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Parliamentary questions
13 November 2017
E-005809/2017
Answer given by Mr Andriukaitis on behalf of the Commission

The Commission is aware of the risk that some medicinal products imported from third countries contain insufficient or falsified active ingredients. In 2011, to address this concern, strengthened rules on the importation of active substances were introduced in the EU(1).

According to EU legislation(2), active substances imported from third countries need to be accompanied by a written confirmation from the competent authority of the exporting third country confirming that the standards of good manufacturing practice and control of the plant are equivalent to those in the EU.

Member States regularly inspect EU and non-EU manufacturing sites of finished medicinal products and their ingredients to check whether those sites meet EU standards of quality and safety. If an inspection by an EU Member State finds that an active substance manufacturing site does not comply with EU Good Manufacturing Practice (GMP) for active substances, a statement of non-compliance is issued and entered in the publicly available EudraGMDP database(3).

These measures, complemented with the obligation to test each production batch at import(4), should ensure the quality of all medicinal products (including generics) to be placed on the EU market.

Based on the above, the Commission does not foresee the need to introduce additional measures to strengthen the controls of medicinal products imported from third countries.

(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 174, 1.7.2011, p. 74).
(2)Article 46(b)(2) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001).
(3)http://eudragmdp.ema.europa.eu/inspections/logonGeneralPublic.do
(4)Article 51(1)(b) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001).

Last updated: 31 January 2018Legal notice