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Health & Consumer Voice - March - 2011 Edition

European Parliament paves the way for protection of citizens from Falsified Medicines

The European Parliament voted favourably in its first reading on the proposed new EU legislation on falsified medicines on 16 February. Falsified Medicines are fake medicines that pass themselves off as real, authorised medicines. Falsified medicines may contain ingredients, including active ingredients, which are of low quality or in the wrong dosage - either too high or too low. Since they have not passed through the necessary evaluation of quality, safety and efficacy as required by the EU authorisation procedure, they can be a major health threat.

The Directive aims at preventing falsified medicines from reaching the patients by introducing harmonised, pan-European safety and control measures. These measures will ensure easier identification of falsified medicines, and improved verifications and controls at EU borders and within the EU.

It also addresses the sale of falsified medicines over the internet. The Directive provides indeed for an obligatory "trust mark" on the websites of legally-operating online pharmacies.

Once the Council will have adopted this new EU legislation, it will have to be transposed by each Member State into its national law within 18 months and is going to apply as of then. In parallel, the Commission will work on various measures to implement and supplement the legislation.

Commissioner for Health and Consumer Policy John Dalli said: “I welcome this vote on a Directive that will increase the protection our citizens from the dangers of falsified medicines and I congratulate and thank the Rapporteur, Ms. Marisa Matias, for all her work. I look forward to a swift implementation of this Directive by the Member States”.

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