Variations Regulation: ENVI Committee of European Parliament adopts Draft Report on Variations

The competent committee of the European Parliament (Environment, Public Health and Food Safety) adopted the proposed draft report on variations to the terms of marketing authorisations for medicinal products with the pertaining amendments on 9 September. Most of the 26 changes are of a technical nature; however, two of the changes are of interest:

1. the harmonised requirements are only to be applied to those medicinal products for which a marketing authorisation is issued after the time by which the corresponding directive on the mutual recognition procedures had to be implemented into national law by the member states. This means that with regard to marketing authorisations granted under a national procedure for medicinal products which had been registered and marketed before 1 January 1998, the member states can now either apply the hitherto valid change procedures or adopt the new system.

2. The member states are meant to implement the legal and administrative provisions necessary to comply with this directive 24 months after its coming into force at the latest (instead of the previously fixed 12 months).

Especially the adaptations mentioned under point 1 were supported by European interest groups, like BAH (German Medicines Manufacturers Association) and AESGP (European Self-Medication Industry).

At present, the changes have not yet been passed; it is now up to the plenary of the European Parliament to vote about them and to adopt the directive accordingly.

Source: ENVI News 2008/12 - 8 September 2008

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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