{"id":4001,"date":"2020-02-28T14:37:22","date_gmt":"2020-02-28T14:37:22","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=4001"},"modified":"2020-03-06T14:51:32","modified_gmt":"2020-03-06T14:51:32","slug":"france-update-of-the-french-gep-reference-document","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/france-update-of-the-french-gep-reference-document\/","title":{"rendered":"FRANCE: Update of the French GEP reference document"},"content":{"rendered":"<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The reference document of Good Experimental Practice (GEP) related to the accreditation to conduct officially recognised efficacy trials (Revision of 2 February 2020) supersedes the same guidance document (Revision of 1 November 2013) <\/span><b>from 1st June 2020<\/b><span style=\"font-weight: 400;\">. This document is the French Reference document on Good Experimental Practice according to EPPO Standard PP 1\/181 in accordance with Section 6 of the annex to regulation (EU) No. 284\/2013 of 1 March 2013.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Main changes with respect to the previous version are:<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">&#8211; Update of the method to register officially recognised efficacy trials using SIDEP system (\u2018Syst\u00e8me d\u2019Information pour la D\u00e9claration des Essais de Produits\u2019) on ANSES website instead of COLEOR website. Also, this declaration (or other elements transmitted to allow this declaration) must be kept for at least 5 years.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">&#8211; Deletion of the term \u201ctrials series\u201d in the guidance document.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">&#8211; Regarding staff monitoring, authorisation and aptitude must be reviewed periodically and their skills confirmed. Also, company must ensure of the homogeneity of practices between operators (observations and assessments).<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">&#8211; The map for access to the\u00a0 trial and trial map must be precise enough to know exactly the trial location.\u00a0<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">&#8211; More details relating to crop destruction are awaited (such as, the name of the responsible person , the estimated quantity, the date and the method of destruction ). In addition, the destruction method must be defined in the trial protocol.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">&#8211; All information related to subcontracted services (trial and data phases ) and subcontractor legal name must be clearly indicated in the trial dossier and trial report.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">&#8211; When a material or an equipment is defective and out of order, it must be identified as such in order to avoid its use and this, until its return to service.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">&#8211; All information related to artificial contaminations must be clearly indicated and described in the trial dossier.\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b>To download: <\/b><a href=\"https:\/\/www.google.com\/url?q=https:\/\/info.agriculture.gouv.fr\/gedei\/site\/bo-agri\/document_administratif-83dbadbc-55db-43cf-83f6-6afd3322ce2c\/telechargement&amp;sa=D&amp;source=hangouts&amp;ust=1583592556130000&amp;usg=AFQjCNHl8XdJIN5szjaw3EIP5stjTwck8g\" target=\"_blank\" rel=\"noopener noreferrer\">Reference document GEP 2020<\/a><b><\/b><a href=\"https:\/\/info.agriculture.gouv.fr\/gedei\/site\/bo-agri\/document_administratif-83dbadbc-55db-43cf-83f6-6afd3322ce2c\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">\u00a0<\/span><\/a><span style=\"font-weight: 400;\">(in French)<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b>Lynxee consulting<\/b><span style=\"font-weight: 400;\">\u2019s team is at your disposal to answer your questions.<\/span><\/p>\n<p><b>Contact us!<\/b> <a href=\"https:\/\/lynxee.consulting\/en\/contact\/\"><span style=\"font-weight: 400;\">https:\/\/lynxee.consulting\/en\/contact\/<\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The reference document of Good Experimental Practice (GEP) related to the accreditation to conduct officially recognised efficacy trials (Revision of 2 February 2020) supersedes the same<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":8,"featured_media":3998,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[68,58],"class_list":["post-4001","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulation","tag-france-en","tag-guidance-document"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1.1 - 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