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Guidance has been published in the United Kingdom regarding a new European variations regulation that comes into effect on Jan. 1, 2010.
Guidance has been published in the United Kingdom regarding a new European variations regulation that comes into effect on Jan. 1, 2010. After consultation, UK health ministers have agreed that the new rules will be adopted for all variations to marketing authorizations, including those held only in the UK. Additionally, an amending fees regulation will be implemented in the UK to establish fees for the new types of work specified in the European Commission regulation. The information has been published on the UK's Medicines and Healthcare products Regulatory Agency (MHRA) website.
1234/2008,which will replace Regulations 1084/2003/EC and 1085/2003/EC, concerns variations to the terms of marketing authorizations that have been granted by the Commission in Centralized Procedures and by the National Licensing Authorities in Mutual Recognition, Decentralized or other harmonizing European Procedures.
According to MHRA, the Commission also intends to extend the scope of the regulation to include variations to "purely National" marketing authorizations. This exclusion will require further legislative changes and will probably not be implemented until 2011. UK health ministers, however, have agreed that the rules within the new regulation will be adopted for all variations to the terms of marketing authorizations, including those granted in “purely National” procedures.
The UK agency has also introduced, effective Jan. 1, 2010, new fee categories to cover grouped and bulk-group applications for multiple changes submitted as part of the same variation application and applications where the UK is the Reference Authority in a European work-sharing procedure.
Further details can be found in the MHRA's National marketing authorization variations Guidance.