Following the UK’s withdrawal from the EU and the Windsor Framework, new guidance outlines modifications to EU pharmacovigilance rules for UK Marketing Authorisation Holders (MAHs) and the licensing authority.
Key Updates:
- Duplicate Management: MAHs must collaborate with regulators to handle duplicate adverse reaction reports.
- Periodic Safety Update Reports (PSURs): A UK regional appendix is required, with UK-specific submission dates for Category 1 products.
- Data Protection: Compliance with UK data protection laws is mandatory.
- Language Requirements: Expected adverse reactions must be reported in English, with summaries for non-English reports.
- Signal Management: Product information must be updated based on scientific and regulatory recommendations.
- Pharmacovigilance System Master File (PSMF): Must detail UK-specific pharmacovigilance processes, computerized systems, and performance metrics.
These modifications ensure alignment with UK regulations while maintaining pharmacovigilance standards.
Region: European Union
Source: https://www.gov.uk/government/publications/exceptions-and-modifications-to-the-eu-guidance-on-good-pharmacovigilance-practices-that-will-apply-to-uk-mahs-and-the-mhra#full-publication-update-history
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