UK Implements Key Changes to Supplementary Protection Certificates (SPCs) Under Windsor Framework

Effective 1 January 2025, the United Kingdom has enacted significant reforms to its Supplementary Protection Certificate (SPC) regime for medicinal products, aligning with the provisions of the Windsor Framework. These changes aim to streamline the regulatory landscape post-Brexit and ensure the uninterrupted supply of medicines across the UK, including Northern Ireland.

 

Overview of the Changes

 

1. Transition to a Single UK-Wide Marketing Authorisation

 

Prior to these reforms, medicinal products could be authorised through multiple routes:

 

• Centralised Authorisations issued by the European Medicines Agency (EMA), effective in Northern Ireland.
• Great Britain (GB) Authorisations issued by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), effective in England, Scotland, and Wales.
• Northern Ireland (NI) Authorisations issued by the MHRA, effective solely in Northern Ireland.

 

Under the new system, all medicinal products will be authorised by the MHRA through a single UK-wide marketing authorisation. This eliminates the need for separate authorisations for different parts of the UK, simplifying the regulatory process for pharmaceutical companies.

 

2. Discontinuation of Centralised Authorisations in Northern Ireland

 

As of 1 January 2025, centralised authorisations granted by the EMA are no longer valid in Northern Ireland. Consequently, these authorisations cannot serve as the basis for SPC applications or paediatric extensions within the UK.

 

3. Amendments to SPC Legislation

 

To accommodate these changes, the UK government introduced the Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024. Key provisions include:

 

• Automatic Expansion of GB Authorisations: Existing GB authorisations now extend to cover the entire UK, provided any corresponding NI authorisation was surrendered by 30 September 2024.
• Transitional Arrangements: For existing SPCs and applications based on both centralised and GB authorisations, no action is required. The GB authorisation’s extension ensures continued UK-wide protection.
• New SPC Applications: Post-1 January 2025, SPC applications must be based on a valid UK-wide authorisation. Centralised authorisations are no longer acceptable for this purpose.

 

What It Means for You: Impacts on UK Businesses

 

1. Simplified Regulatory Pathway

The consolidation into a single UK-wide marketing authorisation streamlines the approval process for medicinal products, reducing administrative burdens and potential delays.

 

2. Strategic Considerations for SPC Applications

Pharmaceutical companies must ensure that their SPC applications are based on valid UK-wide authorisations. Reliance on obsolete centralised authorisations could jeopardise the validity of SPCs and associated market exclusivity.

 

3. Paediatric Extensions

For paediatric extensions to SPCs, the MHRA is now the sole authority. Companies must align their paediatric investigation plans and compliance statements with MHRA requirements to secure these extensions.

 

4. Supply Chain and Labelling Adjustments

All medicinal products placed on the UK market must bear the “UK Only” label, signifying their exclusivity to the UK market. This change necessitates updates to packaging and labelling processes to comply with the new regulations.

 

Conclusion

 

The reforms to the UK’s SPC regime represent a significant shift in the pharmaceutical regulatory landscape, aiming to harmonise the authorisation process and ensure consistent access to medicines across the UK. Businesses operating in this sector must adapt to these changes by reviewing their current authorisations, updating SPC applications, and aligning their regulatory strategies with the new framework. Proactive engagement with the MHRA and thorough understanding of the updated regulations will be crucial in navigating this transition effectively.

Lawble will continue to provide practical guidance to help UK businesses remain compliant and commercially competitive in a changing regulatory environment.