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Parliamentary questions
28 March 2018
E-000908/2018
Answer given by Mr Andriukaitis on behalf of the Commission

The Commission and EU Member States are committed to ensuring that the medicines authentication system under the Falsified Medicines Directive(1) is in place by February 2019. The Commission is working closely with Member States and stakeholders to support the implementation of the system. This includes regular discussions with the Expert Group on safety features to facilitate implementation and contacts with stakeholders (marketing authorisation holders, manufacturers, distributors, hospitals and pharmacies). In particular, the Commission has stressed the importance that industry progresses faster in setting up the European and national databases required for authentication and that all stakeholders are ready to verify safety features from February 2019.

(1)Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, OJ L 1.7.2011, 174/74.

Last updated: 4 April 2018Legal notice