End of the transition period: final guidance updates from the regulators?

26 January, 2021

With the end of the transition period, there has been a final flurry of activity amongst the regulators to clarify the post-Brexit requirements for veterinary medicines.

CMDv and EMA guidance and QRD templates

On the CMDv Brexit page, two new “practical guidance” documents have been published, addressing procedures related to Brexit for VMPs approved via MRP/DCP and for the implementation of the Protocol on Ireland/Northern Ireland for VMPs approved via MRP/DCP (Link). The EMA has also updated its Brexit page, including an updated Q & A document (Link).

Connected with this, the QRD templates have also been updated to add Northern Ireland in the list of local representatives in the package leaflet (CMDv – Link; EMA - Link).

Guidance from the Veterinary Medicines Directorate (VMD)

The UK VMD has updated large parts of its website to reflect the post-Brexit changes and many of the pages include new tutorial videos as part of the guidance.

  • Submission of an application for an animal medicine authorisation – including guidance videos for the Veterinary Medicines Digital Services system (Link)
  • Apply for a Marketing Authorisation in the UK for a veterinary medicine or expire one (Link)
  • Marketing Authorisation Holders, Named Distributors and Local Representatives of veterinary medicines (Link)
  • Marketing authorisations for veterinary medicines (Link)
  • Apply for batch release of an immunological veterinary medicine (Link)
  • Variations to a veterinary Marketing Authorisation or Homeopathic Remedy (Link)
  • Authorisations to manufacture veterinary medicines (Link)
  • Pharmacovigilance of Veterinary Medicines in Great Britain (Link)
  • Common Statement Canada-United Kingdom (Link)
  • From 1 January 2021 MAH and Authorised Personnel Location (Link)
  • From 1 January 2021 Import and export of veterinary medicines explainer (Link)
  • Veterinary medicine wholesale dealer's authorisation (WDA) (Link)
  • The cascade: prescribing unauthorised medicines (Link)
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