Listings categorized post-adoption of the Windsor Framework
Streamlined UK-wide Regulation for Medicines: The Windsor Framework Takes Effect
From 1st January 2025, the Windsor Framework will introduce a new, simplified Marketing Authorisation (MA) system for human medicines in the UK. This system, managed by the Medicines and Healthcare products Regulatory Agency (MHRA), replaces the previous post-Brexit dual-regulatory system and aligns authorisations across Great Britain and Northern Ireland under UK law.
Under the Windsor Framework, all medicines marketed in the UK must hold an MHRA-issued UK-wide Marketing Authorisation under the Human Medicines Regulation 2012 (as amended) [1]. This change means that medicines previously under the EU centralised procedure will now be regulated only under UK law.
The Windsor Framework has established a system of categorization for marketing authorisation applications and products to ensure compliance with relevant rules in the UK. This categorization will be applied consistently across the country.
Regarding labelling and packaging, the MHRA has issued guidance for manufacturers, wholesalers, Qualified Persons (QPs), Responsible Persons (RPs), and Responsible Persons for Import (RPis) [1]. Until 30th June 2025, the "UK Only" designation may be applied using stickers. From 1st July 2025 onwards, the "UK Only" statement must be printed directly on the packaging, and sticker use will no longer be accepted for new releases to the market. Products with stickered "UK Only" labelling that were QP certified before 1st July 2025 can remain in supply until expiry. Parallel imported products are exempt and can continue sticker use [2][4].
For products authorised under EU procedures for the European Economic Area (EEA) and Northern Ireland, separate guidance applies. This guidance covers areas such as pharmacovigilance, risk management plans, and regulatory application requirements, and is coordinated with the European Medicines Agency (EMA) to reflect the Windsor Framework provisions for Northern Ireland's unique status [3].
It is important to note that medical devices fall outside the Windsor Framework’s medicinal product authorisation scope but are subject to separate MHRA schemes. For instance, the upcoming Early Access Service for innovative medical devices is distinct from medicines regulation [1][5].
In summary, the key point is that from 2025, the MHRA provides a single UK-wide authorisation for medicines, with detailed rules on packaging, labelling, and regulatory compliance as set out in amended UK legislation and MHRA guidance documents following the Windsor Framework agreement. EU regulations still apply in certain contexts for Northern Ireland under the Protocol, but the Framework simplifies UK oversight for the rest of the UK market [1][2][3][4].
References:
[1] MHRA. (2024). Windsor Framework: Human Medicines. Retrieved from https://www.gov.uk/government/publications/windsor-framework-human-medicines
[2] MHRA. (2024). Labelling and Packaging of Human Medicines. Retrieved from https://www.gov.uk/guidance/labelling-and-packaging-of-human-medicines
[3] EMA. (2024). Windsor Framework: Northern Ireland. Retrieved from https://www.ema.europa.eu/en/windsor-framework-northern-ireland
[4] UK Government. (2024). Human Medicines Regulations 2012 (as amended). Retrieved from https://www.legislation.gov.uk/uksi/2012/1916/contents/made
[5] MHRA. (2024). Early Access Service: Medical Devices. Retrieved from https://www.gov.uk/government/publications/early-access-service-medical-devices
The Windsor Framework, effective from 2025, will streamline UK regulation for medicines by providing a single UK-wide Marketing Authorisation (MA) for human medicines under the UK law. This new system will oversee labelling, packaging, and health-and-wellness related aspects of medicine, as detailed in amended UK legislation and MHRA guidance documents. On the other hand, science-driven advancements in medical devices will continue to be governed by separate MHRA schemes, such as the Early Access Service for innovative medical devices, distinct from medicines regulation.
