Last updated: 31 August 2024
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The Windsor framework was covered in a previous post. On 9 June 2023, the MHRA published a medicines announcement associated with the framework. It sets out a long-term solution for the supply of medicines into Northern Ireland.
For the sake of completeness, the guidances detailed below are also covered in this post.
On 28 July 2023, the guidance Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework was published. This guidance was significantly updated on 22 December 2023 and last updated on 5 April 2024.
On 29 September 2023, the guidance UK-wide licensing for human medicines was published and significantly updated on 30 August 2024.
On 30 August 2024, the guidance Pharmacovigilance following agreement on the WIndsor Framework was published.
Only a snapshot of all of the above guidances is covered in this post. This post can be used as a starting point for further reading of all of the guidances in order to attain a thorough understanding of the forthcoming changes.
When will the Windsor framework come into effect?
The Windsor Framework will come into effect on 1 January 2025.
What are the changes impacting medicines in the UK once the Windsor framework comes into effect?
The changes impacting medicines are the following:
- New medicines for the UK market will be authorised by UK MHRA enabling medicines to use the same packaging and labelling across the UK
- UK packaging must carry a clearly legible ‘UK only’ label to be allowed onto the UK market, including in Northern Ireland. ‘UK only’ labels may be placed anywhere on a medicine pack. This label will need to follow MHRA guidance on labelling.
- These products will only be able to be sold in the UK, and will not be available on the market in Ireland, or elsewhere in the EU
- Medicines entering Northern Ireland will not display features required under the EU Falsified Medicines Directive (FMD) including 2D barcodes and serialisation numbers that are compliant with the EU FMD Directive
- The MHRA will expect anti-tamper devices to remain on all medicines packaging.
Packs/packaging
- To provide a single deadline for new packaging requirements, the MHRA will continue to allow manufacturers to supply medicines in legacy EU packaging until 31 December 2024, thereby extending by one year, the previous 31 December 2023 deadline requiring medicines for GB to be presented in GB compliant packaging by the end of 2023.
- Packs in existing packaging already on the UK market, and within the supply chain, may remain until the date of their expiry.
- UK-based suppliers or distributors of medicines should prepare for different packaging for medicines to be supplied to UK and EU markets from 1 January 2025.
Before the Framework comes into effect
Before the framework comes into effect:
- the Northern Ireland MHRA Authorised Route (NIMAR) will continue to function to support the supply of medicines into Northern Ireland.
- as a further safeguard for medicines supplies the government will also bring into force a bridging mechanism to allow companies to supply Northern Ireland with innovative medicines (those presently subject to the EU Centrally Authorised Procedure) for up to 6 months when the MHRA licenses a product before the European Medicines Agency (EMA).
Next steps
As further guidance and operational arrangements are developed, the DHSC and the MHRA will continue to engage closely with industry on next steps.
Source: MHRA
Guidance – Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework
On 28 July 2023, the MHRA published the guidance Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework. This guidance was significantly updated on 22 December 2023 and last updated on 5 April 2024 (when section 12 (Parallel Import Packs) was updated to reflect guidance on UK Parallel Import Licences Following Agreement of the Windsor Framework). The details of the updates can be seen at the link above. Further guidance on UK Parallel Import Licences Following Agreement of the Windsor Framework is available here.
This guidance is designed to provide information on the implementation of labelling and packaging requirements for medicinal products for human use following agreement of the Windsor Framework. It repeats some of the points stated elsewhere in this post.
Source: MHRA
Guidance – UK-wide licensing for human medicines
On 29 September 2023, the guidance UK-wide licensing for human medicines was published and significantly updated on 30 August 2024. The guidance is designed to provide information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
| Date | Forthcoming changes |
|---|---|
| By 30 September 2024 | If a MAH currently holds both a NI MA (PLNI) and a GB MA (PLGB) for the same product and wishes to retain UK-wide authorisation, the NI MA will need to be cancelled in order for the existing GB MA to be converted to a UK-wide marketing authorisation. The MAH cannot hold a UK-wide MA and a NI MA simultaneously for the same product. To cancel a NI MA, the MAH should: · Inform the Reference Member State (RMS) of its intention to withdraw NI as a Concerned Member State (CMS) from the Mutual Recognition Procedure or the Decentralised Procedure (MRP/DCP). · Submit a request to the MHRA by 30 September 2024 to cancel the PLNI. The covering letter should refer to the Windsor Framework and specify the effective date of cancellation as 31 December 2024. · The GB MA component will automatically convert to a UK-wide marketing authorisation on 1 January 2025. If the MHRA does not receive a request by 30 September 2024 to cancel the NI MA, the MHRA will automatically cancel the GB MA with effect from 1 January 2025. This means that only the NI MA will remain from 1 January 2025 and the product will no longer have a marketing authorisation for GB. |
| After 31 December 2024 | Marketing Authorisation Holders (MAHs) will not be able to apply for a GB MA (a PLGB covering only Great Britain) after 31 December 2024. The MHRA will retain the right to issue GB MAs after 1 January 2025, but this will not be available through application. They will be issued only in exceptional circumstances to safeguard the interests of patients’ health within the UK. |
| From 1 January 2025 | From 1 January 2025: · the MHRA will regulate medicines through UK-wide marketing authorisations (MAs). · any authorisation issued on or after this date, will have an MA number with a PL prefix. · medicines authorised before that date will retain their current MA number (including the prefix even if that is a PLGB prefix). · union Authorisations issued by the European Commission will no longer be valid for Northern Ireland. Instead, the MHRA will issue UK-wide authorisations for these centrally authorised products (CAPs). · medicines that were previously within the scope of the EU’s Centralised Procedure will be authorised under UK-wide MAs and no longer be limited in territorial scope as GB MAs. These products will be designated in line with definitions in UK law as ‘Category 1’ which includes the the generic, hybrid or biosimilar products of Category 1 reference products. · medicines outside this scope (which can already be authorised as UK-wide MAs), will be designated as ‘Category 2’. · each application and existing authorised product will be assigned by the MHRA to one or other category. · it will not be possible to simultaneously hold a UK-wide MA and a GB MA (PLGB) or NI MA (PLNI) for the same product. The guidance outlines possible scenarios in Section 5 Territorial application. · only Reference Medicinal Products (RMPs) that are, or have been, authorised for at least 8 years in the UK (or GB prior to 1 January 2025) will be valid for generic, hybrid and biosimilar MAAs received. · the date used to calculate the Data Marketing Exclusivity Period of Reference Medicinal Products will be that of the UK product. PLNI products can continue to be supplied to NI after 1 January 2025. |
Category 1 and 2 products from 1 January 2025
1. Category 1 Products
From 1 January 2025, medicines that were previously within the mandatory or optional scope of the EU’s Centralised Procedure will be authorised under UK law on a UK-wide MAs
- They will no longer be limited in territorial scope as GB MAs.
- These products will be designated in line with definitions in UK law as ‘Category 1’.
- Category 1 includes the generic, hybrid or biosimilar products of Category 1 reference products.
The guidance provides further information on Category 1 products under the headings ‘New applications’ and ‘Existing authorised products’.
2. Category 2 products
All products that do not fall within the scope of Category 1 will be Category 2 products.
- Category 2 products are those that do not fall within the mandatory or optional scope of the centralised procedure as set out in detailed criteria in the guidance.
- No products authorised through a conditional marketing authorisation will be included in Category 2.
- These medicines will be licenced on a UK-wide basis.
The guidance provides further information on Category 2 products under the headings ‘New applications’ and ‘Existing authorised products’.
Source: MHRA
Guidance – Pharmacovigilance following agreement of the Windsor Framework
On 30 August 2024, the guidance Pharmacovigilance following agreement on the WIndsor Framework was published.
What information does this guidance provide?
This detailed guidance:
- is designed to provide information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.
- should be used in conjunction with the MHRA’s guidance on the Windsor Framework including UK-wide licensing for human medicines, and labelling and packaging guidance.
- should also be used to supplement the operational guidance in the MHRA’s existing guidance on pharmacovigilance procedures.
When will these changes be implemented from?
These changes will be implemented from 1 January 2025.
How will pharmacovigilance change following the implementation of this guidance?
Following the implementation of these arrangements from 1 January 2025, pharmacovigilance requirements will remain broadly in line with current requirements. However, there will be aspects of pharmacovigilance which will be impacted depending on whether the product is Category 1 or 2 (as defined on this page).
Source: MHRA