{"id":7129,"date":"2024-03-21T05:18:20","date_gmt":"2024-03-21T05:18:20","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=7129"},"modified":"2024-03-21T05:18:20","modified_gmt":"2024-03-21T05:18:20","slug":"france-anses-implementation-of-article-38-of-regulation-ec-no-1107-2009","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/france-anses-implementation-of-article-38-of-regulation-ec-no-1107-2009\/","title":{"rendered":"FRANCE\u2013 ANSES: Implementation of Article 38 of Regulation (EC) No 1107\/2009"},"content":{"rendered":"<p style=\"text-align: justify\"><span style=\"font-weight: 400\">ANSES released\u00a0 on 14 March 2024 a Note setting out the criteria it takes into account when allocating <\/span><b>specification dossiers <\/b><span style=\"font-weight: 400\">between Member States.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">Pursuant to Article 38 of Regulation (EC) No 1107\/2009, from <\/span><b>1 June 2024<\/b><span style=\"font-weight: 400\">, Anses will only assess applications for new origin, new manufacturing site, change of manufacturing process or specification or revision of specifications for an active substance :<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">&#8211; for which it has been <\/span><b>Rapporteur Member State (RMS)<\/b><span style=\"font-weight: 400\"> and has assessed the reference specifications currently in force, or<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">&#8211; which are submitted simultaneously with an application for authorisation of a reference PPP or for renewal of a marketing authorisation for which it is the <\/span><b>zonal rapporteur Member State (zRMS) <\/b><span style=\"font-weight: 400\">or<\/span><b> interzonal rapporteur Member State (izRMS) <\/b><span style=\"font-weight: 400\">.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">The applications that do not fall within this category will not be assessed by Anses and will be rejected. Within this framework, the applicant should contact the Member States likely to take charge of the assessment, in application of the regulatory provisions of Article 38 of Regulation (EC) No 1107\/2009.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><b>To download:\u00a0<\/b><\/p>\n<p style=\"text-align: justify\"><a href=\"https:\/\/www.anses.fr\/fr\/system\/files\/Note_mise_en_oeuvre_art38_reglement_CE1107-2009.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Anses note of 14 march 2024 &#8211; Implementation of Article 38 of Regulation (EC) No 1107\/2009<\/span><\/a><i><span style=\"font-weight: 400\"> (in French)<\/span><\/i><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><b>Lynxee consulting<\/b><span style=\"font-weight: 400\">\u2019s team is at your disposal to answer your questions.<\/span><\/p>\n<p style=\"text-align: justify\"><b>Contact us!<\/b> <a href=\"http:\/\/lynxee.consulting\/en\/contact\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">http:\/\/lynxee.consulting\/en\/contact\/<\/span><\/a><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h6><span style=\"font-weight: 400\">Photo credit:<\/span><span style=\"font-weight: 400\"> fill\/pixabay<\/span><\/h6>\n","protected":false},"excerpt":{"rendered":"<p>ANSES released\u00a0 on 14 March 2024 a Note setting out the criteria it takes into account when allocating specification dossiers between Member States. Pursuant to Article<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":11,"featured_media":7127,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[65,533,534],"class_list":["post-7129","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulation","tag-11072009-en","tag-article-38-en","tag-specifications-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FRANCE\u2013 ANSES: Implementation of Article 38 of Regulation (EC) No 1107\/2009 - Lynxee consulting<\/title>\n<meta name=\"description\" content=\"ANSES released\u00a0 on 14 March 2024 a Note setting out the criteria it takes into account when allocating specification dossiers between Member States.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/lynxee.consulting\/en\/france-anses-implementation-of-article-38-of-regulation-ec-no-1107-2009\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FRANCE\u2013 ANSES: Implementation of Article 38 of Regulation (EC) No 1107\/2009 - 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