Q&A document updated – Clarification to the new Q&A 5.14

The European Commission published a new version of the Questions & Answers (Q&A) document on “Safety Features for Medicinal Products for Human Use (V.20)” in June 2022. Question 5.14 and its answer were added to the document. 

The answer states that a wholesaler may verify beforehand the authenticity of a pack when it is not in their physical possession, but which the wholesaler is in the process of acquiring. This practice should be considered as an additional check if the wholesaler receives the pack e.g. from outside the EU or from another wholesaler. It is still not allowed to change the pack status in the medicines verification system if the pack is not in wholesaler’s possession. The above mentioned right applies only to wholesalers, not to other actors in the supply chain. The additional check of packs does not exempt the wholesaler from the obligation to verify the packs it receives and has in its possession in cases according to Article 20 of Commission Delegated Regulation (EU) 2016/161.