欧盟发布62号令补充文件
出自识林
欧盟发布62号令补充文件
笔记 2012-10-31 EMA 欧盟于10月26日发布了与62号令相关的一些文件，包括第三方出口国的书面确认模板、相关问题解答Q&A、关于此进口API原料新规定的宣传资料、以及信息提供清单。以下为原文及链接： Importation of active substances  Directive 2011/62/EU (968 KB) of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC (633 KB) on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products introduces EU-wide rules for the importation of active substances: According to Article 46b(2) of Directive 2001/83/EC, active substances shall only be imported if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union. The template for the written confirmation has been published in Part III of EudraLex, Volume 4. In addition, a "Questions and Answers" documents (version 2 - October 2012)(54 KB) responds to the most frequently asked questions in relation to this file. An information leaflet on the new rules on importing active pharmaceutical ingredients into the EU is available here (676 KB). Regarding the "Listing of third countries", a list of information to be submitted with the request is here (50 KB). Below is a list of third countries which have so far requested to be listed, as well as the status of the request:
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