出口欧洲的API将需要获得出口国药政部门的书面声明文件.doc

Ref. Ares(2012)836360 - 10/07/2012参考文件号(2012)836360 - 10/07/2012EUROPEAN COMMISSION欧洲委员会HEALTH AND CONSUMERS DIRECTORATE-GENERAL健康与消费者保护总司Health systems and products健康体系与产品Medicinal products – quality, safety and efficacy药品–质量、安全性、有效性Brussels, 布鲁塞尔，2012年7月10日SANCO/SF/sl/ddg1.d.6(2012)997444Template for the written confirmation for active substances exported to the European Union for medicinal products for human use, in accordance with Article 46b(2)(b) of Directive 2001/83/EC根据第2001/83/EC号法令的第46b(2)(b)条，出口欧盟人用药品使用原料药“书面确认”模板1.Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC 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 (OJ L 174, 1.7.2011, p. 74) 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.欧洲议会以及欧洲理事会于2011年6月8日对第2001/83/EC号有关人用药品共同法规进行了修订，为防止伪造药品进入合法供应链(《欧盟官方公告》L174，1.7.2011，第74页)，在欧盟范围对进口原料药采取如下规定：除非另有规定，根据第2001/83/EC号法令的第46b(2)条，仅可进口附有出口第三国药监机构出具的出口原料药生产厂符合等同于欧盟所使用的药品生产质量管理规范标准及对工厂控制的书面确认的原料药。2.The template for this written confirmation is set out in annex.书面确认的模板见附件。Annex:附件：Letterhead of the issuing regulatory authority带有颁发药监机构名头的函Written confirmation for active substances exported to the European Union (EU) for medicinal products for human use, in accordance with Article 46b(2)(b) of Directive 2001/83/EC根据第2001/83/EC号法令的第46b(2)(b)条，出口到欧盟人用药使用原料药的书面确认书Confirmation no. (given by the issuing regulatory authority):确认书编号(由颁发的药监机构编排):1. Name an