{"id":4668,"date":"2021-03-12T12:15:17","date_gmt":"2021-03-12T12:15:17","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=4668"},"modified":"2023-01-26T14:39:58","modified_gmt":"2023-01-26T14:39:58","slug":"europe-efsa-guidance-document-on-active-substance-applications-for-approval-and-renewal-and-on-mrl-applications","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/europe-efsa-guidance-document-on-active-substance-applications-for-approval-and-renewal-and-on-mrl-applications\/","title":{"rendered":"EUROPE &#8211; EFSA: Guidance document on active substance applications for approval and renewal and on MRL applications"},"content":{"rendered":"<p style=\"text-align: justify\">EFSA published on 03 March 2021 a technical report describing the <b>administrative requirements<\/b> for the preparation and submission of the dossier to support an application for the <b>approval<\/b>, the <b>amendment<\/b> or the <b>renewal<\/b> of approval of an active substance, and for applications for setting of maximum residue levels (<b>MRLs<\/b>). This guidance document is applicable for all applications submitted as of <b>27 March 2021<\/b>.<\/p>\n<p style=\"text-align: justify\">This document describes the procedures and the timelines for handling these applications and also includes the new requirements related to the implementation of the Transparency Regulation (<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32019R1381&amp;from=FR\" target=\"_blank\" rel=\"noopener noreferrer\">Regulation (EU) 2019\/1381<\/a>). The different support initiatives available and the interaction between the applicant, EFSA members and RMS\/Co-RMS from the preparation of the application (pre-submission phase) to the adoption and publication of the EFSA\u2019s conclusions or reasoned opinions are presented.<\/p>\n<p style=\"text-align: justify\">Eventually, a practical guidance for applicants and Member States also describes the key technical points for preparing dossiers and assessment reports under Regulation (EC) No 1107\/2009 with the aim to enhance their quality.<\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><b>To download:\u00a0<\/b><\/p>\n<p style=\"text-align: justify\">EFSA Supporting publication 2021:EN-6464: <a href=\"https:\/\/efsa.onlinelibrary.wiley.com\/doi\/epdf\/10.2903\/sp.efsa.2021.EN-6464\" target=\"_blank\" rel=\"noopener noreferrer\">Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances and on the maximum residue level (MRL) application procedure<\/a><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><b>See also our previous articles:\u00a0<\/b><\/p>\n<p style=\"text-align: justify\"><a href=\"https:\/\/lynxee.consulting\/en\/europe-efsa-guidance-on-active-substance-applications-for-approbation-and-renewal\/\" target=\"_blank\" rel=\"noopener noreferrer\">EUROPE-EFSA: Guidance on active substance applications for approbation and renewal<\/a><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify\"><b>Lynxee consulting<\/b>\u2019s team is at your disposal to answer your questions.<\/p>\n<p style=\"text-align: justify\"><b>Contact us!<\/b> <a href=\"https:\/\/lynxee.consulting\/en\/contact\/\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/lynxee.consulting\/en\/contact\/<\/a><\/p>\n<p>&nbsp;<\/p>\n<h6>Photo credit: rainerh11\/pixabay<\/h6>\n","protected":false},"excerpt":{"rendered":"<p>EFSA published on 03 March 2021 a technical report describing the administrative requirements for the preparation and submission of the dossier to support an application for<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":9,"featured_media":4666,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[164,143,58],"class_list":["post-4668","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulation","tag-document-guide-en","tag-efsa","tag-guidance-document"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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