тттттттттттттттттттттт Falsified Medicines Directive - Legal framework and Implementation : SoftGroup

Falsified Medicines Directive – Legal framework and Implementation

Home / news / Falsified Medicines Directive – Legal framework and Implementation

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.

By continuing to use the site, you agree to the terms of our Privacy and Cookies Policy and the use of cookies. Privacy and Cookies Policy

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close