News published about Guidance on Combating Counterfeit Drugs

One of the most important points of the discussion regarding the introduction of the so-called safety features (2D-Data Matrix Code) is the implementation of these fake-proof codes for prescription medicines to be agreed on. For this, a draft was accepted on 21 December. For medicines not subject to prescription safety features are not required in this draft. Exceptions can be made by the EU Commission in case of increased counterfeiting risks. The Commission may also exempt prescription medicines from the safety feature obligation (article 54a). Yet, authentification and identification must be ensured as well as the possibility to track whether the outer packaging has been manipulated (article 54(o)).

The next deliberation on the European Parliament on this matter is expected for mid of February. Because of the implication of the Council of Ministers on this compromise, an approval on the revised Directive is very likely. In this case, the EU Member States would have an 18-month deadline after publication of the Directive for transposing it into their national law, probabely by the end of 2012.

To find out more about the results of this discussion please see the directive proposal.

Dr Robert Eicher

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