The MHRA has updated its guidance on applying for a variation to your marketing authorisation.
The original guidance was published in December 2014. Following the end of the transition period on 31 December 2020, the guidance has been updated with new information on marketing authorisation types.
From 1 January 2021, the following Market Authorisation types will be possible in the United Kingdom (UK):
PL – authorised for use in United Kingdom
- as a purely national UK wide MA
- as part of an MR/DC procedure involving Northern Ireland as CMS, but a UK wide MA
PLGB – authorised for use in Great Britain only (England, Scotland and Wales)
- as a purely Great Britain national
- following conversion of a centrally authorised product (CAP)
- under the unfettered access route (MAH needs to be established in Northern Ireland and any product must access Great Britain, via Northern Ireland as a qualifying Northern Ireland good).
PLNI – authorised for use in Northern Ireland only
- as a purely Northern Ireland national
- as part of an MR/DC procedure including Northern Ireland only
Source: MHRA website