The role of VICH is to harmonise technical requirements for data necessary for the marketing authorisation (also called “registration”) of a veterinary medicinal product. This is achieved by developing harmonised guidelines on the studies to be submitted in a marketing authorisation application.
Typically a VICH guideline describes how a study should be conducted to satisfy quality, safety or efficacy data requirements. VICH also covers data requirements for post-marketing pharmacovigilance systems. The benefit of having harmonised guidelines is to avoid studies being duplicated or repeated.
It is NOT the role of VICH to:
These are typically the roles of national competent authorities and governments.
For more information, please download the VICH Leaflet "Harmonising the global processes for authorising veterinary medicines".
Which areas do VICH guidelines cover?
In the period from its establishment in 1996 to December 2013 VICH has completed in total 51 harmonised guidelines, with further 7 guidelines in preparation. The guidelines cover the areas:
For further details and to download the guideline texts go to the GUIDELINES page.
Process to develop guidelines
The VICH guidelines are developed by expert working groups comprising experts from the VICH members, the observers and from VICH Outreach Forum countries on topics identified by the VICH Steering Committee in a consultative process, and are adopted by the Steering Committee.
Countries that are not part of VICH can send comments that respond to draft VICH guidelines during the public consultation (step 4 of the VICH process). The draft guidelines will be distributed by OIE to the OIE veterinary products focal points.
For further details go to the PROCESS page.