Falsified Medicines Directive 2011/62/EU Released

By the deadline of 9th February 2019, all manufacturers supplying pharmaceutical products to European countries will have to comply with the requirements set out in the Falsified Medicines Directive 2011/62/EU. 

Particular safety features, how medicine authenticity should be verified, and by whom all form part of the Directive which was adopted on 2nd October 2015 and published, after scrutiny by the European Parliament and the Council, on 9th February 2016. Pharmaceutical manufacturers and Contract Manufacturing Organisations (CMOs) that need to comply with the FMD should start now if their sites will be compliant for the deadline in 2019.

Read the detailed rules and requirements for compliance, published in February 2016, here: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf

Read the Directive in full here: http://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf

 

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