EU GMP 附录21药物进口-20200320征求意见稿.pdfVIP

EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 21: Importation of medicinal products Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use. Status of the document: New annex. Reasons for changes: Not applicable at this occasion. It is a new annex. Deadline for coming into operation: to be determined. Page 1 of 4 1 1. Scope 2 3 1.1. This Annex summarizes the GMP requirements applicable to a Manufacturing Import 4 Authorisation (MIA) holder which imports medicinal products (human and veterinary) 5 from outside the EU/EEA. The guidance in the main chapters and annexes of the EU 6 GMP also apply, as appropriate for the activities carried out, and should be consulted 7 for more detailed guidance. 8 Medicinal products which enter EU/EEA with the intention of export only and which 9 are not processed nor released for placing on the EU/EEA market, are not covered by 10 this Annex. 11 12 13 2. Principles 14 2.1. For the purpose of this annex, the term importation refers to t he action of physically 15