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variations

A variation is a change to the dossier of an authorised product. As from 1 January 2010 changes to the file of an authorised medicinal product should, in most cases, be communicated in accordance with the guidelines of the Variation Regulation 1234/2008.

The webpage Human Medicine > Regulatory Affairs > Legislation and guidelines > variations contains up-to-date information regarding the communication of changes to files of authorised products.

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