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.
This documents sets out frequently-asked ‘questions and answers’ regarding the implementation of the rules on the safety features for medicinal products for human use.
New Q&A
s 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.