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MEPs suggest amendments to the Directive on falsified medicines

07 April 2010, 08:58 CET

The European Parliament's Internal Market Committee published yesterday an Opinion suggesting improvements to the Directive on medicinal products, as regards the supply chain of falsified medicinal products.

The rapporteur of the Opinion suggests the following:

  • a clearer definition of the term 'falsified medicinal product'
  • a broader focus on the legal supply chain, including internet sales
  • a more specific Community database
  • more severe sanctions against falsification


According to the report, there is an increase in the European Union of medicinal products which are falsified in relation to their identity, history or source. Falsified medicinal products may contain sub-standard or falsified ingredients, no ingredients or ingredients in the wrong dosage, including active ingredients.

"They pose a major threat to European patients and European industry, and there are strong concerns in the public and amongst policy makers about the steady increase of these products detected in the European Union in the last year," says the report.

"The Commission wishes to establish an effective legislative basis for the fight against falsified medicinal products on the internal market of the European Union by introducing better safety features and track and trace systems of medicinal packaging, simplifying procedures, enhanced transparency and communication, better data collection and evaluation procedures, more involvement of stakeholders and the establishment of best practices."

Opinion of the Committee on the Internal Market and Consumer Protection on the Proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source

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


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