Guidance available for product information templates for veterinary medicines
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News story 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. SHARE THIS PAGE The following links open in a new tab * Share on Facebook (opens in new tab) * Share on Twitter (opens in new tab)