News about GMP/cGMP


New Q&A on safety features concerning falsified medicines

Following the Commission Report on Member State penalties for falsification (we reported) the European Commission has released a Questions and Answers document alongside this topic (Version 9) on 13 February 2018. The document addresses an overall of 90 frequently asked questions regarding the implementation of the rules on the safety features for medicinal products for human use. These rules are enshrined in Articles 47a, 54(o) and 54a of Directive 2001/83/EC, and in the Commission Delegated Regulation (EU) No 2016/161. They will become mandatory in February 2019.

Newly added questions compared to Version 8 range from

  • In case of a bundle of several single packs which is sold as one unit, should the anti-tampering device and unique identifier be placed on the bundle packaging or on each single pack?” or
  • Is it possible to reverse the decommissioned status of a medicinal product which has been exported to third countries, when such product is brought back into the EU?” up to
  • Can a manufacturer use an outer packaging carrying a unique identifier which has been placed by another (contracted) manufacturer?”.

Click here for the 25-page Q&A-document on safety features.


EC Medicinal Products: Latest updates