I have managed to miss this issue until now. (This page was first published 30 March 2021 and has just been updated 11 October 2021.)
Afraid the whole issue of Marketing Authorisation in relation to products which were allowed due to our EU (hence, European Medicines Agency) membership is confusing. Rather than make mistakes in my interpretation, I’ll post the whole article. There are links on the page so if you need more, go to the original page.
The most visible single factor seems to be in relation to Marketing Authorisation Holder numbers – we will see more starting PLGB. Still confused about PLNI numbers for Northern Ireland. And I suspect I am not the only person who hasn’t fully understood.
A list of PLGB numbers for the grandfathering of CAP MAs.
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 11 October 2021 + show all updates
