Windsor Framework - Summary and Frequently Asked Questions
Version update: 27 November 2024
Background
The Windsor Framework sets out the long-term arrangements for the supply of medicines into Northern Ireland (NI). It will ensure that human medicines can be approved and licensed on a United Kingdom (UK)-wide basis by the UK competent authority, the Medicines and Healthcare products Regulatory Agency (MHRA), and provides for the disapplication of European Union (EU) Falsified Medicines Directive (FMD) safety features for medicines marketed and supplied in NI.
To preclude onward movement of these medicines into any part of the EU, or European Economic Area (EEA) while ensuring medicines use the same packaging and labelling across the UK, all licensed medicines on the UK market must be labelled as ‘UK Only’.
These measures will commence on 1 January 2025 and MHRA has published an online information hub detailing the main changes introduced by the Windsor Framework. This can be found via the link below:
MHRA Windsor Framework Hub - GOV.UK
Summary of Windsor Framework Arrangements
Medicine Authorisations
In NI, all innovative and novel medicines that fall under the scope of the EU Centralised Authorisation Procedure will be authorised by the MHRA for the UK market. This means, after 1 January 2025, all authorised medicines released for the NI market will be on a UK-wide or NI-only basis and authorised only by the MHRA.
Medicines currently authorised for the Great Britain(GB) market (PLGB) will become valid for the whole of the UK from 1 January 2025.
These products will only be able to be sold in the UK and export markets where it is lawful for them to be placed on the market or supplied as unlicensed medicines in those markets. These products cannot be supplied to the EU, including Ireland, unless in compliance with regulatory pathways and guidance from respective national competent authorities.
Joint packs between the UK and EU will no longer be possible.
Medicines released to the market, i.e. released by a Qualified Person (QP), by marketing authorisation holders (MAHs) prior to 1 January 2025 can continue to be supplied to the territory for which they were intended after the 1 January 2025 until their expiry date. This includes EU compliant stock, released by a QP before 1 January 2025, which can continue to be supplied to the NI market after 1 January 2025 until their expiry date.
EU Falsified Medicines Directive
EU Falsified Medicines Directive (EU FMD) safety features will no longer apply in NI from 1 January 2025.
From 1 January 2025, the current NI UK(NI) Medicines Verification Organisation, SecureMed, will decommission the UK(NI) National Medicines Verification System (NMVS). The European Medicines Verification Organisation (EMVS) will disconnect the UK(NI) NMVS from EMVS on the same date.
It will not be possible to verify or decommission medicines in NI from 1 January 2025. As such, there will no longer be a requirement for NI pharmacies, doctors and those who were required to verify or decommission medicines from the supply chain under EU FMD requirements.
All existing safety requirements under UK law, for instance on the placement of the expiry date and batch number and other packaging requirements, remain unchanged. In addition, under UK law, MAHs may choose to apply the following features on UK packaging, although this is not compulsory:
- a 2D barcode (Data Matrix), which may encode data including information about the specific medicinal product, the expiry date, batch number, Global Trade Item Number, and serial number if applicable; and
- a serial number of any format.
Whilst the disapplication of FMD will remove the legal requirement for medicines packaging to bear safety features MAHs are being encouraged to use anti-tampering devices on their packaging.
Labelling and Packaging
All medicines intended for the UK or NI market must bear ‘UK only’ on the packaging when released to the market from 1 January 2025 and must not contain 2D barcodes that are recognised by the EU repositories system.
When using the ‘UK Only’ label on packaging, the following will apply:
- ‘UK Only’ may be presented anywhere on the outer packaging of the medicine.
- 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.
The packaging requirements will apply to all licensed General Supply List (GSL), Pharmacy only (P) and Prescription Only Medicine (POM) medicines.
Stickers bearing ‘UK only’ can be applied to the outer packaging of medicines until 30 June 2025. These stickers should remain on the outer packaging until their expiry date.
The MHRA has permitted early implementation of labelling requirements for current UK-wide (PL) and GB only (PLGB) authorised medicines. This means PL and PLGB products can be released to market with ‘UK only’ labelling prior to 1 January 2025. In practice, these changes mean there will be medicines with a variety of valid authorisations and approved medicines packaging e.g. with or without ‘UK only’ on the outer packaging and with or without EU FMD features, that may be present for a period on the NI market after 1 January 2025. If obtained from bona fide sources, these medicines can continue to be supplied until their expiry date.
In the longer term, medicines released prior to 1 January 2025 will be exhausted from the supply chain (e.g. supplied to patients or expired). Therefore, any legacy stock will eventually be replaced with medicines authorised and released to the market under Windsor Framework arrangements after 1 January 2025.
The MHRA has published guidance to assist industry in implementing the arrangements of the Windsor Framework for human medicines. This can be found via the MHRA Windsor Framework hub link above, however, some of the relevant guidance can be found in the links below:
Medicine Authorisation Guidance
UK-wide licensing for human medicines - GOV.UK
Labelling and Packaging Guidance
Wholesalers and Manufacturers Guidance
Wholesalers & manufacturers guidance following agreement of the Windsor Framework - GOV.UK
Frequently Asked Questions
Whilst the MHRA guidance provides comprehensive advice and actions to take for industry, the Department of Health, NI (DoH) has published the following frequently asked questions to assist, advise and reassure NI healthcare professionals and the public of the arrangements that will be implemented for human medicines under the Windsor Framework.
These answers are to be used for guidance purposes only. All relevant legislation must be followed and guidance from healthcare regulators and national competent authorities should be considered.
Will there be disruptions to the supply of medicines as industry implements arrangements under the Windsor Framework?
The Department of Health and Social Care (DHSC), the lead UK Government Department for implementing the Windsor Framework health arrangements, has been proactively engaging with the MHRA, industry, the DoH and other operators within the supply chain, to ensure the smooth transition of new arrangements for human medicines under the agreement.
However, it is important to note that medicines are manufactured as part of a highly complex, regulated and global industry, therefore medicines supply disruptions are not uncommon and can occur for a variety of reasons unrelated to the Windsor Framework. As such, no one can provide an absolute guarantee that there will not be any disruption to supplies in the future, but we can assure the public that we work with all stakeholders to mitigate against any such disruptions. There are already national and local tools and processes in place for managing medicines supply disruptions to ensure patients can have continued access to appropriate treatments.
I currently have stocks of medicines in my pharmacy, clinic, warehouse, etc. that do not bear 'UK only' labelling. Can I continue to supply these previously purchased medicines after 1 Jan 2025?
Yes. Medicines released to the market by marketing authorisation holders (MAHs) prior to 1 January 2025 without ‘UK only’ labelling can continue to be supplied until their expiry date.
If wholesalers supply my pharmacy, clinic, etc. with medicines which do not bear the 'UK only' labelling on its packaging after 1 January 2025, can I supply these or do I need to return these back to my suppliers?
Yes, you can continue to supply medicines received from bona fide sources, such as wholesalers, that do not bear ‘UK only’ after 1 January 2025. Medicines released to the market by MAHs prior to 1 January 2025 are not required to bear ‘UK only’ labelling on their packaging, therefore these medicines may remain on the market until their expiry date.
If received from a bona fide source such as a wholesaler, you can be assured that the MHRA and the Medicines Regulatory Group (MRG) within the DoH will be inspecting manufacturers and wholesalers in line with Windsor Framework requirements, from 1 January 2025.
Can my pharmacy, clinic, etc. supply any medicines obtained with 'UK Only' labelling prior to 1 Jan 2025? For example, is it possible that 'UK Only' packaging will be in circulation in 2024?
Yes, packaging bearing ‘UK only’ can be supplied prior to 1 January 2025.
To assist the implementation of Windsor Framework arrangements, the MHRA has permitted the early implementation of ‘UK only’ on PL and PLGB packaging. This means MAHs can release stock to the market bearing ‘UK only’ on their packaging prior to 1 January 2025, and these stocks can subsequently be supplied.
What products are exempt from the ‘UK only’ labelling requirements?
All medicines authorised for the UK or NI market must bear the ‘UK only’ labelling requirements, which includes all General Sale List (GSL), Pharmacy Only (P), and Prescription Only Medicine (POM) medicines.
However, medicines that do not have a UK or NI authorisation are not required to bear ‘UK only’. This means unlicensed medicines, imported medicines, extemporaneously- prepared products, compliance aids and other actions under Section 10 of the Medicines Act 1968, etc. will not be required to bear ‘UK only’ on their outer packaging after 1 January 2025.
Can I supply or sell medicines that contain ‘UK only’ packaging to patients presenting to the pharmacy from the EEA, including Ireland?
The Windsor Framework does not alter the status of prescriptions originating from approved countries issued by approved health professionals, or the sale of medicines to those who can procure them. The link below provides more information on prescriptions from approved countries:
I saw references to Category 1 and Category 2 products; will this have any impact on supplying or selling these medicines?
No, Category 1 and Category 2 products do not have any impact on the supply or sale of medicines. Both categories will be UK-wide authorisations and categorisation does not alter the territory in which they can be supplied or the ability to supply or sell.
From 1 January 2025, UK authorised medicines will be categorised as Category 1 or Category 2 products. This is to assist MAHs on their obligations such as pharmacovigilance reporting. It does not impact on the territory or ability to supply or sale the product.
What should you do if you have concerns about the authenticity of any medicines? Who should you contact and report this too?
Any concerns in relation to the authenticity of medicines should be reported to the MHRA. Identification of suspected falsified medicines should be reported using the Yellow card scheme as soon as possible.
Additionally, concerns can be raised to the MRG within the DoH via:
mrgcasereferrals@health-ni.gov.uk
I have pharmacy businesses across the UK, can I move compliant stock between my pharmacies in NI and GB?
The Windsor Framework does not alter the movement of medicines within the UK.
Pharmacies within the same legal entity can continue to move compliant stock between their premises within the same business entity. All other movements of medicines, i.e. those outside the same legal entity can only be done so under an appropriate authorisation, such as a wholesaler dealer’s licence (WDA) issued by the MHRA.
I have pharmacy businesses in NI and EEA, e.g. Ireland, can I move stock between my pharmacies?
The appropriate authorisation, such as a wholesaler dealer’s licence (WDA) issued by the MHRA, will continue to be required for the movement of medicines between NI and EU and EEA, including premises in Ireland.
After the 1 January 2025, medicines authorised for the UK or NI market will only be able to be sold in the UK and export markets where it is lawful for them to be placed on the market or supplied as unlicensed medicines in those markets in which the national competent authority accepts them. These products cannot be supplied to Ireland or elsewhere in the EU, unless in compliance with regulatory pathways and guidance from respective national competent authorities.