Collection

MHRA guidance and publications about a possible no-deal Brexit

Information about the regulation of medicines and medical devices if there is a no-deal Brexit.

The Agency is publishing a series of guidance documents for industry and other stakeholders covering our proposed arrangements for the regulation of medicines, medical devices and clinical trials, if there is a no-deal Brexit.

There is also information on the NIBSC website:

We will add further links to this page as new guidance and information is published.

Contacting us about no deal

For enquiries relating to the Agency’s planning and procedures in a no deal Brexit, see our list of emails for these queries on our Contact Us page.

Overall approach to regulation in a no-deal Brexit

Marketing authorisations, variations and licensing guidance

  1. Comparator products in Bioequivalence/Therapeutic Equivalence studies after Brexit
  2. Conversion of Community Marketing Authorisations to UK Marketing Authorisations – letters to industry
  3. Applying for a Certificate of Pharmaceutical Product after Brexit
  4. Guidance on substantial amendments to a clinical trial if the UK leaves the EU with no deal
  5. Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice if there is a no-deal Brexit
  6. Registering new packaging information for medicines after Brexit
  7. Guidance on registration of clinical trials for investigational medicinal products and publication of summary results in a no-deal Brexit
  8. Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on exit day
  9. How Marketing Authorisation Applications referred under Article 29 will be handled after Brexit
  10. Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) in a no-deal Brexit
  11. Handling of Active Substance Master Files and Certificates of Suitability in the event of no-deal Brexit
  12. Guidance on handling of Decentralised and Mutual Recognition Procedures in a no-deal Brexit
  13. Guidance note on new assessment routes in a no-deal Brexit
  14. Reference Medicinal Products (RMPs) after Brexit
  15. Variations to Marketing Authorisations (MAs) after Brexit
  16. Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) in a no-deal Brexit, 'grandfathering' and managing lifecycle changes
  17. Renewing Marketing Authorisations for medicines after Brexit
  18. How the MHRA will manage UK orphan medicinal products after Brexit
  19. Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products in a no-deal Brexit
  20. Licensing biosimilars, ATMPs and PMFs after Brexit
  21. Conversion of existing approved Community Marketing Authorisations to UK Marketing Authorisations (MAs) – letter to industry

Importing and exporting

Medicines for children

Medical devices

Legislation concerning a no deal scenario

Regulatory submissions and vigilance activities

Vaccines and blood products

Technical notices

MHRA consultation on EU exit no-deal legislative proposals

Published 31 January 2019
Last updated 22 October 2019 + show all updates
  1. Added new guidance 'Comparator products in Bioequivalence/Therapeutic Equivalence studies after Brexit' under the 'Marketing authorisations, variations and licensing guidance' heading.
  2. Added new Guideline on Paediatric Investigation Plans, waivers, deferrals and compliance check under the 'Medicines for children' heading.
  3. Added a new publication 'Exceptions and modifications to the EU guidance on good pharmacovigilance practices that will apply in a no-deal Brexit', in the section 'Regulatory submissions and vigilance activities'
  4. Added a link to the guidance on Applying for a Certificate of Pharmaceutical Product in a no deal scenario.
  5. New Group on Vaccines and Blood Products added to the document collection, with a link to the page on 'how to apply to release a vaccine or a blood product to market'. This page includes an updated section with guidance for the OCABR Release and Marketing Information Form processes, if the UK leaves the EU without a deal.
  6. New guidance page on substantial amendments to a clinical trial if the UK leaves the EU with no deal has been added to the page.
  7. New guidance about Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice in a no deal scenario added to the page.
  8. New guidance has been added to the page. This guidance explains the steps companies will need to take to register new artwork for medicines packaging as a result of new marketing authorisations being issued in the event the UK leaves the EU without a deal.
  9. New no deal guidance has been added to the page on procedures for UK-PIPs in the event the UK leaves the EU without a deal
  10. New guidance on registration of clinical trials for investigational medicinal products and publication of summary results if the UK leaves the EU without a deal.
  11. Added a link to a new guidance page on licensing of biological products: biosimilars, ATMPs and PMFs in a no deal scenario.
  12. Added links to new guidance covering marketing authorisations, centrally authorised products and other information about medicines and medicinal products licensing.
  13. Added new guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) if the UK leaves the EU without a deal.
  14. Added a new section on importing and exporting in a no deal scenario.
  15. New section on Vigilance and Risk Management added to the page in addition to a new guidance document which addresses Completed Paediatric Studies - submission, processing and assessment in the event of a no deal scenario.
  16. Added links to two new statements from NIBSC, covering information for customers of biological reference materials and information for collaborators.
  17. Added link to guidance on making submissions to the MHRA in a no deal scenario.
  18. New guidance on regulating medical devices in the event of a no deal scenario added to the page.
  19. We have added a link to updated guidance for manufacturers of biological medicines on NIBSC.org. The guidance addresses independent batch release in the United Kingdom following the UKs departure from the EU without a deal.
  20. First published.