Local Pharmacovigilance Specifics in the UK align closely with the EU’s Good Pharmacovigilance Practices (GVP), while incorporating specific adaptations to cater to the UK’s distinct regulatory environment. This article outlines the critical elements that Marketing Authorisation Holders (MAHs) need to understand and implement to ensure compliance with UK-specific PV requirements.
General Pharmacovigilance Operations
MAHs must submit a range of safety reports to the Medicines and Healthcare products Regulatory Agency (MHRA), which is the primary regulatory body overseeing pharmacovigilance in the UK. Key reports include:
- Individual Case Safety Reports (ICSRs)
- Periodic Safety Update Reports (PSURs)
- Risk Management Plans (RMPs)
- Post-Authorisation Safety Studies (PASS) protocols and reports
ICSRs Submission
For products marketed in the UK, MAHs are required to submit both serious and non-serious ICSRs to the MHRA through the MHRA Gateway or the ICSR Submissions portal. For products marketed in Northern Ireland, MAHs must comply with EU requirements, submitting ICSRs to the Eudravigilance database using the specific country codes “XI” for Northern Ireland or “GB” for Great Britain.
Signal Detection and Management
MAHs must establish and maintain effective systems for detecting and managing safety signals. These systems should enable the identification of potential new safety issues from various data sources. The MHRA conducts its own signal assessments and requires MAHs to report any new information that may impact the marketing authorization. Notably, emerging safety issues must be reported to the MHRA within three working days.
Risk Management Plans (RMPs)
RMPs must follow the EU template and be regularly updated as new safety concerns arise. The MHRA accepts EU-approved RMPs but may require the inclusion of UK-specific annexes. New or updated RMPs should be submitted through the appropriate regulatory procedure, and any educational materials included in these plans must receive MHRA approval before implementation.
Periodic Safety Update Reports (PSURs)
PSURs must be submitted in accordance with the EU Reference Date (EURD) list. While a single PSUR can be submitted to both the MHRA and the EU, any UK-specific information should be included in an annex. PSURs for products marketed exclusively in Great Britain must be submitted via the MHRA PSUR portal, whereas those for Northern Ireland should be submitted to the EU PSUR repository.
Post-Authorisation Safety Studies (PASS)
Non-interventional PASS, whether imposed or voluntary, must be submitted to the MHRA. Protocols for imposed studies require prior MHRA approval, and final study reports must be submitted within 12 months of data collection completion. The fees for these submissions vary depending on whether the studies are UK-only or also involve the EU.
Safety Referrals
UK products, including those in Northern Ireland, remain subject to EU referral procedures. MAHs must implement the outcomes of these referrals via the appropriate variation procedures to ensure alignment with both UK and EU regulatory requirements.
Conclusion
Ensuring compliance with the UK’s pharmacovigilance requirements necessitates a thorough understanding and integration of both EU and UK-specific regulations. By adhering to these guidelines, MAHs can guarantee the safety and efficacy of their products in the UK market.
For detailed guidance and updates, where MAHs do not have any internal local resources, we recommend having the national contact person for pharmacovigilance.
