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variations

A variation is a change to the dossier of an authorised product. As from 1 January 2010, the Variation Regulation 1234/2008 applies to all veterinary medicines that have been authorised via the centralised procedure or via a mutual recognition procedure (MRP or DCP). This facilitates the implementation of simple variations for authorisation dossiers for marketing authorisation holders.

Please note: Since 1 January 2010, the regulation has also been implemented for all nationally authorised veterinary medicines.

Questions?

If you have any questions about the new Variations Regulation 1234/2008 please send an e-mail to: infobd@cbg-meb.nl.

Available documentation

The CMD(v) has revised the Best Practice Guides for type IA, type IB and type II variations and has compiled the Best Practice Guides for grouping and work-sharing procedures. These publications can be found via: www.hma.eu/163.html.

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