The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published (20 December 2024) updated guidance "Variations to Marketing Authorisations (MAs)" outlining the procedures and requirements for variations to marketing authorisations (MAs) in the UK. This guidance applies to medicinal products marketed within the UK and incorporates updates reflecting the Windsor Framework and other post-Brexit regulatory adjustments.
A Variation refers to a change to the terms of a marketing authorisation (MA), including changes to the product's manufacturing process, labelling, or safety information. The variation process ensures that any modifications comply with the high quality, safety, and efficacy standards required for medicinal products.
The guidance is divided into variations for:
UK Marketing Authorisations (UK MAs)
European Union (EU) Authorisations affecting Northern Ireland.
Key Updates (December 2024):
Removal of outdated Brexit-related information.
Inclusion of Windsor Framework provisions.
Updated contact information for MHRA assistance.
Variations to UK MAs are classified into three categories:
Type IA (Minor Variation):
Minimal impact on quality, safety, or efficacy (e.g., administrative updates).
Notification must be submitted within 12 months of implementation.
Type IB (Moderate Variation):
Potential impact on safety, efficacy, or quality, requiring MHRA review.
Approval must be obtained before implementation.
Type II (Major Variation):
Significant changes requiring extensive assessment (e.g., adding new indications).
Applications must be submitted via the MHRA Submissions Portal using the appropriate template. eCTD (Electronic Common Technical Document) format is mandatory for submissions. Variation fees are based on the complexity of the changes and can be found on the MHRA website.
Under the Windsor Framework, medicinal products marketed in Northern Ireland remain subject to EU regulations. The guidance specifies:
Variations for products in Northern Ireland must comply with EU Regulation No. 1234/2008.
Separate submissions may be required for Great Britain (GB) and Northern Ireland (NI).
The guidance addresses transitional provisions for variations submitted before 1 January 2025:
Pending variations will be assessed under the updated regulatory framework.
Sponsors may need to update their applications to align with current requirements, particularly for products transitioning from EU to UK regulatory frameworks.
Sponsors are encouraged to engage with MHRA early during the variation process for classification, submission, and evaluation guidance. For more details and full guidance, visit the MHRA website.
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