EU to harmonise medicine market approval variations

Published: 8-Jun-2009

The European Union (EU) Council of Ministers has filled a legal vacuum over EU regulations on approving variations to existing market approvals for medicines legally sold in EU member states.


The European Union (EU) Council of Ministers has filled a legal vacuum over EU regulations on approving variations to existing market approvals for medicines legally sold in EU member states.

It has authorised the European Commission to devise a harmonised and sufficiently vigorous monitoring and approval system for proposed changes to the conditions under which a medicine can be used in Europe. Until now there have been sometimes contradictory national rules.

A council communique said the reform would "ensure that all medicinal products are subject to the same criteria for the evaluation, approval and administrative treatment of variations in the production process, packaging or the address of the manufacturer."

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