Veterinary medicines : partnership with the British and Irish authorities for the assessment of type II variation files

The FAMHP joined the English (Veterinary Medicines Directorate) and Irish (Irish Medicines Board) authorities in their proposed partnership ("Partnership Initiative") for the evaluation of the change of the marketing authorisation (MA) file (known as type II variation) of veterinary medicines. Resource sharing between partners in terms of assessment will have a positive impact on the management of these dossiers addressed at national level.

Regulation 1234/2008 of the Commission of 24/11/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products must be implemented before July 2012. This regulation provides for a sharing of resources within the framework of the assessment of the type II variation dossiers of the national authorisations.
When an identical variation dossier is introduced in different member states, it should be avoided that each national authority makes the same assessment work.

In 2008 the British and Irish authorities have already taken the initiative to share their resources for the evaluation of the type II variation dossiers related to veterinary medicines. This is known as the "Partnership Initiative".
Each partner evaluates in turn one or other introduced dossiers in accordance with his skills and expertise.

Since 24/09/2010, the FAMHP joined the "Partnership Initiative”.

This partnership will improve the management of the type II variation dossiers and help maintain the deadlines. The marketing authorisation holders will also see an advantage because these dossiers will be managed in the same way (same questions, same time limit) in the partner member states.

The document entitled "Clarification Paper: Partnership Initiative between the UK, Ireland and Belgium for national implementation procedures" provides more information about this. First published on May 23rd 2008 this document was updated on September 9th 2010 to include Belgium in the partnership. It is at the request of a marketing authorisation holder that the procedure "Initiative Partnership" can be applied.


Last updated on 10/11/2010