Mitigation explainer: Renewals
Explainer for the pharmaceutical industry on Renewal requirements mitigations to bridge the gap between the implementation of the EU Regulation on veterinary medicines and the revised Veterinary Medicines Regulations as they have an effect in Great Britain (GB VMR).
Mitigations for Veterinary Medicines Regulations
EU Regulation 2019/6 will apply in the EU from 28 January 2022. We played an active role in developing and negotiating the Regulation when we were part of the EU and therefore agree with much of its content.
The GB Veterinary Medicines Regulation (VMR) is under review and will undergo a formal public consultation. Until such time that the revised GB VMR come into force there will be what we call an “airgap” between both sets of legislation covering EU (NI) and GB.
We recognise that industry is set up to cover the region of Europe, which includes the UK and its regulatory requirements. As an interim measure we have considered areas where we may bridge this gap between the EU Legislation and the current VMR as they have an effect in GB, whilst still respecting both sets of legislation to reduce burdens to the industry and help facilitate the continued availability of veterinary medicines in NI and GB.
IMPORTANT: This is an interim measure and does not pre-empt or prejudice the outcome of the formal consultation on the GB VMR as we will take account of views from a wide range of stakeholders.
Renewals
The EU Regulations remove the requirement to submit a renewal moving to greater reliance on pharmacovigilance and signal detections.
EU (CMDv) guidance states: For nationally authorised products granted by National Procedure, MRP or DCP, the MA will have to be amended by each member state in which the MA is authorised. However, how the end result is achieved will depend on the national law.
Current UK law requires renewal applications to be submitted and a fee to be charged but with a much-reduced data package. We will progress the application administratively with the resulting MA documentation having an unlimited life.
See Apply to renew a marketing authorisation for a veterinary medicine for guidance .
Applications that have already been submitted will continue to be assessed as this mitigation is not applied retrospectively.
Last updated 4 July 2022 + show all updates
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Updated EU guidance information.
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First published.