EU: GMP Annex 19 Updated
The European Commission has published a revised version of Annex 19 “Reference and Retention Samples”. The update mainly affects requirements for reference and retention samples of parallel imported, parallel distributed and parallel traded medicinal products.
The revised annex explicitly states that reference samples of re-packaged products are not required. Instead, a retention sample must be retained for each re-packaging operation.
In cases where the secondary package is not opened, only the packaging material used needs to be retained.
A key change is the explicit acceptance of photographic or digital retention samples where retention of a physical sample is not reasonably feasible and has been agreed with the competent authority. Such records must allow a complete visual examination, show safety features and Braille information, and comply with Annex 11 requirements for data integrity.
The revised Annex will apply from 24 September 2026, three months after its publication by the European Commission.
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