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1. Overview听

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK鈥檚 stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which were taken or carried out at EU-level.听 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.听

2. General approach to grandfathering of鈥�CAPs听

All existing鈥�CAP鈥�MAs鈥痺ere automatically converted into Great Britain鈥�MAs鈥痚ffective from 1 January 2021 in Great Britain only (England, Wales and Scotland) and have been issued with a Great Britain Product Licence (PLGB)鈥�MA鈥痭umber. This process was termed 鈥榞randfathering鈥�. These Great Britain鈥�MAs鈥痑re referred to as 鈥渃onverted EU鈥�MAs鈥� . As a result of the implementation of the Northern Ireland Protocol, existing鈥�CAPs鈥痳emain 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.听听

The list of鈥�PLGB鈥痭umbers for the grandfathered鈥�CAP鈥�MAs鈥痠s available above.听

Marketing authorisation holders (MAHs) had the option to opt-out of the conversion process for all or some of their鈥�CAPs鈥痓y notifying the鈥�MHRA鈥痠n writing. A list of the opt-out鈥�CAP鈥�MAs鈥痠s available above.听

3. Contact听

For further information, contact our鈥疌ustomer Service Centre at鈥�[email protected].