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Decision

GB marketing authorisations for centrally authorised products

A list of Great Britain Product Licence (PLGB) numbers for the grandfathering of centrally authorised product (CAP) marketing authorisations (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

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 2025 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. 

3. Contact 

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

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