20150319欧盟人用药活性物质GDP原则.docxVIP

20150319 欧盟 人用药活性物质GDP原则(2015/C 95/01)??Guidelinesof 19 March 2015on principles ofGood Distribution Practiceof active substances for medicinal products for human use人用药活性物质GDP原则指南(Text with EEA relevance)(2015/C 95/01)?Introduction?概述These guidelines are based on the fourth paragraph of Article 47 of Directive 2001/83/EC (1).这些指南是基于指令2001/83/EC(1)第47条的第4段。They follow the same principles that underlie the guidelines of EudraLex Volume 4, Part II, Chapter 17, with regard to the distribution of active substances and the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2).他们遵守在欧盟药品法第4卷第2部分第17章指南中规定的关于原料药销售，和2013年11月5日人用药GDP规范相同的原则。These guidelines provide stand-alone guidance on Good Distribution Practice (GDP) for importers and distributors of active substances for medicinal products for human use. They complement the rules on distribution set out in the guidelines of EudraLex Volume 4, Part II, and apply also to distributors of active substances manufactured by themselves.这些指南为人用药所用的原料药的分销商和进口商提供了单独的GDP指南。它们补充了欧盟药品法第4卷第2部分指南中所设定的销售规定，也适用于销售自己生产的原料药的分销商。Any manufacturing activities in relation to active substances, including re-packaging, re-labelling or dividing up, are subject to Commission Delegated Regulation (EU) No 1252/2014 (3) and EudraLex Volume 4, Part II.所有与原料药相关的生产活动，包括再包装、再标签或分装均受法规(EU) No 1252/2014 (3)?和欧盟药品法卷4第2部分的管理。Additional requirements apply to the importation of active substances, as laid down in Article 46b of Directive 2001/83/EC.适用于原料药进口的额外要求在指令2001/83/EC第46b中列出。Distributors of active substances for medicinal products for human use should follow these guidelines as of 21 September 2015.人用药原料药分销商自2015年9月21日起应遵守本指南。CHAPTER 1 — SCOPE第1章---范围These guidelines apply to distribution of active substances, as defined in Article 1(3a) of Directive 2001/83/EC, for medicinal products for human use. According to that provision, an active substance is any substance or mixture of substances intended to be used in