Publication of delegated act progresses implementation of Falsified Medicines Directive in Europe

The final release of the delegated act, 2016/161, for the Falsified Medicines Directive in Europe, 2011/62/EU, has been published, moving forward the implementation of new safety features to protect EU consumers from falsified medicines.

Manufacturers and vendors of pharmaceutical products have now only three years left to prepare for serialization following the publication of the delegated act for the Falsified Medicines Directive (picture - Atlantic Zeiser)

The Falsified Medicines Directive (2011/62/EU) was published on July 1, 2011 in the Official Journal of the European Union. This legislation is the outcome of the legal proposal that the European Commission put forward in December 2008. The Falsified Medicines Directive has applied since January 2, 2013.

2016/161 sets out the details of obligatory safety features for medicines which will guarantee medicine authenticity and secure the medicine supply chain.

Atlantic Zeiser has outlined the implication for manufacturers and vendors of pharmaceutical products, who now have three years left to prepare for serialization, with Atlantic Zeiser CEO Manfred Minich stating: ‘The ones who have not yet started to intensively get involved into the topic might run into shortness of time.’

Read more about developments in pharmaceutical labels and packaging in L&L issue 5, 2015 here, and issue 5, 2014, including extensive comment on the EU's Falsified Medicines Directive and delegated act, here

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