Brexit Guidance MHRA

New rules for Brexit post transition period, January 2021

  • From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator.
  • Transition from the EU allows the UK to offer fully independent regulatory decisions for both devices and pharmaceuticals, both nationally and in joint work with other international regulators.

This guidance tells you what you'll need to do from 1 January 2021. It will be updated by the MHRA if anything changes. See links below for overview of specific areas. Please note the references to Grandfathering and Marketing Authorisations under Licencing:

Clinical trials

Devices

Licensing (update from PMCPA press release 10 April 2019)

Importing and exporting

 IT systems

Pharmacovigilance

Paediatrics

Guidance from the National Institute for Biological Standards and Control (NIBSC)

As well as the guidance above, the NIBSC, one of the three centres of the MHRA, has published on information for manufacturers of biological medicines.

Generic guidance on Brexit is also available - check what else you need to do during the transition period.

September 2020