欧盟附录16质量受权人及批放行翻译（2016年4月份实施）.docxVIP

附录16 质量受权人证明及批放行 （实施时间：2016年4月15日）Scope 范围This Annex provides guidance on the certification by a Qualified Person (QP) and on batch release within the European Union (EU) of medicinal products for human or veterinary use holding a marketing authorisation (MA) or made for export. The principles of this guidance also apply to investigational medicinal products (IMP) for human use, subject to any difference in the legal provisions and more specific guidance published by the European Commission. 本《药品生产质量规范指南》（简称《本指南》）附录为质量受权人提供的证明、欧盟（EC ) 或欧洲经济区（EEA ) 内持有上市许可证证的药品放行、出口药品的放行提供指南。指南原则适用于人用临床医疗药品（IMP），但受法律规定的任何不同点及欧盟特定指南的约束。The relevant legislative requirements are provided in Article 51 of Directive 2001/83/EC, as amended, and in Article 55 of Directive 2001/82/EC. Notice is taken of the arrangements referred to in Article 51(2) of Directive 2001/83/EC, as amended, and Article 55(2) of Directive 2001/82/EC, e.g. Mutual Recognition Agreements (MRA). 第2001/83/EC号法令第51条或第 2001/82/EC号法令第55条涵盖了相关法律要求。注意参考 2001/83/EC第51(2) 条或 2001/82/EC第55（2）条，互认协议。This Annex does not address the “Official Control Authority Batch Release” which may be specified for certain blood and immunological products in accordance with Articles 109, 110, 113 and 114 of Directive 2001/83/EC, as amended, and Articles 81 and 82 of Directive 2001/82/EC. However, this Annex does apply to the QP certification and subsequent release of such batches. 本附录未提出官方检验机构根据第2001/83/EC第109条、第110条、第113条、第114条针对某些血液和免疫产品的批放行，2001/82/EC中第81、82条作为补充。但本附录适用于质量受权人证明及随即的批放行。The basic arrangements for batch release for a product are defined by its MA. Nothing in this Annex should be taken as overriding those arrangements. 上市许可证规定了批产品放行的基本要求。本附录的内容不应当超越上市许可证要求。General principles 总则The ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorisation holder (MAH). 对于医药产品在其生命周期，它的安全性、质量和有效性表现的最终责