European Commission publishes new rules on falsified medicines

Home/Policies & Legislation | Posted 26/08/2011 post-comment0 Post your comment

A new directive on falsified medicines was published in the Official Journal of the European Union 1 July 2011.


This legislation is the outcome of the legal proposal that the European Commission put forward in December 2008. The new legislation aims to prevent falsified medicines entering the legal supply chain and reaching patients. This will be done by introducing tougher rules to improve the protection of public health with harmonised safety and more rigorous control measures across Europe, including:

  • obligatory features on the outer packaging of medicines to demonstrate that they are authentic
  • strengthened requirements for the inspection of the manufacturers of active pharmaceutical ingredients
  • the obligation for manufacturers and distributors to report any suspicion of falsified medicines
  • an obligatory and common EU-wide logo that must be placed on the websites of legally operating online pharmacies, with a link to official national registers
  • strengthened record-keeping requirements for wholesale distributors

Falsified medicines are fake medicines that pass themselves off as real, authorised medicines. They may contain ingredients of low quality or in the wrong doses, be mislabelled with respect to their identity or source, or have fake packaging or the wrong ingredients. The sale of fake medicines has become a huge concern for Europe, where seizures have increased by 400% since 2005 [1].

The EMA praised the new directive and added that it is working closely with the European Commission and its national and international partners on the implementation of this legislation over the next 18 months.

What’s next?

The directive came into force on 21 July 2011 and EU Member States will have to start applying its measures from 2 January 2013.


1. GaBI Online - Generics and Biosimilars Initiative. Falsified medicines law approved by European Parliament []. Mol, Belgium: Pro Pharma Communications International; [cited 2011 August 26]. Available from:

Source: European Commission, EMA

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