GovWire

1. Overview

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UKs 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.