Guidance available for product information templates for veterinary medicines
Explainer on product information templates to be used by applicants and Marketing Authorisation Holders (MAHs) of veterinary medicines.
We have updated our national product information template to be used by applicants when applying for initial national Marketing Authorisation (MA) applications or when updating the product information of existing MAs under a G.I.18.z Variation Requiring Assessment (VRA).
As of 29 April, we are accepting applications using product information template v.3. These changes support the requirement of the Veterinary Medicines Regulations (VMR) 2013, as anticipated to be amended by the legislation introduced to Parliament on 4 March.
The aim of publishing this guidance ahead of the VMR amendments coming in to force, is to reduce regulatory burden and on the understanding that all affected applications adopting v.3 will be issued after the VMR 2013, as amended is in effect.
Product information template v.3 and guidance on its use can be found on our Information Hub. We have also updated our Product Literature Standard to reflect these changes.
Last updated 29 April 2024 + show all updates
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Updated to reflect template in use from 29 April with the updated Product Literature Standard.
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First published.