{"id":12641,"date":"2025-09-22T00:00:00","date_gmt":"2025-09-21T22:00:00","guid":{"rendered":"https:\/\/www.cabinet-magar.fr\/actualites\/preparations-hospitalieres-nouvelles-modalites-de-declaration\/"},"modified":"2025-09-22T00:00:00","modified_gmt":"2025-09-21T22:00:00","slug":"preparations-hospitalieres-nouvelles-modalites-de-declaration","status":"publish","type":"post","link":"https:\/\/www.cabinet-magar.fr\/de\/actualites\/preparations-hospitalieres-nouvelles-modalites-de-declaration\/","title":{"rendered":"Pr\u00e9parations hospitali\u00e8res : nouvelles modalit\u00e9s de d\u00e9claration"},"content":{"rendered":"<p>Les pharmaciens peuvent \u00eatre amen\u00e9s \u00e0 r\u00e9aliser eux-m\u00eames des pr\u00e9parations m\u00e9dicamenteuses. Dans ce cas-l\u00e0, ils doivent respecter certaines obligations d\u00e9claratives, qui viennent d\u2019\u00eatre mises \u00e0 jour\u2026<\/p>\n<h2>Une t\u00e9l\u00e9d\u00e9claration \u00e0 faire pour chaque pr\u00e9paration<\/h2>\n<p>Les pharmaciens peuvent r\u00e9aliser des pr\u00e9parations m\u00e9dicamenteuses pour divers usages et notamment pour soigner leur propre patient\u00e8le en officine. Mais ces pr\u00e9parations peuvent \u00e9galement \u00eatre d\u00e9volues \u00e0 un usage hospitalier.<\/p>\n<p>Dans cette hypoth\u00e8se, des obligations d\u00e9claratives viennent s\u2019imposer au pharmacien r\u00e9alisant ces pr\u00e9parations, qu\u2019il soit :<\/p>\n<ul>\n<li>g\u00e9rant d\u2019une pharmacie \u00e0 usage int\u00e9rieur (PUI) d\u2019un \u00e9tablissement de sant\u00e9 public de sant\u00e9 ou d\u2019un groupement d\u2019\u00e9tablissements ;<\/li>\n<li>responsable d\u2019un \u00e9tablissement pharmaceutique g\u00e9r\u00e9 par un \u00e9tablissement public de sant\u00e9 ;<\/li>\n<li>responsable d\u2019un \u00e9tablissement pharmaceutique r\u00e9alisant des pr\u00e9parations pour le compte d\u2019une PUI.<\/li>\n<\/ul>\n<p>Le pharmacien devra d\u00e9clarer toute nouvelle pr\u00e9paration \u00e0 l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM). Pour ce faire, il faudra se rendre sur le <a href=\"https:\/\/icprhosper.ansm.sante.fr\/Public\/\" target=\"_blank\">service de t\u00e9l\u00e9d\u00e9claration<\/a> propos\u00e9 sur le site de l\u2019ANSM dans le mois suivant la r\u00e9alisation de la pr\u00e9paration.<\/p>\n<p>La d\u00e9claration contient :<\/p>\n<ul>\n<li>l\u2019identit\u00e9 du d\u00e9clarant ;<\/li>\n<li>des renseignements g\u00e9n\u00e9raux relatifs \u00e0 la pr\u00e9paration, notamment sa d\u00e9nomination, sa forme pharmaceutique, sa voie d&#8217;administration et son code ATC ;<\/li>\n<li>des informations concernant la justification de l\u2019utilisation de la pr\u00e9paration et la population cibl\u00e9e ;<\/li>\n<li>des donn\u00e9es pharmaceutiques, notamment la composition qualitative et quantitative en substance active et excipient et le conditionnement primaire.<\/li>\n<\/ul>\n<p>De plus, pour chaque ann\u00e9e civile, il faudra, avant le 31 janvier de l\u2019ann\u00e9e suivante, d\u00e9clarer le nombre total de pr\u00e9parations hospitali\u00e8res r\u00e9alis\u00e9es.&nbsp;<\/p>\n<p>Afin de permettre aux pharmaciens concern\u00e9s de s\u2019adapter \u00e0 cette nouvelle version de l\u2019obligation, ils ont jusqu\u2019au 22 f\u00e9vrier 2026 pour faire leurs d\u00e9clarations selon ces modalit\u00e9s.<\/p>\n<div>Sources :  <\/p>\n<ul>\n<li><a href=\"https:\/\/www.legifrance.gouv.fr\/jorf\/id\/JORFTEXT000052125228\" target=\"_blank\">Arr\u00eat\u00e9 du 7 ao\u00fbt 2025 d\u00e9finissant les conditions de d\u00e9claration des pr\u00e9parations hospitali\u00e8res pr\u00e9vues \u00e0 l&#8217;article L. 5121-1 (2\u00b0) du code de la sant\u00e9 publique<\/a><\/li>\n<\/ul>\n<\/div>\n<p><a href=\"https:\/\/www.weblex.fr\/weblex-actualite\/preparations-hospitalieres-nouvelles-modalites-de-declaration\" target=\"_blank\">Pr\u00e9parations hospitali\u00e8res : nouvelles modalit\u00e9s de d\u00e9claration<\/a> &#8211; \u00a9 Copyright WebLex<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/www.weblex.fr\/sites\/default\/files\/actualites\/images\/Shutterstock_preparationshospitalieres.jpg\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Les pharmaciens peuvent \u00eatre amen\u00e9s \u00e0 r\u00e9aliser eux-m\u00eames des pr\u00e9parations m\u00e9dicamenteuses. Dans ce cas-l\u00e0, ils doivent respecter certaines obligations d\u00e9claratives, qui viennent d\u2019\u00eatre mises \u00e0 jour\u2026<\/p>\n","protected":false},"author":0,"featured_media":12642,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[9,7],"tags":[],"class_list":["post-12641","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actu-juridique","category-actualites"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Pr\u00e9parations hospitali\u00e8res : nouvelles modalit\u00e9s de d\u00e9claration - Cabinet Magar<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.cabinet-magar.fr\/actualites\/preparations-hospitalieres-nouvelles-modalites-de-declaration\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pr\u00e9parations hospitali\u00e8res : nouvelles modalit\u00e9s de d\u00e9claration - Cabinet Magar\" \/>\n<meta property=\"og:description\" content=\"Les pharmaciens peuvent \u00eatre amen\u00e9s \u00e0 r\u00e9aliser eux-m\u00eames des pr\u00e9parations m\u00e9dicamenteuses. 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