Falsified Medicines Directive – Legal framework and Implementation


Meet the legal framework and implementation requirements of FMD


The Delegated Act Commission Delegated Regulation (EU) 2016/161 detailing the characteristics of the safety features, how medicine authenticity should be verified, and by whom, was adopted on 2nd October 2015 and published, after scrutiny by the European Parliament and the Council, on 9th February 2016.
The delegated Regulation, and the new medicine verification system it lays down, will apply as of 9th February 2019.
Directive 2011/62/EU provides the basis for a number of legislative implementation measures to be carried out by the Commission. An overview is provided here.

The Commission presented the key elements of the delegated Regulation at a stakeholders’ workshop held on 26 February 2016 in Brussels. The Commission presentation is available here: Commission presentation
To facilitate the implementation of the delegated Regulation and the new rules on medicine verification, the Commission has prepared a “Questions and Answers” document.

Source: eur-lex.europa.eu and ec.europa.eu.

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