% and see against your own field trial 00:14:13.680 --> 00:14:14.870 align:start position:0% and see against your own field trial reports 00:14:14.870 --> 00:14:14.880 align:start position:0% reports 00:14:14.880 --> 00:14:17.030 align:start position:0% reports does<00:14:15.480><c> it</c><00:14:15.660><c> but</c><00:14:15.839><c> do</c><00:14:16.019><c> our</c><00:14:16.200><c> reports</c><00:14:16.560><c> contain</c><00:14:16.860><c> all</c> 00:14:17.030 --> 00:14:17.040 align:start position:0% does it but do our reports contain all 00:14:17.040 --> 00:14:18.530 align:start position:0% does it but do our reports contain all the<00:14:17.160><c> information</c><00:14:17.339><c> that</c><00:14:17.820><c> is</c><00:14:17.940><c> listed</c><00:14:18.300><c> in</c><00:14:18.420><c> the</c> 00:14:18.530 --> 00:14:18.540 align:start position:0% the information that is listed in the 00:14:18.540 --> 00:14:20.150 align:start position:0% the information that is listed in the standard<00:14:18.779><c> if</c><00:14:18.959><c> it</c><00:14:19.139><c> does</c><00:14:19.320><c> there's</c><00:14:19.860><c> a</c><00:14:20.040><c> good</c> 00:14:20.150 --> 00:14:20.160 align:start position:0% standard if it does there's a good 00:14:20.160 --> 00:14:21.470 align:start position:0% standard if it does there's a good chance<00:14:20.279><c> you</c><00:14:20.519><c> can</c><00:14:20.579><c> start</c><00:14:20.700><c> certification</c><00:14:21.240><c> with</c> 00:14:21.470 --> 00:14:21.480 align:start position:0% chance you can start certification with 00:14:21.480 --> 00:14:23.449 align:start position:0% chance you can start certification with them 00:14:23.449 --> 00:14:23.459 align:start position:0% them 00:14:23.459 --> 00:14:25.250 align:start position:0% them um<00:14:23.519><c> can</c><00:14:23.760><c> we</c><00:14:23.940><c> review</c><00:14:24.120><c> field</c><00:14:24.360><c> trial</c><00:14:24.600><c> designs</c><00:14:25.079><c> so</c> 00:14:25.250 --> 00:14:25.260 align:start position:0% um can we review field trial designs so 00:14:25.260 --> 00:14:26.990 align:start position:0% um can we review field trial designs so maybe<00:14:25.440><c> you</c><00:14:25.800><c> you're</c><00:14:26.100><c> in</c><00:14:26.339><c> the</c><00:14:26.459><c> process</c><00:14:26.639><c> of</c><00:14:26.820><c> just</c> 00:14:26.990 --> 00:14:27.000 align:start position:0% maybe you you're in the process of just 00:14:27.000 --> 00:14:29.269 align:start position:0% maybe you you're in the process of just getting<00:14:27.180><c> started</c><00:14:27.540><c> yes</c><00:14:28.019><c> we</c><00:14:28.200><c> can</c> 00:14:29.269 --> 00:14:29.279 align:start position:0% getting started yes we can 00:14:29.279 --> 00:14:30.949 align:start position:0% getting started yes we can simply<00:14:29.760><c> put</c><00:14:29.940><c> if</c><00:14:30.180><c> you</c><00:14:30.300><c> haven't</c><00:14:30.480><c> done</c><00:14:30.660><c> any</c><00:14:30.779><c> field</c> 00:14:30.949 --> 00:14:30.959 align:start position:0% simply put if you haven't done any field 00:14:30.959 --> 00:14:32.569 align:start position:0% simply put if you haven't done any field trials<00:14:31.320><c> you</c><00:14:31.740><c> want</c><00:14:31.860><c> to</c><00:14:31.980><c> start</c><00:14:32.100><c> certification</c> 00:14:32.569 --> 00:14:32.579 align:start position:0% trials you want to start certification 00:14:32.579 --> 00:14:34.009 align:start position:0% trials you want to start certification and<00:14:32.880><c> you</c><00:14:32.940><c> want</c><00:14:33.060><c> to</c><00:14:33.180><c> know</c><00:14:33.240><c> up</c><00:14:33.420><c> front</c><00:14:33.600><c> that</c><00:14:33.839><c> the</c> 00:14:34.009 --> 00:14:34.019 align:start position:0% and you want to know up front that the 00:14:34.019 --> 00:14:35.750 align:start position:0% and you want to know up front that the trials<00:14:34.320><c> you</c><00:14:34.440><c> do</c><00:14:34.560><c> meet</c><00:14:34.740><c> the</c><00:14:34.920><c> requirements</c><00:14:35.399><c> we</c> 00:14:35.750 --> 00:14:35.760 align:start position:0% trials you do meet the requirements we 00:14:35.760 --> 00:14:37.730 align:start position:0% trials you do meet the requirements we can<00:14:35.880><c> approve</c><00:14:36.240><c> them</c><00:14:36.420><c> up</c><00:14:36.899><c> front</c><00:14:37.079><c> before</c> 00:14:37.730 --> 00:14:37.740 align:start position:0% can approve them up front before 00:14:37.740 --> 00:14:40.250 align:start position:0% can approve them up front before actually<00:14:38.040><c> doing</c><00:14:38.279><c> the</c><00:14:38.519><c> trials</c> 00:14:40.250 --> 00:14:40.260 align:start position:0% actually doing the trials 00:14:40.260 --> 00:14:41.629 align:start position:0% actually doing the trials um 00:14:41.629 --> 00:14:41.639 align:start position:0% um 00:14:41.639 --> 00:14:42.949 align:start position:0% um what<00:14:42.060><c> do</c><00:14:42.180><c> you</c><00:14:42.240><c> have</c><00:14:42.360><c> to</c><00:14:42.420><c> do</c><00:14:42.540><c> for</c><00:14:42.660><c> the</c><00:14:42.720><c> risk</c> 00:14:42.949 --> 00:14:42.959 align:start position:0% what do you have to do for the risk 00:14:42.959 --> 00:14:45.410 align:start position:0% what do you have to do for the risk assessment<00:14:43.260><c> because</c><00:14:43.560><c> the</c><00:14:43.740><c> FBR</c><00:14:44.180><c> includes</c><00:14:45.180><c> the</c> 00:14:45.410 --> 00:14:45.420 align:start position:0% assessment because the FBR includes the 00:14:45.420 --> 00:14:46.970 align:start position:0% assessment because the FBR includes the requirement<00:14:45.779><c> to</c><00:14:46.019><c> send</c><00:14:46.139><c> a</c><00:14:46.320><c> risk</c><00:14:46.560><c> assessment</c><00:14:46.800><c> to</c> 00:14:46.970 --> 00:14:46.980 align:start position:0% requirement to send a risk assessment to 00:14:46.980 --> 00:14:49.250 align:start position:0% requirement to send a risk assessment to a<00:14:47.100><c> notified</c><00:14:47.279><c> body</c><00:14:47.519><c> in</c><00:14:47.940><c> truth</c><00:14:48.180><c> you</c><00:14:48.839><c> do</c><00:14:48.959><c> have</c><00:14:49.079><c> to</c> 00:14:49.250 --> 00:14:49.260 align:start position:0% a notified body in truth you do have to 00:14:49.260 --> 00:14:51.530 align:start position:0% a notified body in truth you do have to send<00:14:49.440><c> us</c><00:14:49.560><c> a</c><00:14:49.740><c> document</c><00:14:50.040><c> somehow</c><00:14:51.000><c> explaining</c> 00:14:51.530 --> 00:14:51.540 align:start position:0% send us a document somehow explaining 00:14:51.540 --> 00:14:53.449 align:start position:0% send us a document somehow explaining what<00:14:51.720><c> the</c><00:14:51.839><c> risks</c><00:14:52.139><c> are</c><00:14:52.260><c> of</c><00:14:52.380><c> the</c><00:14:52.560><c> product</c><00:14:52.680><c> but</c><00:14:53.279><c> we</c> 00:14:53.449 --> 00:14:53.459 align:start position:0% what the risks are of the product but we 00:14:53.459 --> 00:14:54.530 align:start position:0% what the risks are of the product but we don't<00:14:53.579><c> actually</c><00:14:53.699><c> evaluate</c><00:14:54.240><c> it</c><00:14:54.360><c> because</c> 00:14:54.530 --> 00:14:54.540 align:start position:0% don't actually evaluate it because 00:14:54.540 --> 00:14:56.269 align:start position:0% don't actually evaluate it because there's<00:14:54.660><c> no</c><00:14:54.839><c> requirement</c><00:14:55.199><c> for</c><00:14:55.380><c> doing</c><00:14:55.560><c> that</c><00:14:55.740><c> so</c> 00:14:56.269 --> 00:14:56.279 align:start position:0% there's no requirement for doing that so 00:14:56.279 --> 00:14:58.189 align:start position:0% there's no requirement for doing that so the<00:14:56.399><c> risk</c><00:14:56.579><c> assessment</c><00:14:56.940><c> is</c><00:14:57.180><c> something</c><00:14:57.420><c> that's</c> 00:14:58.189 --> 00:14:58.199 align:start position:0% the risk assessment is something that's 00:14:58.199 --> 00:14:59.750 align:start position:0% the risk assessment is something that's more<00:14:58.440><c> for</c><00:14:58.620><c> you</c><00:14:58.740><c> internally</c><00:14:59.100><c> to</c><00:14:59.339><c> check</c><00:14:59.459><c> what</c> 00:14:59.750 --> 00:14:59.760 align:start position:0% more for you internally to check what 00:14:59.760 --> 00:15:01.550 align:start position:0% more for you internally to check what are<00:14:59.880><c> the</c><00:15:00.000><c> specific</c><00:15:00.240><c> risks</c><00:15:00.540><c> of</c><00:15:00.660><c> the</c><00:15:00.779><c> product</c><00:15:00.899><c> if</c> 00:15:01.550 --> 00:15:01.560 align:start position:0% are the specific risks of the product if 00:15:01.560 --> 00:15:03.350 align:start position:0% are the specific risks of the product if there<00:15:01.740><c> aren't</c><00:15:01.860><c> any</c> 00:15:03.350 --> 00:15:03.360 align:start position:0% there aren't any 00:15:03.360 --> 00:15:06.230 align:start position:0% there aren't any simple<00:15:03.959><c> that's</c><00:15:04.320><c> it</c> 00:15:06.230 --> 00:15:06.240 align:start position:0% simple that's it 00:15:06.240 --> 00:15:09.530 align:start position:0% simple that's it um<00:15:06.360><c> CMC</c><00:15:07.079><c> 7</c><00:15:07.320><c> and</c><00:15:07.560><c> 10</c><00:15:07.740><c> so</c><00:15:08.220><c> obviously</c><00:15:09.180><c> if</c><00:15:09.360><c> you</c><00:15:09.480><c> have</c> 00:15:09.530 --> 00:15:09.540 align:start position:0% um CMC 7 and 10 so obviously if you have 00:15:09.540 --> 00:15:11.230 align:start position:0% um CMC 7 and 10 so obviously if you have microorganisms<00:15:10.380><c> that</c><00:15:10.500><c> are</c><00:15:10.620><c> not</c><00:15:10.680><c> on</c><00:15:10.800><c> the</c><00:15:10.980><c> list</c> 00:15:11.230 --> 00:15:11.240 align:start position:0% microorganisms that are not on the list 00:15:11.240 --> 00:15:13.730 align:start position:0% microorganisms that are not on the list unfortunately<00:15:12.240><c> you</c><00:15:13.019><c> can't</c><00:15:13.139><c> certify</c><00:15:13.560><c> those</c> 00:15:13.730 --> 00:15:13.740 align:start position:0% unfortunately you can't certify those 00:15:13.740 --> 00:15:15.530 align:start position:0% unfortunately you can't certify those biostiments<00:15:14.579><c> so</c><00:15:14.760><c> if</c><00:15:14.880><c> you</c><00:15:14.940><c> have</c><00:15:15.060><c> a</c><00:15:15.180><c> microbial</c> 00:15:15.530 --> 00:15:15.540 align:start position:0% biostiments so if you have a microbial 00:15:15.540 --> 00:15:18.410 align:start position:0% biostiments so if you have a microbial biostimulant<00:15:16.320><c> with</c><00:15:16.800><c> a</c><00:15:16.920><c> microorganism</c><00:15:17.519><c> in</c><00:15:18.120><c> in</c> 00:15:18.410 --> 00:15:18.420 align:start position:0% biostimulant with a microorganism in in 00:15:18.420 --> 00:15:20.449 align:start position:0% biostimulant with a microorganism in in that's<00:15:18.959><c> not</c><00:15:19.139><c> in</c><00:15:19.380><c> one</c><00:15:19.560><c> of</c><00:15:19.680><c> the</c><00:15:19.800><c> four</c><00:15:19.980><c> four</c> 00:15:20.449 --> 00:15:20.459 align:start position:0% that's not in one of the four four 00:15:20.459 --> 00:15:22.790 align:start position:0% that's not in one of the four four families<00:15:20.820><c> included</c><00:15:21.300><c> in</c><00:15:21.660><c> the</c><00:15:22.019><c> cmc7</c><00:15:22.500><c> list</c> 00:15:22.790 --> 00:15:22.800 align:start position:0% families included in the cmc7 list 00:15:22.800 --> 00:15:25.310 align:start position:0% families included in the cmc7 list unfortunately<00:15:23.459><c> for</c><00:15:23.940><c> now</c><00:15:24.180><c> we</c><00:15:24.899><c> can't</c><00:15:25.019><c> do</c><00:15:25.199><c> the</c> 00:15:25.310 --> 00:15:25.320 align:start position:0% unfortunately for now we can't do the 00:15:25.320 --> 00:15:28.430 align:start position:0% unfortunately for now we can't do the certification 00:15:28.430 --> 00:15:28.440 align:start position:0% 00:15:28.440 --> 00:15:30.410 align:start position:0% um<00:15:28.500><c> same</c><00:15:28.740><c> with</c><00:15:28.920><c> CMC</c><00:15:29.339><c> 10</c><00:15:29.519><c> if</c><00:15:29.760><c> you</c><00:15:29.880><c> have</c><00:15:30.000><c> products</c> 00:15:30.410 --> 00:15:30.420 align:start position:0% um same with CMC 10 if you have products 00:15:30.420 --> 00:15:32.269 align:start position:0% um same with CMC 10 if you have products that<00:15:30.540><c> use</c><00:15:30.720><c> animal</c><00:15:30.959><c> byproducts</c> 00:15:32.269 --> 00:15:32.279 align:start position:0% that use animal byproducts 00:15:32.279 --> 00:15:34.310 align:start position:0% that use animal byproducts unfortunately<00:15:33.000><c> at</c><00:15:33.180><c> the</c><00:15:33.300><c> moment</c><00:15:33.480><c> we</c><00:15:33.959><c> can</c><00:15:34.139><c> only</c> 00:15:34.310 --> 00:15:34.320 align:start position:0% unfortunately at the moment we can only 00:15:34.320 --> 00:15:36.110 align:start position:0% unfortunately at the moment we can only start<00:15:34.920><c> the</c><00:15:35.100><c> certification</c><00:15:35.519><c> but</c><00:15:35.820><c> we</c><00:15:36.000><c> can't</c> 00:15:36.110 --> 00:15:36.120 align:start position:0% start the certification but we can't 00:15:36.120 --> 00:15:37.730 align:start position:0% start the certification but we can't complete<00:15:36.540><c> it</c><00:15:36.660><c> because</c><00:15:37.019><c> we're</c><00:15:37.260><c> still</c><00:15:37.440><c> waiting</c> 00:15:37.730 --> 00:15:37.740 align:start position:0% complete it because we're still waiting 00:15:37.740 --> 00:15:41.210 align:start position:0% complete it because we're still waiting on<00:15:37.920><c> on</c><00:15:38.100><c> an</c><00:15:38.279><c> additional</c><00:15:38.579><c> delegated</c><00:15:39.000><c> Act</c> 00:15:41.210 --> 00:15:41.220 align:start position:0% on on an additional delegated Act 00:15:41.220 --> 00:15:43.490 align:start position:0% on on an additional delegated Act um<00:15:41.279><c> if</c><00:15:41.940><c> can</c><00:15:42.120><c> you</c><00:15:42.300><c> use</c><00:15:42.420><c> existing</c><00:15:42.899><c> test</c><00:15:43.079><c> reports</c> 00:15:43.490 --> 00:15:43.500 align:start position:0% um if can you use existing test reports 00:15:43.500 --> 00:15:45.110 align:start position:0% um if can you use existing test reports for<00:15:43.740><c> example</c><00:15:43.980><c> based</c><00:15:44.459><c> on</c><00:15:44.699><c> German</c><00:15:44.880><c> National</c> 00:15:45.110 --> 00:15:45.120 align:start position:0% for example based on German National 00:15:45.120 --> 00:15:47.329 align:start position:0% for example based on German National rules<00:15:45.480><c> yes</c><00:15:45.779><c> if</c><00:15:46.380><c> you</c><00:15:46.560><c> have</c><00:15:46.620><c> test</c><00:15:46.860><c> reports</c><00:15:47.220><c> from</c> 00:15:47.329 --> 00:15:47.339 align:start position:0% rules yes if you have test reports from 00:15:47.339 --> 00:15:50.689 align:start position:0% rules yes if you have test reports from Veda<00:15:47.699><c> luffa</c><00:15:48.060><c> we</c><00:15:48.660><c> accept</c><00:15:48.839><c> them</c> 00:15:50.689 --> 00:15:50.699 align:start position:0% Veda luffa we accept them 00:15:50.699 --> 00:15:52.910 align:start position:0% Veda luffa we accept them um<00:15:50.820><c> same</c><00:15:51.240><c> with</c><00:15:51.420><c> Claims</c><00:15:51.839><c> can</c><00:15:52.440><c> you</c><00:15:52.620><c> add</c> 00:15:52.910 --> 00:15:52.920 align:start position:0% um same with Claims can you add 00:15:52.920 --> 00:15:54.710 align:start position:0% um same with Claims can you add additional<00:15:53.399><c> claims</c><00:15:53.820><c> later</c><00:15:54.180><c> on</c><00:15:54.420><c> in</c><00:15:54.600><c> the</c> 00:15:54.710 --> 00:15:54.720 align:start position:0% additional claims later on in the 00:15:54.720 --> 00:15:57.170 align:start position:0% additional claims later on in the process<00:15:54.959><c> yes</c><00:15:55.680><c> so</c><00:15:56.279><c> let's</c><00:15:56.399><c> say</c><00:15:56.579><c> you</c><00:15:56.760><c> start</c><00:15:56.940><c> with</c> 00:15:57.170 --> 00:15:57.180 align:start position:0% process yes so let's say you start with 00:15:57.180 --> 00:15:59.569 align:start position:0% process yes so let's say you start with a<00:15:57.300><c> specific</c><00:15:57.540><c> claim</c><00:15:57.959><c> for</c><00:15:58.380><c> broad</c><00:15:58.860><c> acre</c><00:15:59.220><c> crops</c> 00:15:59.569 --> 00:15:59.579 align:start position:0% a specific claim for broad acre crops 00:15:59.579 --> 00:16:01.730 align:start position:0% a specific claim for broad acre crops nutrient<00:16:00.180><c> use</c><00:16:00.360><c> efficiency</c><00:16:00.779><c> and</c><00:16:01.440><c> then</c><00:16:01.560><c> after</c> 00:16:01.730 --> 00:16:01.740 align:start position:0% nutrient use efficiency and then after 00:16:01.740 --> 00:16:03.769 align:start position:0% nutrient use efficiency and then after half<00:16:02.040><c> a</c><00:16:02.220><c> year</c><00:16:02.339><c> you</c><00:16:02.579><c> want</c><00:16:02.699><c> to</c><00:16:02.820><c> expand</c><00:16:03.120><c> that</c><00:16:03.420><c> so</c> 00:16:03.769 --> 00:16:03.779 align:start position:0% half a year you want to expand that so 00:16:03.779 --> 00:16:04.870 align:start position:0% half a year you want to expand that so that<00:16:03.959><c> the</c><00:16:04.079><c> product</c> 00:16:04.870 --> 00:16:04.880 align:start position:0% that the product 00:16:04.880 --> 00:16:07.490 align:start position:0% that the product has<00:16:05.880><c> a</c><00:16:06.060><c> claim</c><00:16:06.300><c> for</c><00:16:06.480><c> for</c><00:16:06.720><c> any</c><00:16:06.959><c> crop</c><00:16:07.199><c> for</c><00:16:07.440><c> any</c> 00:16:07.490 --> 00:16:07.500 align:start position:0% has a claim for for any crop for any 00:16:07.500 --> 00:16:09.470 align:start position:0% has a claim for for any crop for any crop<00:16:07.740><c> group</c><00:16:07.920><c> you</c><00:16:08.699><c> simply</c><00:16:08.940><c> send</c><00:16:09.120><c> in</c><00:16:09.300><c> the</c> 00:16:09.470 --> 00:16:09.480 align:start position:0% crop group you simply send in the 00:16:09.480 --> 00:16:11.150 align:start position:0% crop group you simply send in the additional<00:16:09.779><c> test</c><00:16:09.959><c> reports</c><00:16:10.380><c> so</c><00:16:10.620><c> just</c><00:16:10.800><c> that</c><00:16:10.980><c> bit</c> 00:16:11.150 --> 00:16:11.160 align:start position:0% additional test reports so just that bit 00:16:11.160 --> 00:16:13.310 align:start position:0% additional test reports so just that bit we<00:16:11.760><c> re-evaluate</c><00:16:12.360><c> the</c><00:16:12.480><c> certificate</c><00:16:12.959><c> and</c><00:16:13.139><c> give</c> 00:16:13.310 --> 00:16:13.320 align:start position:0% we re-evaluate the certificate and give 00:16:13.320 --> 00:16:15.110 align:start position:0% we re-evaluate the certificate and give you<00:16:13.380><c> an</c><00:16:13.560><c> updated</c><00:16:13.860><c> certificate</c><00:16:14.459><c> so</c><00:16:14.880><c> that</c> 00:16:15.110 --> 00:16:15.120 align:start position:0% you an updated certificate so that 00:16:15.120 --> 00:16:16.610 align:start position:0% you an updated certificate so that process<00:16:15.360><c> is</c><00:16:15.540><c> quite</c><00:16:15.720><c> simple</c><00:16:15.839><c> as</c><00:16:16.079><c> well</c><00:16:16.260><c> and</c><00:16:16.560><c> of</c> 00:16:16.610 --> 00:16:16.620 align:start position:0% process is quite simple as well and of 00:16:16.620 --> 00:16:17.870 align:start position:0% process is quite simple as well and of course<00:16:16.740><c> the</c><00:16:16.920><c> costs</c><00:16:17.220><c> are</c><00:16:17.279><c> a</c><00:16:17.459><c> lot</c><00:16:17.519><c> lower</c><00:16:17.699><c> than</c> 00:16:17.870 --> 00:16:17.880 align:start position:0% course the costs are a lot lower than 00:16:17.880 --> 00:16:19.569 align:start position:0% course the costs are a lot lower than the<00:16:18.060><c> initial</c><00:16:18.300><c> certification</c> 00:16:19.569 --> 00:16:19.579 align:start position:0% the initial certification 00:16:19.579 --> 00:16:21.889 align:start position:0% the initial certification uh<00:16:20.579><c> same</c><00:16:20.940><c> with</c><00:16:21.120><c> adding</c><00:16:21.360><c> claims</c><00:16:21.660><c> during</c> 00:16:21.889 --> 00:16:21.899 align:start position:0% uh same with adding claims during 00:16:21.899 --> 00:16:23.990 align:start position:0% uh same with adding claims during certification<00:16:22.500><c> if</c><00:16:22.860><c> you</c><00:16:22.980><c> do</c><00:16:23.279><c> the</c><00:16:23.399><c> field</c><00:16:23.519><c> trials</c> 00:16:23.990 --> 00:16:24.000 align:start position:0% certification if you do the field trials 00:16:24.000 --> 00:16:26.150 align:start position:0% certification if you do the field trials and<00:16:24.600><c> then</c><00:16:24.660><c> maybe</c><00:16:24.899><c> you</c><00:16:25.380><c> know</c><00:16:25.440><c> you</c><00:16:25.620><c> order</c><00:16:25.860><c> some</c> 00:16:26.150 --> 00:16:26.160 align:start position:0% and then maybe you know you order some 00:16:26.160 --> 00:16:28.490 align:start position:0% and then maybe you know you order some additional<00:16:26.459><c> ones</c><00:16:26.760><c> and</c><00:16:27.060><c> there</c><00:16:27.720><c> were</c><00:16:27.839><c> maybe</c><00:16:27.959><c> the</c> 00:16:28.490 --> 00:16:28.500 align:start position:0% additional ones and there were maybe the 00:16:28.500 --> 00:16:29.810 align:start position:0% additional ones and there were maybe the product<00:16:28.680><c> does</c><00:16:28.920><c> more</c><00:16:29.220><c> than</c><00:16:29.519><c> what</c><00:16:29.699><c> you</c> 00:16:29.810 --> 00:16:29.820 align:start position:0% product does more than what you 00:16:29.820 --> 00:16:31.910 align:start position:0% product does more than what you initially<00:16:30.120><c> expected</c><00:16:30.540><c> until</c><00:16:31.260><c> the</c><00:16:31.500><c> certificate</c> 00:16:31.910 --> 00:16:31.920 align:start position:0% initially expected until the certificate 00:16:31.920 --> 00:16:33.590 align:start position:0% initially expected until the certificate is<00:16:31.980><c> issued</c><00:16:32.279><c> you</c><00:16:32.459><c> can</c><00:16:32.579><c> basically</c><00:16:32.940><c> send</c><00:16:33.420><c> in</c> 00:16:33.590 --> 00:16:33.600 align:start position:0% is issued you can basically send in 00:16:33.600 --> 00:16:35.629 align:start position:0% is issued you can basically send in evidence<00:16:33.959><c> and</c><00:16:34.320><c> and</c><00:16:34.500><c> as</c><00:16:34.740><c> long</c><00:16:34.920><c> as</c><00:16:34.980><c> you</c><00:16:35.220><c> prove</c><00:16:35.519><c> a</c> 00:16:35.629 --> 00:16:35.639 align:start position:0% evidence and and as long as you prove a 00:16:35.639 --> 00:16:37.430 align:start position:0% evidence and and as long as you prove a particular<00:16:35.880><c> claim</c><00:16:36.240><c> you</c><00:16:36.779><c> can</c><00:16:36.839><c> go</c><00:16:37.019><c> as</c><00:16:37.199><c> as</c> 00:16:37.430 --> 00:16:37.440 align:start position:0% particular claim you can go as as 00:16:37.440 --> 00:16:39.170 align:start position:0% particular claim you can go as as expansive<00:16:37.920><c> as</c><00:16:38.100><c> you</c><00:16:38.220><c> want</c><00:16:38.339><c> during</c><00:16:38.699><c> the</c><00:16:38.880><c> process</c> 00:16:39.170 --> 00:16:39.180 align:start position:0% expansive as you want during the process 00:16:39.180 --> 00:16:41.090 align:start position:0% expansive as you want during the process so<00:16:39.660><c> that</c><00:16:39.839><c> there's</c><00:16:40.199><c> nothing</c><00:16:40.440><c> that's</c><00:16:40.680><c> fixed</c><00:16:40.980><c> up</c> 00:16:41.090 --> 00:16:41.100 align:start position:0% so that there's nothing that's fixed up 00:16:41.100 --> 00:16:43.910 align:start position:0% so that there's nothing that's fixed up front<00:16:41.279><c> in</c><00:16:41.519><c> in</c><00:16:41.699><c> that</c><00:16:42.060><c> regard</c> 00:16:43.910 --> 00:16:43.920 align:start position:0% front in in that regard 00:16:43.920 --> 00:16:45.590 align:start position:0% front in in that regard um 00:16:45.590 --> 00:16:45.600 align:start position:0% um 00:16:45.600 --> 00:16:47.990 align:start position:0% um about<00:16:46.079><c> notified</c><00:16:46.560><c> bodies</c><00:16:47.040><c> are</c><00:16:47.399><c> there</c><00:16:47.579><c> delays</c> 00:16:47.990 --> 00:16:48.000 align:start position:0% about notified bodies are there delays 00:16:48.000 --> 00:16:49.970 align:start position:0% about notified bodies are there delays are<00:16:48.300><c> there</c><00:16:48.420><c> backlogs</c><00:16:49.079><c> I</c><00:16:49.500><c> obviously</c><00:16:49.800><c> can't</c> 00:16:49.970 --> 00:16:49.980 align:start position:0% are there backlogs I obviously can't 00:16:49.980 --> 00:16:51.470 align:start position:0% are there backlogs I obviously can't speak<00:16:50.279><c> for</c> 00:16:51.470 --> 00:16:51.480 align:start position:0% speak for 00:16:51.480 --> 00:16:54.829 align:start position:0% speak for um<00:16:51.959><c> for</c><00:16:52.500><c> everyone</c><00:16:52.740><c> in</c><00:16:53.339><c> Truth</c><00:16:53.699><c> at</c><00:16:54.000><c> the</c><00:16:54.120><c> moment</c><00:16:54.300><c> I</c> 00:16:54.829 --> 00:16:54.839 align:start position:0% um for everyone in Truth at the moment I 00:16:54.839 --> 00:16:57.710 align:start position:0% um for everyone in Truth at the moment I don't<00:16:55.019><c> think</c><00:16:55.199><c> there</c><00:16:55.440><c> are</c><00:16:55.560><c> many</c><00:16:55.740><c> many</c><00:16:56.040><c> backlogs</c> 00:16:57.710 --> 00:16:57.720 align:start position:0% don't think there are many many backlogs 00:16:57.720 --> 00:16:59.269 align:start position:0% don't think there are many many backlogs um<00:16:57.839><c> especially</c><00:16:58.259><c> with</c><00:16:58.380><c> bios</c><00:16:58.680><c> Germans</c><00:16:59.100><c> we</c><00:16:59.160><c> have</c> 00:16:59.269 --> 00:16:59.279 align:start position:0% um especially with bios Germans we have 00:16:59.279 --> 00:17:00.769 align:start position:0% um especially with bios Germans we have a<00:16:59.339><c> lot</c><00:16:59.459><c> of</c><00:16:59.519><c> interest</c><00:16:59.699><c> but</c><00:17:00.300><c> there's</c><00:17:00.420><c> a</c><00:17:00.540><c> lot</c><00:17:00.660><c> of</c> 00:17:00.769 --> 00:17:00.779 align:start position:0% a lot of interest but there's a lot of 00:17:00.779 --> 00:17:02.269 align:start position:0% a lot of interest but there's a lot of companies<00:17:00.959><c> still</c><00:17:01.139><c> doing</c><00:17:01.320><c> field</c><00:17:01.440><c> trials</c><00:17:01.860><c> so</c> 00:17:02.269 --> 00:17:02.279 align:start position:0% companies still doing field trials so 00:17:02.279 --> 00:17:04.010 align:start position:0% companies still doing field trials so that<00:17:02.519><c> two</c><00:17:02.699><c> to</c><00:17:02.820><c> four</c><00:17:02.940><c> week</c><00:17:03.060><c> timeline</c><00:17:03.480><c> that</c><00:17:03.779><c> I</c> 00:17:04.010 --> 00:17:04.020 align:start position:0% that two to four week timeline that I 00:17:04.020 --> 00:17:05.809 align:start position:0% that two to four week timeline that I mentioned<00:17:04.439><c> earlier</c><00:17:04.740><c> will</c><00:17:05.339><c> probably</c><00:17:05.579><c> be</c><00:17:05.699><c> able</c> 00:17:05.809 --> 00:17:05.819 align:start position:0% mentioned earlier will probably be able 00:17:05.819 --> 00:17:07.130 align:start position:0% mentioned earlier will probably be able to<00:17:05.939><c> guarantee</c><00:17:06.240><c> that</c><00:17:06.419><c> for</c><00:17:06.660><c> at</c><00:17:06.780><c> least</c><00:17:06.900><c> the</c><00:17:07.020><c> next</c> 00:17:07.130 --> 00:17:07.140 align:start position:0% to guarantee that for at least the next 00:17:07.140 --> 00:17:08.090 align:start position:0% to guarantee that for at least the next few<00:17:07.319><c> months</c> 00:17:08.090 --> 00:17:08.100 align:start position:0% few months 00:17:08.100 --> 00:17:09.530 align:start position:0% few months could<00:17:08.520><c> there</c><00:17:08.640><c> be</c><00:17:08.760><c> backlogs</c><00:17:09.240><c> in</c><00:17:09.299><c> the</c><00:17:09.419><c> future</c> 00:17:09.530 --> 00:17:09.540 align:start position:0% could there be backlogs in the future 00:17:09.540 --> 00:17:11.329 align:start position:0% could there be backlogs in the future yes<00:17:10.079><c> but</c><00:17:10.380><c> there</c><00:17:10.500><c> will</c><00:17:10.679><c> also</c><00:17:10.860><c> be</c><00:17:10.919><c> more</c><00:17:11.040><c> notified</c> 00:17:11.329 --> 00:17:11.339 align:start position:0% yes but there will also be more notified 00:17:11.339 --> 00:17:13.189 align:start position:0% yes but there will also be more notified bodies<00:17:11.699><c> in</c><00:17:11.819><c> the</c><00:17:11.939><c> future</c><00:17:12.059><c> so</c><00:17:12.480><c> we</c><00:17:12.660><c> don't</c><00:17:12.900><c> expect</c> 00:17:13.189 --> 00:17:13.199 align:start position:0% bodies in the future so we don't expect 00:17:13.199 --> 00:17:14.449 align:start position:0% bodies in the future so we don't expect that<00:17:13.500><c> to</c><00:17:13.679><c> be</c> 00:17:14.449 --> 00:17:14.459 align:start position:0% that to be 00:17:14.459 --> 00:17:16.370 align:start position:0% that to be too<00:17:14.880><c> big</c><00:17:15.059><c> of</c><00:17:15.179><c> a</c><00:17:15.360><c> problem</c><00:17:15.480><c> but</c><00:17:16.079><c> of</c><00:17:16.199><c> course</c> 00:17:16.370 --> 00:17:16.380 align:start position:0% too big of a problem but of course 00:17:16.380 --> 00:17:18.530 align:start position:0% too big of a problem but of course that's<00:17:17.160><c> just</c><00:17:17.339><c> with</c><00:17:17.640><c> our</c><00:17:17.819><c> specific</c><00:17:18.120><c> situation</c> 00:17:18.530 --> 00:17:18.540 align:start position:0% that's just with our specific situation 00:17:18.540 --> 00:17:21.230 align:start position:0% that's just with our specific situation maybe<00:17:19.319><c> with</c><00:17:19.559><c> other</c><00:17:19.740><c> companies</c><00:17:20.280><c> you</c><00:17:20.880><c> know</c><00:17:21.000><c> they</c> 00:17:21.230 --> 00:17:21.240 align:start position:0% maybe with other companies you know they 00:17:21.240 --> 00:17:23.210 align:start position:0% maybe with other companies you know they are<00:17:21.360><c> they</c><00:17:21.720><c> are</c><00:17:21.900><c> facing</c><00:17:22.199><c> backlogs</c><00:17:22.679><c> so</c><00:17:22.860><c> far</c><00:17:22.980><c> we</c> 00:17:23.210 --> 00:17:23.220 align:start position:0% are they are facing backlogs so far we 00:17:23.220 --> 00:17:25.850 align:start position:0% are they are facing backlogs so far we haven't<00:17:23.339><c> heard</c><00:17:23.640><c> too</c><00:17:24.299><c> many</c><00:17:24.419><c> issues</c><00:17:24.780><c> from</c><00:17:24.959><c> that</c> 00:17:25.850 --> 00:17:25.860 align:start position:0% haven't heard too many issues from that 00:17:25.860 --> 00:17:27.710 align:start position:0% haven't heard too many issues from that and<00:17:26.339><c> then</c><00:17:26.459><c> the</c><00:17:26.640><c> last</c><00:17:26.760><c> one</c> 00:17:27.710 --> 00:17:27.720 align:start position:0% and then the last one 00:17:27.720 --> 00:17:29.870 align:start position:0% and then the last one um<00:17:27.780><c> uh</c><00:17:28.439><c> which</c><00:17:28.559><c> was</c><00:17:28.740><c> a</c><00:17:28.860><c> question</c><00:17:29.040><c> that</c><00:17:29.640><c> I</c><00:17:29.820><c> want</c> 00:17:29.870 --> 00:17:29.880 align:start position:0% um uh which was a question that I want 00:17:29.880 --> 00:17:32.270 align:start position:0% um uh which was a question that I want to<00:17:29.940><c> thank</c><00:17:30.059><c> Teresa</c><00:17:30.540><c> for</c><00:17:30.660><c> for</c><00:17:30.900><c> supplying</c> 00:17:32.270 --> 00:17:32.280 align:start position:0% to thank Teresa for for supplying 00:17:32.280 --> 00:17:34.430 align:start position:0% to thank Teresa for for supplying um<00:17:32.340><c> if</c><00:17:32.520><c> you</c><00:17:32.640><c> have</c><00:17:32.760><c> a</c><00:17:32.880><c> dealer</c><00:17:33.240><c> so</c><00:17:33.840><c> you</c><00:17:34.080><c> sell</c><00:17:34.260><c> a</c> 00:17:34.430 --> 00:17:34.440 align:start position:0% um if you have a dealer so you sell a 00:17:34.440 --> 00:17:36.169 align:start position:0% um if you have a dealer so you sell a product<00:17:34.620><c> and</c><00:17:35.100><c> you</c><00:17:35.280><c> have</c><00:17:35.400><c> a</c><00:17:35.520><c> dealer</c><00:17:35.820><c> that</c> 00:17:36.169 --> 00:17:36.179 align:start position:0% product and you have a dealer that 00:17:36.179 --> 00:17:38.390 align:start position:0% product and you have a dealer that rebrands<00:17:37.140><c> that</c><00:17:37.320><c> product</c><00:17:37.500><c> what</c><00:17:38.100><c> does</c><00:17:38.220><c> they</c> 00:17:38.390 --> 00:17:38.400 align:start position:0% rebrands that product what does they 00:17:38.400 --> 00:17:40.490 align:start position:0% rebrands that product what does they have<00:17:38.520><c> to</c><00:17:38.640><c> do</c><00:17:38.760><c> the</c><00:17:39.539><c> truth</c><00:17:39.720><c> is</c><00:17:39.840><c> if</c><00:17:39.960><c> they</c><00:17:40.080><c> Rebrand</c> 00:17:40.490 --> 00:17:40.500 align:start position:0% have to do the truth is if they Rebrand 00:17:40.500 --> 00:17:42.350 align:start position:0% have to do the truth is if they Rebrand it<00:17:40.679><c> and</c><00:17:40.919><c> they</c><00:17:41.039><c> sell</c><00:17:41.220><c> it</c><00:17:41.340><c> under</c><00:17:41.520><c> their</c><00:17:41.820><c> own</c><00:17:42.179><c> name</c> 00:17:42.350 --> 00:17:42.360 align:start position:0% it and they sell it under their own name 00:17:42.360 --> 00:17:44.990 align:start position:0% it and they sell it under their own name they<00:17:43.140><c> become</c><00:17:43.440><c> the</c><00:17:43.559><c> manufacturer</c><00:17:44.160><c> which</c><00:17:44.820><c> means</c> 00:17:44.990 --> 00:17:45.000 align:start position:0% they become the manufacturer which means 00:17:45.000 --> 00:17:46.970 align:start position:0% they become the manufacturer which means they<00:17:45.179><c> will</c><00:17:45.299><c> need</c><00:17:45.480><c> somehow</c><00:17:45.840><c> to</c><00:17:46.380><c> have</c><00:17:46.559><c> access</c><00:17:46.740><c> to</c> 00:17:46.970 --> 00:17:46.980 align:start position:0% they will need somehow to have access to 00:17:46.980 --> 00:17:49.010 align:start position:0% they will need somehow to have access to the<00:17:47.100><c> technical</c><00:17:47.400><c> documentation</c><00:17:48.000><c> now</c><00:17:48.660><c> that</c><00:17:48.840><c> can</c> 00:17:49.010 --> 00:17:49.020 align:start position:0% the technical documentation now that can 00:17:49.020 --> 00:17:51.049 align:start position:0% the technical documentation now that can be<00:17:49.080><c> done</c><00:17:49.200><c> through</c><00:17:49.380><c> a</c><00:17:49.559><c> letter</c><00:17:49.679><c> of</c><00:17:49.860><c> access</c><00:17:50.059><c> if</c> 00:17:51.049 --> 00:17:51.059 align:start position:0% be done through a letter of access if 00:17:51.059 --> 00:17:52.310 align:start position:0% be done through a letter of access if you<00:17:51.179><c> really</c><00:17:51.299><c> like</c><00:17:51.480><c> your</c><00:17:51.660><c> dealer</c><00:17:52.020><c> you</c><00:17:52.140><c> can</c><00:17:52.260><c> just</c> 00:17:52.310 --> 00:17:52.320 align:start position:0% you really like your dealer you can just 00:17:52.320 --> 00:17:53.330 align:start position:0% you really like your dealer you can just send<00:17:52.440><c> them</c><00:17:52.620><c> all</c><00:17:52.740><c> the</c><00:17:52.860><c> technical</c><00:17:53.100><c> information</c> 00:17:53.330 --> 00:17:53.340 align:start position:0% send them all the technical information 00:17:53.340 --> 00:17:55.250 align:start position:0% send them all the technical information which<00:17:53.820><c> I</c><00:17:53.940><c> assume</c><00:17:54.360><c> is</c><00:17:54.480><c> not</c><00:17:54.780><c> something</c><00:17:54.960><c> that</c><00:17:55.200><c> you</c> 00:17:55.250 --> 00:17:55.260 align:start position:0% which I assume is not something that you 00:17:55.260 --> 00:17:57.049 align:start position:0% which I assume is not something that you want<00:17:55.380><c> to</c><00:17:55.559><c> do</c> 00:17:57.049 --> 00:17:57.059 align:start position:0% want to do 00:17:57.059 --> 00:17:59.090 align:start position:0% want to do um<00:17:57.120><c> but</c><00:17:57.960><c> in</c><00:17:58.140><c> truth</c><00:17:58.320><c> either</c><00:17:58.559><c> a</c><00:17:58.799><c> letter</c><00:17:58.919><c> of</c> 00:17:59.090 --> 00:17:59.100 align:start position:0% um but in truth either a letter of 00:17:59.100 --> 00:18:02.029 align:start position:0% um but in truth either a letter of access<00:17:59.220><c> or</c><00:18:00.179><c> somehow</c><00:18:00.660><c> somehow</c><00:18:01.500><c> or</c><00:18:01.620><c> another</c><00:18:01.740><c> you</c> 00:18:02.029 --> 00:18:02.039 align:start position:0% access or somehow somehow or another you 00:18:02.039 --> 00:18:03.770 align:start position:0% access or somehow somehow or another you have<00:18:02.160><c> to</c><00:18:02.280><c> have</c><00:18:02.460><c> them</c><00:18:02.640><c> have</c><00:18:03.240><c> access</c><00:18:03.419><c> to</c><00:18:03.660><c> the</c> 00:18:03.770 --> 00:18:03.780 align:start position:0% have to have them have access to the 00:18:03.780 --> 00:18:07.130 align:start position:0% have to have them have access to the technical<00:18:04.080><c> documentation</c><00:18:04.940><c> or</c><00:18:05.940><c> they</c><00:18:06.720><c> have</c><00:18:06.960><c> to</c> 00:18:07.130 --> 00:18:07.140 align:start position:0% technical documentation or they have to 00:18:07.140 --> 00:18:08.690 align:start position:0% technical documentation or they have to stop<00:18:07.320><c> rebranding</c><00:18:07.919><c> the</c><00:18:08.039><c> product</c><00:18:08.220><c> and</c><00:18:08.580><c> they</c> 00:18:08.690 --> 00:18:08.700 align:start position:0% stop rebranding the product and they 00:18:08.700 --> 00:18:10.250 align:start position:0% stop rebranding the product and they have<00:18:08.820><c> to</c><00:18:08.940><c> sell</c><00:18:09.059><c> it</c><00:18:09.179><c> as</c><00:18:09.360><c> as</c><00:18:09.539><c> your</c><00:18:09.720><c> initial</c><00:18:10.080><c> brand</c> 00:18:10.250 --> 00:18:10.260 align:start position:0% have to sell it as as your initial brand 00:18:10.260 --> 00:18:13.430 align:start position:0% have to sell it as as your initial brand and<00:18:11.220><c> add</c><00:18:11.400><c> the</c><00:18:11.520><c> labeling</c><00:18:12.000><c> branded</c><00:18:12.840><c> repackaged</c> 00:18:13.430 --> 00:18:13.440 align:start position:0% and add the labeling branded repackaged 00:18:13.440 --> 00:18:15.470 align:start position:0% and add the labeling branded repackaged by<00:18:13.620><c> but</c><00:18:14.280><c> if</c><00:18:14.400><c> they</c><00:18:14.580><c> resell</c><00:18:14.940><c> the</c><00:18:15.120><c> product</c><00:18:15.240><c> on</c> 00:18:15.470 --> 00:18:15.480 align:start position:0% by but if they resell the product on 00:18:15.480 --> 00:18:16.850 align:start position:0% by but if they resell the product on their<00:18:15.600><c> own</c><00:18:15.780><c> name</c><00:18:15.960><c> they</c><00:18:16.440><c> become</c><00:18:16.740><c> the</c> 00:18:16.850 --> 00:18:16.860 align:start position:0% their own name they become the 00:18:16.860 --> 00:18:18.289 align:start position:0% their own name they become the manufacturer<00:18:17.340><c> and</c><00:18:17.520><c> so</c><00:18:17.700><c> all</c><00:18:17.880><c> the</c><00:18:18.059><c> legal</c> 00:18:18.289 --> 00:18:18.299 align:start position:0% manufacturer and so all the legal 00:18:18.299 --> 00:18:20.570 align:start position:0% manufacturer and so all the legal responsibilities<00:18:18.780><c> of</c><00:18:19.080><c> that</c><00:18:19.260><c> they</c><00:18:20.160><c> have</c><00:18:20.400><c> to</c> 00:18:20.570 --> 00:18:20.580 align:start position:0% responsibilities of that they have to 00:18:20.580 --> 00:18:21.650 align:start position:0% responsibilities of that they have to meet 00:18:21.650 --> 00:18:21.660 align:start position:0% meet 00:18:21.660 --> 00:18:26.150 align:start position:0% meet unfortunately 00:18:26.150 --> 00:18:26.160 align:start position:0% 00:18:26.160 --> 00:18:27.950 align:start position:0% um<00:18:26.220><c> what</c><00:18:26.580><c> I</c><00:18:26.760><c> will</c><00:18:26.880><c> say</c><00:18:27.000><c> is</c><00:18:27.179><c> this</c><00:18:27.480><c> was</c><00:18:27.600><c> obviously</c> 00:18:27.950 --> 00:18:27.960 align:start position:0% um what I will say is this was obviously 00:18:27.960 --> 00:18:29.090 align:start position:0% um what I will say is this was obviously just<00:18:28.200><c> a</c> 00:18:29.090 --> 00:18:29.100 align:start position:0% just a 00:18:29.100 --> 00:18:31.370 align:start position:0% just a let's<00:18:29.580><c> say</c><00:18:29.700><c> a</c><00:18:29.820><c> sample</c><00:18:30.120><c> of</c><00:18:30.360><c> Arab</c><00:18:30.780><c> inbox</c><00:18:31.140><c> in</c> 00:18:31.370 --> 00:18:31.380 align:start position:0% let's say a sample of Arab inbox in 00:18:31.380 --> 00:18:33.169 align:start position:0% let's say a sample of Arab inbox in terms<00:18:31.559><c> of</c><00:18:31.620><c> frequently</c><00:18:31.980><c> asked</c><00:18:32.280><c> questions</c> 00:18:33.169 --> 00:18:33.179 align:start position:0% terms of frequently asked questions 00:18:33.179 --> 00:18:34.850 align:start position:0% terms of frequently asked questions what<00:18:33.600><c> I</c><00:18:33.720><c> really</c><00:18:33.840><c> say</c><00:18:34.020><c> for</c><00:18:34.200><c> for</c><00:18:34.380><c> anyone</c><00:18:34.620><c> in</c><00:18:34.740><c> the</c> 00:18:34.850 --> 00:18:34.860 align:start position:0% what I really say for for anyone in the 00:18:34.860 --> 00:18:36.350 align:start position:0% what I really say for for anyone in the room<00:18:34.980><c> today</c><00:18:35.100><c> is</c><00:18:35.280><c> if</c><00:18:35.460><c> you</c><00:18:35.640><c> have</c><00:18:35.760><c> a</c><00:18:35.940><c> question</c><00:18:36.059><c> if</c> 00:18:36.350 --> 00:18:36.360 align:start position:0% room today is if you have a question if 00:18:36.360 --> 00:18:37.549 align:start position:0% room today is if you have a question if there's<00:18:36.480><c> something</c><00:18:36.660><c> about</c><00:18:36.840><c> fpr</c><00:18:37.320><c> that</c><00:18:37.500><c> you</c> 00:18:37.549 --> 00:18:37.559 align:start position:0% there's something about fpr that you 00:18:37.559 --> 00:18:38.930 align:start position:0% there's something about fpr that you want<00:18:37.679><c> to</c><00:18:37.799><c> know</c><00:18:37.860><c> or</c><00:18:38.039><c> getting</c><00:18:38.580><c> a</c><00:18:38.820><c> product</c> 00:18:38.930 --> 00:18:38.940 align:start position:0% want to know or getting a product 00:18:38.940 --> 00:18:41.870 align:start position:0% want to know or getting a product certified<00:18:39.419><c> do</c><00:18:40.080><c> please</c><00:18:40.260><c> reach</c><00:18:40.559><c> out</c><00:18:40.679><c> to</c><00:18:40.860><c> us</c> 00:18:41.870 --> 00:18:41.880 align:start position:0% certified do please reach out to us 00:18:41.880 --> 00:18:43.370 align:start position:0% certified do please reach out to us um<00:18:42.000><c> you</c><00:18:42.299><c> know</c><00:18:42.419><c> we're</c><00:18:42.539><c> happy</c><00:18:42.780><c> to</c><00:18:42.960><c> set</c><00:18:43.080><c> up</c><00:18:43.200><c> the</c> 00:18:43.370 --> 00:18:43.380 align:start position:0% um you know we're happy to set up the 00:18:43.380 --> 00:18:44.750 align:start position:0% um you know we're happy to set up the necessary<00:18:43.860><c> calls</c><00:18:44.220><c> it's</c><00:18:44.340><c> not</c><00:18:44.520><c> like</c><00:18:44.640><c> we're</c> 00:18:44.750 --> 00:18:44.760 align:start position:0% necessary calls it's not like we're 00:18:44.760 --> 00:18:46.970 align:start position:0% necessary calls it's not like we're going<00:18:44.940><c> to</c><00:18:45.120><c> charge</c><00:18:45.539><c> you</c><00:18:45.780><c> for</c><00:18:46.020><c> that</c><00:18:46.140><c> we're</c><00:18:46.799><c> happy</c> 00:18:46.970 --> 00:18:46.980 align:start position:0% going to charge you for that we're happy 00:18:46.980 --> 00:18:47.990 align:start position:0% going to charge you for that we're happy to<00:18:47.160><c> give</c><00:18:47.280><c> off</c><00:18:47.400><c> all</c><00:18:47.640><c> the</c><00:18:47.760><c> necessary</c> 00:18:47.990 --> 00:18:48.000 align:start position:0% to give off all the necessary 00:18:48.000 --> 00:18:50.150 align:start position:0% to give off all the necessary information<00:18:48.299><c> and</c><00:18:49.140><c> we</c><00:18:49.320><c> want</c><00:18:49.559><c> a</c><00:18:49.919><c> lot</c><00:18:49.980><c> of</c><00:18:50.039><c> the</c> 00:18:50.150 --> 00:18:50.160 align:start position:0% information and we want a lot of the 00:18:50.160 --> 00:18:51.950 align:start position:0% information and we want a lot of the unclarity<00:18:50.580><c> that</c><00:18:50.820><c> exists</c><00:18:51.059><c> in</c><00:18:51.179><c> the</c><00:18:51.360><c> sector</c><00:18:51.539><c> we</c> 00:18:51.950 --> 00:18:51.960 align:start position:0% unclarity that exists in the sector we 00:18:51.960 --> 00:18:53.690 align:start position:0% unclarity that exists in the sector we want<00:18:52.080><c> to</c><00:18:52.200><c> take</c><00:18:52.320><c> that</c><00:18:52.500><c> away</c><00:18:52.679><c> and</c><00:18:53.280><c> so</c><00:18:53.460><c> if</c><00:18:53.520><c> there's</c> 00:18:53.690 --> 00:18:53.700 align:start position:0% want to take that away and so if there's 00:18:53.700 --> 00:18:54.710 align:start position:0% want to take that away and so if there's anything<00:18:53.880><c> that</c><00:18:54.059><c> you</c><00:18:54.120><c> want</c><00:18:54.240><c> to</c><00:18:54.360><c> know</c><00:18:54.480><c> either</c> 00:18:54.710 --> 00:18:54.720 align:start position:0% anything that you want to know either 00:18:54.720 --> 00:18:56.390 align:start position:0% anything that you want to know either during<00:18:55.440><c> the</c><00:18:55.620><c> conference</c><00:18:55.860><c> feel</c><00:18:56.160><c> free</c><00:18:56.340><c> to</c> 00:18:56.390 --> 00:18:56.400 align:start position:0% during the conference feel free to 00:18:56.400 --> 00:18:58.190 align:start position:0% during the conference feel free to approach<00:18:56.640><c> me</c><00:18:56.760><c> and</c><00:18:56.940><c> otherwise</c><00:18:57.240><c> send</c><00:18:57.900><c> us</c><00:18:58.080><c> an</c> 00:18:58.190 --> 00:18:58.200 align:start position:0% approach me and otherwise send us an 00:18:58.200 --> 00:19:00.529 align:start position:0% approach me and otherwise send us an email<00:18:58.380><c> and</c><00:18:58.980><c> I'll</c><00:18:59.160><c> be</c><00:18:59.340><c> happy</c><00:18:59.520><c> to</c><00:18:59.760><c> to</c><00:19:00.120><c> help</c><00:19:00.360><c> you</c> 00:19:00.529 --> 00:19:00.539 align:start position:0% email and I'll be happy to to help you 00:19:00.539 --> 00:19:02.390 align:start position:0% email and I'll be happy to to help you for<00:19:01.020><c> answer</c><00:19:01.380><c> at</c><00:19:01.620><c> least</c><00:19:01.740><c> help</c><00:19:01.860><c> answer</c><00:19:02.100><c> the</c> 00:19:02.390 --> 00:19:02.400 align:start position:0% for answer at least help answer the 00:19:02.400 --> 00:19:03.770 align:start position:0% for answer at least help answer the questions 00:19:03.770 --> 00:19:03.780 align:start position:0% questions 00:19:03.780 --> 00:19:55.970 align:start position:0% questions foreign 00:19:55.970 --> 00:19:55.980 align:start position:0% 00:19:55.980 --> 00:20:31.090 align:start position:0% um 00:20:31.090 --> 00:20:31.100 align:start position:0% 00:20:31.100 --> 00:20:33.529 align:start position:0% their<00:20:32.100><c> name</c> 00:20:33.529 --> 00:20:33.539 align:start position:0% their name 00:20:33.539 --> 00:20:43.669 align:start position:0% their name is 00:20:43.669 --> 00:20:43.679 align:start position:0% 00:20:43.679 --> 00:20:45.529 align:start position:0% how<00:20:44.160><c> can</c><00:20:44.340><c> I</c><00:20:44.520><c> be</c><00:20:44.820><c> sure</c><00:20:44.940><c> that</c><00:20:45.179><c> there</c><00:20:45.360><c> is</c> 00:20:45.529 --> 00:20:45.539 align:start position:0% how can I be sure that there is 00:20:45.539 --> 00:20:52.190 align:start position:0% how can I be sure that there is currently 00:20:52.190 --> 00:20:52.200 align:start position:0% 00:20:52.200 --> 00:20:53.810 align:start position:0% um<00:20:52.260><c> so</c> 00:20:53.810 --> 00:20:53.820 align:start position:0% um so 00:20:53.820 --> 00:20:56.210 align:start position:0% um so the<00:20:54.360><c> first</c><00:20:54.720><c> the</c><00:20:54.900><c> obviously</c><00:20:55.320><c> we</c><00:20:55.500><c> sign</c><00:20:55.740><c> the</c> 00:20:56.210 --> 00:20:56.220 align:start position:0% the first the obviously we sign the 00:20:56.220 --> 00:20:57.890 align:start position:0% the first the obviously we sign the necessary<00:20:56.520><c> confidentiality</c><00:20:57.360><c> uh</c> 00:20:57.890 --> 00:20:57.900 align:start position:0% necessary confidentiality uh 00:20:57.900 --> 00:20:59.210 align:start position:0% necessary confidentiality uh documentation<00:20:58.440><c> so</c><00:20:58.620><c> when</c><00:20:58.799><c> you</c><00:20:58.919><c> sign</c><00:20:59.039><c> a</c> 00:20:59.210 --> 00:20:59.220 align:start position:0% documentation so when you sign a 00:20:59.220 --> 00:21:00.650 align:start position:0% documentation so when you sign a contract<00:20:59.460><c> with</c><00:20:59.700><c> a</c><00:20:59.820><c> with</c><00:21:00.059><c> a</c><00:21:00.179><c> notified</c><00:21:00.419><c> body</c> 00:21:00.650 --> 00:21:00.660 align:start position:0% contract with a with a notified body 00:21:00.660 --> 00:21:03.350 align:start position:0% contract with a with a notified body there's<00:21:01.080><c> a</c><00:21:01.679><c> confidentiality</c><00:21:02.340><c> NDA</c><00:21:03.059><c> agreement</c> 00:21:03.350 --> 00:21:03.360 align:start position:0% there's a confidentiality NDA agreement 00:21:03.360 --> 00:21:05.090 align:start position:0% there's a confidentiality NDA agreement that's<00:21:03.720><c> included</c><00:21:04.140><c> in</c><00:21:04.260><c> that</c><00:21:04.380><c> which</c><00:21:04.559><c> binds</c> 00:21:05.090 --> 00:21:05.100 align:start position:0% that's included in that which binds 00:21:05.100 --> 00:21:08.090 align:start position:0% that's included in that which binds obviously<00:21:05.700><c> the</c><00:21:05.880><c> Auditors</c><00:21:06.240><c> that</c><00:21:06.360><c> we</c><00:21:06.539><c> have</c> 00:21:08.090 --> 00:21:08.100 align:start position:0% obviously the Auditors that we have 00:21:08.100 --> 00:21:11.029 align:start position:0% obviously the Auditors that we have um<00:21:08.220><c> us</c><00:21:08.760><c> and</c><00:21:09.120><c> and</c><00:21:09.299><c> you</c> 00:21:11.029 --> 00:21:11.039 align:start position:0% um us and and you 00:21:11.039 --> 00:21:12.070 align:start position:0% um us and and you um 00:21:12.070 --> 00:21:12.080 align:start position:0% um 00:21:12.080 --> 00:21:14.450 align:start position:0% um secondly<00:21:13.080><c> I</c><00:21:13.320><c> think</c><00:21:13.380><c> if</c><00:21:13.679><c> we</c><00:21:13.740><c> look</c><00:21:13.860><c> at</c><00:21:14.100><c> how</c><00:21:14.280><c> we</c> 00:21:14.450 --> 00:21:14.460 align:start position:0% secondly I think if we look at how we 00:21:14.460 --> 00:21:16.190 align:start position:0% secondly I think if we look at how we store<00:21:14.640><c> the</c><00:21:14.880><c> documentation</c><00:21:15.419><c> we</c><00:21:15.900><c> obviously</c> 00:21:16.190 --> 00:21:16.200 align:start position:0% store the documentation we obviously 00:21:16.200 --> 00:21:18.590 align:start position:0% store the documentation we obviously follow<00:21:16.440><c> the</c><00:21:16.679><c> necessary</c><00:21:17.100><c> security</c><00:21:17.700><c> protocols</c> 00:21:18.590 --> 00:21:18.600 align:start position:0% follow the necessary security protocols 00:21:18.600 --> 00:21:20.810 align:start position:0% follow the necessary security protocols and<00:21:18.660><c> information</c><00:21:18.840><c> so</c><00:21:19.380><c> in</c><00:21:20.039><c> that</c><00:21:20.100><c> regard</c><00:21:20.400><c> the</c> 00:21:20.810 --> 00:21:20.820 align:start position:0% and information so in that regard the 00:21:20.820 --> 00:21:22.789 align:start position:0% and information so in that regard the information<00:21:21.000><c> that</c><00:21:21.539><c> you</c><00:21:21.660><c> you</c><00:21:21.780><c> send</c><00:21:22.080><c> us</c><00:21:22.260><c> is</c><00:21:22.500><c> just</c> 00:21:22.789 --> 00:21:22.799 align:start position:0% information that you you send us is just 00:21:22.799 --> 00:21:25.430 align:start position:0% information that you you send us is just sent<00:21:22.980><c> to</c><00:21:23.160><c> the</c><00:21:23.340><c> auditors</c> 00:21:25.430 --> 00:21:25.440 align:start position:0% sent to the auditors 00:21:25.440 --> 00:21:27.529 align:start position:0% sent to the auditors um<00:21:25.500><c> we're</c><00:21:26.100><c> not</c><00:21:26.280><c> allowed</c><00:21:26.640><c> both</c><00:21:26.940><c> by</c><00:21:27.240><c> the</c> 00:21:27.529 --> 00:21:27.539 align:start position:0% um we're not allowed both by the 00:21:27.539 --> 00:21:29.450 align:start position:0% um we're not allowed both by the specific<00:21:27.960><c> legal</c><00:21:28.320><c> requirements</c><00:21:28.799><c> of</c><00:21:28.919><c> fpr</c><00:21:29.280><c> and</c> 00:21:29.450 --> 00:21:29.460 align:start position:0% specific legal requirements of fpr and 00:21:29.460 --> 00:21:30.770 align:start position:0% specific legal requirements of fpr and the<00:21:29.580><c> contract</c><00:21:29.820><c> that</c><00:21:30.000><c> we</c><00:21:30.179><c> signed</c><00:21:30.419><c> to</c><00:21:30.539><c> share</c> 00:21:30.770 --> 00:21:30.780 align:start position:0% the contract that we signed to share 00:21:30.780 --> 00:21:33.529 align:start position:0% the contract that we signed to share that<00:21:30.960><c> that</c><00:21:31.380><c> with</c><00:21:31.679><c> anyone</c><00:21:32.039><c> else</c> 00:21:33.529 --> 00:21:33.539 align:start position:0% that that with anyone else 00:21:33.539 --> 00:21:34.730 align:start position:0% that that with anyone else um 00:21:34.730 --> 00:21:34.740 align:start position:0% um 00:21:34.740 --> 00:21:36.770 align:start position:0% um and<00:21:35.100><c> obviously</c><00:21:35.460><c> in</c><00:21:35.760><c> terms</c><00:21:35.940><c> of</c><00:21:36.000><c> I.T</c><00:21:36.600><c> security</c> 00:21:36.770 --> 00:21:36.780 align:start position:0% and obviously in terms of I.T security 00:21:36.780 --> 00:21:38.149 align:start position:0% and obviously in terms of I.T security we<00:21:37.200><c> follow</c><00:21:37.320><c> the</c><00:21:37.500><c> necessary</c><00:21:37.860><c> International</c> 00:21:38.149 --> 00:21:38.159 align:start position:0% we follow the necessary International 00:21:38.159 --> 00:21:40.490 align:start position:0% we follow the necessary International International<00:21:38.940><c> guidelines</c><00:21:39.659><c> what</c><00:21:40.200><c> I</c><00:21:40.380><c> would</c> 00:21:40.490 --> 00:21:40.500 align:start position:0% International guidelines what I would 00:21:40.500 --> 00:21:42.230 align:start position:0% International guidelines what I would also<00:21:40.679><c> say</c><00:21:40.919><c> is</c> 00:21:42.230 --> 00:21:42.240 align:start position:0% also say is 00:21:42.240 --> 00:21:43.010 align:start position:0% also say is um<00:21:42.299><c> I</c><00:21:42.480><c> think</c><00:21:42.600><c> there's</c><00:21:42.720><c> a</c><00:21:42.900><c> difference</c> 00:21:43.010 --> 00:21:43.020 align:start position:0% um I think there's a difference 00:21:43.020 --> 00:21:44.810 align:start position:0% um I think there's a difference sometimes<00:21:43.559><c> between</c><00:21:43.799><c> what</c><00:21:44.159><c> you</c><00:21:44.340><c> have</c><00:21:44.460><c> to</c><00:21:44.640><c> send</c> 00:21:44.810 --> 00:21:44.820 align:start position:0% sometimes between what you have to send 00:21:44.820 --> 00:21:47.149 align:start position:0% sometimes between what you have to send to<00:21:45.000><c> a</c><00:21:45.179><c> notified</c><00:21:45.419><c> body</c><00:21:45.659><c> to</c><00:21:46.020><c> prove</c><00:21:46.380><c> that</c><00:21:46.980><c> the</c> 00:21:47.149 --> 00:21:47.159 align:start position:0% to a notified body to prove that the 00:21:47.159 --> 00:21:48.950 align:start position:0% to a notified body to prove that the product<00:21:47.280><c> is</c><00:21:47.520><c> safe</c><00:21:47.760><c> and</c><00:21:48.480><c> all</c><00:21:48.659><c> the</c><00:21:48.780><c> information</c> 00:21:48.950 --> 00:21:48.960 align:start position:0% product is safe and all the information 00:21:48.960 --> 00:21:50.930 align:start position:0% product is safe and all the information on<00:21:49.380><c> the</c><00:21:49.559><c> specific</c><00:21:49.799><c> formulations</c><00:21:50.340><c> so</c><00:21:50.640><c> we</c><00:21:50.820><c> just</c> 00:21:50.930 --> 00:21:50.940 align:start position:0% on the specific formulations so we just 00:21:50.940 --> 00:21:52.310 align:start position:0% on the specific formulations so we just need<00:21:51.120><c> to</c><00:21:51.240><c> know</c><00:21:51.360><c> what</c><00:21:51.600><c> ingredients</c><00:21:52.020><c> are</c><00:21:52.140><c> in</c> 00:21:52.310 --> 00:21:52.320 align:start position:0% need to know what ingredients are in 00:21:52.320 --> 00:21:54.470 align:start position:0% need to know what ingredients are in there<00:21:52.440><c> and</c><00:21:53.340><c> at</c><00:21:53.700><c> a</c><00:21:53.760><c> high</c><00:21:53.880><c> level</c><00:21:54.000><c> what</c><00:21:54.299><c> the</c> 00:21:54.470 --> 00:21:54.480 align:start position:0% there and at a high level what the 00:21:54.480 --> 00:21:56.090 align:start position:0% there and at a high level what the manufacturing<00:21:54.960><c> process</c><00:21:55.260><c> is</c><00:21:55.500><c> that</c><00:21:55.980><c> doesn't</c> 00:21:56.090 --> 00:21:56.100 align:start position:0% manufacturing process is that doesn't 00:21:56.100 --> 00:21:57.649 align:start position:0% manufacturing process is that doesn't mean<00:21:56.340><c> you</c><00:21:56.520><c> have</c><00:21:56.640><c> to</c><00:21:56.700><c> send</c><00:21:56.880><c> us</c><00:21:57.059><c> every</c><00:21:57.299><c> specific</c> 00:21:57.649 --> 00:21:57.659 align:start position:0% mean you have to send us every specific 00:21:57.659 --> 00:21:59.270 align:start position:0% mean you have to send us every specific every<00:21:58.140><c> specific</c><00:21:58.440><c> step</c><00:21:58.740><c> and</c><00:21:58.919><c> so</c><00:21:59.039><c> in</c><00:21:59.159><c> that</c> 00:21:59.270 --> 00:21:59.280 align:start position:0% every specific step and so in that 00:21:59.280 --> 00:22:01.610 align:start position:0% every specific step and so in that regard<00:21:59.520><c> I</c><00:21:59.700><c> would</c><00:21:59.820><c> also</c><00:22:00.000><c> say</c><00:22:00.600><c> the</c><00:22:01.140><c> most</c> 00:22:01.610 --> 00:22:01.620 align:start position:0% regard I would also say the most 00:22:01.620 --> 00:22:02.990 align:start position:0% regard I would also say the most confidential<00:22:02.100><c> information</c><00:22:02.280><c> is</c><00:22:02.760><c> typically</c> 00:22:02.990 --> 00:22:03.000 align:start position:0% confidential information is typically 00:22:03.000 --> 00:22:04.610 align:start position:0% confidential information is typically not<00:22:03.299><c> necessarily</c><00:22:03.780><c> what</c><00:22:04.020><c> you</c><00:22:04.140><c> have</c><00:22:04.260><c> to</c><00:22:04.380><c> send</c><00:22:04.500><c> to</c> 00:22:04.610 --> 00:22:04.620 align:start position:0% not necessarily what you have to send to 00:22:04.620 --> 00:22:05.810 align:start position:0% not necessarily what you have to send to the<00:22:04.740><c> notified</c><00:22:04.980><c> body</c><00:22:05.159><c> the</c><00:22:05.400><c> bigger</c><00:22:05.640><c> thing</c><00:22:05.700><c> is</c> 00:22:05.810 --> 00:22:05.820 align:start position:0% the notified body the bigger thing is 00:22:05.820 --> 00:22:06.830 align:start position:0% the notified body the bigger thing is you're<00:22:06.059><c> obviously</c><00:22:06.360><c> your</c><00:22:06.480><c> field</c><00:22:06.600><c> trial</c> 00:22:06.830 --> 00:22:06.840 align:start position:0% you're obviously your field trial 00:22:06.840 --> 00:22:09.890 align:start position:0% you're obviously your field trial reports<00:22:07.260><c> that</c><00:22:07.860><c> prove</c><00:22:08.100><c> efficacy</c><00:22:08.640><c> uh</c><00:22:09.600><c> which</c><00:22:09.780><c> are</c> 00:22:09.890 --> 00:22:09.900 align:start position:0% reports that prove efficacy uh which are 00:22:09.900 --> 00:22:11.810 align:start position:0% reports that prove efficacy uh which are are<00:22:10.080><c> less</c><00:22:10.260><c> confidential</c><00:22:10.799><c> at</c><00:22:11.400><c> the</c><00:22:11.520><c> same</c><00:22:11.640><c> time</c> 00:22:11.810 --> 00:22:11.820 align:start position:0% are less confidential at the same time 00:22:11.820 --> 00:22:13.190 align:start position:0% are less confidential at the same time in<00:22:12.000><c> truth</c><00:22:12.240><c> it</c><00:22:12.480><c> doesn't</c><00:22:12.539><c> matter</c><00:22:12.720><c> what</c><00:22:12.960><c> you</c><00:22:13.080><c> send</c> 00:22:13.190 --> 00:22:13.200 align:start position:0% in truth it doesn't matter what you send 00:22:13.200 --> 00:22:14.029 align:start position:0% in truth it doesn't matter what you send us 00:22:14.029 --> 00:22:14.039 align:start position:0% us 00:22:14.039 --> 00:22:15.830 align:start position:0% us it's<00:22:14.460><c> confidential</c><00:22:15.000><c> by</c><00:22:15.179><c> law</c><00:22:15.360><c> it's</c> 00:22:15.830 --> 00:22:15.840 align:start position:0% it's confidential by law it's 00:22:15.840 --> 00:22:17.570 align:start position:0% it's confidential by law it's confidential<00:22:16.440><c> by</c><00:22:16.740><c> by</c><00:22:16.919><c> obviously</c><00:22:17.340><c> our</c><00:22:17.460><c> own</c> 00:22:17.570 --> 00:22:17.580 align:start position:0% confidential by by obviously our own 00:22:17.580 --> 00:22:19.070 align:start position:0% confidential by by obviously our own accreditation<00:22:18.059><c> body</c><00:22:18.240><c> and</c><00:22:18.480><c> we're</c><00:22:18.539><c> audited</c><00:22:18.900><c> for</c> 00:22:19.070 --> 00:22:19.080 align:start position:0% accreditation body and we're audited for 00:22:19.080 --> 00:22:20.210 align:start position:0% accreditation body and we're audited for that 00:22:20.210 --> 00:22:20.220 align:start position:0% that 00:22:20.220 --> 00:22:21.649 align:start position:0% that um<00:22:20.280><c> and</c><00:22:20.520><c> we</c><00:22:20.760><c> obviously</c><00:22:21.059><c> have</c><00:22:21.240><c> the</c><00:22:21.360><c> necessary</c> 00:22:21.649 --> 00:22:21.659 align:start position:0% um and we obviously have the necessary 00:22:21.659 --> 00:22:24.590 align:start position:0% um and we obviously have the necessary I.T<00:22:22.340><c> infrastructure</c><00:22:23.340><c> in</c><00:22:23.520><c> place</c><00:22:23.760><c> to</c><00:22:24.059><c> to</c><00:22:24.240><c> be</c> 00:22:24.590 --> 00:22:24.600 align:start position:0% I.T infrastructure in place to to be 00:22:24.600 --> 00:22:26.930 align:start position:0% I.T infrastructure in place to to be able<00:22:24.720><c> to</c><00:22:24.840><c> protect</c><00:22:25.020><c> that</c> 00:22:26.930 --> 00:22:26.940 align:start position:0% able to protect that 00:22:26.940 --> 00:22:31.909 align:start position:0% able to protect that foreign 00:22:31.909 --> 00:22:31.919 align:start position:0% 00:22:31.919 --> 00:22:34.130 align:start position:0% again 00:22:34.130 --> 00:22:34.140 align:start position:0% again 00:22:34.140 --> 00:23:09.169 align:start position:0% again thank<00:22:34.980><c> God</c><00:22:35.220><c> foreign</c> 00:23:09.169 --> 00:23:09.179 align:start position:0% 00:23:09.179 --> 00:23:15.770 align:start position:0% yeah<00:23:09.780><c> thank</c><00:23:10.380><c> you</c> 00:23:15.770 --> 00:23:15.780 align:start position:0% 00:23:15.780 --> 00:23:19.430 align:start position:0% um<00:23:15.960><c> so</c><00:23:16.880><c> the</c><00:23:17.880><c> there's</c><00:23:18.299><c> there's</c><00:23:18.299><c> two</c><00:23:18.720><c> parts</c><00:23:18.900><c> to</c> 00:23:19.430 --> 00:23:19.440 align:start position:0% um so the there's there's two parts to 00:23:19.440 --> 00:23:20.510 align:start position:0% um so the there's there's two parts to answer<00:23:19.559><c> the</c><00:23:19.799><c> question</c><00:23:19.919><c> the</c><00:23:20.100><c> first</c><00:23:20.280><c> one</c><00:23:20.400><c> is</c> 00:23:20.510 --> 00:23:20.520 align:start position:0% answer the question the first one is 00:23:20.520 --> 00:23:22.070 align:start position:0% answer the question the first one is that<00:23:20.760><c> there's</c><00:23:20.940><c> some</c><00:23:21.240><c> information</c><00:23:21.419><c> for</c> 00:23:22.070 --> 00:23:22.080 align:start position:0% that there's some information for 00:23:22.080 --> 00:23:23.930 align:start position:0% that there's some information for specific<00:23:22.440><c> countries</c><00:23:22.980><c> that</c><00:23:23.520><c> you</c><00:23:23.640><c> have</c><00:23:23.820><c> to</c> 00:23:23.930 --> 00:23:23.940 align:start position:0% specific countries that you have to 00:23:23.940 --> 00:23:25.789 align:start position:0% specific countries that you have to translate<00:23:24.179><c> so</c><00:23:24.539><c> the</c><00:23:24.720><c> label</c><00:23:25.080><c> if</c><00:23:25.380><c> you</c><00:23:25.500><c> sell</c><00:23:25.620><c> that</c> 00:23:25.789 --> 00:23:25.799 align:start position:0% translate so the label if you sell that 00:23:25.799 --> 00:23:27.470 align:start position:0% translate so the label if you sell that in<00:23:25.980><c> Spain</c><00:23:26.220><c> obviously</c><00:23:26.940><c> will</c><00:23:27.059><c> have</c><00:23:27.240><c> to</c><00:23:27.299><c> be</c><00:23:27.360><c> in</c> 00:23:27.470 --> 00:23:27.480 align:start position:0% in Spain obviously will have to be in 00:23:27.480 --> 00:23:29.270 align:start position:0% in Spain obviously will have to be in Spanish<00:23:27.780><c> and</c><00:23:28.080><c> then</c><00:23:28.200><c> France</c><00:23:28.679><c> have</c><00:23:28.980><c> to</c><00:23:29.100><c> be</c><00:23:29.220><c> in</c> 00:23:29.270 --> 00:23:29.280 align:start position:0% Spanish and then France have to be in 00:23:29.280 --> 00:23:31.909 align:start position:0% Spanish and then France have to be in French<00:23:29.480><c> but</c><00:23:30.480><c> let's</c><00:23:30.840><c> say</c><00:23:31.080><c> that</c><00:23:31.440><c> the</c><00:23:31.679><c> Greek</c> 00:23:31.909 --> 00:23:31.919 align:start position:0% French but let's say that the Greek 00:23:31.919 --> 00:23:33.230 align:start position:0% French but let's say that the Greek market<00:23:32.100><c> of</c><00:23:32.400><c> surveillance</c><00:23:32.880><c> Authority</c> 00:23:33.230 --> 00:23:33.240 align:start position:0% market of surveillance Authority 00:23:33.240 --> 00:23:35.149 align:start position:0% market of surveillance Authority requests<00:23:33.840><c> your</c><00:23:33.960><c> technical</c><00:23:34.260><c> file</c><00:23:34.559><c> and</c><00:23:34.980><c> you</c> 00:23:35.149 --> 00:23:35.159 align:start position:0% requests your technical file and you 00:23:35.159 --> 00:23:37.250 align:start position:0% requests your technical file and you submit<00:23:35.460><c> that</c><00:23:35.580><c> in</c><00:23:35.760><c> German</c><00:23:35.880><c> and</c><00:23:36.840><c> they</c><00:23:36.960><c> say</c><00:23:37.080><c> I</c> 00:23:37.250 --> 00:23:37.260 align:start position:0% submit that in German and they say I 00:23:37.260 --> 00:23:38.690 align:start position:0% submit that in German and they say I can't<00:23:37.380><c> read</c><00:23:37.500><c> German</c><00:23:37.740><c> that's</c><00:23:38.400><c> not</c><00:23:38.580><c> your</c> 00:23:38.690 --> 00:23:38.700 align:start position:0% can't read German that's not your 00:23:38.700 --> 00:23:40.130 align:start position:0% can't read German that's not your problem 00:23:40.130 --> 00:23:40.140 align:start position:0% problem 00:23:40.140 --> 00:23:42.350 align:start position:0% problem that's<00:23:40.620><c> their</c><00:23:40.860><c> problem</c><00:23:41.100><c> and</c><00:23:41.700><c> so</c><00:23:41.880><c> what</c><00:23:42.059><c> we</c><00:23:42.179><c> see</c> 00:23:42.350 --> 00:23:42.360 align:start position:0% that's their problem and so what we see 00:23:42.360 --> 00:23:44.270 align:start position:0% that's their problem and so what we see also<00:23:42.659><c> in</c><00:23:42.840><c> in</c><00:23:42.960><c> other</c><00:23:43.200><c> sectors</c><00:23:43.500><c> is</c><00:23:43.740><c> that</c><00:23:43.980><c> they</c> 00:23:44.270 --> 00:23:44.280 align:start position:0% also in in other sectors is that they 00:23:44.280 --> 00:23:45.950 align:start position:0% also in in other sectors is that they then<00:23:44.460><c> but</c><00:23:44.940><c> they</c><00:23:45.120><c> then</c><00:23:45.240><c> go</c><00:23:45.419><c> out</c><00:23:45.539><c> and</c><00:23:45.780><c> either</c> 00:23:45.950 --> 00:23:45.960 align:start position:0% then but they then go out and either 00:23:45.960 --> 00:23:48.169 align:start position:0% then but they then go out and either translate<00:23:46.260><c> it</c><00:23:46.620><c> or</c><00:23:46.980><c> what</c><00:23:47.700><c> typically</c><00:23:47.940><c> happens</c> 00:23:48.169 --> 00:23:48.179 align:start position:0% translate it or what typically happens 00:23:48.179 --> 00:23:51.409 align:start position:0% translate it or what typically happens is<00:23:48.480><c> that</c><00:23:48.659><c> they</c><00:23:48.900><c> will</c><00:23:49.020><c> then</c><00:23:49.200><c> call</c><00:23:49.440><c> the</c><00:23:49.740><c> German</c> 00:23:51.409 --> 00:23:51.419 align:start position:0% is that they will then call the German 00:23:51.419 --> 00:23:53.330 align:start position:0% is that they will then call the German um<00:23:51.480><c> Market</c><00:23:51.840><c> surveillance</c><00:23:52.380><c> Authority</c> 00:23:53.330 --> 00:23:53.340 align:start position:0% um Market surveillance Authority 00:23:53.340 --> 00:23:55.490 align:start position:0% um Market surveillance Authority to<00:23:53.700><c> check</c><00:23:53.880><c> and</c><00:23:54.480><c> have</c><00:23:54.720><c> basically</c><00:23:55.140><c> for</c><00:23:55.320><c> a</c> 00:23:55.490 --> 00:23:55.500 align:start position:0% to check and have basically for a 00:23:55.500 --> 00:23:56.390 align:start position:0% to check and have basically for a consult 00:23:56.390 --> 00:23:56.400 align:start position:0% consult 00:23:56.400 --> 00:23:58.010 align:start position:0% consult so<00:23:56.760><c> we</c><00:23:56.880><c> see</c><00:23:57.000><c> this</c><00:23:57.120><c> in</c><00:23:57.299><c> other</c><00:23:57.419><c> sectors</c><00:23:57.659><c> as</c><00:23:57.900><c> well</c> 00:23:58.010 --> 00:23:58.020 align:start position:0% so we see this in other sectors as well 00:23:58.020 --> 00:23:59.450 align:start position:0% so we see this in other sectors as well and<00:23:58.200><c> where</c><00:23:58.380><c> we're</c><00:23:58.500><c> a</c><00:23:58.679><c> notified</c><00:23:58.860><c> body</c><00:23:59.100><c> as</c><00:23:59.340><c> well</c> 00:23:59.450 --> 00:23:59.460 align:start position:0% and where we're a notified body as well 00:23:59.460 --> 00:24:01.190 align:start position:0% and where we're a notified body as well that<00:23:59.820><c> there</c><00:24:00.000><c> is</c><00:24:00.179><c> partnership</c><00:24:00.539><c> between</c><00:24:00.840><c> the</c> 00:24:01.190 --> 00:24:01.200 align:start position:0% that there is partnership between the 00:24:01.200 --> 00:24:02.810 align:start position:0% that there is partnership between the the<00:24:01.320><c> different</c><00:24:01.559><c> markets</c><00:24:02.100><c> events</c><00:24:02.520><c> authorities</c> 00:24:02.810 --> 00:24:02.820 align:start position:0% the different markets events authorities 00:24:02.820 --> 00:24:04.789 align:start position:0% the different markets events authorities but<00:24:03.419><c> it's</c><00:24:03.539><c> not</c><00:24:03.659><c> like</c><00:24:03.840><c> it's</c><00:24:04.020><c> your</c><00:24:04.260><c> obligation</c> 00:24:04.789 --> 00:24:04.799 align:start position:0% but it's not like it's your obligation 00:24:04.799 --> 00:24:07.010 align:start position:0% but it's not like it's your obligation for<00:24:05.580><c> your</c><00:24:05.820><c> costs</c><00:24:06.120><c> to</c><00:24:06.179><c> have</c><00:24:06.360><c> a</c><00:24:06.539><c> technical</c><00:24:06.780><c> file</c> 00:24:07.010 --> 00:24:07.020 align:start position:0% for your costs to have a technical file 00:24:07.020 --> 00:24:09.710 align:start position:0% for your costs to have a technical file in<00:24:07.320><c> all</c><00:24:07.559><c> the</c><00:24:07.740><c> 20</c><00:24:07.919><c> I</c><00:24:08.400><c> think</c><00:24:08.580><c> 24</c><00:24:08.880><c> languages</c><00:24:09.480><c> that</c> 00:24:09.710 --> 00:24:09.720 align:start position:0% in all the 20 I think 24 languages that 00:24:09.720 --> 00:24:11.570 align:start position:0% in all the 20 I think 24 languages that we<00:24:09.840><c> have</c><00:24:09.960><c> now</c><00:24:10.080><c> in</c><00:24:10.260><c> in</c><00:24:10.380><c> the</c><00:24:10.559><c> EU</c><00:24:10.799><c> that's</c><00:24:11.220><c> not</c><00:24:11.400><c> a</c> 00:24:11.570 --> 00:24:11.580 align:start position:0% we have now in in the EU that's not a 00:24:11.580 --> 00:24:12.409 align:start position:0% we have now in in the EU that's not a requirement 00:24:12.409 --> 00:24:12.419 align:start position:0% requirement 00:24:12.419 --> 00:24:15.230 align:start position:0% requirement so<00:24:12.900><c> what</c><00:24:13.080><c> we</c><00:24:13.200><c> see</c><00:24:13.320><c> at</c><00:24:13.500><c> the</c><00:24:13.620><c> moment</c><00:24:13.740><c> is</c><00:24:14.159><c> uh</c><00:24:15.000><c> the</c> 00:24:15.230 --> 00:24:15.240 align:start position:0% so what we see at the moment is uh the 00:24:15.240 --> 00:24:17.270 align:start position:0% so what we see at the moment is uh the biggest<00:24:15.360><c> language</c><00:24:15.720><c> barrier</c><00:24:16.500><c> is</c><00:24:16.740><c> what</c><00:24:17.039><c> is</c><00:24:17.159><c> the</c> 00:24:17.270 --> 00:24:17.280 align:start position:0% biggest language barrier is what is the 00:24:17.280 --> 00:24:19.070 align:start position:0% biggest language barrier is what is the language<00:24:17.400><c> of</c><00:24:17.640><c> the</c><00:24:17.760><c> notified</c><00:24:18.059><c> bodies</c><00:24:18.480><c> so</c> 00:24:19.070 --> 00:24:19.080 align:start position:0% language of the notified bodies so 00:24:19.080 --> 00:24:20.510 align:start position:0% language of the notified bodies so unfortunately<00:24:19.500><c> because</c><00:24:19.799><c> there's</c><00:24:20.100><c> no</c><00:24:20.280><c> German</c> 00:24:20.510 --> 00:24:20.520 align:start position:0% unfortunately because there's no German 00:24:20.520 --> 00:24:23.330 align:start position:0% unfortunately because there's no German notified<00:24:21.120><c> body</c><00:24:21.419><c> at</c><00:24:21.659><c> the</c><00:24:21.780><c> moment</c><00:24:21.900><c> there</c><00:24:22.799><c> is</c><00:24:22.980><c> no</c> 00:24:23.330 --> 00:24:23.340 align:start position:0% notified body at the moment there is no 00:24:23.340 --> 00:24:25.430 align:start position:0% notified body at the moment there is no notified<00:24:24.059><c> body</c><00:24:24.360><c> that</c><00:24:24.600><c> accepts</c><00:24:24.960><c> files</c><00:24:25.320><c> in</c> 00:24:25.430 --> 00:24:25.440 align:start position:0% notified body that accepts files in 00:24:25.440 --> 00:24:27.049 align:start position:0% notified body that accepts files in German<00:24:25.679><c> so</c><00:24:26.159><c> in</c><00:24:26.220><c> our</c><00:24:26.400><c> case</c><00:24:26.520><c> it</c><00:24:26.640><c> has</c><00:24:26.760><c> to</c><00:24:26.880><c> be</c><00:24:26.940><c> in</c> 00:24:27.049 --> 00:24:27.059 align:start position:0% German so in our case it has to be in 00:24:27.059 --> 00:24:28.029 align:start position:0% German so in our case it has to be in English 00:24:28.029 --> 00:24:28.039 align:start position:0% English 00:24:28.039 --> 00:24:31.010 align:start position:0% English or<00:24:29.039><c> French</c><00:24:29.220><c> or</c><00:24:29.520><c> Italian</c><00:24:29.700><c> but</c><00:24:30.659><c> unfortunately</c> 00:24:31.010 --> 00:24:31.020 align:start position:0% or French or Italian but unfortunately 00:24:31.020 --> 00:24:32.510 align:start position:0% or French or Italian but unfortunately not<00:24:31.200><c> German</c><00:24:31.440><c> so</c><00:24:31.740><c> that</c><00:24:31.919><c> that</c><00:24:32.100><c> for</c><00:24:32.340><c> some</c> 00:24:32.510 --> 00:24:32.520 align:start position:0% not German so that that for some 00:24:32.520 --> 00:24:34.549 align:start position:0% not German so that that for some manufacturers<00:24:33.059><c> will</c><00:24:33.299><c> be</c><00:24:33.419><c> a</c><00:24:33.539><c> barrier</c><00:24:34.020><c> but</c><00:24:34.380><c> for</c> 00:24:34.549 --> 00:24:34.559 align:start position:0% manufacturers will be a barrier but for 00:24:34.559 --> 00:24:38.810 align:start position:0% manufacturers will be a barrier but for the<00:24:34.679><c> markets</c><00:24:35.039><c> defense</c><00:24:35.340><c> authorities</c> 00:24:38.810 --> 00:24:38.820 align:start position:0% 00:24:38.820 --> 00:24:40.190 align:start position:0% they<00:24:39.179><c> have</c><00:24:39.299><c> to</c><00:24:39.419><c> somehow</c><00:24:39.659><c> figure</c><00:24:39.840><c> out</c><00:24:39.960><c> a</c><00:24:40.080><c> way</c> 00:24:40.190 --> 00:24:40.200 align:start position:0% they have to somehow figure out a way 00:24:40.200 --> 00:24:42.230 align:start position:0% they have to somehow figure out a way maybe<00:24:40.380><c> take</c><00:24:40.620><c> a</c><00:24:40.740><c> German</c><00:24:40.860><c> course</c> 00:24:42.230 --> 00:24:42.240 align:start position:0% maybe take a German course 00:24:42.240 --> 00:24:43.909 align:start position:0% maybe take a German course yeah 00:24:43.909 --> 00:24:43.919 align:start position:0% yeah 00:24:43.919 --> 00:24:56.590 align:start position:0% yeah foreign 00:24:56.590 --> 00:24:56.600 align:start position:0% 00:24:56.600 --> 00:24:58.789 align:start position:0% guidance<00:24:57.600><c> document</c><00:24:57.900><c> for</c><00:24:58.260><c> the</c><00:24:58.440><c> technician</c> 00:24:58.789 --> 00:24:58.799 align:start position:0% guidance document for the technician 00:24:58.799 --> 00:25:05.870 align:start position:0% guidance document for the technician documentation 00:25:05.870 --> 00:25:05.880 align:start position:0% 00:25:05.880 --> 00:25:06.890 align:start position:0% um 00:25:06.890 --> 00:25:06.900 align:start position:0% um 00:25:06.900 --> 00:25:08.750 align:start position:0% um so<00:25:07.380><c> firstly</c><00:25:07.740><c> the</c><00:25:07.980><c> the</c><00:25:07.980><c> commission</c><00:25:08.580><c> is</c> 00:25:08.750 --> 00:25:08.760 align:start position:0% so firstly the the commission is 00:25:08.760 --> 00:25:12.350 align:start position:0% so firstly the the commission is actually<00:25:08.940><c> working</c><00:25:09.360><c> on</c><00:25:09.840><c> a</c><00:25:10.140><c> a</c><00:25:10.980><c> document</c><00:25:11.820><c> that</c> 00:25:12.350 --> 00:25:12.360 align:start position:0% actually working on a a document that 00:25:12.360 --> 00:25:14.570 align:start position:0% actually working on a a document that will<00:25:12.780><c> specifically</c><00:25:13.440><c> be</c><00:25:13.679><c> called</c><00:25:13.919><c> guidance</c><00:25:14.400><c> for</c> 00:25:14.570 --> 00:25:14.580 align:start position:0% will specifically be called guidance for 00:25:14.580 --> 00:25:16.010 align:start position:0% will specifically be called guidance for technical<00:25:14.880><c> documentation</c><00:25:15.360><c> unfortunately</c> 00:25:16.010 --> 00:25:16.020 align:start position:0% technical documentation unfortunately 00:25:16.020 --> 00:25:18.049 align:start position:0% technical documentation unfortunately because<00:25:16.500><c> of</c><00:25:16.679><c> the</c><00:25:16.799><c> commission</c><00:25:17.159><c> it</c><00:25:17.700><c> will</c><00:25:17.760><c> take</c><00:25:17.880><c> a</c> 00:25:18.049 --> 00:25:18.059 align:start position:0% because of the commission it will take a 00:25:18.059 --> 00:25:19.490 align:start position:0% because of the commission it will take a bit<00:25:18.179><c> longer</c><00:25:18.480><c> before</c><00:25:18.720><c> that</c><00:25:18.960><c> that</c><00:25:19.140><c> is</c><00:25:19.320><c> ready</c> 00:25:19.490 --> 00:25:19.500 align:start position:0% bit longer before that that is ready 00:25:19.500 --> 00:25:21.830 align:start position:0% bit longer before that that is ready there's<00:25:19.980><c> not</c><00:25:20.159><c> guidance</c><00:25:20.640><c> yet</c><00:25:20.940><c> for</c><00:25:21.600><c> the</c> 00:25:21.830 --> 00:25:21.840 align:start position:0% there's not guidance yet for the 00:25:21.840 --> 00:25:23.830 align:start position:0% there's not guidance yet for the specific<00:25:22.080><c> technical</c><00:25:22.559><c> documentation</c> 00:25:23.830 --> 00:25:23.840 align:start position:0% specific technical documentation 00:25:23.840 --> 00:25:26.210 align:start position:0% specific technical documentation but<00:25:24.840><c> flipping</c><00:25:25.200><c> it</c><00:25:25.320><c> on</c><00:25:25.440><c> its</c><00:25:25.620><c> head</c><00:25:25.740><c> what</c><00:25:25.919><c> I</c><00:25:26.100><c> would</c> 00:25:26.210 --> 00:25:26.220 align:start position:0% but flipping it on its head what I would 00:25:26.220 --> 00:25:29.390 align:start position:0% but flipping it on its head what I would say<00:25:26.340><c> is</c><00:25:26.580><c> for</c><00:25:27.179><c> biosliminants</c><00:25:28.080><c> if</c><00:25:28.740><c> you</c><00:25:28.860><c> have</c><00:25:29.039><c> the</c> 00:25:29.390 --> 00:25:29.400 align:start position:0% say is for biosliminants if you have the 00:25:29.400 --> 00:25:33.049 align:start position:0% say is for biosliminants if you have the the<00:25:30.059><c> test</c><00:25:30.900><c> reports</c><00:25:31.380><c> the</c><00:25:32.039><c> information</c><00:25:32.159><c> for</c><00:25:32.580><c> CMC</c> 00:25:33.049 --> 00:25:33.059 align:start position:0% the test reports the information for CMC 00:25:33.059 --> 00:25:34.490 align:start position:0% the test reports the information for CMC which<00:25:33.299><c> of</c><00:25:33.419><c> course</c><00:25:33.539><c> differs</c><00:25:33.840><c> a</c><00:25:33.960><c> little</c><00:25:34.080><c> bit</c><00:25:34.200><c> but</c> 00:25:34.490 --> 00:25:34.500 align:start position:0% which of course differs a little bit but 00:25:34.500 --> 00:25:36.950 align:start position:0% which of course differs a little bit but there<00:25:34.799><c> are</c><00:25:35.039><c> very</c><00:25:35.460><c> clear</c><00:25:35.640><c> guidelines</c><00:25:36.120><c> per</c><00:25:36.419><c> CMC</c> 00:25:36.950 --> 00:25:36.960 align:start position:0% there are very clear guidelines per CMC 00:25:36.960 --> 00:25:38.690 align:start position:0% there are very clear guidelines per CMC that<00:25:37.140><c> we</c><00:25:37.260><c> can</c><00:25:37.320><c> give</c><00:25:37.500><c> on</c><00:25:37.799><c> what</c><00:25:38.039><c> information</c><00:25:38.279><c> you</c> 00:25:38.690 --> 00:25:38.700 align:start position:0% that we can give on what information you 00:25:38.700 --> 00:25:40.669 align:start position:0% that we can give on what information you have<00:25:38.820><c> to</c><00:25:39.000><c> send</c><00:25:39.179><c> us</c><00:25:39.299><c> and</c><00:25:40.020><c> the</c><00:25:40.140><c> field</c><00:25:40.260><c> trials</c> 00:25:40.669 --> 00:25:40.679 align:start position:0% have to send us and the field trials 00:25:40.679 --> 00:25:41.810 align:start position:0% have to send us and the field trials where<00:25:40.980><c> of</c><00:25:41.159><c> course</c><00:25:41.220><c> there's</c><00:25:41.400><c> the</c><00:25:41.580><c> technical</c> 00:25:41.810 --> 00:25:41.820 align:start position:0% where of course there's the technical 00:25:41.820 --> 00:25:44.210 align:start position:0% where of course there's the technical specifications<00:25:42.559><c> I</c><00:25:43.559><c> think</c><00:25:43.679><c> that</c><00:25:43.919><c> there</c><00:25:44.039><c> is</c> 00:25:44.210 --> 00:25:44.220 align:start position:0% specifications I think that there is 00:25:44.220 --> 00:25:47.029 align:start position:0% specifications I think that there is there<00:25:44.460><c> is</c><00:25:44.580><c> sufficient</c><00:25:45.080><c> guidance</c><00:25:46.080><c> there</c><00:25:46.380><c> there</c> 00:25:47.029 --> 00:25:47.039 align:start position:0% there is sufficient guidance there there 00:25:47.039 --> 00:25:49.250 align:start position:0% there is sufficient guidance there there isn't<00:25:47.279><c> a</c><00:25:47.460><c> single</c><00:25:47.640><c> document</c><00:25:48.000><c> we</c><00:25:48.779><c> do</c><00:25:48.900><c> have</c><00:25:49.020><c> a</c> 00:25:49.250 --> 00:25:49.260 align:start position:0% isn't a single document we do have a 00:25:49.260 --> 00:25:51.409 align:start position:0% isn't a single document we do have a form<00:25:49.440><c> if</c><00:25:50.220><c> you</c><00:25:50.340><c> certify</c><00:25:50.700><c> with</c><00:25:50.820><c> us</c><00:25:50.940><c> that</c><00:25:51.120><c> we</c><00:25:51.299><c> just</c> 00:25:51.409 --> 00:25:51.419 align:start position:0% form if you certify with us that we just 00:25:51.419 --> 00:25:53.510 align:start position:0% form if you certify with us that we just ask<00:25:51.600><c> this</c><00:25:51.900><c> specific</c><00:25:52.200><c> information</c><00:25:52.520><c> including</c> 00:25:53.510 --> 00:25:53.520 align:start position:0% ask this specific information including 00:25:53.520 --> 00:25:55.610 align:start position:0% ask this specific information including for<00:25:54.059><c> the</c><00:25:54.299><c> specific</c><00:25:54.600><c> cmcs</c><00:25:55.200><c> what</c><00:25:55.380><c> information</c> 00:25:55.610 --> 00:25:55.620 align:start position:0% for the specific cmcs what information 00:25:55.620 --> 00:25:57.769 align:start position:0% for the specific cmcs what information we<00:25:56.039><c> want</c><00:25:56.159><c> you</c><00:25:56.279><c> to</c><00:25:56.400><c> upload</c> 00:25:57.769 --> 00:25:57.779 align:start position:0% we want you to upload 00:25:57.779 --> 00:25:59.090 align:start position:0% we want you to upload um 00:25:59.090 --> 00:25:59.100 align:start position:0% um 00:25:59.100 --> 00:26:00.950 align:start position:0% um um<00:25:59.159><c> but</c><00:25:59.400><c> there</c><00:25:59.520><c> is</c><00:25:59.640><c> not</c><00:25:59.760><c> a</c><00:25:59.940><c> unified</c><00:26:00.240><c> guidance</c> 00:26:00.950 --> 00:26:00.960 align:start position:0% um but there is not a unified guidance 00:26:00.960 --> 00:26:02.570 align:start position:0% um but there is not a unified guidance document<00:26:01.260><c> yet</c><00:26:01.500><c> on</c><00:26:01.679><c> technical</c><00:26:01.980><c> documentation</c> 00:26:02.570 --> 00:26:02.580 align:start position:0% document yet on technical documentation 00:26:02.580 --> 00:26:04.549 align:start position:0% document yet on technical documentation so<00:26:03.419><c> what</c><00:26:03.539><c> I</c><00:26:03.720><c> would</c><00:26:03.840><c> say</c><00:26:03.960><c> is</c><00:26:04.140><c> if</c><00:26:04.440><c> that's</c> 00:26:04.549 --> 00:26:04.559 align:start position:0% so what I would say is if that's 00:26:04.559 --> 00:26:06.230 align:start position:0% so what I would say is if that's something<00:26:04.799><c> they</c><00:26:05.159><c> want</c><00:26:05.340><c> to</c><00:26:05.460><c> know</c> 00:26:06.230 --> 00:26:06.240 align:start position:0% something they want to know 00:26:06.240 --> 00:26:07.730 align:start position:0% something they want to know what<00:26:06.600><c> we</c><00:26:06.720><c> can</c><00:26:06.840><c> do</c><00:26:06.900><c> is</c><00:26:06.960><c> set</c><00:26:07.140><c> up</c><00:26:07.260><c> the</c><00:26:07.320><c> team's</c><00:26:07.620><c> call</c> 00:26:07.730 --> 00:26:07.740 align:start position:0% what we can do is set up the team's call 00:26:07.740 --> 00:26:09.769 align:start position:0% what we can do is set up the team's call to<00:26:07.980><c> like</c><00:26:08.640><c> I</c><00:26:08.700><c> said</c><00:26:08.820><c> run</c><00:26:09.059><c> through</c><00:26:09.299><c> what</c> 00:26:09.769 --> 00:26:09.779 align:start position:0% to like I said run through what 00:26:09.779 --> 00:26:11.210 align:start position:0% to like I said run through what ingredients<00:26:10.260><c> they</c><00:26:10.500><c> might</c><00:26:10.679><c> have</c><00:26:10.799><c> and</c><00:26:11.100><c> then</c> 00:26:11.210 --> 00:26:11.220 align:start position:0% ingredients they might have and then 00:26:11.220 --> 00:26:15.409 align:start position:0% ingredients they might have and then explain<00:26:11.640><c> what</c><00:26:11.940><c> information</c><00:26:12.179><c> we</c><00:26:12.539><c> want</c> 00:26:15.409 --> 00:26:15.419 align:start position:0% 00:26:15.419 --> 00:26:17.090 align:start position:0% yeah 00:26:17.090 --> 00:26:17.100 align:start position:0% yeah 00:26:17.100 --> 00:26:20.110 align:start position:0% yeah um 00:26:20.110 --> 00:26:20.120 align:start position:0% 00:26:20.120 --> 00:26:35.690 align:start position:0% [Music] 00:26:35.690 --> 00:26:35.700 align:start position:0% 00:26:35.700 --> 00:26:49.789 align:start position:0% Einstein 00:26:49.789 --> 00:26:49.799 align:start position:0% 00:26:49.799 --> 00:26:57.470 align:start position:0% keep<00:26:50.220><c> the</c><00:26:50.460><c> stats</c> 00:26:57.470 --> 00:26:57.480 align:start position:0% 00:26:57.480 --> 00:27:14.810 align:start position:0% is 00:27:14.810 --> 00:27:14.820 align:start position:0% 00:27:14.820 --> 00:28:05.990 align:start position:0% foreign 00:28:05.990 --> 00:28:06.000 align:start position:0% 00:28:06.000 --> 00:28:14.550 align:start position:0% foreign 00:28:14.550 --> 00:28:14.560 align:start position:0% 00:28:14.560 --> 00:28:33.610 align:start position:0% [Music] 00:28:33.610 --> 00:28:33.620 align:start position:0% 00:28:33.620 --> 00:28:37.130 align:start position:0% that<00:28:34.620><c> you</c><00:28:34.860><c> that</c><00:28:35.340><c> you</c><00:28:35.580><c> either</c><00:28:35.760><c> send</c><00:28:36.240><c> the</c><00:28:36.600><c> single</c> 00:28:37.130 --> 00:28:37.140 align:start position:0% that you that you either send the single 00:28:37.140 --> 00:28:39.470 align:start position:0% that you that you either send the single trials<00:28:37.679><c> to</c><00:28:37.860><c> you</c><00:28:38.039><c> is</c><00:28:38.279><c> that</c><00:28:38.460><c> sufficient</c><00:28:38.940><c> or</c><00:28:39.240><c> is</c> 00:28:39.470 --> 00:28:39.480 align:start position:0% trials to you is that sufficient or is 00:28:39.480 --> 00:28:42.169 align:start position:0% trials to you is that sufficient or is it<00:28:39.659><c> necessary</c><00:28:40.140><c> to</c><00:28:40.500><c> summarize</c><00:28:40.980><c> the</c><00:28:41.279><c> trials</c><00:28:41.700><c> and</c> 00:28:42.169 --> 00:28:42.179 align:start position:0% it necessary to summarize the trials and 00:28:42.179 --> 00:28:45.470 align:start position:0% it necessary to summarize the trials and put<00:28:42.360><c> them</c><00:28:42.539><c> inadocia</c><00:28:43.380><c> together</c> 00:28:45.470 --> 00:28:45.480 align:start position:0% put them inadocia together 00:28:45.480 --> 00:28:47.390 align:start position:0% put them inadocia together um<00:28:45.539><c> it's</c><00:28:45.779><c> not</c><00:28:46.080><c> necessarily</c><00:28:46.559><c> to</c><00:28:46.740><c> summarize</c><00:28:47.159><c> the</c> 00:28:47.390 --> 00:28:47.400 align:start position:0% um it's not necessarily to summarize the 00:28:47.400 --> 00:28:49.190 align:start position:0% um it's not necessarily to summarize the the<00:28:47.520><c> trials</c><00:28:48.120><c> as</c><00:28:48.240><c> a</c><00:28:48.419><c> whole</c><00:28:48.539><c> so</c><00:28:48.779><c> if</c><00:28:48.900><c> you</c><00:28:49.080><c> just</c> 00:28:49.190 --> 00:28:49.200 align:start position:0% the trials as a whole so if you just 00:28:49.200 --> 00:28:51.230 align:start position:0% the trials as a whole so if you just send<00:28:49.440><c> us</c><00:28:49.620><c> nine</c><00:28:50.039><c> nine</c><00:28:50.460><c> field</c><00:28:50.580><c> trial</c><00:28:50.880><c> reports</c> 00:28:51.230 --> 00:28:51.240 align:start position:0% send us nine nine field trial reports 00:28:51.240 --> 00:28:52.789 align:start position:0% send us nine nine field trial reports two<00:28:51.360><c> or</c><00:28:51.600><c> however</c><00:28:51.840><c> many</c><00:28:52.080><c> that</c><00:28:52.320><c> that</c><00:28:52.500><c> you</c><00:28:52.679><c> want</c> 00:28:52.789 --> 00:28:52.799 align:start position:0% two or however many that that you want 00:28:52.799 --> 00:28:54.049 align:start position:0% two or however many that that you want for<00:28:53.039><c> the</c><00:28:53.159><c> claims</c><00:28:53.460><c> that</c><00:28:53.520><c> you</c><00:28:53.640><c> want</c><00:28:53.700><c> to</c><00:28:53.820><c> prove</c> 00:28:54.049 --> 00:28:54.059 align:start position:0% for the claims that you want to prove 00:28:54.059 --> 00:28:56.029 align:start position:0% for the claims that you want to prove that's<00:28:54.539><c> enough</c> 00:28:56.029 --> 00:28:56.039 align:start position:0% that's enough 00:28:56.039 --> 00:28:58.190 align:start position:0% that's enough um<00:28:56.159><c> of</c><00:28:56.400><c> course</c><00:28:56.520><c> what</c><00:28:56.760><c> we</c><00:28:56.880><c> will</c><00:28:57.059><c> then</c><00:28:57.179><c> do</c><00:28:57.419><c> is</c><00:28:57.720><c> go</c> 00:28:58.190 --> 00:28:58.200 align:start position:0% um of course what we will then do is go 00:28:58.200 --> 00:29:00.649 align:start position:0% um of course what we will then do is go through<00:28:58.380><c> each</c><00:28:58.559><c> of</c><00:28:58.679><c> the</c><00:28:58.799><c> trials</c><00:28:59.159><c> see</c><00:29:00.000><c> for</c><00:29:00.480><c> the</c> 00:29:00.649 --> 00:29:00.659 align:start position:0% through each of the trials see for the 00:29:00.659 --> 00:29:02.390 align:start position:0% through each of the trials see for the specific<00:29:00.900><c> claim</c><00:29:01.320><c> that</c><00:29:01.440><c> you</c><00:29:01.500><c> want</c><00:29:01.620><c> to</c><00:29:01.740><c> prove</c><00:29:01.919><c> is</c> 00:29:02.390 --> 00:29:02.400 align:start position:0% specific claim that you want to prove is 00:29:02.400 --> 00:29:04.370 align:start position:0% specific claim that you want to prove is there<00:29:02.520><c> the</c><00:29:02.700><c> necessary</c><00:29:03.000><c> evidence</c><00:29:03.360><c> and</c><00:29:04.020><c> then</c><00:29:04.140><c> we</c> 00:29:04.370 --> 00:29:04.380 align:start position:0% there the necessary evidence and then we 00:29:04.380 --> 00:29:06.710 align:start position:0% there the necessary evidence and then we will<00:29:04.620><c> I</c><00:29:05.400><c> would</c><00:29:05.520><c> almost</c><00:29:05.640><c> say</c><00:29:05.880><c> internally</c><00:29:06.360><c> make</c> 00:29:06.710 --> 00:29:06.720 align:start position:0% will I would almost say internally make 00:29:06.720 --> 00:29:08.810 align:start position:0% will I would almost say internally make that<00:29:06.960><c> summary</c><00:29:07.260><c> of</c><00:29:07.559><c> is</c><00:29:08.039><c> there</c><00:29:08.220><c> enough</c><00:29:08.400><c> trials</c> 00:29:08.810 --> 00:29:08.820 align:start position:0% that summary of is there enough trials 00:29:08.820 --> 00:29:10.130 align:start position:0% that summary of is there enough trials to<00:29:09.000><c> prove</c><00:29:09.299><c> the</c><00:29:09.419><c> claim</c><00:29:09.659><c> that</c><00:29:09.779><c> you</c><00:29:09.900><c> want</c><00:29:10.020><c> to</c> 00:29:10.130 --> 00:29:10.140 align:start position:0% to prove the claim that you want to 00:29:10.140 --> 00:29:12.230 align:start position:0% to prove the claim that you want to prove<00:29:10.320><c> so</c><00:29:10.440><c> it's</c><00:29:10.620><c> not</c><00:29:10.980><c> required</c><00:29:11.760><c> to</c><00:29:11.880><c> make</c><00:29:12.059><c> a</c> 00:29:12.230 --> 00:29:12.240 align:start position:0% prove so it's not required to make a 00:29:12.240 --> 00:29:14.269 align:start position:0% prove so it's not required to make a summary 00:29:14.269 --> 00:29:14.279 align:start position:0% summary 00:29:14.279 --> 00:29:14.990 align:start position:0% summary um 00:29:14.990 --> 00:29:15.000 align:start position:0% um 00:29:15.000 --> 00:29:17.930 align:start position:0% um of<00:29:15.659><c> course</c><00:29:15.840><c> in</c><00:29:16.440><c> some</c><00:29:16.559><c> cases</c><00:29:16.980><c> if</c><00:29:17.340><c> if</c><00:29:17.520><c> you</c><00:29:17.760><c> have</c> 00:29:17.930 --> 00:29:17.940 align:start position:0% of course in some cases if if you have 00:29:17.940 --> 00:29:20.630 align:start position:0% of course in some cases if if you have very<00:29:18.240><c> much</c><00:29:18.480><c> a</c><00:29:18.659><c> lot</c><00:29:18.779><c> of</c><00:29:18.899><c> Trials</c><00:29:19.320><c> if</c><00:29:20.220><c> you</c><00:29:20.340><c> make</c><00:29:20.460><c> a</c> 00:29:20.630 --> 00:29:20.640 align:start position:0% very much a lot of Trials if you make a 00:29:20.640 --> 00:29:22.250 align:start position:0% very much a lot of Trials if you make a summary<00:29:20.940><c> it</c><00:29:21.360><c> might</c><00:29:21.480><c> make</c><00:29:21.659><c> our</c><00:29:21.899><c> assessment</c> 00:29:22.250 --> 00:29:22.260 align:start position:0% summary it might make our assessment 00:29:22.260 --> 00:29:24.950 align:start position:0% summary it might make our assessment time<00:29:22.500><c> shorter</c><00:29:22.980><c> and</c><00:29:23.880><c> so</c><00:29:24.120><c> that's</c><00:29:24.299><c> something</c><00:29:24.539><c> I</c><00:29:24.840><c> I</c> 00:29:24.950 --> 00:29:24.960 align:start position:0% time shorter and so that's something I I 00:29:24.960 --> 00:29:26.510 align:start position:0% time shorter and so that's something I I can't<00:29:25.200><c> give</c><00:29:25.320><c> you</c><00:29:25.440><c> the</c><00:29:25.620><c> the</c><00:29:25.740><c> exact</c><00:29:26.039><c> answer</c><00:29:26.279><c> for</c> 00:29:26.510 --> 00:29:26.520 align:start position:0% can't give you the the exact answer for 00:29:26.520 --> 00:29:28.310 align:start position:0% can't give you the the exact answer for what<00:29:27.059><c> I</c><00:29:27.240><c> would</c><00:29:27.360><c> say</c><00:29:27.480><c> is</c><00:29:27.659><c> if</c><00:29:27.779><c> you</c><00:29:28.020><c> know</c><00:29:28.080><c> if</c><00:29:28.200><c> we're</c> 00:29:28.310 --> 00:29:28.320 align:start position:0% what I would say is if you know if we're 00:29:28.320 --> 00:29:30.590 align:start position:0% what I would say is if you know if we're talking<00:29:28.559><c> 50</c><00:29:29.220><c> 60</c><00:29:29.460><c> trials</c> 00:29:30.590 --> 00:29:30.600 align:start position:0% talking 50 60 trials 00:29:30.600 --> 00:29:32.870 align:start position:0% talking 50 60 trials uh<00:29:31.020><c> if</c><00:29:31.200><c> you</c><00:29:31.260><c> make</c><00:29:31.380><c> a</c><00:29:31.559><c> summary</c><00:29:31.799><c> inherently</c><00:29:32.580><c> that</c> 00:29:32.870 --> 00:29:32.880 align:start position:0% uh if you make a summary inherently that 00:29:32.880 --> 00:29:36.169 align:start position:0% uh if you make a summary inherently that might<00:29:33.120><c> for</c><00:29:33.480><c> us</c><00:29:33.659><c> be</c><00:29:34.020><c> easier</c><00:29:34.500><c> to</c><00:29:34.620><c> go</c><00:29:34.740><c> through</c> 00:29:36.169 --> 00:29:36.179 align:start position:0% might for us be easier to go through 00:29:36.179 --> 00:29:37.850 align:start position:0% might for us be easier to go through um<00:29:36.240><c> but</c><00:29:36.720><c> for</c><00:29:36.960><c> the</c><00:29:37.140><c> assessment</c><00:29:37.440><c> it</c><00:29:37.620><c> makes</c><00:29:37.740><c> no</c> 00:29:37.850 --> 00:29:37.860 align:start position:0% um but for the assessment it makes no 00:29:37.860 --> 00:29:38.870 align:start position:0% um but for the assessment it makes no difference<00:29:38.039><c> because</c><00:29:38.279><c> we</c><00:29:38.399><c> have</c><00:29:38.520><c> to</c><00:29:38.580><c> read</c><00:29:38.700><c> all</c> 00:29:38.870 --> 00:29:38.880 align:start position:0% difference because we have to read all 00:29:38.880 --> 00:29:42.850 align:start position:0% difference because we have to read all the<00:29:39.000><c> individual</c><00:29:39.480><c> reports</c><00:29:39.899><c> anyway</c> 00:29:42.850 --> 00:29:42.860 align:start position:0% 00:29:42.860 --> 00:30:02.830 align:start position:0% absorbed<00:29:43.860><c> and</c><00:29:44.039><c> gets</c><00:29:44.279><c> you</c><00:29:44.399><c> know</c><00:29:44.520><c> whiter</c> 00:30:02.830 --> 00:30:02.840 align:start position:0% 00:30:02.840 --> 00:30:04.850 align:start position:0% positive<00:30:03.840><c> in</c><00:30:04.080><c> effect</c> 00:30:04.850 --> 00:30:04.860 align:start position:0% positive in effect 00:30:04.860 --> 00:30:12.470 align:start position:0% positive in effect is 00:30:12.470 --> 00:30:12.480 align:start position:0% 00:30:12.480 --> 00:30:17.990 align:start position:0% um 00:30:17.990 --> 00:30:18.000 align:start position:0% 00:30:18.000 --> 00:30:22.370 align:start position:0% yeah<00:30:18.480><c> good</c><00:30:18.840><c> question</c><00:30:19.080><c> yeah</c> 00:30:22.370 --> 00:30:22.380 align:start position:0% 00:30:22.380 --> 00:30:23.570 align:start position:0% um 00:30:23.570 --> 00:30:23.580 align:start position:0% um 00:30:23.580 --> 00:30:27.470 align:start position:0% um so<00:30:24.600><c> I</c><00:30:24.899><c> think</c><00:30:25.559><c> that</c><00:30:26.399><c> it's</c><00:30:26.580><c> a</c><00:30:26.820><c> it's</c><00:30:27.120><c> a</c><00:30:27.240><c> very</c><00:30:27.360><c> good</c> 00:30:27.470 --> 00:30:27.480 align:start position:0% so I think that it's a it's a very good 00:30:27.480 --> 00:30:28.310 align:start position:0% so I think that it's a it's a very good question 00:30:28.310 --> 00:30:28.320 align:start position:0% question 00:30:28.320 --> 00:30:29.870 align:start position:0% question um<00:30:28.380><c> what</c><00:30:28.620><c> I</c><00:30:28.740><c> would</c><00:30:28.860><c> say</c><00:30:28.980><c> is</c><00:30:29.159><c> on</c><00:30:29.520><c> the</c><00:30:29.640><c> fourth</c> 00:30:29.870 --> 00:30:29.880 align:start position:0% um what I would say is on the fourth 00:30:29.880 --> 00:30:31.370 align:start position:0% um what I would say is on the fourth slide<00:30:30.120><c> what</c><00:30:30.299><c> I</c><00:30:30.419><c> did</c><00:30:30.539><c> say</c><00:30:30.659><c> is</c><00:30:30.779><c> there's</c><00:30:31.020><c> a</c> 00:30:31.370 --> 00:30:31.380 align:start position:0% slide what I did say is there's a 00:30:31.380 --> 00:30:33.350 align:start position:0% slide what I did say is there's a there's<00:30:31.980><c> a</c><00:30:32.220><c> large</c><00:30:32.340><c> responsibility</c><00:30:32.940><c> for</c><00:30:33.299><c> the</c> 00:30:33.350 --> 00:30:33.360 align:start position:0% there's a large responsibility for the 00:30:33.360 --> 00:30:36.049 align:start position:0% there's a large responsibility for the the<00:30:33.539><c> manufacturer</c><00:30:34.080><c> for</c><00:30:34.320><c> you</c><00:30:34.440><c> to</c><00:30:34.799><c> send</c><00:30:35.520><c> us</c><00:30:35.700><c> the</c> 00:30:36.049 --> 00:30:36.059 align:start position:0% the manufacturer for you to send us the 00:30:36.059 --> 00:30:38.630 align:start position:0% the manufacturer for you to send us the uh<00:30:37.020><c> send</c><00:30:37.260><c> us</c><00:30:37.380><c> the</c><00:30:37.559><c> information</c><00:30:37.679><c> and</c><00:30:38.159><c> and</c><00:30:38.340><c> you</c> 00:30:38.630 --> 00:30:38.640 align:start position:0% uh send us the information and and you 00:30:38.640 --> 00:30:39.710 align:start position:0% uh send us the information and and you know<00:30:38.760><c> to</c><00:30:38.880><c> be</c><00:30:39.000><c> confident</c><00:30:39.299><c> that</c><00:30:39.480><c> the</c><00:30:39.600><c> product</c> 00:30:39.710 --> 00:30:39.720 align:start position:0% know to be confident that the product 00:30:39.720 --> 00:30:41.750 align:start position:0% know to be confident that the product will<00:30:39.899><c> actually</c><00:30:40.140><c> do</c><00:30:40.320><c> something</c><00:30:40.500><c> now</c> 00:30:41.750 --> 00:30:41.760 align:start position:0% will actually do something now 00:30:41.760 --> 00:30:44.570 align:start position:0% will actually do something now in<00:30:42.240><c> theory</c><00:30:42.600><c> if</c><00:30:43.200><c> you</c><00:30:43.380><c> send</c><00:30:43.559><c> us</c><00:30:43.740><c> tomorrow</c><00:30:43.980><c> a</c><00:30:44.340><c> file</c> 00:30:44.570 --> 00:30:44.580 align:start position:0% in theory if you send us tomorrow a file 00:30:44.580 --> 00:30:46.909 align:start position:0% in theory if you send us tomorrow a file with<00:30:45.179><c> five</c><00:30:45.419><c> field</c><00:30:45.659><c> trial</c><00:30:45.899><c> reports</c><00:30:46.380><c> that</c><00:30:46.740><c> meet</c> 00:30:46.909 --> 00:30:46.919 align:start position:0% with five field trial reports that meet 00:30:46.919 --> 00:30:48.590 align:start position:0% with five field trial reports that meet all<00:30:47.159><c> the</c><00:30:47.279><c> requirements</c><00:30:47.760><c> you'll</c><00:30:48.419><c> get</c><00:30:48.539><c> a</c> 00:30:48.590 --> 00:30:48.600 align:start position:0% all the requirements you'll get a 00:30:48.600 --> 00:30:50.269 align:start position:0% all the requirements you'll get a certificate<00:30:49.140><c> and</c><00:30:49.620><c> that'll</c><00:30:49.799><c> be</c><00:30:49.919><c> the</c><00:30:50.039><c> case</c><00:30:50.159><c> for</c> 00:30:50.269 --> 00:30:50.279 align:start position:0% certificate and that'll be the case for 00:30:50.279 --> 00:30:51.590 align:start position:0% certificate and that'll be the case for all<00:30:50.460><c> the</c><00:30:50.520><c> notified</c><00:30:50.760><c> bodies</c><00:30:51.120><c> because</c><00:30:51.299><c> we</c><00:30:51.480><c> don't</c> 00:30:51.590 --> 00:30:51.600 align:start position:0% all the notified bodies because we don't 00:30:51.600 --> 00:30:53.450 align:start position:0% all the notified bodies because we don't know<00:30:51.779><c> that</c><00:30:51.960><c> you</c><00:30:52.080><c> maybe</c><00:30:52.260><c> have</c><00:30:52.440><c> done</c><00:30:52.679><c> 15</c><00:30:52.860><c> trials</c> 00:30:53.450 --> 00:30:53.460 align:start position:0% know that you maybe have done 15 trials 00:30:53.460 --> 00:30:55.490 align:start position:0% know that you maybe have done 15 trials that<00:30:53.940><c> don't</c><00:30:54.120><c> meet</c><00:30:54.240><c> the</c><00:30:54.419><c> requirements</c><00:30:54.960><c> because</c> 00:30:55.490 --> 00:30:55.500 align:start position:0% that don't meet the requirements because 00:30:55.500 --> 00:30:56.630 align:start position:0% that don't meet the requirements because of<00:30:55.679><c> course</c><00:30:55.860><c> we're</c><00:30:56.039><c> not</c><00:30:56.220><c> a</c><00:30:56.460><c> national</c> 00:30:56.630 --> 00:30:56.640 align:start position:0% of course we're not a national 00:30:56.640 --> 00:30:57.950 align:start position:0% of course we're not a national government<00:30:56.940><c> we're</c><00:30:57.360><c> not</c><00:30:57.480><c> a</c><00:30:57.659><c> policing</c> 00:30:57.950 --> 00:30:57.960 align:start position:0% government we're not a policing 00:30:57.960 --> 00:30:59.870 align:start position:0% government we're not a policing Authority<00:30:58.380><c> and</c><00:30:58.919><c> so</c><00:30:59.100><c> we</c><00:30:59.279><c> are</c><00:30:59.399><c> not</c><00:30:59.580><c> going</c><00:30:59.700><c> to</c><00:30:59.820><c> go</c> 00:30:59.870 --> 00:30:59.880 align:start position:0% Authority and so we are not going to go 00:30:59.880 --> 00:31:01.850 align:start position:0% Authority and so we are not going to go into<00:31:00.000><c> your</c><00:31:00.179><c> files</c><00:31:00.539><c> and</c><00:31:00.720><c> and</c><00:31:00.840><c> check</c><00:31:01.140><c> is</c><00:31:01.740><c> there</c> 00:31:01.850 --> 00:31:01.860 align:start position:0% into your files and and check is there 00:31:01.860 --> 00:31:04.310 align:start position:0% into your files and and check is there something<00:31:02.039><c> hidden</c><00:31:02.460><c> away</c><00:31:02.580><c> under</c><00:31:02.820><c> the</c><00:31:03.000><c> couch</c> 00:31:04.310 --> 00:31:04.320 align:start position:0% something hidden away under the couch 00:31:04.320 --> 00:31:07.070 align:start position:0% something hidden away under the couch and<00:31:04.980><c> so</c><00:31:05.220><c> in</c><00:31:05.940><c> the</c><00:31:06.000><c> theoretical</c><00:31:06.480><c> sense</c><00:31:06.659><c> what</c><00:31:06.899><c> I</c> 00:31:07.070 --> 00:31:07.080 align:start position:0% and so in the theoretical sense what I 00:31:07.080 --> 00:31:08.690 align:start position:0% and so in the theoretical sense what I would<00:31:07.200><c> say</c><00:31:07.320><c> is</c><00:31:07.440><c> you</c><00:31:07.799><c> could</c><00:31:07.919><c> probably</c><00:31:08.100><c> get</c><00:31:08.460><c> a</c> 00:31:08.690 --> 00:31:08.700 align:start position:0% would say is you could probably get a 00:31:08.700 --> 00:31:10.850 align:start position:0% would say is you could probably get a module<00:31:08.940><c> B</c><00:31:09.059><c> certification</c><00:31:09.600><c> with</c><00:31:10.140><c> five</c><00:31:10.620><c> field</c> 00:31:10.850 --> 00:31:10.860 align:start position:0% module B certification with five field 00:31:10.860 --> 00:31:12.529 align:start position:0% module B certification with five field trials<00:31:11.279><c> that</c><00:31:11.399><c> meet</c><00:31:11.520><c> the</c><00:31:11.700><c> requirements</c><00:31:12.179><c> and</c><00:31:12.360><c> 15</c> 00:31:12.529 --> 00:31:12.539 align:start position:0% trials that meet the requirements and 15 00:31:12.539 --> 00:31:14.630 align:start position:0% trials that meet the requirements and 15 that<00:31:12.899><c> don't</c><00:31:13.080><c> if</c><00:31:13.440><c> you</c><00:31:13.559><c> don't</c><00:31:13.679><c> send</c><00:31:13.860><c> us</c><00:31:14.039><c> to</c><00:31:14.159><c> 15.</c> 00:31:14.630 --> 00:31:14.640 align:start position:0% that don't if you don't send us to 15. 00:31:14.640 --> 00:31:16.070 align:start position:0% that don't if you don't send us to 15. but<00:31:15.120><c> of</c><00:31:15.240><c> course</c><00:31:15.360><c> then</c><00:31:15.539><c> comes</c><00:31:15.840><c> the</c><00:31:15.899><c> question</c> 00:31:16.070 --> 00:31:16.080 align:start position:0% but of course then comes the question 00:31:16.080 --> 00:31:18.169 align:start position:0% but of course then comes the question what<00:31:16.320><c> happens</c><00:31:16.500><c> if</c><00:31:16.919><c> if</c><00:31:17.279><c> a</c><00:31:17.520><c> market</c><00:31:17.640><c> surveillance</c> 00:31:18.169 --> 00:31:18.179 align:start position:0% what happens if if a market surveillance 00:31:18.179 --> 00:31:20.570 align:start position:0% what happens if if a market surveillance Authority<00:31:18.600><c> knocks</c><00:31:19.260><c> on</c><00:31:19.320><c> your</c><00:31:19.500><c> door</c> 00:31:20.570 --> 00:31:20.580 align:start position:0% Authority knocks on your door 00:31:20.580 --> 00:31:22.669 align:start position:0% Authority knocks on your door uh<00:31:21.299><c> because</c><00:31:21.480><c> they've</c><00:31:21.779><c> gotten</c><00:31:22.020><c> reports</c><00:31:22.500><c> that</c> 00:31:22.669 --> 00:31:22.679 align:start position:0% uh because they've gotten reports that 00:31:22.679 --> 00:31:24.350 align:start position:0% uh because they've gotten reports that uh<00:31:22.860><c> that</c><00:31:23.100><c> your</c><00:31:23.220><c> bio</c><00:31:23.399><c> stimulant</c><00:31:23.880><c> is</c><00:31:24.000><c> not</c><00:31:24.120><c> doing</c> 00:31:24.350 --> 00:31:24.360 align:start position:0% uh that your bio stimulant is not doing 00:31:24.360 --> 00:31:27.169 align:start position:0% uh that your bio stimulant is not doing what<00:31:25.200><c> supposedly</c><00:31:25.679><c> the</c><00:31:26.100><c> the</c><00:31:26.399><c> label</c><00:31:26.940><c> claims</c> 00:31:27.169 --> 00:31:27.179 align:start position:0% what supposedly the the label claims 00:31:27.179 --> 00:31:31.909 align:start position:0% what supposedly the the label claims that<00:31:27.299><c> it</c><00:31:27.419><c> does</c> 00:31:31.909 --> 00:31:31.919 align:start position:0% 00:31:31.919 --> 00:31:34.190 align:start position:0% um<00:31:32.039><c> well</c><00:31:32.220><c> they</c><00:31:32.520><c> have</c><00:31:32.700><c> in</c><00:31:33.120><c> they</c><00:31:33.539><c> have</c><00:31:33.779><c> the</c><00:31:34.020><c> the</c> 00:31:34.190 --> 00:31:34.200 align:start position:0% um well they have in they have the the 00:31:34.200 --> 00:31:36.289 align:start position:0% um well they have in they have the the legal<00:31:34.679><c> right</c><00:31:34.919><c> to</c><00:31:35.399><c> Simply</c><00:31:35.640><c> ask</c><00:31:35.880><c> for</c><00:31:36.120><c> your</c> 00:31:36.289 --> 00:31:36.299 align:start position:0% legal right to Simply ask for your 00:31:36.299 --> 00:31:39.110 align:start position:0% legal right to Simply ask for your technical<00:31:36.600><c> documentation</c> 00:31:39.110 --> 00:31:39.120 align:start position:0% technical documentation 00:31:39.120 --> 00:31:40.789 align:start position:0% technical documentation um now<00:31:39.539><c> of</c><00:31:39.659><c> course</c><00:31:39.779><c> if</c><00:31:39.960><c> you</c><00:31:40.080><c> only</c><00:31:40.260><c> then</c><00:31:40.559><c> send</c> 00:31:40.789 --> 00:31:40.799 align:start position:0% um now of course if you only then send 00:31:40.799 --> 00:31:42.049 align:start position:0% um now of course if you only then send them<00:31:40.919><c> the</c><00:31:41.039><c> fire</c><00:31:41.159><c> field</c><00:31:41.399><c> chart</c><00:31:41.580><c> reports</c><00:31:41.940><c> and</c> 00:31:42.049 --> 00:31:42.059 align:start position:0% them the fire field chart reports and 00:31:42.059 --> 00:31:44.810 align:start position:0% them the fire field chart reports and you<00:31:42.179><c> don't</c><00:31:42.299><c> send</c><00:31:42.419><c> them</c><00:31:42.539><c> the</c><00:31:42.779><c> 15</c><00:31:42.919><c> then</c><00:31:43.919><c> they</c> 00:31:44.810 --> 00:31:44.820 align:start position:0% you don't send them the 15 then they 00:31:44.820 --> 00:31:46.490 align:start position:0% you don't send them the 15 then they what<00:31:45.299><c> they</c><00:31:45.600><c> can't</c><00:31:45.720><c> necessarily</c><00:31:46.260><c> they</c><00:31:46.380><c> can't</c> 00:31:46.490 --> 00:31:46.500 align:start position:0% what they can't necessarily they can't 00:31:46.500 --> 00:31:48.470 align:start position:0% what they can't necessarily they can't really<00:31:46.620><c> do</c><00:31:46.799><c> anything</c> 00:31:48.470 --> 00:31:48.480 align:start position:0% really do anything 00:31:48.480 --> 00:31:49.549 align:start position:0% really do anything um<00:31:48.600><c> of</c><00:31:48.779><c> course</c><00:31:48.899><c> they</c><00:31:49.140><c> are</c><00:31:49.260><c> the</c><00:31:49.440><c> national</c> 00:31:49.549 --> 00:31:49.559 align:start position:0% um of course they are the national 00:31:49.559 --> 00:31:51.169 align:start position:0% um of course they are the national government<00:31:49.860><c> Authority</c><00:31:50.340><c> so</c><00:31:50.520><c> maybe</c><00:31:50.700><c> they</c><00:31:51.000><c> could</c> 00:31:51.169 --> 00:31:51.179 align:start position:0% government Authority so maybe they could 00:31:51.179 --> 00:31:53.510 align:start position:0% government Authority so maybe they could if<00:31:51.779><c> there's</c><00:31:51.960><c> for</c><00:31:52.500><c> example</c><00:31:52.740><c> by</c><00:31:52.980><c> a</c><00:31:53.159><c> court</c><00:31:53.279><c> order</c> 00:31:53.510 --> 00:31:53.520 align:start position:0% if there's for example by a court order 00:31:53.520 --> 00:31:55.970 align:start position:0% if there's for example by a court order that<00:31:53.760><c> they</c><00:31:53.940><c> could</c><00:31:54.120><c> request</c><00:31:54.480><c> the</c><00:31:54.659><c> files</c><00:31:54.980><c> that</c> 00:31:55.970 --> 00:31:55.980 align:start position:0% that they could request the files that 00:31:55.980 --> 00:31:57.649 align:start position:0% that they could request the files that hasn't<00:31:56.700><c> happened</c><00:31:56.880><c> in</c><00:31:57.059><c> any</c><00:31:57.240><c> of</c><00:31:57.360><c> the</c><00:31:57.539><c> other</c> 00:31:57.649 --> 00:31:57.659 align:start position:0% hasn't happened in any of the other 00:31:57.659 --> 00:32:00.710 align:start position:0% hasn't happened in any of the other sectors<00:31:57.960><c> yet</c><00:31:58.200><c> that</c><00:31:58.440><c> they're</c><00:31:58.919><c> that</c><00:31:59.100><c> aggressive</c> 00:32:00.710 --> 00:32:00.720 align:start position:0% sectors yet that they're that aggressive 00:32:00.720 --> 00:32:03.409 align:start position:0% sectors yet that they're that aggressive um<00:32:01.320><c> so</c><00:32:01.919><c> I</c><00:32:02.399><c> don't</c><00:32:02.520><c> think</c><00:32:02.640><c> there's</c><00:32:02.880><c> there's</c><00:32:03.179><c> not</c> 00:32:03.409 --> 00:32:03.419 align:start position:0% um so I don't think there's there's not 00:32:03.419 --> 00:32:05.690 align:start position:0% um so I don't think there's there's not a<00:32:03.600><c> a</c><00:32:03.840><c> one-to-one</c><00:32:04.440><c> answer</c><00:32:04.620><c> but</c><00:32:05.100><c> in</c><00:32:05.279><c> essence</c><00:32:05.520><c> if</c> 00:32:05.690 --> 00:32:05.700 align:start position:0% a a one-to-one answer but in essence if 00:32:05.700 --> 00:32:06.830 align:start position:0% a a one-to-one answer but in essence if you<00:32:05.820><c> have</c><00:32:05.940><c> the</c><00:32:06.059><c> field</c><00:32:06.179><c> trial</c><00:32:06.480><c> reports</c><00:32:06.779><c> that</c> 00:32:06.830 --> 00:32:06.840 align:start position:0% you have the field trial reports that 00:32:06.840 --> 00:32:08.269 align:start position:0% you have the field trial reports that prove<00:32:07.080><c> Conformity</c><00:32:07.559><c> even</c><00:32:07.799><c> if</c><00:32:07.980><c> you</c><00:32:08.039><c> have</c><00:32:08.159><c> other</c> 00:32:08.269 --> 00:32:08.279 align:start position:0% prove Conformity even if you have other 00:32:08.279 --> 00:32:11.269 align:start position:0% prove Conformity even if you have other ones<00:32:08.520><c> that</c><00:32:08.700><c> don't</c> 00:32:11.269 --> 00:32:11.279 align:start position:0% 00:32:11.279 --> 00:32:15.649 align:start position:0% you<00:32:11.880><c> you</c><00:32:12.120><c> would</c><00:32:12.360><c> get</c><00:32:12.480><c> certification</c> 00:32:15.649 --> 00:32:15.659 align:start position:0% 00:32:15.659 --> 00:32:17.269 align:start position:0% um<00:32:15.720><c> and</c><00:32:16.020><c> then</c><00:32:16.140><c> Market</c><00:32:16.320><c> surveillance</c><00:32:16.980><c> and</c> 00:32:17.269 --> 00:32:17.279 align:start position:0% um and then Market surveillance and 00:32:17.279 --> 00:32:19.310 align:start position:0% um and then Market surveillance and maybe<00:32:17.460><c> within</c><00:32:18.059><c> the</c><00:32:18.179><c> associations</c><00:32:18.659><c> might</c><00:32:19.020><c> be</c><00:32:19.140><c> a</c> 00:32:19.310 --> 00:32:19.320 align:start position:0% maybe within the associations might be a 00:32:19.320 --> 00:32:21.470 align:start position:0% maybe within the associations might be a forear<00:32:19.799><c> to</c><00:32:20.039><c> discuss</c><00:32:20.279><c> is</c><00:32:20.880><c> that</c><00:32:21.059><c> something</c><00:32:21.240><c> that</c> 00:32:21.470 --> 00:32:21.480 align:start position:0% forear to discuss is that something that 00:32:21.480 --> 00:32:22.669 align:start position:0% forear to discuss is that something that we<00:32:21.600><c> want</c><00:32:21.720><c> is</c><00:32:22.020><c> there</c><00:32:22.140><c> something</c><00:32:22.320><c> that</c><00:32:22.500><c> we</c><00:32:22.559><c> have</c> 00:32:22.669 --> 00:32:22.679 align:start position:0% we want is there something that we have 00:32:22.679 --> 00:32:24.289 align:start position:0% we want is there something that we have to<00:32:22.799><c> do</c><00:32:22.860><c> with</c><00:32:22.980><c> against</c><00:32:23.100><c> that</c><00:32:23.460><c> for</c><00:32:23.820><c> the</c><00:32:24.059><c> notified</c> 00:32:24.289 --> 00:32:24.299 align:start position:0% to do with against that for the notified 00:32:24.299 --> 00:32:25.610 align:start position:0% to do with against that for the notified bodies 00:32:25.610 --> 00:32:25.620 align:start position:0% bodies 00:32:25.620 --> 00:32:29.029 align:start position:0% bodies you<00:32:26.039><c> know</c><00:32:26.100><c> we</c><00:32:26.520><c> just</c><00:32:26.700><c> do</c><00:32:27.059><c> what</c><00:32:27.600><c> you</c><00:32:28.140><c> know</c><00:32:28.260><c> uh</c> 00:32:29.029 --> 00:32:29.039 align:start position:0% you know we just do what you know uh 00:32:29.039 --> 00:32:31.310 align:start position:0% you know we just do what you know uh what<00:32:29.820><c> the</c><00:32:29.880><c> FBR</c><00:32:30.179><c> says</c><00:32:30.600><c> that</c><00:32:30.779><c> we</c><00:32:30.899><c> have</c><00:32:31.020><c> to</c><00:32:31.140><c> check</c> 00:32:31.310 --> 00:32:31.320 align:start position:0% what the FBR says that we have to check 00:32:31.320 --> 00:32:33.710 align:start position:0% what the FBR says that we have to check and<00:32:32.159><c> so</c><00:32:32.279><c> in</c><00:32:32.399><c> that</c><00:32:32.520><c> regard</c><00:32:32.760><c> yes</c> 00:32:33.710 --> 00:32:33.720 align:start position:0% and so in that regard yes 00:32:33.720 --> 00:32:38.769 align:start position:0% and so in that regard yes that<00:32:34.260><c> is</c><00:32:34.440><c> perhaps</c><00:32:35.220><c> a</c><00:32:35.279><c> flaw</c> 00:32:38.769 --> 00:32:38.779 align:start position:0% 00:32:38.779 --> 00:32:45.169 align:start position:0% okay<00:32:39.799><c> yeah</c><00:32:40.799><c> further</c><00:32:41.399><c> questions</c> 00:32:45.169 --> 00:32:45.179 align:start position:0% 00:32:45.179 --> 00:33:14.330 align:start position:0% foreign 00:33:14.330 --> 00:33:14.340 align:start position:0% 00:33:14.340 --> 00:33:26.330 align:start position:0% foreign 00:33:26.330 --> 00:33:26.340 align:start position:0% 00:33:26.340 --> 00:33:27.889 align:start position:0% no<00:33:27.120><c> so</c> 00:33:27.889 --> 00:33:27.899 align:start position:0% no so 00:33:27.899 --> 00:33:30.710 align:start position:0% no so um<00:33:27.960><c> no</c><00:33:28.620><c> no</c><00:33:28.620><c> no</c><00:33:28.679><c> so</c><00:33:29.760><c> um</c><00:33:29.880><c> there's</c><00:33:30.120><c> no</c><00:33:30.299><c> for</c><00:33:30.539><c> example</c> 00:33:30.710 --> 00:33:30.720 align:start position:0% um no no no so um there's no for example 00:33:30.720 --> 00:33:32.810 align:start position:0% um no no no so um there's no for example geographical<00:33:31.380><c> restrictions</c><00:33:31.919><c> uh</c><00:33:32.460><c> so</c><00:33:32.580><c> if</c><00:33:32.700><c> you</c> 00:33:32.810 --> 00:33:32.820 align:start position:0% geographical restrictions uh so if you 00:33:32.820 --> 00:33:34.070 align:start position:0% geographical restrictions uh so if you have<00:33:32.940><c> field</c><00:33:33.179><c> trial</c><00:33:33.419><c> reports</c><00:33:33.779><c> just</c><00:33:33.899><c> from</c> 00:33:34.070 --> 00:33:34.080 align:start position:0% have field trial reports just from 00:33:34.080 --> 00:33:35.930 align:start position:0% have field trial reports just from Germany<00:33:34.440><c> Germany</c><00:33:34.980><c> you</c><00:33:35.340><c> get</c><00:33:35.460><c> a</c><00:33:35.580><c> certificate</c> 00:33:35.930 --> 00:33:35.940 align:start position:0% Germany Germany you get a certificate 00:33:35.940 --> 00:33:37.130 align:start position:0% Germany Germany you get a certificate which<00:33:36.120><c> allows</c><00:33:36.360><c> you</c><00:33:36.419><c> to</c><00:33:36.539><c> sell</c><00:33:36.659><c> the</c><00:33:36.840><c> product</c><00:33:36.960><c> in</c> 00:33:37.130 --> 00:33:37.140 align:start position:0% which allows you to sell the product in 00:33:37.140 --> 00:33:38.450 align:start position:0% which allows you to sell the product in Spain<00:33:37.320><c> right</c><00:33:37.559><c> so</c><00:33:37.740><c> that's</c><00:33:37.860><c> that's</c><00:33:38.220><c> already</c> 00:33:38.450 --> 00:33:38.460 align:start position:0% Spain right so that's that's already 00:33:38.460 --> 00:33:39.950 align:start position:0% Spain right so that's that's already something<00:33:38.760><c> that</c><00:33:39.179><c> where</c><00:33:39.480><c> you</c><00:33:39.720><c> know</c><00:33:39.779><c> if</c><00:33:39.840><c> you</c> 00:33:39.950 --> 00:33:39.960 align:start position:0% something that where you know if you 00:33:39.960 --> 00:33:41.870 align:start position:0% something that where you know if you look<00:33:40.019><c> at</c><00:33:40.140><c> protection</c><00:33:40.679><c> products</c><00:33:41.039><c> it's</c><00:33:41.460><c> it's</c><00:33:41.519><c> a</c> 00:33:41.870 --> 00:33:41.880 align:start position:0% look at protection products it's it's a 00:33:41.880 --> 00:33:43.850 align:start position:0% look at protection products it's it's a bit<00:33:42.000><c> simpler</c><00:33:42.360><c> but</c><00:33:42.899><c> in</c><00:33:43.080><c> terms</c><00:33:43.260><c> of</c><00:33:43.320><c> you</c><00:33:43.620><c> know</c><00:33:43.679><c> the</c> 00:33:43.850 --> 00:33:43.860 align:start position:0% bit simpler but in terms of you know the 00:33:43.860 --> 00:33:45.110 align:start position:0% bit simpler but in terms of you know the the<00:33:43.980><c> years</c><00:33:44.220><c> if</c><00:33:44.519><c> you</c><00:33:44.640><c> have</c><00:33:44.700><c> field</c><00:33:44.880><c> trial</c> 00:33:45.110 --> 00:33:45.120 align:start position:0% the years if you have field trial 00:33:45.120 --> 00:33:48.289 align:start position:0% the years if you have field trial reports<00:33:45.539><c> from</c><00:33:45.840><c> four</c><00:33:46.440><c> years</c><00:33:46.620><c> ago</c><00:33:46.919><c> we</c><00:33:47.880><c> will</c><00:33:48.000><c> ask</c> 00:33:48.289 --> 00:33:48.299 align:start position:0% reports from four years ago we will ask 00:33:48.299 --> 00:33:50.210 align:start position:0% reports from four years ago we will ask you<00:33:48.480><c> to</c><00:33:48.899><c> declare</c><00:33:49.200><c> that</c><00:33:49.500><c> the</c><00:33:49.620><c> formulation</c><00:33:49.980><c> is</c> 00:33:50.210 --> 00:33:50.220 align:start position:0% you to declare that the formulation is 00:33:50.220 --> 00:33:51.830 align:start position:0% you to declare that the formulation is the<00:33:50.460><c> same</c><00:33:50.580><c> and</c><00:33:51.120><c> that's</c><00:33:51.240><c> something</c><00:33:51.419><c> as</c><00:33:51.659><c> a</c> 00:33:51.830 --> 00:33:51.840 align:start position:0% the same and that's something as a 00:33:51.840 --> 00:33:52.909 align:start position:0% the same and that's something as a manufacturer<00:33:52.200><c> that</c><00:33:52.380><c> you</c><00:33:52.500><c> do</c><00:33:52.620><c> have</c><00:33:52.740><c> to</c><00:33:52.860><c> make</c> 00:33:52.909 --> 00:33:52.919 align:start position:0% manufacturer that you do have to make 00:33:52.919 --> 00:33:54.230 align:start position:0% manufacturer that you do have to make sure<00:33:53.100><c> that</c><00:33:53.340><c> it</c><00:33:53.399><c> is</c><00:33:53.519><c> right</c><00:33:53.700><c> so</c><00:33:53.880><c> if</c><00:33:54.059><c> you've</c> 00:33:54.230 --> 00:33:54.240 align:start position:0% sure that it is right so if you've 00:33:54.240 --> 00:33:55.370 align:start position:0% sure that it is right so if you've changed<00:33:54.480><c> the</c><00:33:54.600><c> product</c><00:33:54.720><c> after</c><00:33:54.960><c> two</c><00:33:55.260><c> years</c> 00:33:55.370 --> 00:33:55.380 align:start position:0% changed the product after two years 00:33:55.380 --> 00:33:58.789 align:start position:0% changed the product after two years those<00:33:56.220><c> field</c><00:33:56.399><c> trial</c><00:33:56.580><c> reports</c><00:33:57.539><c> possibly</c><00:33:58.380><c> might</c> 00:33:58.789 --> 00:33:58.799 align:start position:0% those field trial reports possibly might 00:33:58.799 --> 00:33:59.990 align:start position:0% those field trial reports possibly might no<00:33:58.919><c> longer</c><00:33:59.159><c> be</c><00:33:59.220><c> affected</c><00:33:59.519><c> but</c><00:33:59.700><c> if</c><00:33:59.820><c> you've</c><00:33:59.940><c> been</c> 00:33:59.990 --> 00:34:00.000 align:start position:0% no longer be affected but if you've been 00:34:00.000 --> 00:34:02.389 align:start position:0% no longer be affected but if you've been making<00:34:00.240><c> the</c><00:34:00.480><c> same</c><00:34:00.659><c> product</c><00:34:00.840><c> for</c><00:34:01.380><c> seven</c><00:34:02.220><c> years</c> 00:34:02.389 --> 00:34:02.399 align:start position:0% making the same product for seven years 00:34:02.399 --> 00:34:03.769 align:start position:0% making the same product for seven years and<00:34:02.700><c> you</c><00:34:02.820><c> have</c><00:34:02.940><c> field</c><00:34:03.059><c> trial</c><00:34:03.419><c> reports</c><00:34:03.659><c> from</c> 00:34:03.769 --> 00:34:03.779 align:start position:0% and you have field trial reports from 00:34:03.779 --> 00:34:05.990 align:start position:0% and you have field trial reports from six<00:34:03.960><c> years</c><00:34:04.200><c> five</c><00:34:04.559><c> years</c><00:34:04.740><c> four</c><00:34:05.039><c> years</c><00:34:05.220><c> ago</c><00:34:05.519><c> you</c> 00:34:05.990 --> 00:34:06.000 align:start position:0% six years five years four years ago you 00:34:06.000 --> 00:34:08.030 align:start position:0% six years five years four years ago you can<00:34:06.120><c> use</c><00:34:06.299><c> those</c><00:34:06.539><c> reports</c> 00:34:08.030 --> 00:34:08.040 align:start position:0% can use those reports 00:34:08.040 --> 00:34:09.409 align:start position:0% can use those reports um<00:34:08.159><c> as</c><00:34:08.280><c> long</c><00:34:08.399><c> as</c><00:34:08.520><c> they</c><00:34:08.639><c> meet</c><00:34:08.820><c> the</c><00:34:09.000><c> requirements</c> 00:34:09.409 --> 00:34:09.419 align:start position:0% um as long as they meet the requirements 00:34:09.419 --> 00:34:11.570 align:start position:0% um as long as they meet the requirements of<00:34:09.540><c> the</c><00:34:09.720><c> technical</c><00:34:09.960><c> specifications</c><00:34:10.560><c> and</c><00:34:11.399><c> the</c> 00:34:11.570 --> 00:34:11.580 align:start position:0% of the technical specifications and the 00:34:11.580 --> 00:34:12.950 align:start position:0% of the technical specifications and the technical<00:34:11.820><c> specifications</c><00:34:12.359><c> don't</c><00:34:12.780><c> have</c> 00:34:12.950 --> 00:34:12.960 align:start position:0% technical specifications don't have 00:34:12.960 --> 00:34:15.470 align:start position:0% technical specifications don't have requirements<00:34:13.440><c> for</c><00:34:13.679><c> expiry</c><00:34:14.280><c> dates</c><00:34:14.580><c> or</c><00:34:15.119><c> indeed</c> 00:34:15.470 --> 00:34:15.480 align:start position:0% requirements for expiry dates or indeed 00:34:15.480 --> 00:34:21.470 align:start position:0% requirements for expiry dates or indeed for<00:34:15.659><c> example</c><00:34:15.919><c> geographical</c><00:34:16.919><c> locations</c> 00:34:21.470 --> 00:34:21.480 align:start position:0% 00:34:21.480 --> 00:34:22.730 align:start position:0% thank<00:34:21.839><c> you</c> 00:34:22.730 --> 00:34:22.740 align:start position:0% thank you 00:34:22.740 --> 00:34:23.950 align:start position:0% thank you okay 00:34:23.950 --> 00:34:23.960 align:start position:0% okay 00:34:23.960 --> 00:34:27.409 align:start position:0% okay it's<00:34:24.960><c> my</c><00:34:25.200><c> min</c> 00:34:27.409 --> 00:34:27.419 align:start position:0% it's my min 00:34:27.419 --> 00:34:44.270 align:start position:0% it's my min foreign 00:34:44.270 --> 00:34:44.280 align:start position:0% 00:34:44.280 --> 00:34:46.730 align:start position:0% thank<00:34:44.820><c> you</c><00:34:45.000><c> yeah</c><00:34:45.240><c> if</c><00:34:45.659><c> it's</c><00:34:45.899><c> possible</c><00:34:46.200><c> to</c><00:34:46.440><c> to</c> 00:34:46.730 --> 00:34:46.740 align:start position:0% thank you yeah if it's possible to to 00:34:46.740 --> 00:34:49.310 align:start position:0% thank you yeah if it's possible to to use<00:34:47.040><c> international</c><00:34:47.480><c> trials</c><00:34:48.480><c> that</c><00:34:48.960><c> were</c><00:34:49.139><c> not</c> 00:34:49.310 --> 00:34:49.320 align:start position:0% use international trials that were not 00:34:49.320 --> 00:34:52.750 align:start position:0% use international trials that were not done<00:34:49.500><c> in</c><00:34:49.740><c> Europe</c> 00:34:52.750 --> 00:34:52.760 align:start position:0% 00:34:52.760 --> 00:34:55.609 align:start position:0% so<00:34:53.760><c> at</c><00:34:54.300><c> the</c><00:34:54.419><c> moment</c><00:34:54.540><c> if</c><00:34:54.780><c> we</c><00:34:54.899><c> if</c><00:34:55.080><c> we</c><00:34:55.320><c> read</c><00:34:55.440><c> the</c> 00:34:55.609 --> 00:34:55.619 align:start position:0% so at the moment if we if we read the 00:34:55.619 --> 00:34:57.109 align:start position:0% so at the moment if we if we read the technical<00:34:55.919><c> specifications</c><00:34:56.460><c> the</c><00:34:56.820><c> answer</c><00:34:56.940><c> is</c> 00:34:57.109 --> 00:34:57.119 align:start position:0% technical specifications the answer is 00:34:57.119 --> 00:34:58.910 align:start position:0% technical specifications the answer is yes<00:34:57.359><c> and</c><00:34:57.900><c> so</c><00:34:58.080><c> if</c><00:34:58.260><c> you're</c><00:34:58.440><c> an</c><00:34:58.800><c> American</c> 00:34:58.910 --> 00:34:58.920 align:start position:0% yes and so if you're an American 00:34:58.920 --> 00:35:00.950 align:start position:0% yes and so if you're an American manufacturer 00:35:00.950 --> 00:35:00.960 align:start position:0% manufacturer 00:35:00.960 --> 00:35:02.750 align:start position:0% manufacturer um<00:35:01.020><c> and</c><00:35:01.200><c> you</c><00:35:01.260><c> have</c><00:35:01.440><c> trials</c><00:35:01.859><c> in</c><00:35:02.220><c> in</c><00:35:02.400><c> the</c><00:35:02.640><c> states</c> 00:35:02.750 --> 00:35:02.760 align:start position:0% um and you have trials in in the states 00:35:02.760 --> 00:35:05.210 align:start position:0% um and you have trials in in the states there's<00:35:03.660><c> no</c><00:35:03.839><c> requirement</c><00:35:04.320><c> in</c><00:35:04.800><c> the</c><00:35:04.920><c> technical</c> 00:35:05.210 --> 00:35:05.220 align:start position:0% there's no requirement in the technical 00:35:05.220 --> 00:35:06.710 align:start position:0% there's no requirement in the technical specifications<00:35:05.760><c> that</c><00:35:06.000><c> that's</c><00:35:06.240><c> not</c><00:35:06.420><c> allowed</c> 00:35:06.710 --> 00:35:06.720 align:start position:0% specifications that that's not allowed 00:35:06.720 --> 00:35:10.010 align:start position:0% specifications that that's not allowed so<00:35:07.200><c> that</c><00:35:07.320><c> that</c><00:35:07.500><c> would</c><00:35:07.740><c> be</c><00:35:07.859><c> allowed</c><00:35:08.160><c> and</c><00:35:09.000><c> so</c> 00:35:10.010 --> 00:35:10.020 align:start position:0% so that that would be allowed and so 00:35:10.020 --> 00:35:12.290 align:start position:0% so that that would be allowed and so um<00:35:10.560><c> in</c><00:35:11.040><c> that</c><00:35:11.220><c> regard</c><00:35:11.520><c> the</c><00:35:11.760><c> the</c><00:35:11.880><c> no</c> 00:35:12.290 --> 00:35:12.300 align:start position:0% um in that regard the the no 00:35:12.300 --> 00:35:14.870 align:start position:0% um in that regard the the no geographical<00:35:13.020><c> restrictions</c> 00:35:14.870 --> 00:35:14.880 align:start position:0% geographical restrictions 00:35:14.880 --> 00:35:17.510 align:start position:0% geographical restrictions um<00:35:15.000><c> that</c><00:35:15.480><c> I</c><00:35:15.540><c> just</c><00:35:15.660><c> mentioned</c><00:35:15.960><c> that</c><00:35:16.859><c> applies</c><00:35:17.339><c> to</c> 00:35:17.510 --> 00:35:17.520 align:start position:0% um that I just mentioned that applies to 00:35:17.520 --> 00:35:20.089 align:start position:0% um that I just mentioned that applies to the<00:35:17.640><c> EU</c><00:35:17.880><c> as</c><00:35:18.060><c> well</c><00:35:18.720><c> so</c><00:35:19.200><c> if</c><00:35:19.380><c> you</c><00:35:19.619><c> have</c><00:35:19.740><c> trials</c> 00:35:20.089 --> 00:35:20.099 align:start position:0% the EU as well so if you have trials 00:35:20.099 --> 00:35:21.470 align:start position:0% the EU as well so if you have trials from 00:35:21.470 --> 00:35:21.480 align:start position:0% from 00:35:21.480 --> 00:35:22.970 align:start position:0% from um<00:35:21.599><c> again</c><00:35:21.900><c> from</c><00:35:22.260><c> the</c><00:35:22.380><c> States</c><00:35:22.560><c> from</c><00:35:22.800><c> Canada</c> 00:35:22.970 --> 00:35:22.980 align:start position:0% um again from the States from Canada 00:35:22.980 --> 00:35:24.530 align:start position:0% um again from the States from Canada which<00:35:23.400><c> we're</c><00:35:23.520><c> now</c><00:35:23.700><c> getting</c><00:35:23.820><c> applications</c><00:35:24.300><c> for</c> 00:35:24.530 --> 00:35:24.540 align:start position:0% which we're now getting applications for 00:35:24.540 --> 00:35:36.530 align:start position:0% which we're now getting applications for those<00:35:25.140><c> can</c><00:35:25.440><c> be</c><00:35:25.619><c> used</c> 00:35:36.530 --> 00:35:36.540 align:start position:0% 00:35:36.540 --> 00:35:48.470 align:start position:0% and<00:35:36.960><c> that's</c><00:35:37.200><c> their</c><00:35:37.640><c> fpr</c><00:35:38.640><c> I've</c><00:35:38.880><c> heard</c> 00:35:48.470 --> 00:35:48.480 align:start position:0% 00:35:48.480 --> 00:35:51.349 align:start position:0% okay<00:35:49.380><c> understood</c><00:35:49.980><c> the</c><00:35:50.160><c> question</c> 00:35:51.349 --> 00:35:51.359 align:start position:0% okay understood the question 00:35:51.359 --> 00:35:52.670 align:start position:0% okay understood the question so 00:35:52.670 --> 00:35:52.680 align:start position:0% so 00:35:52.680 --> 00:35:55.250 align:start position:0% so if<00:35:53.339><c> I</c><00:35:53.820><c> mean</c><00:35:53.880><c> it</c><00:35:54.060><c> does</c><00:35:54.359><c> depend</c><00:35:54.660><c> a</c><00:35:54.780><c> little</c><00:35:54.900><c> bit</c><00:35:55.020><c> on</c> 00:35:55.250 --> 00:35:55.260 align:start position:0% if I mean it does depend a little bit on 00:35:55.260 --> 00:35:56.750 align:start position:0% if I mean it does depend a little bit on on<00:35:55.440><c> where</c><00:35:55.859><c> it</c><00:35:56.040><c> doesn't</c><00:35:56.220><c> meet</c><00:35:56.520><c> the</c> 00:35:56.750 --> 00:35:56.760 align:start position:0% on where it doesn't meet the 00:35:56.760 --> 00:35:58.550 align:start position:0% on where it doesn't meet the requirements 00:35:58.550 --> 00:35:58.560 align:start position:0% requirements 00:35:58.560 --> 00:36:01.130 align:start position:0% requirements um<00:35:58.680><c> so</c><00:35:59.160><c> if</c><00:35:59.280><c> if</c><00:35:59.460><c> we</c><00:35:59.820><c> get</c><00:36:00.000><c> a</c><00:36:00.119><c> file</c> 00:36:01.130 --> 00:36:01.140 align:start position:0% um so if if we get a file 00:36:01.140 --> 00:36:03.290 align:start position:0% um so if if we get a file um<00:36:01.200><c> with</c><00:36:01.680><c> it</c><00:36:01.800><c> with</c><00:36:02.040><c> a</c><00:36:02.160><c> test</c><00:36:02.280><c> report</c><00:36:02.520><c> and</c><00:36:03.119><c> for</c> 00:36:03.290 --> 00:36:03.300 align:start position:0% um with it with a test report and for 00:36:03.300 --> 00:36:05.630 align:start position:0% um with it with a test report and for example<00:36:03.540><c> the</c><00:36:03.780><c> pathogen</c><00:36:04.140><c> content</c><00:36:04.500><c> is</c><00:36:04.680><c> too</c><00:36:04.859><c> high</c> 00:36:05.630 --> 00:36:05.640 align:start position:0% example the pathogen content is too high 00:36:05.640 --> 00:36:07.430 align:start position:0% example the pathogen content is too high there's<00:36:05.940><c> no</c><00:36:06.119><c> way</c><00:36:06.240><c> to</c><00:36:06.359><c> go</c><00:36:06.480><c> around</c><00:36:06.599><c> that</c><00:36:06.900><c> but</c><00:36:07.320><c> of</c> 00:36:07.430 --> 00:36:07.440 align:start position:0% there's no way to go around that but of 00:36:07.440 --> 00:36:09.589 align:start position:0% there's no way to go around that but of course<00:36:07.560><c> if</c><00:36:07.740><c> we</c><00:36:07.859><c> get</c><00:36:08.040><c> a</c><00:36:08.220><c> a</c><00:36:08.460><c> file</c><00:36:09.000><c> where</c><00:36:09.420><c> the</c> 00:36:09.589 --> 00:36:09.599 align:start position:0% course if we get a a file where the 00:36:09.599 --> 00:36:12.170 align:start position:0% course if we get a a file where the field<00:36:09.780><c> trials</c><00:36:10.200><c> don't</c><00:36:10.380><c> exactly</c><00:36:10.980><c> meet</c><00:36:11.280><c> the</c> 00:36:12.170 --> 00:36:12.180 align:start position:0% field trials don't exactly meet the 00:36:12.180 --> 00:36:13.310 align:start position:0% field trials don't exactly meet the requirements<00:36:12.660><c> from</c><00:36:12.900><c> the</c><00:36:13.079><c> technical</c> 00:36:13.310 --> 00:36:13.320 align:start position:0% requirements from the technical 00:36:13.320 --> 00:36:15.290 align:start position:0% requirements from the technical specifications 00:36:15.290 --> 00:36:15.300 align:start position:0% specifications 00:36:15.300 --> 00:36:16.550 align:start position:0% specifications um<00:36:15.420><c> but</c><00:36:15.720><c> you</c><00:36:15.839><c> have</c><00:36:15.960><c> for</c><00:36:16.140><c> example</c><00:36:16.320><c> other</c> 00:36:16.550 --> 00:36:16.560 align:start position:0% um but you have for example other 00:36:16.560 --> 00:36:18.410 align:start position:0% um but you have for example other evidence<00:36:16.859><c> or</c><00:36:17.040><c> you</c><00:36:17.220><c> used</c><00:36:17.339><c> other</c><00:36:17.579><c> standards</c><00:36:18.060><c> for</c> 00:36:18.410 --> 00:36:18.420 align:start position:0% evidence or you used other standards for 00:36:18.420 --> 00:36:21.230 align:start position:0% evidence or you used other standards for uh<00:36:19.320><c> for</c><00:36:19.740><c> performing</c><00:36:20.040><c> the</c><00:36:20.160><c> field</c><00:36:20.280><c> trials</c><00:36:20.700><c> that</c> 00:36:21.230 --> 00:36:21.240 align:start position:0% uh for performing the field trials that 00:36:21.240 --> 00:36:22.970 align:start position:0% uh for performing the field trials that is<00:36:21.359><c> allowed</c><00:36:21.720><c> but</c><00:36:22.020><c> then</c><00:36:22.140><c> you</c><00:36:22.320><c> have</c><00:36:22.440><c> to</c><00:36:22.619><c> as</c><00:36:22.800><c> a</c> 00:36:22.970 --> 00:36:22.980 align:start position:0% is allowed but then you have to as a 00:36:22.980 --> 00:36:24.290 align:start position:0% is allowed but then you have to as a manufacturer<00:36:23.400><c> think</c><00:36:23.640><c> about</c><00:36:23.760><c> well</c><00:36:24.000><c> what</c> 00:36:24.290 --> 00:36:24.300 align:start position:0% manufacturer think about well what 00:36:24.300 --> 00:36:26.390 align:start position:0% manufacturer think about well what standard<00:36:24.660><c> am</c><00:36:25.020><c> I</c><00:36:25.140><c> using</c><00:36:25.380><c> how</c><00:36:25.859><c> am</c><00:36:26.040><c> I</c><00:36:26.099><c> proving</c> 00:36:26.390 --> 00:36:26.400 align:start position:0% standard am I using how am I proving 00:36:26.400 --> 00:36:28.490 align:start position:0% standard am I using how am I proving efficacy<00:36:26.880><c> and</c><00:36:27.660><c> so</c><00:36:27.839><c> these</c><00:36:28.200><c> technical</c> 00:36:28.490 --> 00:36:28.500 align:start position:0% efficacy and so these technical 00:36:28.500 --> 00:36:30.770 align:start position:0% efficacy and so these technical specifications<00:36:29.160><c> they're</c><00:36:29.700><c> not</c> 00:36:30.770 --> 00:36:30.780 align:start position:0% specifications they're not 00:36:30.780 --> 00:36:31.690 align:start position:0% specifications they're not um 00:36:31.690 --> 00:36:31.700 align:start position:0% um 00:36:31.700 --> 00:36:34.730 align:start position:0% um they're<00:36:32.700><c> not</c><00:36:32.820><c> the</c><00:36:33.000><c> only</c><00:36:33.180><c> only</c><00:36:33.599><c> solution</c><00:36:34.140><c> and</c> 00:36:34.730 --> 00:36:34.740 align:start position:0% they're not the only only solution and 00:36:34.740 --> 00:36:36.829 align:start position:0% they're not the only only solution and so<00:36:34.859><c> I</c><00:36:35.040><c> would</c><00:36:35.160><c> say</c><00:36:35.280><c> if</c><00:36:35.520><c> if</c><00:36:35.640><c> for</c><00:36:36.240><c> some</c><00:36:36.359><c> reason</c><00:36:36.540><c> it</c> 00:36:36.829 --> 00:36:36.839 align:start position:0% so I would say if if for some reason it 00:36:36.839 --> 00:36:38.810 align:start position:0% so I would say if if for some reason it doesn't<00:36:37.020><c> meet</c><00:36:37.260><c> the</c><00:36:37.440><c> requirements</c><00:36:37.980><c> from</c><00:36:38.640><c> the</c> 00:36:38.810 --> 00:36:38.820 align:start position:0% doesn't meet the requirements from the 00:36:38.820 --> 00:36:40.310 align:start position:0% doesn't meet the requirements from the technical<00:36:39.119><c> specifications</c> 00:36:40.310 --> 00:36:40.320 align:start position:0% technical specifications 00:36:40.320 --> 00:36:42.349 align:start position:0% technical specifications look<00:36:40.859><c> at</c><00:36:41.040><c> where</c><00:36:41.339><c> so</c><00:36:41.700><c> where</c><00:36:41.940><c> it</c><00:36:42.060><c> doesn't</c><00:36:42.180><c> meet</c> 00:36:42.349 --> 00:36:42.359 align:start position:0% look at where so where it doesn't meet 00:36:42.359 --> 00:36:44.170 align:start position:0% look at where so where it doesn't meet the<00:36:42.540><c> requirements</c><00:36:42.900><c> for</c><00:36:43.020><c> example</c><00:36:43.260><c> and</c><00:36:43.619><c> then</c> 00:36:44.170 --> 00:36:44.180 align:start position:0% the requirements for example and then 00:36:44.180 --> 00:36:46.190 align:start position:0% the requirements for example and then discuss<00:36:45.180><c> with</c><00:36:45.359><c> the</c><00:36:45.480><c> notified</c><00:36:45.720><c> body</c><00:36:45.960><c> whether</c> 00:36:46.190 --> 00:36:46.200 align:start position:0% discuss with the notified body whether 00:36:46.200 --> 00:36:49.250 align:start position:0% discuss with the notified body whether that's<00:36:46.380><c> allowed</c><00:36:46.740><c> to</c><00:36:47.040><c> give</c><00:36:47.160><c> just</c><00:36:47.339><c> one</c><00:36:47.520><c> example</c> 00:36:49.250 --> 00:36:49.260 align:start position:0% that's allowed to give just one example 00:36:49.260 --> 00:36:51.530 align:start position:0% that's allowed to give just one example um<00:36:49.320><c> the</c><00:36:50.160><c> the</c><00:36:50.280><c> standards</c><00:36:50.940><c> at</c><00:36:51.060><c> the</c><00:36:51.180><c> moment</c><00:36:51.300><c> say</c> 00:36:51.530 --> 00:36:51.540 align:start position:0% um the the standards at the moment say 00:36:51.540 --> 00:36:53.390 align:start position:0% um the the standards at the moment say you<00:36:51.780><c> have</c><00:36:51.900><c> to</c><00:36:52.079><c> hire</c><00:36:52.260><c> a</c><00:36:52.560><c> cro</c><00:36:52.680><c> to</c><00:36:53.099><c> do</c><00:36:53.220><c> the</c><00:36:53.280><c> field</c> 00:36:53.390 --> 00:36:53.400 align:start position:0% you have to hire a cro to do the field 00:36:53.400 --> 00:36:55.310 align:start position:0% you have to hire a cro to do the field Trails<00:36:53.820><c> but</c><00:36:54.240><c> what</c><00:36:54.359><c> if</c><00:36:54.540><c> you</c><00:36:54.660><c> as</c><00:36:54.780><c> a</c><00:36:54.960><c> company</c><00:36:55.020><c> have</c> 00:36:55.310 --> 00:36:55.320 align:start position:0% Trails but what if you as a company have 00:36:55.320 --> 00:36:56.810 align:start position:0% Trails but what if you as a company have done<00:36:55.500><c> the</c><00:36:55.619><c> field</c><00:36:55.680><c> trials</c><00:36:56.099><c> internally</c><00:36:56.400><c> with</c> 00:36:56.810 --> 00:36:56.820 align:start position:0% done the field trials internally with 00:36:56.820 --> 00:36:58.910 align:start position:0% done the field trials internally with your<00:36:57.000><c> own</c><00:36:57.060><c> resources</c><00:36:57.480><c> is</c><00:36:57.960><c> that</c><00:36:58.079><c> allowed</c> 00:36:58.910 --> 00:36:58.920 align:start position:0% your own resources is that allowed 00:36:58.920 --> 00:37:00.050 align:start position:0% your own resources is that allowed possibly 00:37:00.050 --> 00:37:00.060 align:start position:0% possibly 00:37:00.060 --> 00:37:01.609 align:start position:0% possibly if<00:37:00.359><c> you</c><00:37:00.480><c> have</c><00:37:00.599><c> the</c><00:37:00.720><c> evidence</c><00:37:00.960><c> if</c><00:37:01.320><c> you</c><00:37:01.380><c> can</c><00:37:01.500><c> make</c> 00:37:01.609 --> 00:37:01.619 align:start position:0% if you have the evidence if you can make 00:37:01.619 --> 00:37:03.410 align:start position:0% if you have the evidence if you can make it<00:37:01.740><c> objective</c><00:37:02.220><c> and</c><00:37:02.760><c> you</c><00:37:02.880><c> can</c><00:37:03.000><c> prove</c><00:37:03.300><c> the</c> 00:37:03.410 --> 00:37:03.420 align:start position:0% it objective and you can prove the 00:37:03.420 --> 00:37:05.329 align:start position:0% it objective and you can prove the results<00:37:03.599><c> then</c><00:37:04.320><c> possibly</c><00:37:04.680><c> it</c><00:37:04.859><c> will</c><00:37:04.980><c> be</c><00:37:05.099><c> allowed</c> 00:37:05.329 --> 00:37:05.339 align:start position:0% results then possibly it will be allowed 00:37:05.339 --> 00:37:07.670 align:start position:0% results then possibly it will be allowed to<00:37:05.520><c> use</c><00:37:05.700><c> your</c><00:37:05.940><c> own</c><00:37:06.000><c> trials</c><00:37:06.420><c> rather</c><00:37:06.960><c> than</c><00:37:07.140><c> ones</c> 00:37:07.670 --> 00:37:07.680 align:start position:0% to use your own trials rather than ones 00:37:07.680 --> 00:37:09.470 align:start position:0% to use your own trials rather than ones with<00:37:07.800><c> a</c><00:37:07.920><c> cro</c> 00:37:09.470 --> 00:37:09.480 align:start position:0% with a cro 00:37:09.480 --> 00:37:11.210 align:start position:0% with a cro but<00:37:09.900><c> of</c><00:37:10.020><c> course</c><00:37:10.140><c> depends</c><00:37:10.560><c> on</c><00:37:10.680><c> a</c><00:37:10.800><c> case-by-case</c> 00:37:11.210 --> 00:37:11.220 align:start position:0% but of course depends on a case-by-case 00:37:11.220 --> 00:37:12.650 align:start position:0% but of course depends on a case-by-case basis 00:37:12.650 --> 00:37:12.660 align:start position:0% basis 00:37:12.660 --> 00:38:00.410 align:start position:0% basis foreign 00:38:00.410 --> 00:38:00.420 align:start position:0% 00:38:00.420 --> 00:38:01.609 align:start position:0% yeah 00:38:01.609 --> 00:38:01.619 align:start position:0% yeah 00:38:01.619 --> 00:38:30.349 align:start position:0% yeah um 00:38:30.349 --> 00:38:30.359 align:start position:0% 00:38:30.359 --> 00:38:31.790 align:start position:0% okay<00:38:30.780><c> thank</c><00:38:31.079><c> you</c> 00:38:31.790 --> 00:38:31.800 align:start position:0% okay thank you 00:38:31.800 --> 00:38:33.829 align:start position:0% okay thank you that's<00:38:32.339><c> if</c><00:38:32.579><c> you</c><00:38:32.700><c> have</c><00:38:32.760><c> a</c><00:38:32.820><c> bio</c><00:38:33.000><c> student</c> 00:38:33.829 --> 00:38:33.839 align:start position:0% that's if you have a bio student 00:38:33.839 --> 00:38:36.470 align:start position:0% that's if you have a bio student if<00:38:34.380><c> if</c><00:38:34.380><c> you</c><00:38:34.740><c> have</c><00:38:34.859><c> a</c><00:38:34.980><c> biosimilant</c> 00:38:36.470 --> 00:38:36.480 align:start position:0% if if you have a biosimilant 00:38:36.480 --> 00:38:39.290 align:start position:0% if if you have a biosimilant um<00:38:36.540><c> which</c><00:38:37.200><c> was</c><00:38:37.380><c> applied</c><00:38:37.859><c> to</c><00:38:38.099><c> for</c><00:38:38.460><c> example</c><00:38:38.760><c> seed</c> 00:38:39.290 --> 00:38:39.300 align:start position:0% um which was applied to for example seed 00:38:39.300 --> 00:38:40.670 align:start position:0% um which was applied to for example seed or<00:38:39.480><c> whatever</c> 00:38:40.670 --> 00:38:40.680 align:start position:0% or whatever 00:38:40.680 --> 00:38:43.190 align:start position:0% or whatever where<00:38:41.280><c> where</c><00:38:41.280><c> to</c><00:38:41.820><c> put</c><00:38:42.000><c> the</c><00:38:42.180><c> label</c><00:38:42.480><c> with</c><00:38:42.839><c> a</c><00:38:43.020><c> with</c> 00:38:43.190 --> 00:38:43.200 align:start position:0% where where to put the label with a with 00:38:43.200 --> 00:38:46.550 align:start position:0% where where to put the label with a with a<00:38:43.320><c> claim</c> 00:38:46.550 --> 00:38:46.560 align:start position:0% 00:38:46.560 --> 00:38:47.450 align:start position:0% um 00:38:47.450 --> 00:38:47.460 align:start position:0% um 00:38:47.460 --> 00:38:49.730 align:start position:0% um if<00:38:47.880><c> we</c><00:38:47.940><c> look</c><00:38:48.060><c> at</c><00:38:48.240><c> that</c><00:38:48.359><c> from</c><00:38:48.660><c> the</c> 00:38:49.730 --> 00:38:49.740 align:start position:0% if we look at that from the 00:38:49.740 --> 00:38:50.329 align:start position:0% if we look at that from the um 00:38:50.329 --> 00:38:50.339 align:start position:0% um 00:38:50.339 --> 00:38:51.950 align:start position:0% um from<00:38:50.700><c> the</c><00:38:50.820><c> FBR</c><00:38:51.060><c> perspective</c><00:38:51.540><c> if</c><00:38:51.839><c> you're</c> 00:38:51.950 --> 00:38:51.960 align:start position:0% from the FBR perspective if you're 00:38:51.960 --> 00:38:54.550 align:start position:0% from the FBR perspective if you're applying<00:38:52.440><c> or</c><00:38:53.220><c> for</c><00:38:53.520><c> example</c><00:38:53.760><c> mixing</c><00:38:54.300><c> a</c> 00:38:54.550 --> 00:38:54.560 align:start position:0% applying or for example mixing a 00:38:54.560 --> 00:38:56.930 align:start position:0% applying or for example mixing a biostimulant<00:38:55.560><c> with</c><00:38:55.680><c> a</c><00:38:55.800><c> fertilizer</c><00:38:56.339><c> it</c><00:38:56.520><c> will</c> 00:38:56.930 --> 00:38:56.940 align:start position:0% biostimulant with a fertilizer it will 00:38:56.940 --> 00:38:58.250 align:start position:0% biostimulant with a fertilizer it will become<00:38:57.180><c> a</c><00:38:57.300><c> blend</c> 00:38:58.250 --> 00:38:58.260 align:start position:0% become a blend 00:38:58.260 --> 00:39:00.290 align:start position:0% become a blend and<00:38:58.800><c> so</c><00:38:59.040><c> then</c><00:38:59.160><c> what</c><00:38:59.400><c> you</c><00:38:59.520><c> have</c><00:38:59.640><c> to</c><00:38:59.760><c> do</c><00:38:59.880><c> is</c><00:39:00.060><c> on</c> 00:39:00.290 --> 00:39:00.300 align:start position:0% and so then what you have to do is on 00:39:00.300 --> 00:39:01.910 align:start position:0% and so then what you have to do is on that<00:39:00.480><c> product</c><00:39:00.720><c> that</c><00:39:00.960><c> you</c><00:39:01.140><c> then</c><00:39:01.260><c> sell</c><00:39:01.500><c> as</c><00:39:01.740><c> a</c> 00:39:01.910 --> 00:39:01.920 align:start position:0% that product that you then sell as a 00:39:01.920 --> 00:39:03.829 align:start position:0% that product that you then sell as a blend<00:39:02.400><c> you</c><00:39:02.820><c> have</c><00:39:02.940><c> to</c><00:39:03.060><c> put</c><00:39:03.180><c> the</c><00:39:03.300><c> label</c><00:39:03.599><c> from</c> 00:39:03.829 --> 00:39:03.839 align:start position:0% blend you have to put the label from 00:39:03.839 --> 00:39:05.690 align:start position:0% blend you have to put the label from both<00:39:04.079><c> products</c><00:39:04.560><c> so</c><00:39:05.160><c> you</c><00:39:05.280><c> have</c><00:39:05.339><c> to</c><00:39:05.460><c> put</c><00:39:05.579><c> the</c> 00:39:05.690 --> 00:39:05.700 align:start position:0% both products so you have to put the 00:39:05.700 --> 00:39:07.310 align:start position:0% both products so you have to put the label<00:39:06.000><c> from</c><00:39:06.180><c> the</c><00:39:06.300><c> the</c><00:39:06.420><c> biostimulant</c><00:39:07.200><c> product</c> 00:39:07.310 --> 00:39:07.320 align:start position:0% label from the the biostimulant product 00:39:07.320 --> 00:39:09.950 align:start position:0% label from the the biostimulant product that<00:39:07.740><c> you</c><00:39:08.460><c> might</c><00:39:08.579><c> as</c><00:39:08.940><c> a</c><00:39:09.180><c> blender</c><00:39:09.359><c> get</c><00:39:09.599><c> from</c><00:39:09.780><c> a</c> 00:39:09.950 --> 00:39:09.960 align:start position:0% that you might as a blender get from a 00:39:09.960 --> 00:39:11.630 align:start position:0% that you might as a blender get from a different<00:39:10.079><c> manufacturer</c><00:39:10.740><c> you</c><00:39:11.280><c> have</c><00:39:11.400><c> to</c><00:39:11.520><c> put</c> 00:39:11.630 --> 00:39:11.640 align:start position:0% different manufacturer you have to put 00:39:11.640 --> 00:39:14.210 align:start position:0% different manufacturer you have to put that<00:39:11.820><c> on</c><00:39:12.060><c> the</c><00:39:12.180><c> blend</c><00:39:12.420><c> and</c><00:39:13.140><c> then</c><00:39:13.320><c> put</c><00:39:13.920><c> on</c><00:39:14.099><c> the</c> 00:39:14.210 --> 00:39:14.220 align:start position:0% that on the blend and then put on the 00:39:14.220 --> 00:39:16.730 align:start position:0% that on the blend and then put on the blend<00:39:14.460><c> the</c><00:39:14.760><c> label</c><00:39:15.060><c> from</c> 00:39:16.730 --> 00:39:16.740 align:start position:0% blend the label from 00:39:16.740 --> 00:39:19.670 align:start position:0% blend the label from um<00:39:17.099><c> yeah</c><00:39:17.640><c> for</c><00:39:17.820><c> example</c><00:39:18.060><c> the</c><00:39:18.240><c> mpk</c> 00:39:19.670 --> 00:39:19.680 align:start position:0% um yeah for example the mpk 00:39:19.680 --> 00:39:20.870 align:start position:0% um yeah for example the mpk um<00:39:19.740><c> and</c><00:39:19.920><c> then</c><00:39:20.040><c> you</c><00:39:20.160><c> just</c><00:39:20.280><c> have</c><00:39:20.400><c> to</c><00:39:20.520><c> put</c><00:39:20.579><c> both</c><00:39:20.760><c> of</c> 00:39:20.870 --> 00:39:20.880 align:start position:0% um and then you just have to put both of 00:39:20.880 --> 00:39:23.030 align:start position:0% um and then you just have to put both of those<00:39:21.000><c> labels</c><00:39:21.300><c> on</c><00:39:21.599><c> the</c><00:39:21.720><c> product</c><00:39:21.839><c> and</c><00:39:22.740><c> you</c> 00:39:23.030 --> 00:39:23.040 align:start position:0% those labels on the product and you 00:39:23.040 --> 00:39:25.730 align:start position:0% those labels on the product and you cannot<00:39:23.339><c> even</c><00:39:23.880><c> really</c><00:39:24.780><c> amend</c><00:39:25.140><c> those</c><00:39:25.320><c> labels</c><00:39:25.560><c> so</c> 00:39:25.730 --> 00:39:25.740 align:start position:0% cannot even really amend those labels so 00:39:25.740 --> 00:39:27.589 align:start position:0% cannot even really amend those labels so you<00:39:25.859><c> have</c><00:39:25.980><c> to</c><00:39:26.040><c> keep</c><00:39:26.460><c> them</c><00:39:26.640><c> essentially</c><00:39:27.240><c> copy</c> 00:39:27.589 --> 00:39:27.599 align:start position:0% you have to keep them essentially copy 00:39:27.599 --> 00:39:33.890 align:start position:0% you have to keep them essentially copy them<00:39:27.720><c> verbatim</c> 00:39:33.890 --> 00:39:33.900 align:start position:0% 00:39:33.900 --> 00:39:39.349 align:start position:0% okay<00:39:34.380><c> uh</c><00:39:35.160><c> yes</c> 00:39:39.349 --> 00:39:39.359 align:start position:0% 00:39:39.359 --> 00:40:00.890 align:start position:0% um 00:40:00.890 --> 00:40:00.900 align:start position:0% 00:40:00.900 --> 00:40:03.050 align:start position:0% done 00:40:03.050 --> 00:40:03.060 align:start position:0% done 00:40:03.060 --> 00:40:06.170 align:start position:0% done so<00:40:03.780><c> if</c><00:40:04.560><c> you're</c><00:40:05.099><c> um</c><00:40:05.099><c> if</c><00:40:05.339><c> it's</c><00:40:05.400><c> not</c><00:40:05.579><c> a</c><00:40:05.760><c> blend</c><00:40:05.940><c> so</c> 00:40:06.170 --> 00:40:06.180 align:start position:0% so if you're um if it's not a blend so 00:40:06.180 --> 00:40:08.210 align:start position:0% so if you're um if it's not a blend so if<00:40:06.300><c> you're</c><00:40:06.480><c> for</c><00:40:06.780><c> example</c><00:40:07.020><c> coding</c><00:40:07.500><c> it</c><00:40:07.680><c> and</c><00:40:07.980><c> and</c> 00:40:08.210 --> 00:40:08.220 align:start position:0% if you're for example coding it and and 00:40:08.220 --> 00:40:10.010 align:start position:0% if you're for example coding it and and for<00:40:08.940><c> whatever</c><00:40:09.060><c> or</c><00:40:09.359><c> you're</c><00:40:09.480><c> just</c><00:40:09.599><c> mixing</c><00:40:09.900><c> it</c> 00:40:10.010 --> 00:40:10.020 align:start position:0% for whatever or you're just mixing it 00:40:10.020 --> 00:40:11.870 align:start position:0% for whatever or you're just mixing it and<00:40:10.140><c> for</c><00:40:10.320><c> so</c><00:40:10.500><c> for</c><00:40:10.680><c> whatever</c><00:40:10.920><c> reason</c><00:40:11.220><c> you</c> 00:40:11.870 --> 00:40:11.880 align:start position:0% and for so for whatever reason you 00:40:11.880 --> 00:40:14.270 align:start position:0% and for so for whatever reason you cannot<00:40:12.119><c> call</c><00:40:12.300><c> it</c><00:40:12.420><c> a</c><00:40:12.540><c> blend</c> 00:40:14.270 --> 00:40:14.280 align:start position:0% cannot call it a blend 00:40:14.280 --> 00:40:15.650 align:start position:0% cannot call it a blend um<00:40:14.339><c> then</c> 00:40:15.650 --> 00:40:15.660 align:start position:0% um then 00:40:15.660 --> 00:40:17.450 align:start position:0% um then um<00:40:15.780><c> the</c> 00:40:17.450 --> 00:40:17.460 align:start position:0% um the 00:40:17.460 --> 00:40:19.310 align:start position:0% um the the end<00:40:18.060><c> product</c><00:40:18.300><c> has</c><00:40:18.660><c> to</c><00:40:18.780><c> be</c><00:40:18.900><c> one</c><00:40:19.079><c> of</c><00:40:19.200><c> the</c> 00:40:19.310 --> 00:40:19.320 align:start position:0% the end product has to be one of the 00:40:19.320 --> 00:40:21.890 align:start position:0% the end product has to be one of the other<00:40:19.440><c> six</c><00:40:19.980><c> pfcs</c><00:40:20.640><c> and</c><00:40:20.760><c> so</c><00:40:20.820><c> then</c><00:40:20.940><c> it</c><00:40:21.119><c> can</c><00:40:21.240><c> be</c><00:40:21.359><c> it</c> 00:40:21.890 --> 00:40:21.900 align:start position:0% other six pfcs and so then it can be it 00:40:21.900 --> 00:40:23.750 align:start position:0% other six pfcs and so then it can be it can<00:40:22.020><c> be</c><00:40:22.140><c> a</c><00:40:22.260><c> fertilizer</c><00:40:22.800><c> but</c><00:40:23.339><c> then</c><00:40:23.520><c> of</c><00:40:23.640><c> course</c> 00:40:23.750 --> 00:40:23.760 align:start position:0% can be a fertilizer but then of course 00:40:23.760 --> 00:40:25.609 align:start position:0% can be a fertilizer but then of course then<00:40:23.880><c> the</c><00:40:24.060><c> bio</c><00:40:24.240><c> stimulant</c><00:40:24.720><c> has</c><00:40:24.900><c> to</c><00:40:24.960><c> be</c><00:40:25.020><c> a</c><00:40:25.140><c> CMC</c> 00:40:25.609 --> 00:40:25.619 align:start position:0% then the bio stimulant has to be a CMC 00:40:25.619 --> 00:40:27.589 align:start position:0% then the bio stimulant has to be a CMC so<00:40:26.160><c> then</c><00:40:26.339><c> for</c><00:40:26.520><c> example</c><00:40:26.760><c> it</c><00:40:26.940><c> might</c><00:40:27.119><c> have</c><00:40:27.240><c> to</c><00:40:27.420><c> be</c> 00:40:27.589 --> 00:40:27.599 align:start position:0% so then for example it might have to be 00:40:27.599 --> 00:40:30.770 align:start position:0% so then for example it might have to be uh<00:40:28.560><c> re-registered</c><00:40:29.280><c> it</c><00:40:29.520><c> might</c><00:40:29.640><c> have</c><00:40:29.820><c> to</c><00:40:29.940><c> be</c><00:40:30.060><c> a</c><00:40:30.300><c> a</c> 00:40:30.770 --> 00:40:30.780 align:start position:0% uh re-registered it might have to be a a 00:40:30.780 --> 00:40:32.089 align:start position:0% uh re-registered it might have to be a a biosumer<00:40:31.440><c> that</c><00:40:31.560><c> this</c><00:40:31.680><c> is</c><00:40:31.740><c> just</c><00:40:31.859><c> a</c><00:40:31.920><c> plant</c> 00:40:32.089 --> 00:40:32.099 align:start position:0% biosumer that this is just a plant 00:40:32.099 --> 00:40:34.609 align:start position:0% biosumer that this is just a plant extract<00:40:32.520><c> either</c><00:40:33.240><c> way</c><00:40:33.420><c> it</c><00:40:33.660><c> has</c><00:40:33.780><c> to</c><00:40:33.900><c> be</c><00:40:34.140><c> listed</c> 00:40:34.609 --> 00:40:34.619 align:start position:0% extract either way it has to be listed 00:40:34.619 --> 00:40:36.950 align:start position:0% extract either way it has to be listed as<00:40:34.800><c> a</c><00:40:34.920><c> CMC</c><00:40:35.280><c> ingredient</c><00:40:35.460><c> and</c><00:40:36.240><c> so</c><00:40:36.359><c> then</c><00:40:36.540><c> if</c> 00:40:36.950 --> 00:40:36.960 align:start position:0% as a CMC ingredient and so then if 00:40:36.960 --> 00:40:38.450 align:start position:0% as a CMC ingredient and so then if you're<00:40:37.020><c> doing</c><00:40:37.260><c> that</c><00:40:37.500><c> and</c><00:40:37.920><c> you're</c><00:40:38.099><c> selling</c><00:40:38.400><c> it</c> 00:40:38.450 --> 00:40:38.460 align:start position:0% you're doing that and you're selling it 00:40:38.460 --> 00:40:41.030 align:start position:0% you're doing that and you're selling it as<00:40:38.579><c> a</c><00:40:38.700><c> PFC</c><00:40:39.119><c> as</c><00:40:39.540><c> a</c><00:40:39.839><c> fertilizer</c><00:40:40.260><c> so</c><00:40:40.320><c> as</c><00:40:40.440><c> PFC</c><00:40:40.859><c> one</c> 00:40:41.030 --> 00:40:41.040 align:start position:0% as a PFC as a fertilizer so as PFC one 00:40:41.040 --> 00:40:42.890 align:start position:0% as a PFC as a fertilizer so as PFC one then<00:40:41.579><c> you</c><00:40:41.760><c> cannot</c><00:40:41.940><c> put</c><00:40:42.119><c> any</c><00:40:42.300><c> claims</c><00:40:42.660><c> on</c><00:40:42.780><c> the</c> 00:40:42.890 --> 00:40:42.900 align:start position:0% then you cannot put any claims on the 00:40:42.900 --> 00:40:44.750 align:start position:0% then you cannot put any claims on the label<00:40:43.140><c> what</c><00:40:43.740><c> you</c><00:40:43.920><c> can</c><00:40:44.040><c> of</c><00:40:44.160><c> course</c><00:40:44.280><c> also</c><00:40:44.520><c> do</c><00:40:44.640><c> is</c> 00:40:44.750 --> 00:40:44.760 align:start position:0% label what you can of course also do is 00:40:44.760 --> 00:40:46.490 align:start position:0% label what you can of course also do is sell<00:40:44.940><c> a</c><00:40:45.060><c> biostimulant</c><00:40:45.660><c> that</c><00:40:45.839><c> has</c><00:40:45.960><c> nutrients</c> 00:40:46.490 --> 00:40:46.500 align:start position:0% sell a biostimulant that has nutrients 00:40:46.500 --> 00:40:48.109 align:start position:0% sell a biostimulant that has nutrients but<00:40:46.800><c> then</c><00:40:46.920><c> you</c><00:40:47.040><c> cannot</c><00:40:47.220><c> put</c><00:40:47.400><c> the</c><00:40:47.520><c> the</c><00:40:47.640><c> NPK</c> 00:40:48.109 --> 00:40:48.119 align:start position:0% but then you cannot put the the NPK 00:40:48.119 --> 00:40:51.410 align:start position:0% but then you cannot put the the NPK values<00:40:48.540><c> on</c><00:40:48.960><c> the</c><00:40:49.020><c> biostimulant</c><00:40:49.680><c> label</c> 00:40:51.410 --> 00:40:51.420 align:start position:0% values on the biostimulant label 00:40:51.420 --> 00:40:53.150 align:start position:0% values on the biostimulant label um<00:40:51.540><c> I</c><00:40:51.960><c> what</c><00:40:52.200><c> I</c><00:40:52.320><c> would</c><00:40:52.440><c> say</c><00:40:52.560><c> is</c><00:40:52.740><c> if</c><00:40:52.920><c> you're</c> 00:40:53.150 --> 00:40:53.160 align:start position:0% um I what I would say is if you're 00:40:53.160 --> 00:40:55.310 align:start position:0% um I what I would say is if you're combining<00:40:53.640><c> in</c><00:40:53.940><c> whatever</c><00:40:54.060><c> way</c><00:40:54.359><c> two</c><00:40:54.900><c> products</c> 00:40:55.310 --> 00:40:55.320 align:start position:0% combining in whatever way two products 00:40:55.320 --> 00:40:57.349 align:start position:0% combining in whatever way two products so<00:40:55.500><c> that</c><00:40:55.800><c> that</c><00:40:55.980><c> one</c><00:40:56.220><c> that</c><00:40:56.400><c> is</c><00:40:56.520><c> labeled</c><00:40:56.760><c> as</c><00:40:56.880><c> PFC</c> 00:40:57.349 --> 00:40:57.359 align:start position:0% so that that one that is labeled as PFC 00:40:57.359 --> 00:40:59.390 align:start position:0% so that that one that is labeled as PFC one<00:40:57.540><c> and</c><00:40:58.200><c> one</c><00:40:58.440><c> that</c><00:40:58.560><c> is</c><00:40:58.680><c> labeled</c><00:40:58.920><c> as</c><00:40:59.040><c> six</c><00:40:59.220><c> so</c> 00:40:59.390 --> 00:40:59.400 align:start position:0% one and one that is labeled as six so 00:40:59.400 --> 00:41:01.609 align:start position:0% one and one that is labeled as six so fertilizer<00:41:00.000><c> and</c><00:41:00.119><c> a</c><00:41:00.240><c> bio</c><00:41:00.359><c> stimulant</c><00:41:00.839><c> in</c><00:41:01.500><c> almost</c> 00:41:01.609 --> 00:41:01.619 align:start position:0% fertilizer and a bio stimulant in almost 00:41:01.619 --> 00:41:04.130 align:start position:0% fertilizer and a bio stimulant in almost all<00:41:01.859><c> cases</c><00:41:02.160><c> it</c><00:41:02.400><c> can</c><00:41:02.579><c> be</c><00:41:02.760><c> a</c><00:41:02.880><c> blend</c><00:41:03.180><c> even</c><00:41:03.720><c> if</c><00:41:03.960><c> it's</c> 00:41:04.130 --> 00:41:04.140 align:start position:0% all cases it can be a blend even if it's 00:41:04.140 --> 00:41:05.930 align:start position:0% all cases it can be a blend even if it's that's<00:41:04.560><c> an</c><00:41:04.800><c> example</c><00:41:05.040><c> that</c><00:41:05.220><c> we've</c><00:41:05.400><c> seen</c><00:41:05.520><c> if</c> 00:41:05.930 --> 00:41:05.940 align:start position:0% that's an example that we've seen if 00:41:05.940 --> 00:41:09.470 align:start position:0% that's an example that we've seen if you're<00:41:06.060><c> combining</c><00:41:06.420><c> two</c><00:41:06.599><c> granular</c><00:41:06.960><c> products</c> 00:41:09.470 --> 00:41:09.480 align:start position:0% 00:41:09.480 --> 00:41:10.609 align:start position:0% yeah 00:41:10.609 --> 00:41:10.619 align:start position:0% yeah 00:41:10.619 --> 00:41:13.970 align:start position:0% yeah um phylite<00:41:11.280><c> if</c><00:41:11.400><c> you</c><00:41:11.579><c> like</c><00:41:11.640><c> guns</c><00:41:11.940><c> codes</c> 00:41:13.970 --> 00:41:13.980 align:start position:0% um phylite if you like guns codes 00:41:13.980 --> 00:41:27.190 align:start position:0% um phylite if you like guns codes um 00:41:27.190 --> 00:41:27.200 align:start position:0% 00:41:27.200 --> 00:41:29.089 align:start position:0% of<00:41:28.200><c> the</c> 00:41:29.089 --> 00:41:29.099 align:start position:0% of the 00:41:29.099 --> 00:41:29.810 align:start position:0% of the um 00:41:29.810 --> 00:41:29.820 align:start position:0% um 00:41:29.820 --> 00:42:03.950 align:start position:0% um foreign 00:42:03.950 --> 00:42:03.960 align:start position:0% 00:42:03.960 --> 00:42:43.550 align:start position:0% foreign 00:42:43.550 --> 00:42:43.560 align:start position:0% 00:42:43.560 --> 00:43:14.930 align:start position:0% foreign 00:43:14.930 --> 00:43:14.940 align:start position:0% 00:43:14.940 --> 00:43:28.870 align:start position:0% foreign 00:43:28.870 --> 00:43:28.880 align:start position:0% 00:43:28.880 --> 00:43:32.750 align:start position:0% no<00:43:29.880><c> so</c><00:43:30.060><c> the</c><00:43:30.300><c> the</c><00:43:30.480><c> one</c><00:43:31.079><c> uh</c><00:43:31.980><c> practical</c><00:43:32.339><c> example</c> 00:43:32.750 --> 00:43:32.760 align:start position:0% no so the the one uh practical example 00:43:32.760 --> 00:43:34.490 align:start position:0% no so the the one uh practical example that<00:43:32.940><c> I</c><00:43:33.060><c> would</c><00:43:33.180><c> add</c><00:43:33.300><c> that</c><00:43:33.660><c> just</c><00:43:33.839><c> maybe</c><00:43:34.079><c> it</c> 00:43:34.490 --> 00:43:34.500 align:start position:0% that I would add that just maybe it 00:43:34.500 --> 00:43:36.710 align:start position:0% that I would add that just maybe it might<00:43:34.680><c> might</c><00:43:34.920><c> help</c><00:43:35.160><c> clarify</c><00:43:35.700><c> it</c><00:43:35.760><c> is</c><00:43:36.599><c> um</c> 00:43:36.710 --> 00:43:36.720 align:start position:0% might might help clarify it is um 00:43:36.720 --> 00:43:38.569 align:start position:0% might might help clarify it is um completely<00:43:37.500><c> different</c><00:43:37.680><c> product</c><00:43:38.160><c> group</c><00:43:38.400><c> but</c> 00:43:38.569 --> 00:43:38.579 align:start position:0% completely different product group but 00:43:38.579 --> 00:43:40.849 align:start position:0% completely different product group but Inhibitors<00:43:39.119><c> the</c><00:43:39.900><c> manufacturer</c><00:43:40.440><c> has</c><00:43:40.680><c> a</c> 00:43:40.849 --> 00:43:40.859 align:start position:0% Inhibitors the manufacturer has a 00:43:40.859 --> 00:43:43.849 align:start position:0% Inhibitors the manufacturer has a product<00:43:41.099><c> that</c><00:43:41.520><c> is</c><00:43:41.700><c> both</c><00:43:42.359><c> a</c><00:43:43.140><c> urease</c><00:43:43.380><c> inhibitor</c> 00:43:43.849 --> 00:43:43.859 align:start position:0% product that is both a urease inhibitor 00:43:43.859 --> 00:43:46.190 align:start position:0% product that is both a urease inhibitor and<00:43:44.339><c> a</c><00:43:44.460><c> nitrification</c><00:43:45.000><c> inhibitor</c><00:43:45.540><c> so</c><00:43:46.020><c> what</c> 00:43:46.190 --> 00:43:46.200 align:start position:0% and a nitrification inhibitor so what 00:43:46.200 --> 00:43:47.870 align:start position:0% and a nitrification inhibitor so what we're<00:43:46.319><c> doing</c><00:43:46.500><c> now</c><00:43:46.680><c> is</c><00:43:46.859><c> certifying</c><00:43:47.400><c> it</c><00:43:47.520><c> as</c><00:43:47.700><c> both</c> 00:43:47.870 --> 00:43:47.880 align:start position:0% we're doing now is certifying it as both 00:43:47.880 --> 00:43:50.809 align:start position:0% we're doing now is certifying it as both and<00:43:48.839><c> then</c><00:43:48.960><c> with</c><00:43:49.440><c> those</c><00:43:49.619><c> two</c><00:43:49.859><c> certificates</c><00:43:50.339><c> it</c> 00:43:50.809 --> 00:43:50.819 align:start position:0% and then with those two certificates it 00:43:50.819 --> 00:43:52.309 align:start position:0% and then with those two certificates it becomes<00:43:51.119><c> a</c><00:43:51.180><c> blend</c> 00:43:52.309 --> 00:43:52.319 align:start position:0% becomes a blend 00:43:52.319 --> 00:43:54.109 align:start position:0% becomes a blend uh<00:43:53.160><c> and</c><00:43:53.280><c> then</c><00:43:53.400><c> what</c><00:43:53.520><c> we</c><00:43:53.640><c> still</c><00:43:53.760><c> have</c><00:43:53.880><c> to</c><00:43:53.940><c> check</c> 00:43:54.109 --> 00:43:54.119 align:start position:0% uh and then what we still have to check 00:43:54.119 --> 00:43:56.150 align:start position:0% uh and then what we still have to check is<00:43:54.300><c> is</c><00:43:54.540><c> is</c><00:43:54.540><c> what</c><00:43:55.140><c> how</c><00:43:55.380><c> exactly</c><00:43:55.680><c> that</c><00:43:55.859><c> gets</c> 00:43:56.150 --> 00:43:56.160 align:start position:0% is is is what how exactly that gets 00:43:56.160 --> 00:43:57.770 align:start position:0% is is is what how exactly that gets labeled<00:43:56.400><c> that's</c><00:43:56.880><c> something</c><00:43:57.119><c> that</c><00:43:57.300><c> even</c><00:43:57.480><c> we</c> 00:43:57.770 --> 00:43:57.780 align:start position:0% labeled that's something that even we 00:43:57.780 --> 00:43:58.730 align:start position:0% labeled that's something that even we haven't 00:43:58.730 --> 00:43:58.740 align:start position:0% haven't 00:43:58.740 --> 00:44:00.470 align:start position:0% haven't exactly<00:43:59.460><c> defined</c><00:43:59.819><c> yet</c><00:44:00.000><c> because</c><00:44:00.180><c> it</c><00:44:00.359><c> is</c> 00:44:00.470 --> 00:44:00.480 align:start position:0% exactly defined yet because it is 00:44:00.480 --> 00:44:02.210 align:start position:0% exactly defined yet because it is obviously<00:44:00.720><c> this</c><00:44:00.960><c> is</c><00:44:01.140><c> quite</c><00:44:01.319><c> it's</c><00:44:01.859><c> a</c><00:44:01.980><c> bit</c><00:44:02.040><c> of</c><00:44:02.160><c> a</c> 00:44:02.210 --> 00:44:02.220 align:start position:0% obviously this is quite it's a bit of a 00:44:02.220 --> 00:44:03.829 align:start position:0% obviously this is quite it's a bit of a gray<00:44:02.339><c> area</c> 00:44:03.829 --> 00:44:03.839 align:start position:0% gray area 00:44:03.839 --> 00:44:05.210 align:start position:0% gray area um<00:44:03.960><c> but</c><00:44:04.380><c> within</c><00:44:04.619><c> the</c><00:44:04.740><c> next</c><00:44:04.859><c> few</c><00:44:04.980><c> months</c> 00:44:05.210 --> 00:44:05.220 align:start position:0% um but within the next few months 00:44:05.220 --> 00:44:06.470 align:start position:0% um but within the next few months obviously<00:44:05.640><c> that's</c><00:44:05.760><c> the</c><00:44:05.940><c> product</c><00:44:06.060><c> that</c><00:44:06.359><c> we</c> 00:44:06.470 --> 00:44:06.480 align:start position:0% obviously that's the product that we 00:44:06.480 --> 00:44:08.510 align:start position:0% obviously that's the product that we will<00:44:06.599><c> we</c><00:44:06.839><c> will</c><00:44:06.960><c> certify</c><00:44:07.440><c> and</c><00:44:07.619><c> what</c><00:44:08.160><c> it</c><00:44:08.280><c> looks</c> 00:44:08.510 --> 00:44:08.520 align:start position:0% will we will certify and what it looks 00:44:08.520 --> 00:44:10.490 align:start position:0% will we will certify and what it looks like<00:44:08.579><c> now</c><00:44:08.819><c> is</c><00:44:09.060><c> that</c><00:44:09.240><c> the</c><00:44:09.420><c> label</c><00:44:09.960><c> will</c><00:44:10.200><c> indeed</c> 00:44:10.490 --> 00:44:10.500 align:start position:0% like now is that the label will indeed 00:44:10.500 --> 00:44:13.609 align:start position:0% like now is that the label will indeed just<00:44:10.619><c> be</c><00:44:10.800><c> a</c><00:44:10.980><c> PFC</c><00:44:11.579><c> 7</c><00:44:11.940><c> mentioned</c><00:44:12.780><c> but</c><00:44:13.260><c> that's</c><00:44:13.380><c> for</c> 00:44:13.609 --> 00:44:13.619 align:start position:0% just be a PFC 7 mentioned but that's for 00:44:13.619 --> 00:44:16.069 align:start position:0% just be a PFC 7 mentioned but that's for also<00:44:13.859><c> for</c><00:44:13.980><c> a</c><00:44:14.160><c> specific</c><00:44:14.339><c> manufacturer</c><00:44:15.000><c> so</c> 00:44:16.069 --> 00:44:16.079 align:start position:0% also for a specific manufacturer so 00:44:16.079 --> 00:44:17.930 align:start position:0% also for a specific manufacturer so it's<00:44:16.500><c> something</c><00:44:16.680><c> that</c><00:44:16.980><c> still</c><00:44:17.099><c> has</c><00:44:17.280><c> to</c><00:44:17.460><c> be</c><00:44:17.579><c> has</c> 00:44:17.930 --> 00:44:17.940 align:start position:0% it's something that still has to be has 00:44:17.940 --> 00:44:19.670 align:start position:0% it's something that still has to be has to<00:44:18.119><c> be</c><00:44:18.240><c> has</c><00:44:18.420><c> to</c><00:44:18.599><c> be</c><00:44:18.720><c> worked</c><00:44:18.960><c> out</c> 00:44:19.670 --> 00:44:19.680 align:start position:0% to be has to be worked out 00:44:19.680 --> 00:44:20.990 align:start position:0% to be has to be worked out um<00:44:19.740><c> what</c><00:44:20.099><c> I</c><00:44:20.220><c> would</c><00:44:20.280><c> say</c><00:44:20.400><c> is</c><00:44:20.520><c> if</c><00:44:20.760><c> there</c><00:44:20.940><c> are</c> 00:44:20.990 --> 00:44:21.000 align:start position:0% um what I would say is if there are 00:44:21.000 --> 00:44:22.250 align:start position:0% um what I would say is if there are these<00:44:21.180><c> types</c><00:44:21.420><c> of</c><00:44:21.480><c> questions</c><00:44:21.599><c> and</c><00:44:21.900><c> and</c><00:44:22.079><c> you</c> 00:44:22.250 --> 00:44:22.260 align:start position:0% these types of questions and and you 00:44:22.260 --> 00:44:23.690 align:start position:0% these types of questions and and you send<00:44:22.440><c> them</c><00:44:22.560><c> to</c><00:44:22.680><c> us</c><00:44:22.800><c> if</c><00:44:23.040><c> we</c><00:44:23.220><c> don't</c><00:44:23.280><c> immediately</c> 00:44:23.690 --> 00:44:23.700 align:start position:0% send them to us if we don't immediately 00:44:23.700 --> 00:44:25.910 align:start position:0% send them to us if we don't immediately have<00:44:23.880><c> an</c><00:44:24.000><c> answer</c><00:44:24.180><c> they're</c><00:44:25.140><c> of</c><00:44:25.380><c> course</c><00:44:25.500><c> you</c> 00:44:25.910 --> 00:44:25.920 align:start position:0% have an answer they're of course you 00:44:25.920 --> 00:44:28.550 align:start position:0% have an answer they're of course you know<00:44:26.040><c> the</c><00:44:26.220><c> the</c><00:44:26.460><c> we</c><00:44:27.180><c> and</c><00:44:27.420><c> and</c><00:44:27.660><c> Iva</c><00:44:28.380><c> and</c> 00:44:28.550 --> 00:44:28.560 align:start position:0% know the the we and and Iva and 00:44:28.560 --> 00:44:30.589 align:start position:0% know the the we and and Iva and different<00:44:28.800><c> associations</c><00:44:29.460><c> are</c><00:44:30.060><c> in</c><00:44:30.240><c> talks</c><00:44:30.540><c> with</c> 00:44:30.589 --> 00:44:30.599 align:start position:0% different associations are in talks with 00:44:30.599 --> 00:44:32.690 align:start position:0% different associations are in talks with the<00:44:30.780><c> commission</c><00:44:31.140><c> so</c><00:44:31.680><c> we</c><00:44:31.859><c> do</c><00:44:31.980><c> what</c><00:44:32.160><c> we</c><00:44:32.280><c> see</c><00:44:32.400><c> also</c> 00:44:32.690 --> 00:44:32.700 align:start position:0% the commission so we do what we see also 00:44:32.700 --> 00:44:34.609 align:start position:0% the commission so we do what we see also try<00:44:33.000><c> and</c><00:44:33.180><c> and</c><00:44:33.359><c> get</c><00:44:33.599><c> the</c><00:44:33.780><c> get</c><00:44:33.960><c> the</c><00:44:34.140><c> answers</c><00:44:34.380><c> to</c> 00:44:34.609 --> 00:44:34.619 align:start position:0% try and and get the get the answers to 00:44:34.619 --> 00:44:35.930 align:start position:0% try and and get the get the answers to you<00:44:34.680><c> we</c><00:44:35.160><c> might</c><00:44:35.280><c> not</c><00:44:35.400><c> always</c><00:44:35.579><c> have</c><00:44:35.819><c> them</c> 00:44:35.930 --> 00:44:35.940 align:start position:0% you we might not always have them 00:44:35.940 --> 00:44:37.250 align:start position:0% you we might not always have them immediately<00:44:36.359><c> but</c><00:44:36.480><c> it</c><00:44:36.599><c> is</c><00:44:36.720><c> something</c><00:44:36.900><c> that</c><00:44:37.140><c> we</c> 00:44:37.250 --> 00:44:37.260 align:start position:0% immediately but it is something that we 00:44:37.260 --> 00:44:38.930 align:start position:0% immediately but it is something that we help<00:44:37.380><c> with</c><00:44:37.560><c> and</c><00:44:37.859><c> more</c><00:44:38.160><c> importantly</c><00:44:38.460><c> obviously</c> 00:44:38.930 --> 00:44:38.940 align:start position:0% help with and more importantly obviously 00:44:38.940 --> 00:44:54.250 align:start position:0% help with and more importantly obviously the<00:44:39.000><c> associations</c><00:44:39.359><c> help</c><00:44:39.660><c> with</c> 00:44:54.250 --> 00:44:54.260 align:start position:0% 00:44:54.260 --> 00:44:56.809 align:start position:0% in<00:44:55.260><c> the</c><00:44:55.440><c> coordination</c><00:44:55.920><c> group</c><00:44:56.280><c> there</c><00:44:56.640><c> are</c> 00:44:56.809 --> 00:44:56.819 align:start position:0% in the coordination group there are 00:44:56.819 --> 00:44:58.550 align:start position:0% in the coordination group there are notified<00:44:57.060><c> bodies</c> 00:44:58.550 --> 00:44:58.560 align:start position:0% notified bodies 00:44:58.560 --> 00:45:41.329 align:start position:0% notified bodies um 00:45:41.329 --> 00:45:41.339 align:start position:0% 00:45:41.339 --> 00:45:58.870 align:start position:0% foreign 00:45:58.870 --> 00:45:58.880 align:start position:0% 00:45:58.880 --> 00:46:01.670 align:start position:0% and<00:45:59.880><c> it</c><00:46:00.000><c> depends</c><00:46:00.359><c> a</c><00:46:00.540><c> little</c><00:46:00.599><c> bit</c><00:46:00.780><c> on</c><00:46:01.079><c> on</c><00:46:01.319><c> on</c><00:46:01.440><c> on</c> 00:46:01.670 --> 00:46:01.680 align:start position:0% and it depends a little bit on on on on 00:46:01.680 --> 00:46:04.430 align:start position:0% and it depends a little bit on on on on the<00:46:02.280><c> product</c><00:46:02.400><c> so</c><00:46:03.180><c> if</c><00:46:03.599><c> you're</c><00:46:03.720><c> if</c><00:46:04.020><c> you</c><00:46:04.200><c> have</c><00:46:04.319><c> a</c> 00:46:04.430 --> 00:46:04.440 align:start position:0% the product so if you're if you have a 00:46:04.440 --> 00:46:06.530 align:start position:0% the product so if you're if you have a biosity<00:46:04.859><c> and</c><00:46:05.040><c> it's</c><00:46:05.520><c> it's</c><00:46:05.700><c> based</c><00:46:06.060><c> on</c><00:46:06.119><c> a</c><00:46:06.300><c> plant</c> 00:46:06.530 --> 00:46:06.540 align:start position:0% biosity and it's it's based on a plant 00:46:06.540 --> 00:46:08.030 align:start position:0% biosity and it's it's based on a plant extract<00:46:06.960><c> and</c><00:46:07.140><c> you're</c><00:46:07.319><c> simply</c><00:46:07.680><c> saying</c><00:46:07.920><c> I'm</c> 00:46:08.030 --> 00:46:08.040 align:start position:0% extract and you're simply saying I'm 00:46:08.040 --> 00:46:09.230 align:start position:0% extract and you're simply saying I'm getting<00:46:08.220><c> that</c><00:46:08.400><c> plant</c><00:46:08.579><c> to</c><00:46:08.819><c> extract</c><00:46:09.060><c> from</c> 00:46:09.230 --> 00:46:09.240 align:start position:0% getting that plant to extract from 00:46:09.240 --> 00:46:11.990 align:start position:0% getting that plant to extract from somewhere<00:46:09.540><c> else</c><00:46:09.660><c> we</c><00:46:10.560><c> won't</c><00:46:10.800><c> say</c><00:46:11.160><c> you</c><00:46:11.760><c> have</c><00:46:11.880><c> to</c> 00:46:11.990 --> 00:46:12.000 align:start position:0% somewhere else we won't say you have to 00:46:12.000 --> 00:46:13.790 align:start position:0% somewhere else we won't say you have to redo<00:46:12.240><c> the</c><00:46:12.359><c> field</c><00:46:12.480><c> trials</c><00:46:12.900><c> but</c><00:46:13.380><c> if</c><00:46:13.500><c> you</c><00:46:13.619><c> just</c> 00:46:13.790 --> 00:46:13.800 align:start position:0% redo the field trials but if you just 00:46:13.800 --> 00:46:16.010 align:start position:0% redo the field trials but if you just have<00:46:13.920><c> an</c><00:46:14.040><c> mpk</c><00:46:14.520><c> and</c><00:46:15.300><c> you're</c><00:46:15.540><c> one</c><00:46:15.839><c> of</c><00:46:15.900><c> the</c> 00:46:16.010 --> 00:46:16.020 align:start position:0% have an mpk and you're one of the 00:46:16.020 --> 00:46:17.750 align:start position:0% have an mpk and you're one of the ingredients<00:46:16.500><c> for</c><00:46:16.680><c> the</c><00:46:16.800><c> mpk</c><00:46:17.220><c> is</c><00:46:17.400><c> ammonium</c> 00:46:17.750 --> 00:46:17.760 align:start position:0% ingredients for the mpk is ammonium 00:46:17.760 --> 00:46:19.609 align:start position:0% ingredients for the mpk is ammonium nitrate<00:46:18.180><c> and</c><00:46:18.720><c> you're</c><00:46:18.839><c> switching</c><00:46:19.319><c> to</c><00:46:19.440><c> a</c> 00:46:19.609 --> 00:46:19.619 align:start position:0% nitrate and you're switching to a 00:46:19.619 --> 00:46:22.069 align:start position:0% nitrate and you're switching to a completely<00:46:19.859><c> different</c><00:46:20.040><c> supplier</c> 00:46:22.069 --> 00:46:22.079 align:start position:0% completely different supplier 00:46:22.079 --> 00:46:25.430 align:start position:0% completely different supplier um<00:46:22.500><c> I'm</c><00:46:23.160><c> not</c><00:46:23.460><c> sure</c><00:46:23.760><c> whether</c><00:46:24.540><c> we</c><00:46:24.780><c> wouldn't</c><00:46:24.960><c> ask</c> 00:46:25.430 --> 00:46:25.440 align:start position:0% um I'm not sure whether we wouldn't ask 00:46:25.440 --> 00:46:28.010 align:start position:0% um I'm not sure whether we wouldn't ask for<00:46:26.339><c> a</c><00:46:26.700><c> reassessment</c><00:46:27.180><c> at</c><00:46:27.420><c> least</c><00:46:27.480><c> of</c><00:46:27.660><c> the</c><00:46:27.780><c> heavy</c> 00:46:28.010 --> 00:46:28.020 align:start position:0% for a reassessment at least of the heavy 00:46:28.020 --> 00:46:30.109 align:start position:0% for a reassessment at least of the heavy metal<00:46:28.140><c> values</c> 00:46:30.109 --> 00:46:30.119 align:start position:0% metal values 00:46:30.119 --> 00:46:31.210 align:start position:0% metal values um 00:46:31.210 --> 00:46:31.220 align:start position:0% um 00:46:31.220 --> 00:46:33.650 align:start position:0% um but<00:46:32.220><c> what</c><00:46:32.339><c> I</c><00:46:32.520><c> would</c><00:46:32.640><c> say</c><00:46:32.760><c> more</c><00:46:33.119><c> often</c><00:46:33.359><c> than</c><00:46:33.480><c> not</c> 00:46:33.650 --> 00:46:33.660 align:start position:0% but what I would say more often than not 00:46:33.660 --> 00:46:34.970 align:start position:0% but what I would say more often than not and<00:46:33.839><c> that's</c><00:46:34.020><c> something</c><00:46:34.140><c> that</c><00:46:34.380><c> we</c><00:46:34.740><c> definitely</c> 00:46:34.970 --> 00:46:34.980 align:start position:0% and that's something that we definitely 00:46:34.980 --> 00:46:36.050 align:start position:0% and that's something that we definitely want<00:46:35.160><c> to</c><00:46:35.280><c> discuss</c><00:46:35.460><c> with</c><00:46:35.640><c> the</c><00:46:35.760><c> coordination</c> 00:46:36.050 --> 00:46:36.060 align:start position:0% want to discuss with the coordination 00:46:36.060 --> 00:46:38.030 align:start position:0% want to discuss with the coordination group<00:46:36.300><c> is</c><00:46:36.540><c> to</c><00:46:36.660><c> say</c><00:46:36.780><c> look</c><00:46:37.020><c> in</c><00:46:37.560><c> some</c><00:46:37.680><c> cases</c> 00:46:38.030 --> 00:46:38.040 align:start position:0% group is to say look in some cases 00:46:38.040 --> 00:46:39.950 align:start position:0% group is to say look in some cases whether<00:46:38.700><c> whether</c><00:46:39.060><c> it's</c><00:46:39.240><c> a</c><00:46:39.359><c> change</c><00:46:39.540><c> or</c><00:46:39.780><c> for</c> 00:46:39.950 --> 00:46:39.960 align:start position:0% whether whether it's a change or for 00:46:39.960 --> 00:46:41.390 align:start position:0% whether whether it's a change or for example<00:46:40.200><c> it's</c><00:46:40.380><c> two</c><00:46:40.619><c> formulations</c><00:46:41.099><c> of</c><00:46:41.280><c> a</c> 00:46:41.390 --> 00:46:41.400 align:start position:0% example it's two formulations of a 00:46:41.400 --> 00:46:42.950 align:start position:0% example it's two formulations of a product<00:46:41.520><c> where</c><00:46:41.819><c> the</c><00:46:42.300><c> only</c><00:46:42.359><c> difference</c><00:46:42.599><c> is</c><00:46:42.839><c> the</c> 00:46:42.950 --> 00:46:42.960 align:start position:0% product where the only difference is the 00:46:42.960 --> 00:46:44.809 align:start position:0% product where the only difference is the colorant<00:46:43.380><c> does</c><00:46:44.040><c> it</c><00:46:44.160><c> require</c><00:46:44.400><c> two</c> 00:46:44.809 --> 00:46:44.819 align:start position:0% colorant does it require two 00:46:44.819 --> 00:46:47.410 align:start position:0% colorant does it require two certificates<00:46:45.300><c> or</c><00:46:45.660><c> can</c><00:46:45.780><c> it</c><00:46:45.960><c> be</c><00:46:46.140><c> can</c><00:46:46.440><c> it</c><00:46:46.619><c> be</c><00:46:46.800><c> one</c> 00:46:47.410 --> 00:46:47.420 align:start position:0% certificates or can it be can it be one 00:46:47.420 --> 00:46:49.550 align:start position:0% certificates or can it be can it be one so<00:46:48.420><c> I</c><00:46:48.540><c> don't</c><00:46:48.660><c> have</c><00:46:48.780><c> an</c><00:46:48.900><c> answer</c> 00:46:49.550 --> 00:46:49.560 align:start position:0% so I don't have an answer 00:46:49.560 --> 00:46:52.069 align:start position:0% so I don't have an answer there<00:46:50.160><c> are</c><00:46:50.339><c> certainly</c><00:46:50.640><c> options</c><00:46:51.420><c> to</c><00:46:51.720><c> say</c><00:46:51.839><c> well</c> 00:46:52.069 --> 00:46:52.079 align:start position:0% there are certainly options to say well 00:46:52.079 --> 00:46:53.930 align:start position:0% there are certainly options to say well we<00:46:52.319><c> don't</c><00:46:52.619><c> want</c><00:46:52.859><c> to</c><00:46:52.980><c> you</c><00:46:53.220><c> know</c><00:46:53.339><c> we</c><00:46:53.520><c> we</c><00:46:53.760><c> don't</c> 00:46:53.930 --> 00:46:53.940 align:start position:0% we don't want to you know we we don't 00:46:53.940 --> 00:46:55.790 align:start position:0% we don't want to you know we we don't want<00:46:54.119><c> to</c><00:46:54.240><c> require</c><00:46:54.540><c> recertification</c><00:46:55.440><c> in</c><00:46:55.680><c> that</c> 00:46:55.790 --> 00:46:55.800 align:start position:0% want to require recertification in that 00:46:55.800 --> 00:46:58.069 align:start position:0% want to require recertification in that regard<00:46:56.099><c> but</c><00:46:57.060><c> there</c><00:46:57.240><c> will</c><00:46:57.420><c> also</c><00:46:57.660><c> be</c><00:46:57.720><c> cases</c> 00:46:58.069 --> 00:46:58.079 align:start position:0% regard but there will also be cases 00:46:58.079 --> 00:46:59.510 align:start position:0% regard but there will also be cases especially<00:46:58.440><c> in</c><00:46:58.619><c> the</c><00:46:58.740><c> simpler</c><00:46:59.040><c> products</c><00:46:59.339><c> when</c> 00:46:59.510 --> 00:46:59.520 align:start position:0% especially in the simpler products when 00:46:59.520 --> 00:47:00.829 align:start position:0% especially in the simpler products when we're<00:46:59.700><c> just</c><00:46:59.819><c> talking</c><00:46:59.940><c> about</c><00:47:00.180><c> heavy</c><00:47:00.480><c> metals</c> 00:47:00.829 --> 00:47:00.839 align:start position:0% we're just talking about heavy metals 00:47:00.839 --> 00:47:02.510 align:start position:0% we're just talking about heavy metals where<00:47:01.260><c> we</c><00:47:01.440><c> say</c><00:47:01.560><c> look</c><00:47:01.680><c> it's</c><00:47:01.859><c> more</c><00:47:02.040><c> proportional</c> 00:47:02.510 --> 00:47:02.520 align:start position:0% where we say look it's more proportional 00:47:02.520 --> 00:47:05.210 align:start position:0% where we say look it's more proportional to<00:47:02.700><c> just</c><00:47:02.880><c> ask</c><00:47:03.119><c> for</c><00:47:03.300><c> retesting</c> 00:47:05.210 --> 00:47:05.220 align:start position:0% to just ask for retesting 00:47:05.220 --> 00:47:06.650 align:start position:0% to just ask for retesting um<00:47:05.280><c> so</c><00:47:05.460><c> to</c><00:47:05.640><c> some</c><00:47:05.760><c> extent</c><00:47:06.000><c> we</c><00:47:06.180><c> have</c><00:47:06.300><c> to</c><00:47:06.420><c> sort</c><00:47:06.540><c> of</c> 00:47:06.650 --> 00:47:06.660 align:start position:0% um so to some extent we have to sort of 00:47:06.660 --> 00:47:08.390 align:start position:0% um so to some extent we have to sort of figure<00:47:06.780><c> that</c><00:47:07.020><c> out</c><00:47:07.140><c> a</c><00:47:07.319><c> bit</c><00:47:07.680><c> on</c><00:47:07.800><c> a</c><00:47:07.920><c> case-by-case</c> 00:47:08.390 --> 00:47:08.400 align:start position:0% figure that out a bit on a case-by-case 00:47:08.400 --> 00:47:10.250 align:start position:0% figure that out a bit on a case-by-case basis<00:47:08.760><c> now</c><00:47:08.880><c> and</c><00:47:09.420><c> then</c><00:47:09.480><c> come</c><00:47:09.720><c> to</c><00:47:09.900><c> some</c><00:47:10.020><c> kind</c><00:47:10.200><c> of</c> 00:47:10.250 --> 00:47:10.260 align:start position:0% basis now and then come to some kind of 00:47:10.260 --> 00:47:24.650 align:start position:0% basis now and then come to some kind of common<00:47:10.380><c> agreement</c> 00:47:24.650 --> 00:47:24.660 align:start position:0% 00:47:24.660 --> 00:47:42.349 align:start position:0% um 00:47:42.349 --> 00:47:42.359 align:start position:0% 00:47:42.359 --> 00:48:31.120 align:start position:0% foreign 00:48:31.120 --> 00:48:31.130 align:start position:0% 00:48:31.130 --> 00:48:32.890 align:start position:0% [Music] 00:48:32.890 --> 00:48:32.900 align:start position:0% [Music] 00:48:32.900 --> 00:49:01.069 align:start position:0% [Music] standards<00:48:33.900><c> foreign</c> 00:49:01.069 --> 00:49:01.079 align:start position:0% 00:49:01.079 --> 00:49:40.190 align:start position:0% foreign 00:49:40.190 --> 00:49:40.200 align:start position:0% 00:49:40.200 --> 00:50:06.410 align:start position:0% foreign 00:50:06.410 --> 00:50:06.420 align:start position:0% 00:50:06.420 --> 00:50:20.950 align:start position:0% price 00:50:20.950 --> 00:50:20.960 align:start position:0% 00:50:20.960 --> 00:50:23.569 align:start position:0% foreign<00:50:22.260><c> yes</c> 00:50:23.569 --> 00:50:23.579 align:start position:0% foreign yes 00:50:23.579 --> 00:50:24.190 align:start position:0% foreign yes um 00:50:24.190 --> 00:50:24.200 align:start position:0% um 00:50:24.200 --> 00:50:26.930 align:start position:0% um exactly<00:50:25.200><c> that</c><00:50:25.319><c> so</c><00:50:25.560><c> I</c><00:50:25.680><c> don't</c><00:50:25.980><c> even</c><00:50:26.099><c> think</c><00:50:26.400><c> if</c> 00:50:26.930 --> 00:50:26.940 align:start position:0% exactly that so I don't even think if 00:50:26.940 --> 00:50:28.190 align:start position:0% exactly that so I don't even think if you<00:50:27.000><c> have</c><00:50:27.119><c> a</c><00:50:27.240><c> certificate</c><00:50:27.599><c> with</c><00:50:27.839><c> one</c><00:50:28.020><c> company</c> 00:50:28.190 --> 00:50:28.200 align:start position:0% you have a certificate with one company 00:50:28.200 --> 00:50:30.050 align:start position:0% you have a certificate with one company and<00:50:28.560><c> then</c><00:50:28.740><c> fire</c><00:50:29.099><c> and</c><00:50:29.339><c> letter</c><00:50:29.520><c> of</c><00:50:29.700><c> access</c><00:50:29.819><c> you</c> 00:50:30.050 --> 00:50:30.060 align:start position:0% and then fire and letter of access you 00:50:30.060 --> 00:50:31.970 align:start position:0% and then fire and letter of access you go<00:50:30.180><c> to</c><00:50:30.240><c> another</c><00:50:30.420><c> notified</c><00:50:30.780><c> body</c><00:50:31.079><c> you</c><00:50:31.740><c> would</c><00:50:31.859><c> be</c> 00:50:31.970 --> 00:50:31.980 align:start position:0% go to another notified body you would be 00:50:31.980 --> 00:50:34.010 align:start position:0% go to another notified body you would be attached<00:50:32.460><c> so</c><00:50:32.819><c> if</c><00:50:33.000><c> we</c><00:50:33.359><c> get</c><00:50:33.480><c> an</c><00:50:33.599><c> application</c> 00:50:34.010 --> 00:50:34.020 align:start position:0% attached so if we get an application 00:50:34.020 --> 00:50:36.290 align:start position:0% attached so if we get an application through<00:50:34.440><c> an</c><00:50:34.619><c> Loa</c><00:50:35.099><c> with</c><00:50:35.640><c> a</c><00:50:35.700><c> product</c><00:50:35.880><c> certified</c> 00:50:36.290 --> 00:50:36.300 align:start position:0% through an Loa with a product certified 00:50:36.300 --> 00:50:37.849 align:start position:0% through an Loa with a product certified with<00:50:36.540><c> a</c><00:50:36.720><c> different</c><00:50:36.839><c> notified</c><00:50:37.200><c> body</c><00:50:37.440><c> I</c><00:50:37.740><c> think</c> 00:50:37.849 --> 00:50:37.859 align:start position:0% with a different notified body I think 00:50:37.859 --> 00:50:40.670 align:start position:0% with a different notified body I think we<00:50:38.099><c> could</c><00:50:38.280><c> probably</c><00:50:38.520><c> rely</c><00:50:39.420><c> on</c><00:50:39.599><c> that</c><00:50:39.780><c> uh</c> 00:50:40.670 --> 00:50:40.680 align:start position:0% we could probably rely on that uh 00:50:40.680 --> 00:50:43.430 align:start position:0% we could probably rely on that uh regardless<00:50:41.220><c> if</c><00:50:41.819><c> a</c><00:50:42.420><c> manufacturer</c><00:50:42.960><c> say</c><00:50:43.200><c> you</c> 00:50:43.430 --> 00:50:43.440 align:start position:0% regardless if a manufacturer say you 00:50:43.440 --> 00:50:45.050 align:start position:0% regardless if a manufacturer say you know<00:50:43.560><c> Thomas</c><00:50:43.859><c> produces</c><00:50:44.339><c> a</c><00:50:44.460><c> bios</c><00:50:44.700><c> stimulant</c> 00:50:45.050 --> 00:50:45.060 align:start position:0% know Thomas produces a bios stimulant 00:50:45.060 --> 00:50:47.870 align:start position:0% know Thomas produces a bios stimulant sells<00:50:45.839><c> that</c><00:50:45.900><c> to</c><00:50:46.079><c> another</c><00:50:46.200><c> company</c><00:50:46.560><c> who</c><00:50:47.160><c> slaps</c> 00:50:47.870 --> 00:50:47.880 align:start position:0% sells that to another company who slaps 00:50:47.880 --> 00:50:49.609 align:start position:0% sells that to another company who slaps its<00:50:48.059><c> own</c><00:50:48.119><c> label</c><00:50:48.359><c> on</c><00:50:48.480><c> it</c><00:50:48.599><c> if</c><00:50:49.020><c> we've</c><00:50:49.319><c> provided</c> 00:50:49.609 --> 00:50:49.619 align:start position:0% its own label on it if we've provided 00:50:49.619 --> 00:50:51.470 align:start position:0% its own label on it if we've provided the<00:50:49.740><c> certification</c><00:50:50.160><c> to</c><00:50:50.339><c> combo</c><00:50:50.700><c> expert</c><00:50:51.000><c> the</c> 00:50:51.470 --> 00:50:51.480 align:start position:0% the certification to combo expert the 00:50:51.480 --> 00:50:54.109 align:start position:0% the certification to combo expert the certification<00:50:51.900><c> costs</c><00:50:52.380><c> for</c><00:50:52.619><c> that</c><00:50:52.859><c> dealer</c><00:50:53.280><c> are</c> 00:50:54.109 --> 00:50:54.119 align:start position:0% certification costs for that dealer are 00:50:54.119 --> 00:50:57.349 align:start position:0% certification costs for that dealer are probably<00:50:54.619><c> 75</c><00:50:55.619><c> percent</c><00:50:55.920><c> less</c> 00:50:57.349 --> 00:50:57.359 align:start position:0% probably 75 percent less 00:50:57.359 --> 00:50:58.790 align:start position:0% probably 75 percent less uh 00:50:58.790 --> 00:50:58.800 align:start position:0% uh 00:50:58.800 --> 00:51:01.549 align:start position:0% uh um<00:50:58.980><c> obviously</c><00:50:59.760><c> it</c><00:51:00.300><c> does</c><00:51:00.839><c> have</c><00:51:01.020><c> to</c><00:51:01.079><c> be</c><00:51:01.200><c> just</c><00:51:01.380><c> a</c> 00:51:01.549 --> 00:51:01.559 align:start position:0% um obviously it does have to be just a 00:51:01.559 --> 00:51:02.990 align:start position:0% um obviously it does have to be just a standard<00:51:01.800><c> Loa</c><00:51:02.160><c> and</c><00:51:02.339><c> the</c><00:51:02.460><c> product</c><00:51:02.520><c> has</c><00:51:02.819><c> to</c><00:51:02.880><c> be</c> 00:51:02.990 --> 00:51:03.000 align:start position:0% standard Loa and the product has to be 00:51:03.000 --> 00:51:05.089 align:start position:0% standard Loa and the product has to be the<00:51:03.180><c> same</c><00:51:03.300><c> uh</c><00:51:04.200><c> but</c><00:51:04.319><c> if</c><00:51:04.440><c> the</c><00:51:04.559><c> product</c><00:51:04.680><c> is</c><00:51:04.920><c> the</c> 00:51:05.089 --> 00:51:05.099 align:start position:0% the same uh but if the product is the 00:51:05.099 --> 00:51:06.410 align:start position:0% the same uh but if the product is the same<00:51:05.220><c> and</c><00:51:05.400><c> the</c><00:51:05.579><c> standards</c><00:51:06.059><c> are</c><00:51:06.119><c> less</c><00:51:06.300><c> then</c> 00:51:06.410 --> 00:51:06.420 align:start position:0% same and the standards are less then 00:51:06.420 --> 00:51:08.030 align:start position:0% same and the standards are less then there<00:51:06.599><c> is</c><00:51:06.720><c> a</c><00:51:06.839><c> fast</c><00:51:06.960><c> track</c><00:51:07.140><c> because</c><00:51:07.680><c> of</c><00:51:07.920><c> course</c> 00:51:08.030 --> 00:51:08.040 align:start position:0% there is a fast track because of course 00:51:08.040 --> 00:51:09.829 align:start position:0% there is a fast track because of course that's<00:51:08.220><c> a</c><00:51:08.460><c> very</c><00:51:08.520><c> simple</c><00:51:08.700><c> assessment</c><00:51:09.180><c> and</c><00:51:09.660><c> it's</c> 00:51:09.829 --> 00:51:09.839 align:start position:0% that's a very simple assessment and it's 00:51:09.839 --> 00:51:11.450 align:start position:0% that's a very simple assessment and it's much<00:51:10.140><c> cheaper</c><00:51:10.500><c> because</c><00:51:10.740><c> of</c><00:51:10.980><c> course</c><00:51:11.099><c> for</c><00:51:11.339><c> us</c> 00:51:11.450 --> 00:51:11.460 align:start position:0% much cheaper because of course for us 00:51:11.460 --> 00:51:15.589 align:start position:0% much cheaper because of course for us we've<00:51:12.059><c> already</c><00:51:12.119><c> certified</c><00:51:12.540><c> that</c><00:51:12.839><c> product</c> 00:51:15.589 --> 00:51:15.599 align:start position:0% 00:51:15.599 --> 00:51:16.549 align:start position:0% yeah 00:51:16.549 --> 00:51:16.559 align:start position:0% yeah 00:51:16.559 --> 00:51:19.130 align:start position:0% yeah so<00:51:17.099><c> with</c><00:51:17.940><c> that</c><00:51:18.059><c> so</c> 00:51:19.130 --> 00:51:19.140 align:start position:0% so with that so 00:51:19.140 --> 00:51:21.530 align:start position:0% so with that so 500<00:51:19.859><c> euros</c><00:51:20.220><c> maybe</c><00:51:20.579><c> a</c><00:51:20.760><c> bit</c><00:51:20.880><c> more</c><00:51:21.000><c> but</c><00:51:21.300><c> that's</c> 00:51:21.530 --> 00:51:21.540 align:start position:0% 500 euros maybe a bit more but that's 00:51:21.540 --> 00:51:24.230 align:start position:0% 500 euros maybe a bit more but that's about<00:51:21.720><c> it</c><00:51:21.960><c> so</c><00:51:22.440><c> that's</c><00:51:22.559><c> not</c><00:51:22.859><c> yeah</c> 00:51:24.230 --> 00:51:24.240 align:start position:0% about it so that's not yeah 00:51:24.240 --> 00:51:25.910 align:start position:0% about it so that's not yeah and<00:51:24.599><c> obviously</c><00:51:24.900><c> in</c><00:51:25.020><c> terms</c><00:51:25.200><c> of</c><00:51:25.260><c> timelines</c><00:51:25.619><c> it's</c> 00:51:25.910 --> 00:51:25.920 align:start position:0% and obviously in terms of timelines it's 00:51:25.920 --> 00:51:27.589 align:start position:0% and obviously in terms of timelines it's it's<00:51:26.099><c> a</c><00:51:26.520><c> lot</c><00:51:26.579><c> less</c> 00:51:27.589 --> 00:51:27.599 align:start position:0% it's a lot less 00:51:27.599 --> 00:51:30.599 align:start position:0% it's a lot less so Transcript (plain text) Kind: captions Language: en check um yeah so good morning everyone thank you all for for being here firstly um let me just say apologies this presentation will be in English not in German uh the fpr is let's say a little bit complicated and if I do the presentation in German it might raise more questions than that it might answer um my name is Phil tetler I'm the chairman of the efci register uh we are one of the now five actually uh notified bodies that are appointed and accredited to do certification for biostimulus um we're based in the Netherlands [Music] um what I want to talk to you about today is is obviously the fpr but very specifically how can you actually get a product certified um so very briefly because the other speakers spoke on it as well just shortly about the fpr um the goal of the regulation is to create a single market for fertilizing products and biostimulants is one of the types of products that is now included in that regulation the regulation is optional which is quite unique it means if you're selling a biostimulant at the moment um under for example a national registration in France or in Spain you can keep doing that but on top of this from the 16th of July you can choose to use the fpr to sell a biosity Amendment um so it doesn't replace National rules it just provides an additional framework that you can work under um like Theresa mentioned earlier the regulation splits products up into a PFC there are seven of these obviously interesting for today is we have pfc6 which is biostimulants and there are two categories that you can choose you can have a microbial biostimulant or a non-microbial biostimulant you have to have one or the other and then and then you have to meet those requirements and there are of course cmcs so the ingredients that you use to formulate your product have to meet certain requirements um important for the day there's no form of national registration instead there's a system of certification there's CE marking but there are also modules and the modules Define how you get a product certified what requirements you have to meet and how you can actually start selling the product in the case of biostimulants you have to get certification and you have to choose either module b or module D1 the difference is module B just looks at the technical design of a product so it's a remote and document based audit it's a bit simpler but module D1 looks at the management system that means that a notified body visits your company once every year and audits all the production locations it typically for a biostimulant company module B is more efficient uh it's an easier module to choose because we do the audit once and then you get a certificate and there's no form of reassessment for at least five years but of course if you have a large portfolio of products D1 could potentially be economically more interesting in some cases depending on the ingredients that you use it will be required to choose module D1 to sell your product in both cases you will have to employ a notified body um the fpr is of course the first time that a truly comprehensive framework for biostimulants has been defined at EU level um it provides a system of certification labeling Market access and everything else um thus it's quite unique thus there are of course a lot of questions uh and we're happy to help in that regard what the fpr also introduces is C marking there is also already mentioned it allows you to if you sell under fpr and you have the certification you can affix the CE marking to your product so um if we look specifically about getting to Market um a lot of you might be used to National registration authorities uh to do approval either for biostiminants in specific countries or of course black protection products in the case of FBR you can see notified bodies as the new type of registration Authority um they are private so like I said we are one of the five if you want certification for bios gaming you can work with us or you can choose one of the other five companies and we expect during the course of next year that more notified bodies including some from Germany will become listed on the Nando list um so you can choose the notified body in theory and what we see in practice as well is that is quite a pragmatic approach it means you can find an authority that you like to work with that maybe speaks your language or responds quite quickly it means we keep on another sharp and it means notified bodies inherently have to be approachable so if you send us a question you know you'll get a response within a few days rather than you know weeks or months and we do want to help um in essence the system for for getting a product to Market an FBR is quite simple you submit a dossier to a notified body if they approve the file you get a certificate and that allows you to sell in the entire in the entirety of the EU so there's no specific National rules that you have to meet you do it once you get the certificate and you're done um the Civic will be valid for three to five years depending on both the notified body and the module um and what's important is that the module you choose it doesn't make a difference for the the acceptance whether you have a certificate for b or D1 either one is valid either one allows you to sell the product and it allows you to sell the product in every European country um the potential of that is obviously that it could possibly uh through a single system of approval greatly expand the market potential for for your products um what's important to note is once you're certified the obligations don't stop there Market surveillance is a big part of fpr and National governments will be testing products they will be taking Products off shelves and checking whether you meet the requirements and they can do that a year after you've sold a product two years three years doesn't matter they can come up with a plan they can take one of your products off the shelf and if you then if that product doesn't meet their the requirements of the FBR you could possibly have a problem so it's an ongoing obligation there's also requirements to hold the technical information for at least five years after a sale so you have to be aware that there are specific obligations not just to get certified but also to hold records um in the case of module B and D1 if you change the product so if you change the formulation if you add an ingredient you have to report that to the notified body and you have to have the notified body assess that change if you um if you just for example open a new production location especially under module B that won't be required to be reported but if you change the formulation you have to have it reassessed um the fpr and because it's part of the legal framework for CE marking means there is a lot of responsibility for the manufacturer Thomas already said there's technical specifications but in truth you don't even have to use those specifications if you want to use other standards or different standards for analysis for proving claims all of that is in the hands of the manufacturer and a lot of the legal responsibility is also in the hands of the manufacturer so something goes wrong it's not the notified bodies problem per se or it's still your responsibility as a manufacturer that's something definitely to watch out for obviously um in the uh in this sector if someone comes in and says there's a simple system of registration there's always the question what's the catch and in truth um the system if it works efficiently and if you have all the documentation um is as pragmatic as I just described it there is no catch getting a certificate in essence is quite simple and it's quite straight to the point and it can be done quite quickly and it only requires a few uh documents so I just want to run through them quickly to get you an idea um you need a test report proving that the product contains or doesn't contain certain contaminants and pathogens you need to have information per ingredient that it meets the requirements of the chosen CMC you need to send us an example of the label you need to send us some details on at a very high level the manufacturing process and of course for a biostiminant you have to Define what the product actually does so you have to Define claims and you have to prove them how you prove them is somewhat up to you usually it'll be field trials but if you want to submit a dossier with literature studies to a notified body in theory that's also allowed um if you send us this information we send it to to one of our Auditors this is obviously in the case of module B um the auditor will assess it and within two to four weeks if the file meets the requirements we can have we can handle the paperwork and issue the certificate so the process can be quite quick of course if we're still waiting on information or if you still have to do field trials it'll take as long as as it takes similar to the costs so um it depends a little bit obviously on the notified body you choose because they're they're private just from our example um with us you get a price up front and that's fixed and so for a buyer statement the costs for getting a product certified will be between 2 000 and 3 500 euros the 3 500 euros is pretty much very much the really the the top limit uh uh but that's for very complicated products or for manufacturers that have not done any form of preparation usually the costs are about 2500 Euros that of course gets you a certificate that's valid for five years uh and so if you keep making that product you don't have to do a reassessment uh and after five years and this is something specific to us if you haven't changed the product you get a re-certification for free so in essence the certificate is valid for as long as you keep making that same product uh of course if you change the product you have to do a reassessment um in that regard if you can spread the cost out it is still manageable same with the timeline so if we look at our specific company process and how we would handle the certification this is the best way for me to explain how would it actually work and how how straight to the point and simple this process can in reality be let's say after the conference you want to start with one product and that's that's your right because it's optional you can apply a single product send us a file and then just as a as a trail what we always do with manufacturers is set up a teams call just to get an idea what are your questions uh what are you running into what are you unsure about and that's where we always help so that's typically an hour and a half where we just run through what are your specific products what are you worried about uh give you the answers to your questions and then see if the process is something that that you want to pursue if it is you obviously get all the information you need to get started so the contract that we typically sign the the pricing everything up front and it's fixed so you know inherently what you're going into of course if it's something you want to continue with fill in the application form sign the contract that's step one until the contract is signed all the information is is non-binding so if you just want to know something feel free to send us a question and until the contract we can give you all the information that you need so that's also an open offer to everyone in the in the room once we've signed the contract what we ask from you is you just send in the documentation simple via email or via we transfer send in all the information that I just listed so the test reports the field trial reports the label the dossier per CMC and we evaluate that if there are any points you'll get a report from the auditor uh on which points he he or she might not have found enough evidence to that you meet the requirements you get that presented in very simple list and you can go and fix that those points those non-conformities those aren't concerning that's not an issue you can take as long as you want to fix it um and it's not something to be worried about and of course if the product already meets the requirements simple then we go straight to phase three uh which is that we review the documents internally and issue the certificate obviously with the first product a lot of Manufacturers are running into a lot of questions once you get an idea what's required process becomes very simple to run through because then it becomes predictable just from from our side some of the questions that we've already run into uh some of the questions that I'm sure you have as well and that I wanted to present because I think they are they are important and uh and and if I'm honest they make a lot of they make a lot of sense we see these questions from a lot of Manufacturers and I'm sure you're running into them as well um do you have to do field trials probably yes uh the standard has a big preference for field trials but if you have literature studies or if you have other forms of evidence that you say prove a particular function a particular claim that's allowed so you're allowed to submit that to the notified body the worst that will happen is that we simply say we don't see enough evidence so that's a discussion you have to have with the auditor but the room exists and you're allowed to do that is there a standard that you can test your field trials maybe that you already performed against yes there is I've actually put it on on the screen as well it's this technical specification that family um that's a family of five standards that contain the specific criteria for doing field trials and for proving specific claims so if you want some more information on you know maybe the field trials you've already done and do they meet the requirements buy those specific standards those five read through them and see against your own field trial reports does it but do our reports contain all the information that is listed in the standard if it does there's a good chance you can start certification with them um can we review field trial designs so maybe you you're in the process of just getting started yes we can simply put if you haven't done any field trials you want to start certification and you want to know up front that the trials you do meet the requirements we can approve them up front before actually doing the trials um what do you have to do for the risk assessment because the FBR includes the requirement to send a risk assessment to a notified body in truth you do have to send us a document somehow explaining what the risks are of the product but we don't actually evaluate it because there's no requirement for doing that so the risk assessment is something that's more for you internally to check what are the specific risks of the product if there aren't any simple that's it um CMC 7 and 10 so obviously if you have microorganisms that are not on the list unfortunately you can't certify those biostiments so if you have a microbial biostimulant with a microorganism in in that's not in one of the four four families included in the cmc7 list unfortunately for now we can't do the certification um same with CMC 10 if you have products that use animal byproducts unfortunately at the moment we can only start the certification but we can't complete it because we're still waiting on on an additional delegated Act um if can you use existing test reports for example based on German National rules yes if you have test reports from Veda luffa we accept them um same with Claims can you add additional claims later on in the process yes so let's say you start with a specific claim for broad acre crops nutrient use efficiency and then after half a year you want to expand that so that the product has a claim for for any crop for any crop group you simply send in the additional test reports so just that bit we re-evaluate the certificate and give you an updated certificate so that process is quite simple as well and of course the costs are a lot lower than the initial certification uh same with adding claims during certification if you do the field trials and then maybe you know you order some additional ones and there were maybe the product does more than what you initially expected until the certificate is issued you can basically send in evidence and and as long as you prove a particular claim you can go as as expansive as you want during the process so that there's nothing that's fixed up front in in that regard um about notified bodies are there delays are there backlogs I obviously can't speak for um for everyone in Truth at the moment I don't think there are many many backlogs um especially with bios Germans we have a lot of interest but there's a lot of companies still doing field trials so that two to four week timeline that I mentioned earlier will probably be able to guarantee that for at least the next few months could there be backlogs in the future yes but there will also be more notified bodies in the future so we don't expect that to be too big of a problem but of course that's just with our specific situation maybe with other companies you know they are they are facing backlogs so far we haven't heard too many issues from that and then the last one um uh which was a question that I want to thank Teresa for for supplying um if you have a dealer so you sell a product and you have a dealer that rebrands that product what does they have to do the truth is if they Rebrand it and they sell it under their own name they become the manufacturer which means they will need somehow to have access to the technical documentation now that can be done through a letter of access if you really like your dealer you can just send them all the technical information which I assume is not something that you want to do um but in truth either a letter of access or somehow somehow or another you have to have them have access to the technical documentation or they have to stop rebranding the product and they have to sell it as as your initial brand and add the labeling branded repackaged by but if they resell the product on their own name they become the manufacturer and so all the legal responsibilities of that they have to meet unfortunately um what I will say is this was obviously just a let's say a sample of Arab inbox in terms of frequently asked questions what I really say for for anyone in the room today is if you have a question if there's something about fpr that you want to know or getting a product certified do please reach out to us um you know we're happy to set up the necessary calls it's not like we're going to charge you for that we're happy to give off all the necessary information and we want a lot of the unclarity that exists in the sector we want to take that away and so if there's anything that you want to know either during the conference feel free to approach me and otherwise send us an email and I'll be happy to to help you for answer at least help answer the questions foreign um their name is how can I be sure that there is currently um so the first the obviously we sign the necessary confidentiality uh documentation so when you sign a contract with a with a notified body there's a confidentiality NDA agreement that's included in that which binds obviously the Auditors that we have um us and and you um secondly I think if we look at how we store the documentation we obviously follow the necessary security protocols and information so in that regard the information that you you send us is just sent to the auditors um we're not allowed both by the specific legal requirements of fpr and the contract that we signed to share that that with anyone else um and obviously in terms of I.T security we follow the necessary International International guidelines what I would also say is um I think there's a difference sometimes between what you have to send to a notified body to prove that the product is safe and all the information on the specific formulations so we just need to know what ingredients are in there and at a high level what the manufacturing process is that doesn't mean you have to send us every specific every specific step and so in that regard I would also say the most confidential information is typically not necessarily what you have to send to the notified body the bigger thing is you're obviously your field trial reports that prove efficacy uh which are are less confidential at the same time in truth it doesn't matter what you send us it's confidential by law it's confidential by by obviously our own accreditation body and we're audited for that um and we obviously have the necessary I.T infrastructure in place to to be able to protect that foreign again thank God foreign yeah thank you um so the there's there's two parts to answer the question the first one is that there's some information for specific countries that you have to translate so the label if you sell that in Spain obviously will have to be in Spanish and then France have to be in French but let's say that the Greek market of surveillance Authority requests your technical file and you submit that in German and they say I can't read German that's not your problem that's their problem and so what we see also in in other sectors is that they then but they then go out and either translate it or what typically happens is that they will then call the German um Market surveillance Authority to check and have basically for a consult so we see this in other sectors as well and where we're a notified body as well that there is partnership between the the different markets events authorities but it's not like it's your obligation for your costs to have a technical file in all the 20 I think 24 languages that we have now in in the EU that's not a requirement so what we see at the moment is uh the biggest language barrier is what is the language of the notified bodies so unfortunately because there's no German notified body at the moment there is no notified body that accepts files in German so in our case it has to be in English or French or Italian but unfortunately not German so that that for some manufacturers will be a barrier but for the markets defense authorities they have to somehow figure out a way maybe take a German course yeah foreign guidance document for the technician documentation um so firstly the the commission is actually working on a a document that will specifically be called guidance for technical documentation unfortunately because of the commission it will take a bit longer before that that is ready there's not guidance yet for the specific technical documentation but flipping it on its head what I would say is for biosliminants if you have the the test reports the information for CMC which of course differs a little bit but there are very clear guidelines per CMC that we can give on what information you have to send us and the field trials where of course there's the technical specifications I think that there is there is sufficient guidance there there isn't a single document we do have a form if you certify with us that we just ask this specific information including for the specific cmcs what information we want you to upload um um but there is not a unified guidance document yet on technical documentation so what I would say is if that's something they want to know what we can do is set up the team's call to like I said run through what ingredients they might have and then explain what information we want yeah um [Music] Einstein keep the stats is foreign [Music] that you that you either send the single trials to you is that sufficient or is it necessary to summarize the trials and put them inadocia together um it's not necessarily to summarize the the trials as a whole so if you just send us nine nine field trial reports two or however many that that you want for the claims that you want to prove that's enough um of course what we will then do is go through each of the trials see for the specific claim that you want to prove is there the necessary evidence and then we will I would almost say internally make that summary of is there enough trials to prove the claim that you want to prove so it's not required to make a summary um of course in some cases if if you have very much a lot of Trials if you make a summary it might make our assessment time shorter and so that's something I I can't give you the the exact answer for what I would say is if you know if we're talking 50 60 trials uh if you make a summary inherently that might for us be easier to go through um but for the assessment it makes no difference because we have to read all the individual reports anyway absorbed and gets you know whiter positive in effect is um yeah good question yeah um so I think that it's a it's a very good question um what I would say is on the fourth slide what I did say is there's a there's a large responsibility for the the manufacturer for you to send us the uh send us the information and and you know to be confident that the product will actually do something now in theory if you send us tomorrow a file with five field trial reports that meet all the requirements you'll get a certificate and that'll be the case for all the notified bodies because we don't know that you maybe have done 15 trials that don't meet the requirements because of course we're not a national government we're not a policing Authority and so we are not going to go into your files and and check is there something hidden away under the couch and so in the theoretical sense what I would say is you could probably get a module B certification with five field trials that meet the requirements and 15 that don't if you don't send us to 15. but of course then comes the question what happens if if a market surveillance Authority knocks on your door uh because they've gotten reports that uh that your bio stimulant is not doing what supposedly the the label claims that it does um well they have in they have the the legal right to Simply ask for your technical documentation um now of course if you only then send them the fire field chart reports and you don't send them the 15 then they what they can't necessarily they can't really do anything um of course they are the national government Authority so maybe they could if there's for example by a court order that they could request the files that hasn't happened in any of the other sectors yet that they're that aggressive um so I don't think there's there's not a a one-to-one answer but in essence if you have the field trial reports that prove Conformity even if you have other ones that don't you you would get certification um and then Market surveillance and maybe within the associations might be a forear to discuss is that something that we want is there something that we have to do with against that for the notified bodies you know we just do what you know uh what the FBR says that we have to check and so in that regard yes that is perhaps a flaw okay yeah further questions foreign no so um no no no so um there's no for example geographical restrictions uh so if you have field trial reports just from Germany Germany you get a certificate which allows you to sell the product in Spain right so that's that's already something that where you know if you look at protection products it's it's a bit simpler but in terms of you know the the years if you have field trial reports from four years ago we will ask you to declare that the formulation is the same and that's something as a manufacturer that you do have to make sure that it is right so if you've changed the product after two years those field trial reports possibly might no longer be affected but if you've been making the same product for seven years and you have field trial reports from six years five years four years ago you can use those reports um as long as they meet the requirements of the technical specifications and the technical specifications don't have requirements for expiry dates or indeed for example geographical locations thank you okay it's my min foreign thank you yeah if it's possible to to use international trials that were not done in Europe so at the moment if we if we read the technical specifications the answer is yes and so if you're an American manufacturer um and you have trials in in the states there's no requirement in the technical specifications that that's not allowed so that that would be allowed and so um in that regard the the no geographical restrictions um that I just mentioned that applies to the EU as well so if you have trials from um again from the States from Canada which we're now getting applications for those can be used and that's their fpr I've heard okay understood the question so if I mean it does depend a little bit on on where it doesn't meet the requirements um so if if we get a file um with it with a test report and for example the pathogen content is too high there's no way to go around that but of course if we get a a file where the field trials don't exactly meet the requirements from the technical specifications um but you have for example other evidence or you used other standards for uh for performing the field trials that is allowed but then you have to as a manufacturer think about well what standard am I using how am I proving efficacy and so these technical specifications they're not um they're not the only only solution and so I would say if if for some reason it doesn't meet the requirements from the technical specifications look at where so where it doesn't meet the requirements for example and then discuss with the notified body whether that's allowed to give just one example um the the standards at the moment say you have to hire a cro to do the field Trails but what if you as a company have done the field trials internally with your own resources is that allowed possibly if you have the evidence if you can make it objective and you can prove the results then possibly it will be allowed to use your own trials rather than ones with a cro but of course depends on a case-by-case basis foreign yeah um okay thank you that's if you have a bio student if if you have a biosimilant um which was applied to for example seed or whatever where where to put the label with a with a claim um if we look at that from the um from the FBR perspective if you're applying or for example mixing a biostimulant with a fertilizer it will become a blend and so then what you have to do is on that product that you then sell as a blend you have to put the label from both products so you have to put the label from the the biostimulant product that you might as a blender get from a different manufacturer you have to put that on the blend and then put on the blend the label from um yeah for example the mpk um and then you just have to put both of those labels on the product and you cannot even really amend those labels so you have to keep them essentially copy them verbatim okay uh yes um done so if you're um if it's not a blend so if you're for example coding it and and for whatever or you're just mixing it and for so for whatever reason you cannot call it a blend um then um the the end product has to be one of the other six pfcs and so then it can be it can be a fertilizer but then of course then the bio stimulant has to be a CMC so then for example it might have to be uh re-registered it might have to be a a biosumer that this is just a plant extract either way it has to be listed as a CMC ingredient and so then if you're doing that and you're selling it as a PFC as a fertilizer so as PFC one then you cannot put any claims on the label what you can of course also do is sell a biostimulant that has nutrients but then you cannot put the the NPK values on the biostimulant label um I what I would say is if you're combining in whatever way two products so that that one that is labeled as PFC one and one that is labeled as six so fertilizer and a bio stimulant in almost all cases it can be a blend even if it's that's an example that we've seen if you're combining two granular products yeah um phylite if you like guns codes um of the um foreign no so the the one uh practical example that I would add that just maybe it might might help clarify it is um completely different product group but Inhibitors the manufacturer has a product that is both a urease inhibitor and a nitrification inhibitor so what we're doing now is certifying it as both and then with those two certificates it becomes a blend uh and then what we still have to check is is is what how exactly that gets labeled that's something that even we haven't exactly defined yet because it is obviously this is quite it's a bit of a gray area um but within the next few months obviously that's the product that we will we will certify and what it looks like now is that the label will indeed just be a PFC 7 mentioned but that's for also for a specific manufacturer so it's something that still has to be has to be has to be worked out um what I would say is if there are these types of questions and and you send them to us if we don't immediately have an answer they're of course you know the the we and and Iva and different associations are in talks with the commission so we do what we see also try and and get the get the answers to you we might not always have them immediately but it is something that we help with and more importantly obviously the associations help with in the coordination group there are notified bodies um foreign and it depends a little bit on on on on the product so if you're if you have a biosity and it's it's based on a plant extract and you're simply saying I'm getting that plant to extract from somewhere else we won't say you have to redo the field trials but if you just have an mpk and you're one of the ingredients for the mpk is ammonium nitrate and you're switching to a completely different supplier um I'm not sure whether we wouldn't ask for a reassessment at least of the heavy metal values um but what I would say more often than not and that's something that we definitely want to discuss with the coordination group is to say look in some cases whether whether it's a change or for example it's two formulations of a product where the only difference is the colorant does it require two certificates or can it be can it be one so I don't have an answer there are certainly options to say well we don't want to you know we we don't want to require recertification in that regard but there will also be cases especially in the simpler products when we're just talking about heavy metals where we say look it's more proportional to just ask for retesting um so to some extent we have to sort of figure that out a bit on a case-by-case basis now and then come to some kind of common agreement um foreign [Music] standards foreign foreign price foreign yes um exactly that so I don't even think if you have a certificate with one company and then fire and letter of access you go to another notified body you would be attached so if we get an application through an Loa with a product certified with a different notified body I think we could probably rely on that uh regardless if a manufacturer say you know Thomas produces a bios stimulant sells that to another company who slaps its own label on it if we've provided the certification to combo expert the certification costs for that dealer are probably 75 percent less uh um obviously it does have to be just a standard Loa and the product has to be the same uh but if the product is the same and the standards are less then there is a fast track because of course that's a very simple assessment and it's much cheaper because of course for us we've already certified that product yeah so with that so 500 euros maybe a bit more but that's about it so that's not yeah and obviously in terms of timelines it's it's a lot less so Transcript language en Transcript track kind ASR Transcript format vtt Transcript synced at Di. 23 Jun 2026 - 10:29