{"id":8465,"date":"2025-07-03T04:47:50","date_gmt":"2025-07-03T04:47:50","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=8465"},"modified":"2025-07-29T07:09:03","modified_gmt":"2025-07-29T07:09:03","slug":"france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/","title":{"rendered":"FRANCE &#8211; ANSES: Notifications for new marketing authorisation applications,  major use extensions and generic products"},"content":{"rendered":"<p style=\"text-align: justify\"><span style=\"font-weight: 400\">ANSES published a <\/span><b>new note on notifications of applications for new marketing authorisations, label extensions for major uses and generic products (PBIS)<\/b><span style=\"font-weight: 400\">, in accordance with Article 33\u00a0 and or Article 34 of Regulation (EC) No 1107\/2009 and in application of the European Commission guidance document <\/span><strong><a href=\"https:\/\/food.ec.europa.eu\/system\/files\/2021-01\/pesticides_aas_guidance_mut_rec_en.pdf\" target=\"_blank\" rel=\"noopener\">SANCO\/13169\/2010<\/a><\/strong><span style=\"font-weight: 400\"> on zonal evaluation and mutual recognition, withdrawal and amendment of authorisations.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">This Note completes the procedures presented in the guidance document by confirming that <\/span><b>n<\/b><span style=\"font-weight: 400\">ew applications for marketing authorisations and label extensions for major uses under Article 33 or under both Articles 33 and 34 of Regulation (EC) No 1107\/2009,\u00a0 must be notified to Anses at least\u00a0 6 months before the date on which the application is due to be submitted.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-weight: 400\">For <\/span><b>generic product <\/b><span style=\"font-weight: 400\">(<\/span><b>PBIS) applications<\/b><span style=\"font-weight: 400\"> under Article 34, notifications must now be sent to Anses <\/span><b>at least 3 months before the date on which the application is due to be submitted<\/b><span style=\"font-weight: 400\">. The 8-month deadline for the submission of a PBIS application, which must be met before the renewal of the approval of the active substances contained in the products, remains unchanged.<\/span><\/p>\n<p style=\"text-align: justify\"><b>For generic products, the note applies to new applications from 2 October 2025.<\/b><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><b>To download <\/b><i><span style=\"font-weight: 400\">(in French)<\/span><\/i><b>:\u00a0<\/b><\/p>\n<p style=\"text-align: justify\"><a href=\"https:\/\/www.anses.fr\/fr\/system\/files\/Note_notifications_pbis_Vf.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">Note d\u2019information relative aux notifications des demandes de nouvelles AMM, d\u2019extensions d\u2019usage et de produit g\u00e9n\u00e9riques (PBIS), selon l\u2019article 33 mobilisant ou non l\u2019article 34 du r\u00e8glement (CE) majeur n\u00b01107\/2009 et en application du document d\u2019orientation SANCO\/13169\/2010<\/span><\/a><\/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><span style=\"font-weight: 400\">\u00a0<\/span><\/p>\n<h6><span style=\"font-weight: 400\">Photo credit: <\/span><span style=\"font-weight: 400\">Hans\/pixabay<\/span><\/h6>\n","protected":false},"excerpt":{"rendered":"<p>ANSES published a new note on notifications of applications for new marketing authorisations, label extensions for major uses and generic products (PBIS), in accordance with Article<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":11,"featured_media":8463,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[64,625,572,623,624],"class_list":["post-8465","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulation","tag-anses-en","tag-article-34-en","tag-note-en","tag-notification-en","tag-pbis-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FRANCE - ANSES: Notifications for new marketing authorisation applications, major use extensions and generic products - Lynxee consulting<\/title>\n<meta name=\"description\" content=\"ANSES published a new note on notifications of applications for new marketing authorisations, label extensions for major uses and generic products (PBIS),\" \/>\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-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FRANCE - ANSES: Notifications for new marketing authorisation applications, major use extensions and generic products - Lynxee consulting\" \/>\n<meta property=\"og:description\" content=\"ANSES published a new note on notifications of applications for new marketing authorisations, label extensions for major uses and generic products (PBIS),\" \/>\n<meta property=\"og:url\" content=\"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/\" \/>\n<meta property=\"og:site_name\" content=\"Lynxee consulting\" \/>\n<meta property=\"article:published_time\" content=\"2025-07-03T04:47:50+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-07-29T07:09:03+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/lynxee.consulting\/wp-content\/uploads\/2025\/07\/wheat-4765516_1280_Hans.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1280\" \/>\n\t<meta property=\"og:image:height\" content=\"854\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Tanalou Djae\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Tanalou Djae\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/\",\"url\":\"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/\",\"name\":\"FRANCE - ANSES: Notifications for new marketing authorisation applications, major use extensions and generic products - Lynxee consulting\",\"isPartOf\":{\"@id\":\"https:\/\/lynxee.consulting\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/lynxee.consulting\/wp-content\/uploads\/2025\/07\/wheat-4765516_1280_Hans.jpg\",\"datePublished\":\"2025-07-03T04:47:50+00:00\",\"dateModified\":\"2025-07-29T07:09:03+00:00\",\"author\":{\"@id\":\"https:\/\/lynxee.consulting\/#\/schema\/person\/da8f9efd807b456019d890b71820bbd4\"},\"description\":\"ANSES published a new note on notifications of applications for new marketing authorisations, label extensions for major uses and generic products (PBIS),\",\"breadcrumb\":{\"@id\":\"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/#primaryimage\",\"url\":\"https:\/\/lynxee.consulting\/wp-content\/uploads\/2025\/07\/wheat-4765516_1280_Hans.jpg\",\"contentUrl\":\"https:\/\/lynxee.consulting\/wp-content\/uploads\/2025\/07\/wheat-4765516_1280_Hans.jpg\",\"width\":1280,\"height\":854},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\/\/lynxee.consulting\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"FRANCE &#8211; ANSES: Notifications for new marketing authorisation applications, major use extensions and generic products\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/lynxee.consulting\/#website\",\"url\":\"https:\/\/lynxee.consulting\/\",\"name\":\"Lynxee consulting\",\"description\":\"Innovative support for regulatory issues\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/lynxee.consulting\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/lynxee.consulting\/#\/schema\/person\/da8f9efd807b456019d890b71820bbd4\",\"name\":\"Tanalou Djae\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/lynxee.consulting\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/lynxee.consulting\/wp-content\/uploads\/2021\/10\/Photo_site-web_TDJ-Copie-e1638363904581-96x96.jpg\",\"contentUrl\":\"https:\/\/lynxee.consulting\/wp-content\/uploads\/2021\/10\/Photo_site-web_TDJ-Copie-e1638363904581-96x96.jpg\",\"caption\":\"Tanalou Djae\"},\"url\":\"https:\/\/lynxee.consulting\/en\/author\/tanalou-djae\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"FRANCE - ANSES: Notifications for new marketing authorisation applications, major use extensions and generic products - Lynxee consulting","description":"ANSES published a new note on notifications of applications for new marketing authorisations, label extensions for major uses and generic products (PBIS),","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/","og_locale":"en_US","og_type":"article","og_title":"FRANCE - ANSES: Notifications for new marketing authorisation applications, major use extensions and generic products - Lynxee consulting","og_description":"ANSES published a new note on notifications of applications for new marketing authorisations, label extensions for major uses and generic products (PBIS),","og_url":"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/","og_site_name":"Lynxee consulting","article_published_time":"2025-07-03T04:47:50+00:00","article_modified_time":"2025-07-29T07:09:03+00:00","og_image":[{"width":1280,"height":854,"url":"https:\/\/lynxee.consulting\/wp-content\/uploads\/2025\/07\/wheat-4765516_1280_Hans.jpg","type":"image\/jpeg"}],"author":"Tanalou Djae","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Tanalou Djae","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/","url":"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/","name":"FRANCE - ANSES: Notifications for new marketing authorisation applications, major use extensions and generic products - Lynxee consulting","isPartOf":{"@id":"https:\/\/lynxee.consulting\/#website"},"primaryImageOfPage":{"@id":"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/#primaryimage"},"image":{"@id":"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/#primaryimage"},"thumbnailUrl":"https:\/\/lynxee.consulting\/wp-content\/uploads\/2025\/07\/wheat-4765516_1280_Hans.jpg","datePublished":"2025-07-03T04:47:50+00:00","dateModified":"2025-07-29T07:09:03+00:00","author":{"@id":"https:\/\/lynxee.consulting\/#\/schema\/person\/da8f9efd807b456019d890b71820bbd4"},"description":"ANSES published a new note on notifications of applications for new marketing authorisations, label extensions for major uses and generic products (PBIS),","breadcrumb":{"@id":"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/#primaryimage","url":"https:\/\/lynxee.consulting\/wp-content\/uploads\/2025\/07\/wheat-4765516_1280_Hans.jpg","contentUrl":"https:\/\/lynxee.consulting\/wp-content\/uploads\/2025\/07\/wheat-4765516_1280_Hans.jpg","width":1280,"height":854},{"@type":"BreadcrumbList","@id":"https:\/\/lynxee.consulting\/en\/france-anses-notifications-of-applications-for-new-marketing-authorisation-applications-major-use-extensions-and-generic-products\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/lynxee.consulting\/en\/"},{"@type":"ListItem","position":2,"name":"FRANCE &#8211; ANSES: Notifications for new marketing authorisation applications, major use extensions and generic products"}]},{"@type":"WebSite","@id":"https:\/\/lynxee.consulting\/#website","url":"https:\/\/lynxee.consulting\/","name":"Lynxee consulting","description":"Innovative support for regulatory issues","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/lynxee.consulting\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/lynxee.consulting\/#\/schema\/person\/da8f9efd807b456019d890b71820bbd4","name":"Tanalou Djae","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/lynxee.consulting\/#\/schema\/person\/image\/","url":"https:\/\/lynxee.consulting\/wp-content\/uploads\/2021\/10\/Photo_site-web_TDJ-Copie-e1638363904581-96x96.jpg","contentUrl":"https:\/\/lynxee.consulting\/wp-content\/uploads\/2021\/10\/Photo_site-web_TDJ-Copie-e1638363904581-96x96.jpg","caption":"Tanalou Djae"},"url":"https:\/\/lynxee.consulting\/en\/author\/tanalou-djae\/"}]}},"_links":{"self":[{"href":"https:\/\/lynxee.consulting\/en\/wp-json\/wp\/v2\/posts\/8465","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lynxee.consulting\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lynxee.consulting\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lynxee.consulting\/en\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/lynxee.consulting\/en\/wp-json\/wp\/v2\/comments?post=8465"}],"version-history":[{"count":4,"href":"https:\/\/lynxee.consulting\/en\/wp-json\/wp\/v2\/posts\/8465\/revisions"}],"predecessor-version":[{"id":8471,"href":"https:\/\/lynxee.consulting\/en\/wp-json\/wp\/v2\/posts\/8465\/revisions\/8471"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lynxee.consulting\/en\/wp-json\/wp\/v2\/media\/8463"}],"wp:attachment":[{"href":"https:\/\/lynxee.consulting\/en\/wp-json\/wp\/v2\/media?parent=8465"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lynxee.consulting\/en\/wp-json\/wp\/v2\/categories?post=8465"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lynxee.consulting\/en\/wp-json\/wp\/v2\/tags?post=8465"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}