Revisions to Annex 19 Eudralex Volume 4 concerning reference and retention samples for parallel imports

The provisions of Annex 19 to Eudralex Volume 4 concerning reference and retention samples for parallel imported, parallel distributed, and parallel traded medicinal products will change from 24 September 2026.

Previous related requirements provided that, where the secondary packaging is not opened, only the packaging material used needs to be retained. The revised Annex amplifies this requirement to require physical samples