European Commission publishes new Variations Regulation Draft

GMP News
16 July 2008

European Commission publishes new Variations Regulation Draft

On 10 June the Commission's regular committee passed and published a revised draft of the variations regulation, entitled COMMISSION REGULATION (EC) … concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products. It is available at

An important goal of the regulation is to further decrease the overall number of variations procedures. It is supposed to enable the competent authorities to concentrate on those changes that will in fact impact quality, safety or efficacy. For certain, less severe changes it is planned to introduce a system with annual reports - similar to the system already established in the US. These changes will not have to be approved in advance and should be notified within a 12 months period after their implementation. This would also mean a tremendous relief for the pharmaceutical industry, especially with regard to changes concerning the continuous improvement of manufacturing processes.

In addition there are a number of new requirements concerning the classification of changes. It is also supposed to be possible to propose a reference authority for changes to multiple authorisations. Under certain conditions changes can be grouped and submitted to the authorities in a single notice.

The European Parliament and the Council have three months now to review the draft before it can finally be passed. One year after becoming effective the new regulation will have to be implemented.

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

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