{"id":12339,"date":"2022-03-03T16:40:36","date_gmt":"2022-03-03T15:40:36","guid":{"rendered":"https:\/\/www.laffineur.com\/?p=12339"},"modified":"2022-03-03T16:41:30","modified_gmt":"2022-03-03T15:41:30","slug":"securite-des-produits-medicaments","status":"publish","type":"post","link":"https:\/\/www.laffineur.com\/en\/securite-des-produits-medicaments\/","title":{"rendered":"Product Safety \u2013 medicinal products"},"content":{"rendered":"<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32021R1280&amp;qid=1645535027906\">COMMISSION IMPLEMENTING REGULATION (EU) 2021\/1280 of 2\u00a0August 2021 &#8211; as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation\u00a0(EU)\u00a02019\/6 of the European Parliament and of the Council<\/a><\/p>\n<p>Article\u00a093(1)(j) of Regulation\u00a0(EU)\u00a02019\/6 requires the holders of a manufacturing authorisation to use only active substances which have been manufactured in accordance with good manufacturing practice for active substances and distributed in accordance with good distribution practice for active substances.<\/p>\n<p>Accordingly, the new regulation on GDPs aims to ensure the identity, integrity, traceability and quality of active substances used as starting materials in veterinary medicinal products during their movements from the premises where they are manufactured to the manufacturers of veterinary medicinal products by means of various specific modes of transport and by the use of various specific storage methods, so that those active substances remain within the legal supply chain during storage and transport.<\/p>\n<p>The measures on good distribution practice for active substances used as starting materials in veterinary medicinal products laid down in this Regulation should ensure consistency with and complement the implementing measures on good manufacturing practice (GMP) for veterinary medicinal products and active substances used as starting materials provided for in Article\u00a093(2) of Regulation\u00a0(EU)\u00a02019\/6 and good distribution practice for veterinary medicinal products provided for in Article\u00a099(6) of that Regulation.<\/p>\n<p>The persons distributing active substances used as starting materials in veterinary medicinal products should have suitable and adequate premises, installations and equipment, in order to ensure proper storage and distribution of active substances used as starting materials in veterinary medicinal products.<\/p>\n<p>Procedures should describe all distribution activities that affect the identity, traceability and quality of the active substances used as starting materials in veterinary medicinal products. Complaints, returns, and recalls should be recorded and handled carefully in accordance with established procedures. Records should be made available to the competent authorities. An assessment of returned active substances used as starting materials in veterinary medicinal products should be performed before any approval for resale.<\/p>\n<p>A written contract between the contract giver and the contract acceptor should clearly establish the duties of each party.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>COMMISSION IMPLEMENTING REGULATION (EU) 2021\/1280 of 2\u00a0August 2021 &#8211; as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation\u00a0(EU)\u00a02019\/6 of the European Parliament and of the Council Article\u00a093(1)(j) of Regulation\u00a0(EU)\u00a02019\/6 requires the holders of a manufacturing authorisation to use only active substances which [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[151],"tags":[],"class_list":["post-12339","post","type-post","status-publish","format-standard","hentry","category-european-law"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Product Safety \u2013 medicinal products - Laffineur - Cabinet d&#039;avocats<\/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.laffineur.com\/en\/securite-des-produits-medicaments\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Product Safety \u2013 medicinal products - Laffineur - Cabinet d&#039;avocats\" \/>\n<meta property=\"og:description\" content=\"COMMISSION IMPLEMENTING REGULATION (EU) 2021\/1280 of 2\u00a0August 2021 &#8211; as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation\u00a0(EU)\u00a02019\/6 of the European Parliament and of the Council Article\u00a093(1)(j) of Regulation\u00a0(EU)\u00a02019\/6 requires the holders of a manufacturing authorisation to use only active substances which [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.laffineur.com\/en\/securite-des-produits-medicaments\/\" \/>\n<meta property=\"og:site_name\" content=\"Laffineur - Cabinet d&#039;avocats\" \/>\n<meta property=\"article:published_time\" content=\"2022-03-03T15:40:36+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-03-03T15:41:30+00:00\" \/>\n<meta name=\"author\" content=\"Cabinet Laffineur\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.laffineur.com\/en\/securite-des-produits-medicaments\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.laffineur.com\/en\/securite-des-produits-medicaments\/\"},\"author\":{\"name\":\"Cabinet Laffineur\",\"@id\":\"https:\/\/www.laffineur.com\/#\/schema\/person\/38ae6eb8d47b2a8d64290be9e794b3f3\"},\"headline\":\"Product Safety \u2013 medicinal products\",\"datePublished\":\"2022-03-03T15:40:36+00:00\",\"dateModified\":\"2022-03-03T15:41:30+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.laffineur.com\/en\/securite-des-produits-medicaments\/\"},\"wordCount\":360,\"publisher\":{\"@id\":\"https:\/\/www.laffineur.com\/#organization\"},\"articleSection\":[\"European Law\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.laffineur.com\/en\/securite-des-produits-medicaments\/\",\"url\":\"https:\/\/www.laffineur.com\/en\/securite-des-produits-medicaments\/\",\"name\":\"Product Safety \u2013 medicinal products - Laffineur - Cabinet d&#039;avocats\",\"isPartOf\":{\"@id\":\"https:\/\/www.laffineur.com\/#website\"},\"datePublished\":\"2022-03-03T15:40:36+00:00\",\"dateModified\":\"2022-03-03T15:41:30+00:00\",\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.laffineur.com\/en\/securite-des-produits-medicaments\/\"]}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.laffineur.com\/#website\",\"url\":\"https:\/\/www.laffineur.com\/\",\"name\":\"Laffineur - Cabinet d'avocats\",\"description\":\"Laffineur - Cabinet d&#039;avocats\",\"publisher\":{\"@id\":\"https:\/\/www.laffineur.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.laffineur.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.laffineur.com\/#organization\",\"name\":\"Cabinet Laffineur\",\"url\":\"https:\/\/www.laffineur.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.laffineur.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.laffineur.com\/wp-content\/uploads\/2021\/03\/Logo-Laffineur-v326x154.png\",\"contentUrl\":\"https:\/\/www.laffineur.com\/wp-content\/uploads\/2021\/03\/Logo-Laffineur-v326x154.png\",\"width\":326,\"height\":154,\"caption\":\"Cabinet Laffineur\"},\"image\":{\"@id\":\"https:\/\/www.laffineur.com\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/in\/jean-luc-laffineur-4a6365\/?originalSubdomain=be\"]},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.laffineur.com\/#\/schema\/person\/38ae6eb8d47b2a8d64290be9e794b3f3\",\"name\":\"Cabinet Laffineur\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.laffineur.com\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/www.laffineur.com\/wp-content\/uploads\/2021\/03\/Avatar-g_b.png\",\"contentUrl\":\"https:\/\/www.laffineur.com\/wp-content\/uploads\/2021\/03\/Avatar-g_b.png\",\"caption\":\"Cabinet Laffineur\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Product Safety \u2013 medicinal products - Laffineur - Cabinet d&#039;avocats","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.laffineur.com\/en\/securite-des-produits-medicaments\/","og_locale":"en_US","og_type":"article","og_title":"Product Safety \u2013 medicinal products - Laffineur - Cabinet d&#039;avocats","og_description":"COMMISSION IMPLEMENTING REGULATION (EU) 2021\/1280 of 2\u00a0August 2021 &#8211; 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