Serialization - Version 20 of the Q&As on Safety Features

Recommendation

15/16 November 2023

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

The European Commission published version 20 of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. Compared to the previous version 19, the new version contains one new Q&A.

New Q&A

5.14 Is it allowed to verify the authenticity of the Unique Identifier (UI) when the product is not in physical possession?

The answer to this question is: Yes, but only as an additional check.

Wholesalers are required to verify the authenticity of the UI for at least the following medicinal products (MPs) in their physical possession:

• MPs returned by persons authorized or entitled to supply MPs to the public or by another wholesaler;
• MPs he receives from a wholesaler who is neither the manufacturer nor the wholesaler holding the marketing authorization nor a wholesaler who is designated by the MAH, by means of a written contract, to store and distribute the products covered by his marketing authorization on his behalf.

This is a minimum requirement. A wholesaler may verify the authenticity of other products of other origins via the UI when the product is not in physical possession. However, this does not exempt from the obligation to verify the UI once the product is in physical possession and can thus not replace it. Moreover, only authorized suppliers located in the EU can put medicinal products on the market in the EU. Verifying the UI of packs located outside the EU does not replace import testing and QP batch certification after import.

For more information please see version 20 of the "Safety features for medicinal products for human use - Questions & Answers".