As taken from the link above: ‘After the implementation of the Windsor Framework, the Medicines and Healthcare products Regulatory Agency (MHRA) will license all medicines across the whole of the UK’.
This presents a number of significant changes to the current licensing system which aren’t immediately obvious. For example:
- Existing PLGBs will automatically convert to PLs with no action necessary for MA holders (apart from updating the labelling and packaging requirements etc.), unless:
- The MA holder holds both PLGB and PLNI licenses, in which case the MA holder must:
- Cancel the PLNI licence, or
- The MHRA will cancel the PLGB
The deadline for requesting cancellation of a PLNI is the 30th September 2024 for cancellation as of 31st December 2024.
An additional little quirk is as follows (again from the above link):
‘Existing licence numbers
The change in territorial scope of a licence does not require a change in licence numbers. Medicines with existing PLGB numbers will become geographically valid UK-wide, where the PLGB converts to a PL. However, these medicines will retain the same licence number, including the prefix ‘PLGB’. These letters will no longer have any relevance in terms of the territorial scope of legal supply. ‘PLNI’ however, will continue to denote medicines that can be supplied to NI only’.
So, as distributors, we will continue to see the PLGB licence number on product packs but the MHRA will have automatically converted it to PL.
Remember, batches released after the 1st January 2025 must carry the ‘UK Only’ statement on product packs.
PCL are dedicating our 24th September 2024 RP Forum to discussing the Windsor Framework and will also have a new Windsor Framework training course coming soon.
Please check out our website for more details: