{"id":7200,"date":"2024-04-17T07:38:01","date_gmt":"2024-04-17T07:38:01","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=7200"},"modified":"2024-04-17T07:40:47","modified_gmt":"2024-04-17T07:40:47","slug":"france-ppp-marketing-authorisations-and-declarations-update-of-cerfa-and-associated-explanatory-notes","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/france-ppp-marketing-authorisations-and-declarations-update-of-cerfa-and-associated-explanatory-notes\/","title":{"rendered":"FRANCE &#8211; PPP: Marketing authorisations and declarations &#8211; Update of Cerfa and associated explanatory notes"},"content":{"rendered":"<p style=\"text-align: justify\">Cerfa No. 15722 concerning marketing authorisation for a plant protection product, an adjuvant or a mixed product, Cerfa No. 15723 on declaration regarding a marketing authorisation or trial permit, Cerfa No. 15721 on parallel trade permits and the associated explanatory notes No. 52173, No. 52174 and No. 52172 have just been updated.<\/p>\n<p style=\"text-align: justify\">The main changes are:<\/p>\n<p style=\"text-align: justify\">&#8211; For applications regarding a marketing authorisation<\/p>\n<ul>\n<li style=\"text-align: justify\">New methods for entering product packaging and manufacturing sites, consistent with data entry on the Dphy platform;<\/li>\n<li style=\"text-align: justify\">Addition of adjuvant substances in section 5;<\/li>\n<li style=\"text-align: justify\">Removal of identity statement for paper \/ electronic documents;<\/li>\n<li style=\"text-align: justify\">Important clarifications regarding marketing authorisation by mutual recognition, namely the possibility to submit additional information to the reports provided to the reference member state. This additional information can only be taken into account if the time necessary to evaluate it is compliant with the timelines of Art. 42 of Regulation (EC) No. 1107\/2009. If the time required for evaluation is not compatible with EU regulatory timeline, and in case of refusal of the authorisation, this additional information may be submitted as part of a new marketing authorisation application, according to Art. 33 of Regulation (EC) No. 1107\/2009, which benefits, when submitted within 6 months following the refusal, from accelerated processing as well as a reduced fee.<\/li>\n<\/ul>\n<p>&#8211; For declarations relating to a marketing authorisation<\/p>\n<ul style=\"text-align: justify\">\n<li>New methods for entering product manufacturing sites, consistent with data entry on the Dphy platform;<\/li>\n<li>Introduction on section 7 of a category of products, for which a first marketing authorisation demand is in progress;<\/li>\n<li>Removal of identity statement for paper \/ electronic documents;<\/li>\n<li>Introduction of explanations to fulfil demand \u201c1.3 Management of manufacturing site of an authorised product\u201d on the Dphy platform.<\/li>\n<\/ul>\n<p style=\"text-align: justify\">&#8211; For requests regarding a parallel trade permit<\/p>\n<ul style=\"text-align: justify\">\n<li>Removal of the renewal demand;<\/li>\n<li>Addition of the \u201corigin extension\u201d section;<\/li>\n<li>New methods for entering product packaging.<\/li>\n<\/ul>\n<p style=\"text-align: justify\">&#8211; And finally, update of the \u201cDossier preparation\u201d section in the explanatory notes and addition of the preferred submission method <i>via <\/i>the <a href=\"https:\/\/dphy.anses.fr\/#\/login\">Dphy<\/a> platform.<\/p>\n<p style=\"text-align: justify\">These Cerfa forms and their explanatory notes are available through hypertext links in the general note on dossier submission to Anses, updated on 09\/04\/2024.<\/p>\n<p>&nbsp;<\/p>\n<p><b>To download (<\/b><b><i>in French<\/i><\/b><b>):<\/b><\/p>\n<p><a href=\"https:\/\/www.anses.fr\/system\/files\/Note_formulaires_notices_dossier_PPP.pdf\" target=\"_blank\" rel=\"noopener\">General note on dossier submission (Cerfa forms and notices to be used)<\/a> (09\/04\/2024)<\/p>\n<p><a href=\"https:\/\/www.formulaires.service-public.fr\/gf\/cerfa_15722.do\" target=\"_blank\" rel=\"noopener\"><b>Cerfa N\u00b0 15722*04 Marketing authorisation request<\/b><\/a><\/p>\n<p><a href=\"https:\/\/www.formulaires.service-public.fr\/gf\/getNotice.do?cerfaNotice=%252301&amp;cerfaFormulaire=15722\" target=\"_blank\" rel=\"noopener\"><b>Explanatory note 52173*04 Marketing authorisation request<\/b><\/a><\/p>\n<p><a href=\"https:\/\/www.formulaires.service-public.fr\/gf\/cerfa_15722.do\" target=\"_blank\" rel=\"noopener\"><b>Cerfa N<\/b><\/a><a href=\"https:\/\/www.formulaires.service-public.fr\/gf\/cerfa_15723.do\"><b>\u00b0 15723 Declaration<\/b><\/a><\/p>\n<p><a href=\"https:\/\/www.formulaires.service-public.fr\/gf\/getNotice.do?cerfaNotice=%252301&amp;cerfaFormulaire=15722\"><b>Explanatory note<\/b><\/a><a href=\"https:\/\/www.formulaires.service-public.fr\/gf\/getNotice.do?cerfaNotice=52174&amp;cerfaFormulaire=15723\" target=\"_blank\" rel=\"noopener\"><b> N\u00b0 52174*03 Declaration<\/b><\/a><\/p>\n<p><a href=\"https:\/\/www.formulaires.service-public.fr\/gf\/cerfa_15722.do\" target=\"_blank\" rel=\"noopener\"><b>Cerfa N<\/b><\/a><a href=\"https:\/\/www.formulaires.service-public.fr\/gf\/cerfa_15721.do\"><b>\u00b0 15721*02 Parallel trade permit<\/b><\/a><\/p>\n<p><a href=\"https:\/\/www.formulaires.service-public.fr\/gf\/getNotice.do?cerfaNotice=%252301&amp;cerfaFormulaire=15722\"><b>Explanatory note<\/b><\/a><a href=\"https:\/\/www.formulaires.service-public.fr\/gf\/getNotice.do?cerfaNotice=52172&amp;cerfaFormulaire=15721\" target=\"_blank\" rel=\"noopener\"><b> N\u00b0 52172*02 Parallel trade permit<\/b><\/a><\/p>\n<p>&nbsp;<\/p>\n<p><b>See also our previous article:\u00a0<\/b><\/p>\n<p><a href=\"https:\/\/lynxee.consulting\/en\/france-anses-update-of-the-explanatory-note-cerfa-form-and-application-procedure-for-trial-permits\/\" target=\"_blank\" rel=\"noopener\"><b>FRANCE \u2013 ANSES : Update of the explanatory note, cerfa form and application procedure for trial permits<\/b><\/a><\/p>\n<p>&nbsp;<\/p>\n<p><b>Lynxee consulting<\/b>\u2019s team is at your disposal to answer your questions.<\/p>\n<p><b>Contact us!<\/b> <a href=\"http:\/\/lynxee.consulting\/en\/contact\/\" target=\"_blank\" rel=\"noopener\">http:\/\/lynxee.consulting\/en\/contact\/<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h6><b>Photo credit: <\/b>roszie\/pixabay<\/h6>\n","protected":false},"excerpt":{"rendered":"<p>Cerfa No. 15722 concerning marketing authorisation for a plant protection product, an adjuvant or a mixed product, Cerfa No. 15723 on declaration regarding a marketing authorisation<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":14,"featured_media":7196,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[15,36],"tags":[125,64,396,395],"class_list":["post-7200","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-non-classe-en","category-regulation","tag-amm-en","tag-anses-en","tag-cerfa-form","tag-explanatory-notes"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FRANCE - PPP: Marketing authorisations and declarations - Update of Cerfa and associated explanatory notes - Lynxee consulting<\/title>\n<meta name=\"description\" content=\"Cerfa No. 15722 concerning marketing authorisation for a plant protection product, an adjuvant or a mixed product, Cerfa No. 15723 on declaration\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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