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Parliamentary questions
25 October 2017
E-006653-17
Question for written answer
to the Commission
Rule 130
Maria Spyraki (PPE)

 Subject:  Detection of illegal medicines

Directive FMD 2011/62/EU introduces harmonised, Europe-wide safety and control measures for the detection of counterfeit medicines. Furthermore, in accordance with Regulation DR 2016/61, Member States are creating a repository system at national level where a database will be kept with all the serial numbers of boxes of medicines available to the public.

The illegal medicines detection rate is soaring at 12% for Greece, and counterfeit medicines even end up in pharmacies and are sold without any problems.

Since the date of entry into force of the regulation on 9/2/2019, Greece is among the countries that have secured deferral for 6 years from that date, can the Commission say:
1. What steps are being taken to ensure compliance with the FMD Directive 2011/62/EU on harmonised, Europe-wide safety and control measures?
2. What steps will be taken to raise awareness among EU citizens to prevent the purchase of counterfeit medicines?
3. What measures will the European Medicines Agency take?
Original language of question: EL 
Last updated: 10 November 2017Legal notice