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Parliamentary questions
4 May 2017
E-001188/2017
Answer given by Mr Andriukaitis on behalf of the Commission

The European Union has adopted a number of measures to fight against falsified medicines including the introduction of safety features(1).

The safety features consist of a unique identifier (a 2-dimension barcode containing a sequence of numeric or alphanumeric characters that is unique to a given pack of a medicinal product) and an anti-tampering device(2).

The principle of unique identifier across Europe is for prescription medicinal products. Nevertheless, Member States may, for the purposes of reimbursement or pharmacovigilance, extend the scope of application of the unique identifier to any medicinal product subject to prescription or subject to reimbursement(3).

Moreover, all reimbursable medicinal products placed on the French market will have to bear the unique identifier, regardless of the country of origin of the manufacturing authorisation holder.

Consequently, the Commission would like to confirm that the Member States can go beyond the scope of prescription medicines and that the French obligation to extend the scope is compatible with the European legislation.

(1)Article 54(o) and Article 54a of Directive 2001/83/EC, both introduced by Directive 2011/62/EU
(2)Article 54(o) of Directive 2001/83/EC
(3)Article 54a.5 of Directive 2001/83/EC.

Last updated: 16 May 2017Legal notice