European Commission Q&A, version 17, on “Safety Features for Medicinal Products for Human Use”

Version 17 of the Q&A “Safety Features for Medicinal Products for Human Use” has been released. The changes in the latest version are the addition of a new Q&A (5.11) and the revision of Q&A 1.22.

1.22 revised question

In case of parallel-traded packs, can parallel traders cover or remove the safety features of the original pack?

"The new unique identifier should comply with the requirements of the Member State where the medicine is intended to be placed on the market (Article 17 of Commission Delegated Regulation Regulation (EU) 2016/161).

Centrally authorised products that are subject to the covering or removing of existing safety features are expected to display the original manufacturer's batch number.

In all cases, traceability must be maintained in the repository system in accordance with Article 35(4)."

5.11 new question

5.11. Question: Should wholesalers be connected to the national repositories or can they be connected to the European hub?

"A wholesaler physically holding products and performing activities related to wholesale outlined in Articles 20-23 Commission Delegated Regulation (EU) 2016/161 (such as the verification of returns or decommissioning for export) should be connected to and perform operations in the national repository where the activities take place. A connection to the national system is necessary to ensure that the the audit trail is accurate and complete."


You can download the latest version here, which has the revisions highlighted for your ease.