Last updated: 20 November 2024
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The Windsor framework was covered in a previous post.
The guidances in the table below are covered in this post.
Only a snapshot of each guidance is provided. 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.
Table 1
| Date | Guidance |
|---|---|
| 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. |
| 28 July 2023 | The guidance Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework was published. It 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 |
| 29 September 2023 | The guidance UK-wide licensing for human medicines was published and significantly updated on 30 August 2024. |
| 5 April 2024 | The Guidance UK Parallel Import Licences Following Agreement of the Windsor Framework was published. |
| 30 August 2024, | The guidance Pharmacovigilance following agreement on the WIndsor Framework was published. |
| 12 September 2024 | The guidance Wholesalers & manufacturers guidance following agreement of the Windsor Framework was published. |
| 7 November 2024 | The guidance Advertising and Promotion following agreement of the Windsor Framework was published. |
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 and below.
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.
Table 2
| 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
From 1 January 2025, each application and existing authorised product will be assigned by the MHRA to one of the two categories outlined below.
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 – UK Parallel Import Licences Following Agreement of the Windsor Framework
On 5 April 2024, the guidance UK Parallel Import Licences Following Agreement of the Windsor Framework was published.
Parallel Distribution Notices (PDNs) are notice letters which parallel distributors must obtain from the European Medicines Agency before placing a centrally authorised product on the market. PDNs are no longer valid in Great Britain (England, Scotland, Wales).
These were replaced by Parallel Import Licences (PLPIs) via the PDN to PLPI conversion process, which allow the products to be marketed in Great Britain (GB) only. PDNs currently remain valid in Northern Ireland.
What will happen to PDNs from 1 January 2025?
From the implementation of the Windsor Framework on 1 January 2025, the MHRA will license all medicines across the whole of the UK and PDNs will no longer be valid in Northern Ireland.
This means that all Parallel Imports (including Centrally Authorised Products):
- will be authorised to be marketed across the whole of the UK.
- will need a valid PLPI licence.
All PLPIs with a current territorial limitation of GB will be converted to UK-wide authorisation automatically. This includes:
- all previous Parallel Distributed Notices (PDNs) that were converted to UK Parallel Import Licences (PLPIs) and
- any other PLPI licences that have a current GB territorial limitation. *A variation will not be required to change the territory from GB to UK-wide.
Other changes/important points include include:
- All PLPI licences will continue to have the prefix ‘PLPI’ and the licence number will not change.
- All new packs placed on the UK market on or after 1 January 2025 must display ‘UK Only’ label. This includes PLPI licences with a current UK territory.
- ‘UK Only’ may be presented anywhere on the outer packaging only of the medicine.
- The ‘UK Only’ statement may be applied to existing products at an appropriate regulatory opportunity where the label documentation is updated and any new applications from the date of publication of this guidance.
- PLPI licence holders may apply the ‘UK Only’ statement by either stickering or indelibly (i.e. printing directly on the packaging).
- PLPI licence holders must either submit a notification document for stickering or have approved artwork with ‘UK Only’ on the labelling for all PLPI licences, before 1 January 2025.
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
Guidance – Wholesalers & manufacturers guidance following agreement of the Windsor Framework
On 12 September 2024, the guidance Wholesalers & manufacturers guidance following agreement of the Windsor Framework was published.
Who is this guidance meant to support?
The published guidance is meant to support the following in order to implement the arrangements of the Windsor Framework for human medicines:
Manufacturers and wholesale dealers authorised by the MHRA including the following persons:
- Qualified Persons (QPs)
- Responsible Persons (RPs)
- Responsible Persons for Import (RPis)
The published guidance provides further information for each of the above persons.
This guidance is meant to be read in conjunction with which other guidance?
This guidance is intended to be read in conjunction with the labelling and packaging guidance and associated Q&As.
Are medical devices within the scope of this guidance?
Medical devices are outside of the scope of this guidance, however combination products which are medicinal products will be required to comply with MHRA guidance.
Some salient points from the guidance
Whilst some salient points from the guidance are provided below, is is essential that the published guidance is read in its entirety for a thorough understanding of the requirements:
- From 1 January 2025, to enable medicines to use the same packaging and labelling across the UK, packaging for all UK human medicinal products (Prescription Only Medicine and Pharmacy and General Sales List) must carry a clearly legible ‘UK Only’ label to be placed on the UK market.
- Any stock QP certified from 1 January 2025 must include “UK Only” on the packaging.
- Stickering with “UK Only” label -The ‘UK Only’ statement can be applied to the outer pack, via an indelible sticker for a limited period of 6 months, to 30 June 2025. After this date, ‘UK Only’ must be printed directly onto the packaging. Stickering will not be accepted after this date.
- Early release to market – The ‘UK Only’ label can be applied to packaging and released to the Great Britain market before 1 January 2025.
- PLGB medicines featuring “UK Only” labelling which have been QP certified prior to midnight 31 December 2024 will be valid for immediate supply to the Northern Ireland market after 1 January 2025.
- From 1 January 2025, joint EU/UK packs can no longer be QP certified and released to the UK supply chain. A joint pack is one that is shared with another EU country or countries that present administrative details for both the UK and the other markets sharing the pack.
- The Falsified Medicines Directive will be disapplied UK-wide from midnight 31 December 2024 and the UK repository will no longer be accessible.
Source: MHRA
Guidance for manufacturers: Independent control testing (batch release) for the United Kingdom
This guidance was last updated on 25 September 2024. Updates include information about changes to the control testing (batch release) process for Northern Ireland following the agreement of the Windsor Framework.
This guidance is designed to provide information on the certification of batches of immunological medicinal products or medicinal products derived from human blood or plasma products (‘biological medicines’, including plasma pools), in accordance with the Human Medicines Regulations 2012.
Since 1 January 2021, the MHRA retains functions as the Official Medicines Control Laboratory (OMCL) for the United Kingdom (Great Britain and Northern Ireland) through NIBSC.
From 1 January 2025, different batch control testing (batch release) processes will apply in Northern Ireland following the agreement of the Windsor Framework.
You can view the updated guidance here.
Source: MHRA
Guidance: Apply to release a vaccine or a blood product to market
This guidance was last updated on 25 September 2024.
When a MAH wants to release a batch of a vaccine or a blood product to the UK market, they must get the batch independently tested and certified by the UK National Control Laboratory. After the UK certificate has been issued, the MAH can release the batch.
In accordance with the Human Medicines Regulation 2012, products in scope of this guidance include:
- live vaccines
- immunological products that are used in primary immunisations or public health immunisation programmes
- new immunological products that are manufactured using new or altered kinds of technology or are new for a particular manufacturer
- products derived from blood or human plasma.
You can view the updated guidance here.
Source: MHRA
Guidance – Advertising and Promotion following agreement of the Windsor Framework
This guidance was published on 7 November 2024.
This guidance is designed to provide information on the implementation of changes to advertising and promotion of medicines authorised in the UK from 1 January 2025.
This guidance:
- should be used in conjunction with the MHRA’s guidance on the Windsor Framework including UK-wide licensing for human medicines
- should also be used to supplement the operational guidance in the MHRA’s existing Blue Guide on the Advertising and Promotion of Medicines in the UK.
From 1 January 2025, all medicines in the UK will be licensed by the MHRA and authorised under the Human Medicines Regulation 2012 (as amended) (HMRs).
- The UK legislation regulating the advertising of medicines applies to all forms and means of advertising licensed medicinal products.
- As well as products with a UK-wide licence, it also covers products licensed by the MHRA for sale only in Great Britain (GB) or only in Northern Ireland (NI) where those continue to exist.
- The relevant UK legislation on advertising is Part 14 of the Human Medicines Regulations 2012 (“the Regulations” – SI 2012/1916 as amended).
- Further information on the legislative framework outlining the requirements for the advertising and promotion of medicinal products in the UK is given in the MHRA Blue Guide.
- Following changes made by the Windsor Framework, the vast majority of Marketing Authorisations (MAs) will be UK-wide and as such these medicinal products can be advertised UK-wide.
- In the exceptional circumstances where a medicinal product is only licensed in part of the UK (e.g., GB or NI), the product may only be advertised in the territory where it is licensed. MAHs and advertisers must take reasonable precautions to ensure that advertisements do not appear in a territory where the product is not licensed.
- In these cases, applicable territory-specific information in the advertisement continues to be required for these products as outlined in the Blue Guide (chapters 5 and 6).
- From 1 January 2025, the EU licence number that was assigned to licences in respect of the territory of NI no longer applies: this number should be phased out from UK advertisements over time
- When making any updates to Prescribing Information, companies and advertisers are advised to take the opportunity to review the information to remove, amend, or clarify any references to territories as may be appropriate to avoid any potential confusion.
- For example, the statement that a product has a GB MA may need to be removed where this is changing to a UK-wide MA from 1 January 2025; headings that may have signposted to specific geographical regions at whom the information was targeted may also need to be reviewed as required.
Further detailed information is provided at the link below.
Source: MHRA
Guidance – MHRA Windsor Framework Video Explainers
On 20 November 2024, the MHRA posted a video series explaining the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland. You can access them at the links below.
- Video 1: Top 3 things that industry needs to know and action by 31 December 2024
- Video 2: How single marketing authorisation will cover the whole UK
- Video 3: Adding ‘UK Only’ labelling to packaging
- Video 4: Disapplying the EU Falsified Medicines Directive for Northern Ireland
- Video 5: Maintaining dual market access for Northern Ireland
- Video 6: How medicinal products will be classified into two categories
- Full playlist of all 6 videos
Source: MHRA
Guidance – Windsor Framework explainer document
On 20 November 2204, the MHRA published a Windsor Framework explainer document. You can view it here.
An explainer document for the pharmaceutical industry which brings together in a simpler format the information published in our It explains the main changes that implementing the Windsor Framework will introduce on 1 January 2025 and what you need to do to prepare.
Source: MHRA
Webinars
The MHRA has held a series of MHRA Webinars in preparation for the Windsor Framework implementation date.
Here is a link to the MHRA Windsor Framework Industry Webinar of 19 September 2024.
The webinar consists of the following sections. Rough time stamps are provided.
- Windsor Framework Implementation – 0.50 min
- UK-wide licensing – 3.37min
- Pharmacovigilance – 23.46 min
- Labelling and packaging – 49.39 min
- Distribution and manufacturing – 1hr 02
- Question and answer
Here is a link to the MHRA Windsor Framework Industry Webinar of 23 October 2024
The webinar consists of the following sections. Rough time stamps are provided.
- Windsor Framework Implementation – 0.00-5.00 min
- UK wide licensing: further details – 5.01 – 15.00min
- Paediatrics – 31.04min
- Distribution and manufacturing – 36.57min
- Advertising and promotion of medicines – 44.48min
- Question and Answer – 51.09 min
The full guidance collection can be viewed at the MHRA Windsor Framework Hub.