With the changes to the regulation of veterinary medicines in the UK as a result of Brexit, the Veterinary Medicines Directorate has created a helpful information hub pulling together its communications on current and future regulatory changes. Access the Hub here, including useful explainers on “Application and authorisation“, “Manufacturing and distribution“, and “Pharmacovigilance“, and see below for a summary of some key points. 

Key points

Legal controls on veterinary medicines

  • The Veterinary Medicines Regulations (VMR) 2013, as amended, remains in force for the regulation of veterinary medicines in the UK.
  • The Northern Ireland Protocol (the Protocol) provides for Northern Ireland to remain subject to EU legislation.

Future Veterinary Medicines Regulations

  • Continued recognition of certain regulatory functions carried out in the EU for batches placed on to the market by 31 December 2022 (described within the Veterinary Medicines Directorate (VMD) Information Hub explainers).
  • Many of the requirements from 2023 will form part of the new Veterinary Medicines Regulations.
  • Proposed changes to the Regulations will be subject to formal, public consultation in 2021, when Veterinary Businesses will have an opportunity to comment (date TBC).

The EU and UK Trade and Cooperation Agreement

  • The Trade and Cooperation Agreement (TCA) between the EU and the UK sets out the conditions for the mutual recognition of GMP certificates issued by NCAs for medicinal products, including veterinary medicines. (See the VMD’s Manufacturing and distribution explainer for further guidance).
  • Batch (QC) testing is not included in the agreement (see Manufacturing and distribution and Product Movement explainers for more detail), but the UK will unilaterally recognise batch (QC) testing conducted in the EU/EEA until 31 December 2022.

We have in place continued recognition of certain regulatory functions carried out in the EU for batches placed on to the market by 31 December 2022. These are described within our Information Hub explainers. Many of the requirements from 2023 will form part of the new Veterinary Medicines Regulations. The proposed changes to the Regulations will be subject to formal, public consultation in 2021, when you will have an opportunity to comment.

https://www.gov.uk/guidance/vmd-information-hub

Author

Tanvi is a Senior Associate and Solicitor-Advocate in Baker McKenzie's London Intellectual Property team, having joined the firm in August 2016. She has particular expertise in patents and is recognised by the Legal 500 as a key lawyer in the UK for Patents (Contentious and Non-Contentious). During her career Tanvi has also gained in-house experience having been seconded for a year to the in-house R&D legal team of a global pharmaceutical company, focused on providing legal support for clinical trials across Europe, and for three months (on a pro bono basis) to Cancer Research UK's legal team. Prior to becoming a solicitor Tanvi obtained an MSc degree in Chemistry from Imperial College London and carried out research in the field of biophysical chemistry at the Ludwig-Maximilians Universität, Munich (Germany).

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