{"id":4054,"date":"2022-12-13T09:00:49","date_gmt":"2022-12-13T01:00:49","guid":{"rendered":"https:\/\/regask.com\/?p=4054"},"modified":"2024-09-27T10:30:28","modified_gmt":"2024-09-27T02:30:28","slug":"amendement-ctr-imp-etiquetage","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/ctr-amendment-imp-labeling\/","title":{"rendered":"UE : Modification du r\u00e8glement sur les essais cliniques (CTR)\u2026"},"content":{"rendered":"<div>\n<div><a href=\"https:\/\/ec.europa.eu\/info\/index_en\" target=\"_blank\" rel=\"noopener\">La Commission europ\u00e9enne (CE)<\/a> L&#039;Union europ\u00e9enne a r\u00e9vis\u00e9 les exigences actuelles en mati\u00e8re d&#039;\u00e9tiquetage pr\u00e9vues par le r\u00e8glement sur les essais cliniques (CTR) pour les m\u00e9dicaments exp\u00e9rimentaux (MIE) en ce qui concerne les dates de p\u00e9remption au moyen d&#039;un r\u00e8glement d\u00e9l\u00e9gu\u00e9. Le r\u00e8glement a maintenant \u00e9t\u00e9 publi\u00e9 au Journal officiel de l&#039;Union europ\u00e9enne.<\/div>\n<div><\/div>\n<div>Le CTR entrera en vigueur le 31 janvier 2022. Il s&#039;accompagne d&#039;une s\u00e9paration des exigences GMP pour les m\u00e9dicaments exp\u00e9rimentaux et celles des m\u00e9dicaments autoris\u00e9s. Dans le cas de produits qui n&#039;ont pas encore \u00e9t\u00e9 approuv\u00e9s, les \u00e9tudes de stabilit\u00e9 et de dur\u00e9e de conservation ne sont souvent pas termin\u00e9es et de nouvelles informations concernant la date de p\u00e9remption du m\u00e9dicament exp\u00e9rimental apparaissent au cours de la phase de d\u00e9veloppement. Il en r\u00e9sulte la n\u00e9cessit\u00e9 de r\u00e9\u00e9tiqueter ult\u00e9rieurement les m\u00e9dicaments exp\u00e9rimentaux d\u00e9j\u00e0 d\u00e9livr\u00e9s et personnalis\u00e9s pour le patient avec la nouvelle date de p\u00e9remption.<\/div>\n<div><\/div>\n<div>La r\u00e9glementation actuelle impose l&#039;\u00e9tiquetage des emballages int\u00e9rieurs et ext\u00e9rieurs. Ainsi, en cas de modification, les emballages doivent \u00e9galement \u00eatre ouverts pour mettre \u00e0 jour les informations figurant sur l&#039;emballage int\u00e9rieur. Les mises \u00e0 jour fr\u00e9quentes de la date de p\u00e9remption sur l&#039;emballage primaire de m\u00e9dicaments non approuv\u00e9s utilis\u00e9s dans les essais cliniques peuvent, dans certains cas, pr\u00e9senter des risques potentiels pour la qualit\u00e9 et la s\u00e9curit\u00e9 de ces produits (par exemple, par la n\u00e9cessit\u00e9 d&#039;ouvrir l&#039;emballage, la n\u00e9cessit\u00e9 de briser les scell\u00e9s inviolables et de d\u00e9monter les ensembles constitu\u00e9s de plusieurs couches ou par une exposition prolong\u00e9e \u00e0 la lumi\u00e8re ou \u00e0 des temp\u00e9ratures plus \u00e9lev\u00e9es pour les m\u00e9dicaments sensibles \u00e0 cet \u00e9gard).<\/div>\n<div><\/div>\n<div>La Commission europ\u00e9enne estime donc que dans certains cas, compte tenu de la nature et de l\u2019ampleur du risque, il est appropri\u00e9 et proportionn\u00e9 de ne pas mentionner la date de p\u00e9remption sur le conditionnement primaire. Pour mettre en \u0153uvre cette option dans le cadre l\u00e9gislatif du CTR, la Commission europ\u00e9enne a publi\u00e9 un amendement au CTR avec le r\u00e8glement d\u00e9l\u00e9gu\u00e9 2022\/2239.<\/div>\n<\/div>\n<div><\/div>\n<div class=\"MuiGrid-root jss1499 MuiGrid-item MuiGrid-grid-md-12\">\n<div class=\"jss1501\">\n<div class=\"jss1521\">\n<div class=\"jss409 jss434 summaryParagraph\">\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<p><a href=\"https:\/\/regask.com\/fr\/contact-2\/\">Contactez RegASK pour en savoir plus sur les changements de r\u00e9glementation dans l&#039;UE.\u00a0<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<a href=\"https:\/\/regask.com\/fr\/contact-2\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contactez RegASK pour plus de d\u00e9tails<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX:32022R2239\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>En savoir plus<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-159028714\">\n\n\t<div id=\"col-1462591563\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/fr\/etudes-de-cas\/ressources-etudes-de-cas-pharma-biotech\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lisez les \u00e9tudes de cas sur l&#039;industrie pharmaceutique et biotechnologique<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"MuiGrid-root jss1499 MuiGrid-item MuiGrid-grid-xs-12\">\n<div class=\"jss1500\">\n<div class=\"jss409 jss417 dataText\"><\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>La Commission europ\u00e9enne (CE) a r\u00e9vis\u00e9 les exigences actuelles en mati\u00e8re d\u2019\u00e9tiquetage pr\u00e9vues dans le r\u00e8glement sur les essais cliniques (CTR) pour les m\u00e9dicaments exp\u00e9rimentaux (MIE) concernant les dates de p\u00e9remption au moyen d\u2019un r\u00e8glement d\u00e9l\u00e9gu\u00e9. Le r\u00e8glement a maintenant \u00e9t\u00e9 publi\u00e9 au Journal officiel de l\u2019Union europ\u00e9enne. Le CTR s\u2019applique \u00e0 compter du 31 janvier 2022. Il a \u00e9t\u00e9\u2026<\/p>","protected":false},"author":39,"featured_media":4047,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35],"tags":[40],"class_list":["post-4054","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.4 (Yoast SEO v28.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EU Clinical Trials Regulation: IMP Labeling Update | RegASK<\/title>\n<meta name=\"description\" content=\"The EU Clinical Trials Regulation (CTR) has amended current labelling requirements regarding investigational medicinal products (IMP).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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