EU-GMP-附录16：药品质量受权人签发证书与放行批产品-英文.docVIP

Scope This Annex provides guidance on the certification by a? \o 分类:质量受权人 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. The relevant legislative requirements are provided in? \o Directive 2001-83-EC Article 51 of Directive 2001/83/EC, as amende