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 of packaging materials used in the re-packaging process, such as labels, carton, patient information leaflet, other package inserts, to be retained for the duration of the shelf-life of the re-packaged finished product. ‍

The Annex introduces a number of new requirements including:

• The requirement that the retention sample represent the re-packaged finished product released for the market and include the primary package as well as the secondary package. Where the secondary package is not opened, only the packaging material used need be retained;

• With the prior agreement of the competent authority, where it is demonstrated that a physical sample of the re-packaged finished product cannot reasonably be retained, a photographic/digital sample may be retained. This should provide sufficient information to permit full visual examination and permit the same level of investigation of the repackaged product as that possible with a physical retention sample;

• The photographic/digital sample should also show evidence that required safety features have been applied and allow the identification of information in braille;

• Any photographic/digital sample stored electronically, should comply with the principles of Annex 11 to Eudralex Volume 4 governing computerised systems.‍