14/15 June 2021
Version 17 of the European Commission's "Questions & Answers" (Q&As) on safety features has been published.
The new version of the Q&As of the EU Commission on the Falsified Medicines Directive 2011/62/ EU and the Delegated Regulation (EU) 2016/161 contains a new Q&A point 5.11 and a revised Q&A point 1.22 compared to the previous version No. 16.
The new point 5.11 concerns wholesalers and whether they should be connected to the national repositories or to the EU hub. It is clarified that wholesalers who physically store products and carry out activities in accordance with the Delegated Regulation (such as verifying returns or decommissioning for export) have to be connected to the respective national database system and perform operations therein. The connection to the national database system is also necessary to ensure that the audit trail is accurate and complete.
The revised point 1.22 deals with parallel traders who remove or cover the original safety features.
Parallel traders covering or removing the existing safety features are required to place equivalent safety features. The safety feature must meet the requirements of the Member State in which the medicinal product is being marketed. If the product code and/or batch number changes compared to the original, parallel traders must place the new unique identifier (UI) after first decommissioning the original one. It is also expected that for centrally authorized products where existing safety features are covered or removed, the batch number of the original manufacturer will continue to be displayed. When placing an equivalent UI, parallel traders must, among other things, fulfil the obligations laid down in the Delegated Regulation with regard to uploading and updating the information in the repository system. In all cases, traceability must be maintained in the repository system.
For more information please refer to the "Questions & Answers - Version 17 regarding the implementation of the rule on safety features for medicinal products for human use".