The Responsible Person for Import (RPi) is an important role to maintain oversight of the supply chain of medicines imported for use in the UK.
The RPi is responsible for implementing a system to confirm products that have been imported into Great Britain from countries on an approved country for import list:
- that the required QP certification has taken place
- that the required independent batch release certificate is available for biological products
On 1st January 2025, the revised Windsor Framework requirements were implemented throughout the UK impacting importers, manufacturers, distributors and Marketing Authorisation Holders (MAH).
In March 2025, the MHRA published their responses following on from the feedback and questions the industry posed during the MHRA Webinar sessions which can be viewed here.
The ‘Windsor Framework wholesaler and manufacturer Q&A’ and the ‘Windsor Framework disapplication of EU falsified medicines directive Q&A’ are now available. So, what are the main changes for the RPi?
1. ‘UK Only’ packaging
One of the biggest changes is due to the packaging and labelling obligations for UK licensed medicines to now contain ‘UK Only’ somewhere on the carton. Marketing Authorisation Holders had until 31st December 2024 to implement the new artwork as either stickers (permitted until 30th June 2025) or as part of the artwork itself. All batches released to market (e.g. QP certified) from 1st January 2025 onwards must contain this text to be compliant.
The RPi needs to ensure that the QP certification they are reviewing for batches released to market after the 1st January 2025, is for batches that have ‘UK Only’ on their packaging. RPi’s need to ensure that where the duty of checking packaging is delegated to other teams, they retain oversight of the imported batch to ensure it complies
2. 2D Data Matrix
The need for the 2D data matrix to contain serialisation data as defined in the EU Falsified Medicines Directive (FMD) Delegated Regulation (EU) 2016/161 has been disapplied from all UK wide bathes released to market from 1st January 2025. Packs may continue to have a 2D data matrix which contain information about the specific medicinal product, the expiry date, batch number, Global Trade Item Number, and serial number if applicable, however the serial numbers will NOT be uploaded to the
EMVS/NMVS. The RPi is expected to verify that packs received with a 2D data matrix comply with the Windsor Framework by having, but not limited to: appropriate supplier qualification, supplier/manufacturer quality technical agreements, written confirmation from the Marketing Authorisation Holder/manufacturer or risk assessments. The RPi is NOT expected to scan or verify the 2D data matrix themselves as access to the EMVS is no longer possible.
3. Segregation and supply of packs
- UK-wide MA: a product licensed by the MHRA, across the whole of the UK, (this may include marketing authorisations (MAs) with a PL or PLGB prefix)
- NI MA (PLNI): a product licensed by the MHRA that covers Northern Ireland (NI) only as the territorial application with PLNI as the MA number prefix
- GB MA (PLGB): a product licensed by the MHRA that covers Great Britain (GB) only as the territorial application with PLGB as the MA number prefix
GB licensed packs (excluding Northern Ireland) have automatically converted to UK-wide licensed packs (including Northern Ireland) on 1st January 2025. This now means that packs that were previously received by wholesalers as ‘PLGB’ may now be received with UK wide ‘PL’ numbers on their packaging.
During this transition, packs which were released with ‘PLGB’ numbers on them may continue to be supplied to Northern Ireland, only if they are the NIMAR list.
Packs that are ‘PL’ can be freely supplied to the whole of the UK.
When receiving packs the RPi (or RP for domestic shipments) is expected to identify packs which are ‘PLGB’ compared to ‘PL’ to ensure adequate segregation of stock to prevent the incorrect packs being supplied to Northern Ireland.
Are you interested in becoming an RPi?
To become an approved RPi on your WDA, you must meet the expectations for qualifications, experience and membership of professional bodies. Please review the MHRA’s requirements here.
If you are considering becoming an RPi or need a refresher following the Windsor Framework, check out Pharmacy Consulting Limited upcoming courses.