In June 2026, the European Commission published a revised version of EU GMP Annex 19 – Reference and Retention Samples, applicable from 24 September 2026.
Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on theCommunity code relating to medicinal products for human use. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in as laid down in Commission Directive 2017/1572/EU for medicinal products for human use.
Status of the document: Revision of the 2006 version of Annex 19.
Reasons for changes: The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly recommend that the current version of annex 19, on the Reference and Retention Samples, is revised with respect to reference and retention Samples for Parallel Imported/Parallel Distributed/Parallel Traded Products.
Deadline for coming into operation: 3 months from the date of publication by the European Commission.