This blog features:
- A comprehensive overview of Brexit
- Its impact on various sectors
- Significant changes in pharmacovigilance observed in the UK following Brexit
Table of Contents:
- Introduction
- The overall impact of Brexit
- Key changes in PV Post-Brexit
- Key takeaways
- Conclusion
- Abbreviations
- References
Introduction:
In this specialized regulatory blog, we explore the impact of Brexit, marking the UK’s withdrawal from the European Union (EU).
Specifically, we delve into regulatory changes and their implications for pharmacovigilance following this significant event.
The overall impact of Brexit
Brexit led to the creation of a new trade deal known as the EU-UK Trade and Cooperation Agreement (TCA).
This change was anticipated to significantly affect trade flows between the EU and the United Kingdom, as well as migration, foreign direct investment, regulations, the financial sector, science, education, and other aspects of the UK economy.
From the UK’s perspective, it transitioned to becoming a third country outside the EU. This shift inevitably brought about new pharmaceutical regulations with certain restrictions and adjustments.
The persistent uncertainty surrounding Brexit has raised concerns within the pharmaceutical industry, healthcare professionals, and patient communities, impacting supply chains significantly due to the UK no longer being a member of the European Medicines Agency (EMA).
“Brexit has not only divided the economy but also set the political compass adrift, leaving the UK navigating a solitary path through uncertain woods.”
Key changes in PV Post-Brexit
- The MHRA now makes independent regulatory decisions in Great Britain, shaping the UK legal framework.
- EU Good Vigilance Practices (GVP) continue to apply in the UK, with specific exceptions and modifications outlined in MHRA guidance.
- All companies holding Marketing Authorisations in the UK (GB and/or NI) must register via the MHRA Submissions Portal.
- UK (including NI) ICSRs (both serious and non-serious) and serious non-UK ICSRs must be submitted through the new MHRA Gateway or ICSR Submissions Portal.
- ICSRs originating from Northern Ireland should indicate the country code ‘XI’ and adhere to EU requirements for submission to the EudraVigilance database.
- This distinction ensures compliance, especially regarding the movement of licensed products across the NI/Ireland border despite the UK being a third country.
- Third-country reporting rules apply to all UK (including NI) clinical trial SUSAR cases, with the country code ‘GB’ used for all reportable UK SUSARs.
- Some Marketing Authorisation Holders (MAHs) have experienced challenges with ICSR submissions via MHRA systems; the MHRA offers support and updates guidance promptly.
- Effective January 1st, 2021, the MHRA assumed full responsibility for Pharmacovigilance.
- GB cases encompass England, Wales, and Scotland, adhering to UK regulations, while NI follows EU requirements.
- Regarding the Qualified Person for Pharmacovigilance (QPPV), residency within the UK or EU is mandatory. MAHs outside these regions must appoint a national contact person for pharmacovigilance.
- The national contact person operates locally and reports to the QPPV.
Key takeaways
- Regulatory Independence: Since Brexit, the MHRA autonomously makes regulatory decisions for Great Britain.
- Continued Application of EU GVP: UK follows EU Good Vigilance Practices (GVP) with MHRA-adapted guidelines to align with EU standards where applicable.
- Registration Mandate: All companies with Marketing Authorisations in Great Britain and/or Northern Ireland must register via the MHRA Submissions Portal.
- Regional Alpha Codes: Great Britain uses ‘GB’ and Northern Ireland uses ‘NI’ as unique alpha codes.
- Regional Compliance: England, Wales, and Scotland adhere to UK regulations, while Northern Ireland aligns with EU requirements.
- QPPV Requirement: The Qualified Person for Pharmacovigilance (QPPV) must reside in the UK to fulfill their responsibilities.
Conclusion
This informative blog aims to clarify recent regulatory changes following Brexit, focusing on their impact on pharmacovigilance processes.
We highlight significant developments while acknowledging areas where changes are still evolving.
Your thoughts and comments on these regulatory shifts are welcome below.
Abbreviations:
- GB: Great Britain
- NI: Northern Ireland
- GVP: Good Vigilance Practice
- EU: European Union
- QPPV: Qualified Person For Pharmacovigilance
- MHRA: Medicines and Healthcare products Regulatory Agency
- MAH: Marketing Authorisation Holder
- SUSAR: Suspected Unexpected Serious Adverse Reactions
- EMA: European Medicines Agency
- TCA: Trade and Cooperation Agreement
Leave a Reply