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
Devices
Importing and exporting
- The Northern Ireland MHRA Authorised Route (NIMAR)
- Importing medicines into Northern Ireland
- Supplying investigational medicinal products to Northern Ireland
- Supplying authorised medicines to Northern Ireland
- Sourcing medicines for the UK Market
- Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland
- Importing investigational medicinal products into Great Britain from approved countries
- List of approved countries for authorised human medicines
- Acting as a Responsible Person (import)
IT systems
Legislation
Licensing
- Great Britain Marketing Authorisations (MAs) for Centrally Authorised Products (CAPs)
- Marketing Authorisation Application submission dates for 150-days national and European Commission decision reliance procedures
- Decentralised and mutual recognition reliance procedure for marketing authorisations
- Unfettered Access Procedure for marketing authorisations approved in Northern Ireland
- European Commission (EC) Decision Reliance Procedure
- 150-day assessment for national applications for medicines
- Rolling review for marketing authorisation applications
- Guidance on handling of Decentralised and Mutual Recognition Procedures which are approved or pending
- Procedural advice for Northern Ireland on applications for European Commission Centralised Marketing Authorisations
- Guidance on MAH and QPPV location
- Variations to Marketing Authorisations (MAs)
- Conversion of Community Marketing Authorisations (CAPs) to Great Britain Marketing Authorisations (MAs) - letter to industry
- Orphan medicinal products
- Registering new packaging information for medicines
- Guidance on the handling of applications for Centrally Authorised Products (CAPs)
- How Marketing Authorisation Applications referred under Article 29 are handled
- Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs)
- Handling of Active Substance Master Files and Certificates of Suitability
- Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
- Reference Medicinal Products (RMPs)
- Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), 'grandfathering' and managing lifecycle changes
- Renewing Marketing Authorisations for medicines
- Guidance on new provisions for traditional herbal medicinal products and homeopathic medicinal products
- Guidance on licensing biosimilars, ATMPs and PMFs
- Comparator products in Bioequivalence/Therapeutic Equivalence studies
Pharmacovigilance
Paediatrics
Last updated 30 March 2021 + show all updates
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Added 'Great Britain Marketing Authorisations (MAs) for Centrally Authorised Products (CAPs)' to the Licensing section
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Added new guidance 'Importing medicines into Northern Ireland before 31 December 2021' in the 'Importing and Exporting' section.
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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.
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Added links to new guidance for retailers on supplying over-the-counter medicines to Northern Ireland, and supplying medical devices to Northern Ireland
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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.
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First published.