MHRA Brexit Guidance
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:
- Registration of clinical trials for investigational medicinal products and publication of summary results from 1 January 2021
- Guidance on substantial amendments to a clinical trial from 1 January 2021
Licensing (update from PMCPA press release 10 April 2019)
- Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice from 1 January 2021
- Registering new packaging information for medicines from 1 January 2021
- Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021
- How Marketing Authorisation Applications referred under Article 29 will be handled from 1 January 2021
- Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) from 1 January 2021
- Handling of Active Substance Master Files and Certificates of Suitability from 1 January 2021
- Reference Medicinal Products (RMPs) from 1 January 2021
- Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, 'grandfathering' and managing lifecycle changes
- Renewing Marketing Authorisations for medicines from 1 January 2021
- Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products from 1 January 2021
- Guidance on licensing biosimilars, ATMPs and PMFs from 1 January 2021
- Comparator products in Bioequivalence/Therapeutic Equivalence studies from 1 January 2021
- Importing medicines on an approved country for import list from 1 January 2021
- Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021
- Importing investigational medicinal products into Great Britain from approved countries from 1 January 2021
- List of approved countries for authorised human medicines from 1 January 2021
- Acting as a Responsible Person (import) from 1 January 2021
- Applying for a Certificate of Pharmaceutical Product from 1 January 2021
- Registering to make submissions to the MHRA from 1 January 2021
- Webinars: preparing to make submissions to the MHRA from 1 January 2021
- Guidance on pharmacovigilance procedures in the event from 1 January 2021
- Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021
- Procedures for UK Paediatric Investigation Plan (PIPs) from 1 January 2021
- Completed Paediatric Studies - submission, processing and assessment from 1 January 2021
- Format and content of applications for agreement or modification of a Paediatric Investigation Plan and requests for waivers or deferrals and concerning the operation of the compliance check from 1 January 2021
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