The Windsor Framework: Q&A’s

These Q&A’s are based on feedback from the DHSC and MHRA Windsor Framework Guidance Webinar: Medicines, which was held on Thursday 26 October 2023.

Yes, early implementation of labelling will be permitted for PLs and PLGBs.

No, the prefix PLGB will continue as a legacy prefix after 01 January 2025. This means that no action is required from the marketing authorisation holder of a PLGB license regarding switching the prefix. PLGB MAs will automatically become UK wide on the 01 January 2025, but will retain the PLGB prefix. All future marketing authorisation applications will be given the prefix PL.

No, however depending on the type of MA the MAH may need to take action prior to the 01 January 2025. Where the product is PLGB only (i.e., the product is under the scope of the centralised procedure or it is a GB only MA), no action is required. Where there is a PLGB number and a PLNI number for the same product the MAH will need to make a decision as to whether they wish to have a UK wide MA (which will continue to use the existing PLGB prefix) or a Northern Ireland only MA (using the PLNI prefix); if they are retaining the PLGB as a UK wide MA then they need to ask that the MHRA cancel the PLNI by the 30 September 2024, and the PLNI will be cancelled on the 31 December 2024, the PLGB MA will convert to UK wide as of the 01 January 2025. Where the MAH wishes to retain the PLNI instead no action needs to be taken and the PLGB will automatically be cancelled on the 31 December 2024.

Main packaging guidance includes:

  • The text must be conspicuous and clearly legible, at least 7-point font and in line with Article 5 of EU Regulation 2023/1182, current MHRA expectations and best practice guidance.
  • There are no restrictions on the number of sizes the label can appear as long as it is on the packaging at least once,
  • Stickers to show “UK Only” are allowed on products for the first 6 months after the implementation of the Windsor Framework (i.e, until 30 June 2023),
  • Only needed on exterior packaging,
  • It is not mandatory for parallel imports to have this labelling applied.

Multi-language elements are not allowed on the outer packaging; therefore, the pack must be in English for UK Only products. However, inner packaging (including the bottle/blister labelling and the patient information leaflet) can be multi-language where there is regulatory alignment.

Any products approved and on the market before 01 January 2025 can continue to be marketed. No withdrawal will be required, including product without “UK Only” labelling and multilingual packs.

: No, the MHRA must be notified of new UK-wide packaging updates. This can be done via any regulatory opportunity (apart from a Type IA) between now and 2024, or by self-notification.

This is dependent on country-specific criteria. Packs provided for export from the UK will need to meet the individual requirements of the countries that they are being exported to.

No. After 01 January 2025, the centrally authorised product will not be valid, and the product cannot be marketed after this date in Northern Ireland. If you do not have a PLGB for this product, you will not automatically get a PL license. To get a UK-wide license after 01 January 2025, you can use the national or international recognition procedure route to get the UK to recognise a centralised license. It is not possible to apply for standalone PLNI licenses except via the mutual recognition procedure (MRP) or decentralised procedure (DCP).

Existing PLNI’s as part of the MRP/DCP can continue to be managed in alignment with those procedures as can PL numbers licensed as of the MRP/DCP (until such a time that the MHRA requests changes that mean that the PL MA can no longer be aligned with the rest of the MRP/DCP).

Yes, but only if the product is on the NIMAR list. Any PLGB products not on the NIMAR list can only be supplied to GB before 01 January 2025 (after which date the NIMAR list will cease to be applied).

No action is required to existing generics in regard to the reference product used at the time of the marketing authorisation grant. Those generics are currently PL, so UK-wide generics will stay the same. Requirements for packaging and labelling will need to be met.

Not currently. Any changes discussed in the guidance are for medicines only.

James Hall