The end of the Brexit transition period results in new government regulatory provisions in the United Kingdom (UK) to accommodate the unique situation on the island of Ireland to help prevent a “hard border” between Northern Ireland (NI) and the Republic of Ireland. As of 01 January 2021 these provisions will impact on Veterinary Medicines Regulations (VRM) relating to authorizations referring to NI.
Relating to legal controls on veterinary medicines, the Veterinary Medicines Regulations (VMR) 2013 (Statutory Instrument (SI) 2033), as amended, will remain in force for the regulation of veterinary medicines in the UK beyond the end of the Brexit transition period.
The NI Protocol (the Protocol) provides for NI to remain subject to European Union legislation. To ensure effective implementation of the Protocol, the VMR will be amended to provide, in effect, 2 sets of VMR having effect in Great Britain and NI, respectively. These amendments will take effect from 1 January 2021.
Whilst the GB and NI VMRs will remain similar, the UK Veterinary Medicines Directorate (VMD) have details on the differences within the Information Hub explainers.
VMD have in place continued recognition for the sites of certain regulatory functions carried out in the EU for batches placed on to the market until January 2023. These are described within the Information Hub explainers.
Many of the requirements beyond this are to be included in the new VMR, which are planned to come into effect in 2022. Proposed changes to the VMR will be subject to formal, public consultation which is not expected to take place before the Spring of 2021.
VMDs main objective remains to seek agreements with other countries, including the EU, that benefit veterinary medicine industries in the respective countries. Such reciprocal agreements may be via free trade agreements (FTAs) or mutual recognition agreements (MRAs).
The VMD Information Hub will be updated as more information materializes. Readers are encouraged to view this site regularly over the next 12 months.