Anticounterfeiting package continues its progress

Published: 5-May-2010
Ingredients

The proposed EU anticounterfeiting measures for medicines continue through the legislative process

The proposed European Union anticounterfeiting measures for medicinal products continue their progress through the European legislative process. By the end of April they had reached the voting stage in the various Committees considering them during the first reading in the European Parliament.

There has been a lively debate in the Committees on a number of aspects of the proposals such as unique pack identification, control of traders and control of active pharmaceutical ingredients. The MEPs have also advocated the inclusion of provisions relating to control of internet trading in medicines.

The amendments agreed as a result of the Committee discussions will be the subject of a plenary vote in the European Parliament - probably in June.

Work has also continued in the Council of Ministers working party looking at the proposal and discussions between it and the European Parliament on the proposed amendments will follow.

On the issue of verification of packs of medicinal products at the point of dispensing, the European pharmaceutical trade association, EFPIA, recently published a report on a pilot project on product verification. The project was carried out in the latter part of last year in Sweden in collaboration with the Swedish pharmaceutical retail chain Apoteket. The pilot successfully demonstrated that a product verification system at the point of dispensing, based on a two-dimensional data matrix, is both robust and effective.

The implementation of a robust regulatory framework to address the trade in counterfeit medicines and of an effective system for verifying the authenticity of medicinal products are a priority for all stakeholders and progress on these issues will be reviewed here as it develops.
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