Decision

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

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

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

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 except for decisions on Marketing Authorisation (MA) applications made through the European procedures to market products in Northern Ireland.

General approach to grandfathering of CAPs

All existing CAP MAs have been 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. These Great Britain MAs are referred to as “converted EU MAs”. As a result of the implementation of the Northern Ireland Protocol, existing CAPs will remain valid for marketing products in Northern Ireland.

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

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 CAPs MAs is available above.

Within the period of one year starting on 1 January 2021, the MAH must submit the information as stated in the guidance to the MHRA for each converted EU MA.

For further information of guidance please contact the MHRA Customer Service Centre at info@mhra.gov.uk.

Published 30 March 2021
Last updated 24 March 2022 + show all updates
  1. Updated PLGB numbers for the grandfathering of CAP MAs

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

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

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

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

  6. Updated grandfathered products list

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

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

  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 versions of the lists

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

  13. Updated documents were uploaded.

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

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

  16. First published.