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Parliamentary questions
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13 February 2018
E-000908-18
Question for written answer E-000908-18
to the Commission
Rule 130
Cristian-Silviu Buşoi (PPE)

 Subject:  Falsified Medicines Directive
 Answer in writing 

At present, counterfeit medicines account for one out of every 10 000 medicine packets in the EU, and more than 400 cases of falsification were reported by the Member States between 2013 and 2017.

In 2011, the EU adopted the Falsified Medicines Directive (Directive 2011/62/EU) with the following measures to be implemented:
medicines authentication system (a unique number incorporated in the barcode in order to identify each individual package) on prescription medicines from February 2019;
requirements for Member States to implement effective penalties regarding the falsification of medicines and active substances (Commission to report to Parliament and the Council by January 2018);
common logo for online retailers of medicines in the EU.

However, the conference ‘Safer Europe Without Falsified Medicines’, organised by the Estonian Presidency in November 2017, highlighted that the European industry and hospitals would not be ready to implement the safety measures in February 2019.

What is the Commission’s position regarding the abovementioned issue?

Last updated: 28 February 2018Legal notice