{"id":3426,"date":"2019-05-14T09:34:51","date_gmt":"2019-05-14T09:34:51","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=3426"},"modified":"2024-11-08T08:29:39","modified_gmt":"2024-11-08T08:29:39","slug":"france-evaluation-grouping-article-43-products-containing-lore-than-one-substance","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/france-evaluation-grouping-article-43-products-containing-lore-than-one-substance\/","title":{"rendered":"France: Article 43 evaluation grouping for products containing more than one active substance"},"content":{"rendered":"

Anses has published a note detailing the requirements for grouping article 43 renewal applications in accordance with Regulation (EC) No.1107\/2009.<\/p>\n

It is noted that the applicant shall apply for a renewal of authorisation within 3 months of the renewal of each \u00a0active substance contained in the product. When the product contains more than one active substance, evaluations of the renewal dossiers of the product can be grouped, if the approval expiry dates of the substances are spaced by less than 12 months. The decision of grouping is granted by the zonal Rapporteur Member State (zRMS). When evaluations are grouped, only one fee is requested. The fee can also be adjusted \u00a0in some cases.<\/p>\n


\nTo download: <\/strong><\/p>\n

Gestion d\u2019une demande de renouvellement d\u2019AMM pour un produit phytopharmaceutique comportant au moins deux substances actives dont les dates de fin d\u2019approbation sont espac\u00e9es de moins d\u2019un an<\/a> (in French – Version dated \u00a010 April 2019)<\/p>\n


\nLynxee consulting<\/strong>\u2019s team is at your disposal to answer your questions.<\/p>\n

Contact us!<\/strong> https:\/\/lynxee.consulting\/en\/contact\/<\/a><\/p>\n

 <\/p>\n

 <\/p>\n

Photo credit: fill\/pixabay<\/h6>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Anses has published a note detailing the requirements for grouping article 43 renewal applications in accordance with Regulation (EC) No.1107\/2009. It is noted that the applicant [\u2026]<\/span><\/p>\n","protected":false},"author":5,"featured_media":3421,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[64,97],"class_list":["post-3426","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulation","tag-anses-en","tag-article-43-en"],"yoast_head":"\nFrance: Article 43 evaluation grouping for products containing more than one active substance - Lynxee consulting<\/title>\n<meta name=\"description\" content=\"Anses has published a note detailing the requirements for grouping article 43 renewal applications in accordance with Regulation (EC) No.1107\/2009. 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