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Update to EU GMP Guidelines – Revised Annex 19 on Reference and Retention Samples

The European Commission has published a revised version of Annex 19 of EudraLex Volume 4. The update is focused on Section 9 of the annex which addresses reference and retention samples for parallel traded products.

The revised annex includes expectations around the use of photographic or digital samples as an alternative to physical retention samples for Parallel Imported/Parallel Distributed/Parallel Traded Products.

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