The Windsor Framework was implemented to ensure continued supply of medicines to Northern Ireland, and as of 01 January 2025, new requirements come into effect for packaging and labelling of medicines. These include the requirement for a ‘UK only’ label on the outer packaging of a medicine, the medicine must not contain a serial number which has been uploaded to the European repository. The responsibilities of the releasing EU QP and RPi (Responsible Person Import) are not altered by the Windsor Framework.
As simple as this sounds, the intricacies of implementation and impact to medicines already released raises several questions for both releasing QPs and for the wider supply chain. This is recognised and supported by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK with publication of guidance documents and hosting a webinar of the Windsor Framework overview on 19 September 2024. Similarly, the Health Products Regulatory Authority (HPRA) in Ireland have published Questions and Answers on the Windsor Framework and medicines for human use (hpra.ie) to address common queries.
The questions most pertinent to a certifying QP involve definition of release. It was clarified by the MHRA that “Release to the market” refers to QP certification whereas ‘place’ on market is a commercial function where product is placed on the market for sale. To further clarify ‘“Release to the market” refers to QP certification only and does not mean RPi release.
Packs ‘released’ to the market before 31 December 2024 can remain in supply until their expiry. For supply chain planning this means ensuring all batches without ‘UK Only’ label and/or which have been serialised must be QP certified before 31 December 2024. Existing serialised packs already released will not need to be decommissioned from EMVO.
Any batches intended for release from 01 January 2025 onwards must have the ‘UK Only’ label. Crucially the artwork updates/ mock-ups with ‘UK Only’ must be notified to the MHRA prior to implementation and by 31 December 2024 at the latest. It is acceptable to include the ‘UK Only’ label on packs placed on the market prior to 01 Jan 2025.
MIAS Pharma is licenced by both the HPRA and MHRA to provide QP Batch certification services.
Get more information about our QP services here.
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