Decision

Great Britain Marketing Authorisations (MAs) for Centrally Authorised Products (CAPs)

A list of PLGB numbers for the grandfathering of CAP MAs.

From:
Medicines and Healthcare products Regulatory Agency
Published
30 March 2021
Last updated
15 November 2024 — See all updates

Documents

PLGB numbers for the grandfathering of CAP MAs

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List of the opt out CAPs MAs

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Details

1. Overview 

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which were taken or carried out at EU-level.  At the time of EU exit an exception to this was for decisions on Marketing Authorisation (MA) applications made through the European procedures to market products in Northern Ireland. 

2. General approach to grandfathering of CAPs 

All existing CAP MAs were automatically converted into Great Britain MAs effective from 1 January 2021 in Great Britain only (England, Wales and Scotland) and have been issued with a Great Britain Product Licence (PLGB) MA number. This process was termed ‘grandfathering’. These Great Britain MAs are referred to as “converted EU MAs” . As a result of the implementation of the Northern Ireland Protocol, existing CAPs remain valid for marketing products in Northern Ireland until 31 December 2024.  Following implementation of the Windsor Framework on 1 January 20251 the existing CAPs will cease to be valid in Northern Ireland and the Great Britain authorisations will be effective UK-wide. See further guidance on UK-wide licensing.  

The list of PLGB numbers for the grandfathered CAP MAs is available above. 

Marketing Authorisation Holders (MAHs) had the option to opt-out of the conversion process for all or some of their CAPs by notifying the MHRA in writing. A list of the opt out CAP MAs is available above. 

1. Subject to the UK providing written guarantees to the European Commission as provided for in Article 8 of EU Regulation 2023/1182 and following the entry into force and application procedure provided for in Article 14

3. Contact 

For further information, please contact our Customer Service Centre at info@mhra.gov.uk.

Updates to this page

Published 30 March 2021
Last updated 15 November 2024 + show all updates

  1. Removed outdated information.

  2. Updated PLGB numbers for the grandfathering of CAP MAs

  3. Updated "PLGB numbers for the grandfathering of CAP MAs"

  4. Updated "PLGB numbers for the grandfathering of CAP MAs" attachment.

  5. Updated file: PLGB numbers for the grandfathering CAP MAs

  6. File updated - PLGB numbers for the grandfathering of CAP MAs

  7. Updated grandfathered products list

  8. Updated the PLGB list for the grandfathering of CAP MAs

  9. Updated the PLGB numbers for the grandfathering of CAP MAs spreadsheet.

  10. Updated the PLGB numbers for the grandfathering of CAP MAs spreadsheet.

  11. Updated the PLGB numbers for the grandfathering of CAP MAs spreadsheet.

  12. Updated versions of the lists

  13. Updated the list of PLGB numbers for the grandfathering of CAP MAs, and List of the opt out CAPs MAs.

  14. Updated documents were uploaded.

  15. Updated the PLGB numbers for the grandfathering of CAP MAs list

  16. Updated the link 'PLGB numbers for the grandfathering of CAP MAs'.

  17. First published.

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