6/7 June 2023
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.
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:
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".