New guidance and information for industry from the MHRA

Guidance for industry and organisations to follow from 1 January 2021.

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s standalone medicines and medical devices regulator.

The below guidance should be followed from 1 January 2021. It replaces previously published guidance on what to do from the end of the transition period.

Guidance from NIBSC

As well as the below guidance, the National Institute for Biological Standards and Control (NIBSC), one of the three centres of the MHRA, has published on information for manufacturers of biological medicines.

Clinical trials


Importing and exporting

IT systems





Published 1 January 2021
Last updated 30 March 2021 + show all updates
  1. Added 'Great Britain Marketing Authorisations (MAs) for Centrally Authorised Products (CAPs)' to the Licensing section

  2. Added new guidance 'Importing medicines into Northern Ireland before 31 December 2021' in the 'Importing and Exporting' section.

  3. Added a link to new guidance on 'Marketing Authorisation Application submission dates for 150-days national and European Commission decision reliance procedures', in the Licensing section.

  4. Added links to new guidance for retailers on supplying over-the-counter medicines to Northern Ireland, and supplying medical devices to Northern Ireland

  5. Added links in the Licensing section to new guidance on unfettered access, the European Commission (EC) decision reliance procedure and decentralised and mutual recognition procedures.

  6. First published.