The Windsor Framework: Repercussions

Repercussions of the Windsor Framework

by Natasha Long, Fusion Pharma Limited

Delegates at the 2025 UK GDP Association CIC Annual Conference heard from a wide range of industry specialists from across the pharmaceutical, and healthcare sectors.
Among them was Natasha Long, whose session explored the evolving regulatory landscape following the introduction of the Windsor Framework.

Her presentation examined the regulatory implications for medicinal product marketing authorisations and highlighted the importance of maintaining compliance during a period of significant post-Brexit changes in the UK.

About Fusion Pharma Limited

Fusion Pharma is a UK-based regulatory affairs consultancy that supports pharmaceutical companies in navigating the complex regulatory landscape associated with developing and maintaining medicinal products.

Founded in 2013 and headquartered in London, Fusion Pharma specialises in providing bespoke regulatory consultancy services, helping organisations obtain and maintain product licences across the UK and EU markets. The company works with a wide range of clients, from large pharmaceutical organisations to small and emerging biotech companies, offering expertise across the full product lifecycle, from clinical development and marketing authorisation applications through to post-approval lifecycle management and regulatory strategy.

About Natasha Long

Natasha Long is Fusion Pharma Ltd.'s, Senior Regulatory Consultant and her regulatory career spans over 20 years in the pharmaceutical industry, from drug development and registration, through to innovation and maintenance activities. Natasha has held key regulatory positions across big pharma and consultancies. Specialising in regulatory submissions in UK and EU procedures, marketing authorisation applications, variations, and clinical trial applications.

Representing Fusion Pharma, Natasha delivered a practical and informative session titled “Repercussions of the Windsor Framework Regarding Marketing Authorisation Licences.” Drawing on her regulatory affairs expertise, she walked attendees through the fundamentals of marketing authorisation processes and the key changes affecting pharmaceutical companies operating in the UK and Northern Ireland.

The Role of Regulatory Affairs

Natasha began by outlining the core function of regulatory affairs within the pharmaceutical industry. At its heart, regulatory affairs ensures that medicines are developed, manufactured and supplied in compliance with national and international legislation.

 Regulatory professionals work across several critical areas, including:

• • Interpreting and applying regulations
  • Understanding regulatory guidance
  • Ensuring company compliance with legal requirements

 These responsibilities ultimately support three key goals: patient safety, product quality and the efficient availability of medicines.

Regulatory affairs teams are involved throughout the entire lifecycle of a medicinal product.
Their role spans multiple stages of development, including: 

• • Medicines discovery
  • Pre-clinical trials
  • Clinical trials
  • Marketing authorisation submissions
  • Post-authorisation regulatory maintenance

Because regulatory compliance touches every stage of development and supply, regulatory professionals act as an essential bridge between scientific innovation, legal frameworks and public health protection.

Marketing Authorisation Applications

A significant portion of Natasha’s session focused on the structure and submission of Marketing Authorisation (MA) applications, which are required before a medicinal product can be placed on the market. An MA application is made up of five modules, each containing specific information required by regulatory authorities:

 

• Module 1: Administrative information
  This includes documentation such as application forms, risk assessments and supporting licences, including Manufacturing Import Authorisations (MIAs).

• Module 2: Overviews and summaries
  This module provides expert summaries and overviews of the data presented in the other modules.

• Module 3: Quality data
  Details on the manufacturing process, product composition and quality control measures are included here.

• Module 4: Non-clinical study reports
  Data from pre-clinical studies that assess safety prior to human trials.

• Module 5: Clinical study reports
  Evidence gathered from clinical trials demonstrating the safety and efficacy of the medicine.

Once compiled, these modules are submitted to the relevant regulatory authority depending on the jurisdiction in which approval is being sought. In the UK, this typically involves the Medicines and Healthcare products Regulatory Agency (MHRA), while applications in the EU may involve the European Medicines Agency (EMA) or national authorities such as the Health Products Regulatory Authority (HPRA) in Ireland.

Marketing Authorisation Procedures

Natasha went on to outline the different regulatory procedures available for obtaining a marketing authorisation.

 These include: 

Centralised Procedure:
Managed by the European Medicines Agency, this route allows a product to be authorised across all EU member states through a single application. 

Mutual Recognition Procedure (MRP):
This pathway allows an authorisation granted in one EU member state to be recognised by others. 

Decentralised Procedure (DCP):
Used when a product has not yet been authorised in any EU country, allowing multiple member states to review the application simultaneously. 

National Procedure:
This route applies to medicines seeking approval solely within a specific country, such as the UK through the Medicines and Healthcare products Regulatory Agency.

 Natasha highlighted that the UK also has mechanisms to recognise certain medicines already authorised in other jurisdictions, allowing the regulatory process to be expedited in certain circumstances.

Windsor Framework Requirements

The introduction of the Windsor Framework has brought important changes to medicines regulation affecting the UK and Northern Ireland.

 Under the updated framework, the Medicines and Healthcare products Regulatory Agency is responsible for authorising all UK marketing authorisations. Several practical changes have also been introduced for pharmaceutical companies and supply chain partners.

 One of the most visible changes relates to labelling and packaging requirements. Medicines intended solely for the UK market must now display “UK Only” on the packaging. While temporary sticker solutions were permitted during the transition period, this concession ended on 30 June 2025, meaning that permanent packaging updates are now required.

 Another significant regulatory shift is that the Falsified Medicines Directive no longer applies in this context.

 Natasha also noted that products that were Qualified Person (QP) released and already in the UK before 31 December 2024 can continue to be marketed until their expiry date, providing a transitional pathway for existing stock.

The NIMAR List

During the session, Natasha also referenced updates to the NIMAR list (Northern Ireland MHRA Authorised Route), which plays a role in ensuring continued access to medicines in Northern Ireland when certain regulatory routes may not otherwise be available. Attendees were encouraged to monitor updates to this list to ensure ongoing compliance with evolving regulatory requirements.

Managing Changes to a Marketing Authorisation 

A crucial takeaway from Natasha’s presentation was the importance of maintaining strict compliance with the terms of a marketing authorisation.

Any deviation from the authorised conditions can potentially impact patient safety and regulatory compliance. As such, changes to a marketing authorisation must follow clearly defined regulatory procedures.

 Two key change management pathways were highlighted:

 

Do and Tell

This process allows certain lower-risk changes to be implemented immediately, with the regulatory authority notified afterwards. Examples may include: 

• • Changes to a site address
  • Increasing product specifications above the original requirements

Currently these notifications are submitted on an ad hoc basis, although Natasha explained that this process will soon move towards annual submissions to the MHRA.

 

Do, Tell and Wait

Higher-impact changes require regulatory approval before implementation. Examples include:

• • Extending product shelf life
  • Broadening product specifications

In these cases, companies must submit the proposed change and wait for regulatory approval before making any adjustments. Implementing such changes without approval could result in serious regulatory consequences, including product recalls.

A Changing Regulatory Landscape

Natasha Long’s session provided conference attendees with a valuable overview of the complex regulatory environment surrounding marketing authorisations in the UK.

As regulatory frameworks continue to evolve following the implementation of the Windsor Framework, it is clear that pharmaceutical companies must remain vigilant in monitoring changes and maintaining compliance. Regulatory affairs professionals play a critical role in ensuring that medicines remain safe, effective and accessible to patients.

For those involved in pharmaceutical supply chains, Natasha’s insights served as a timely reminder that regulatory compliance is not a one-time activity but an ongoing process that extends throughout the lifecycle of every medicinal product.

Registering for the 2026 conference

The UK GDP Association C.I.C (Community Interest Company) is delighted to announce that our third Annual Conference will be held on Tuesday 16th June 2026 and Wednesday 17th June 2026, in Northampton.

As with previous years, we have some amazing high-profile speakers, subject matter experts and multiple workshops scheduled each day to make this an industry leading interactive experience for delegates. The conference will cover a broad range of relevant GDP topics over the two whole days.  

There are discounted tickets available for UK GDP Association members, members can save £100 when attending both conference days. However, our commitment to low-cost, high-value educational content means that conference tickets will still be the best value whether you chose to join as members or not.

Membership is only £29 +VAT per individual, per year and offers reduced costs on consulting, training and conference tickets. If you buy tickets for both conference days, there is an even greater discount. Costs for non-members is just £224.50 per day, a fraction of the cost of other industry events!

In addition, on the evening of Tuesday 16th June, we will be hosting an evening event of dinner, networking, and even some of Dave’s infamous karaoke, for just £49 +VAT per person. This is a fundraising dinner in aid of the MVA Society.

Please see here for more information on the conference and to book your conference and evening dinner tickets.

We are very much looking forward to seeing you all at the conference!