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4 March 2008

European Commission:
Adoption of the Commission proposal on variations (co-decision part)

On 4 March 2008, the Commission has adopted its proposal for a Directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products. The proposal is available in all EU official languages.

The proposal is accompanied by an Impact Assessment. Both the proposal and the impact assessment will now be discussed in the European Parliament and in the Council Review of the Variations Regulations