Discussion of the EU Pharma Package in the European Council of Ministers

On the occasion of the pharma package proposed by the European Commission, the Council of Ministers discussed the topic of counterfeit safety in mid April. The document that was created during this session has been available to the public for a short while.

Unanimity has been reached about the necessity to introduce safety features. In contrast to the Commission and the competent Committee of the Environment, however, the majority of member states supports the extension of mandatory safety features to non-prescription medicinal products. Here, a risk-based approach shall be used to determine which medicinal products in particular must have a safety feature. For this purpose, the Commission is meant to define medicinal product categories according to the price, sales volume and the number of known incidences of falsifications. It is also very interesting that the Council only intends the underlying system to guarantee the identification and authentication - traceability has been dropped here. This would be comparable to the CIP13 system in France. So it remains interesting to see how the discussion between Council of Ministers, Commission and Parliament can go on and if, as hitherto envisaged, they can come to an agreement before the summer break. However, there is also the possibility that the EU prefers to leave all options open so that the states are to decide themselves about the scope of their safety systems.

The discussion paper by the Council of Ministers can be found here.

Conference Recommendations

Go back

GMP Conferences by Topics