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

06/29/2016

The implementation of the Delegated Regulation (EU) 2016/161 poses some questions in the pharmaceutical industry, which should be resolved by the deadline on February 9th, 2019.

For this reason, the European Commission, as executive organ of the EU, published the 5th 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.

Background:

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, […]."

The transition period started now, for most of the European countries (almost all) prescription drugs must bear the features from 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:
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0161&from=EN

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