New MHRA Brexit guidance…more to come!


On 1 September, the Medicines and Healthcare products Regulatory Agency (MHRA) released a tranche of new Brexit guidance. The guidance covers a broad range of subjects, such as:

  • Clinical trials
  • Medical devices
  • Licensing of Medicinal Products (including guidance on conditional marketing authorisations, converting centrally authorised products to UK marketing authorisations and new applications)
  • Import and export of Medicinal Products
  • Pharmacovigilance
  • Paediatrics

The team is currently working through this substantial volume of new guidance and will publish summaries in the near future. No doubt sponsors, manufacturers and marketing authorisation holders will be doing the same, with the MHRA noting that all “stakeholders need to get ready for new rules from 1 January 2021”.