Tracking & Tracing: EU decides on Amendments to Guidelines

The Committee on Internal Market and Consumer Protection of the European Parliament held a vote on March 17th on numerous amendments to the draft directive from the EU Commission on the combating of counterfeit medicines.

We reported on the EU "pharma package" in our News on 27 January 2010, which referred, amongst others, to the draft guidelines.

In total 56 amendments to the draft guidelines have now been voted on, whereby a large number of the amendments relate to the topic of the introduction of safety features (2D-Data Matrix Code). Recently there have been intense discussions, on which safety features are to be prescribed and for which medicines. An amendment from Greece in which this specification was to be extended - from one just for medicines available on prescription - to also include non-prescription medicines, was requested, but rejected. However if the amendment is undertaken, the European Commission will be obliged to submit field reports every two years on the application of the guidelines, in particular experiences with safety features. This should evaluate, whether an expansion of the coding obligation is required and should please manufacturers of OTC products, since according to information from the Federal Trade Association of Pharmaceutical Manufacturers (BAH), investment costs up to 120,000€ per production line will be necessary to carry out the technical specifications.

An additional motion of legislative procedure remains unchanged, and votes in the leading EU Environmental Committee (ENVI) are scheduled at the end of April and in June 2010. Should the Commission, the EU parliament and EU council agree on the content, it is to be assumed that the guidelines will finally be approved in summer 2010.

Dr Robert Eicher
On behalf of the European Compliance Academy (ECA)

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