Update: Delegated Regulation (EU) 2016/161 – Questions and Answers Version 14

The EU just released a new version of the FAQ document.

The European Commission, as executive organ of the EU, just published the 14th version of the FAQ document "Safety Features for Medicinal Products for Human Use".
We are pleased to keep you up-to-date on this topic.

The current version is available here.

FAQ Document Version 14


The European Commission released the "COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015".

The regulation describes a system, which allows for an "end-to-end" verification of medical products bearing the safety features. "In practice, the authenticity and integrity of the safety features placed on the packaging of a medicinal product at the beginning of the supply chain should be verified at the time the medicinal product is supplied to the public, […]."

In most of the European countries (almost all) prescription drugs must bear the features since 9th of February 2019 onwards.

Talk to us on this topic, raise your questions on this regulation, and discuss your business needs with us.

Link to English regulation