Revised Annex 19 on Reference and Retention Samples

Recommendation

9-11 March 2027
Barcelona, Spain

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On 24 June 2026, the European Commission has published a revised version of Annex 19 (Reference and Retention Samples) of EudraLex Volume 4 (EU GMP Guidelines).

The following reason for the change is given: "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."

The update is focused on Section 9, which addresses reference and retention samples for parallel imported/parallel distributed/parallel traded products. In particular, the revised version now includes expectations around the use of a photographic/digital sample as an alternative to a physical retention sample (where justified and agreed in advance with the competent authority).

The revised Annex 19 applies from 24 September 2026 (three months from the date of publication).

Both the current version and the revised version are available for download in the EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines section.