The Role of the QPPV: Navigating Responsibilities and Challenges

In the dynamic world of pharmaceuticals, the Qualified Person for Pharmacovigilance (QPPV) is the cornerstone of patient safety. Whether in the UK or the EU, the QPPV plays a critical role in ensuring that medicinal products on the market are continuously monitored for safety risk and that regulatory obligations are met. This article focuses on the QPPV role overall, with specific insights into the UK QPPV role following regulatory changes brought by Brexit and the Windsor Framework.

What is a QPPV?

A QPPV is an individual who is legally responsible for the pharmacovigilance (PV) system of a Marketing Authorisation Holder (MAH). Their primary duty is to ensure that medicines are monitored effectively and that safety data is properly assessed and reported to regulators.

In the EU, the QPPV is mandated under EU Regulation 726/2004 and Directive 2001/83/EC.

In the UK, following Brexit, the requirement for a QPPV is outlined under the Human Medicines Regulations 2012 (as amended). Where a product is authorised for the Great Britain (England, Scotland, and Wales) market, the MAH must ensure that a UK QPPV or an EU QPPV is appointed depending on the type of marketing authorisation (UK-only or EU/NI). If the QPPV is not based in the UK, a UK National Contact Person for Pharmacovigilance (NCPPV) must also be designated.

Responsibilities of the EU and UK QPPV

While the responsibilities are largely aligned between the UK and EU, there are nuances:

• Maintaining the PV System Master File (PSMF) (EU and UK versions, where applicable)

• Oversight of signal detection and risk management activities

• Ensuring compliance with regulatory reporting (e.g., ICSRs, PSURs, DSURs)

• Being continuously available (or delegating to a deputy) to address urgent safety concerns

• Ensuring the company’s PV system is inspection-ready

The Unique Role of the UK QPPV

Since Brexit, UK QPPVs and MAHs must:

• Ensure that a UK-based QPPV or EU-based QPPV (depending on the licence) is appointed, with a UK NCPPV if required.

• Ensure that Northern Ireland reporting follows EU pharmacovigilance rules under the Windsor Framework (dual reporting to both MHRA and EudraVigilance for NI)

• Maintain a separate UK-specific PSMF, held at a UK-based location

Challenges Facing Today’s QPPVs

With regulatory frameworks diverging between the EU and UK, QPPVs face increased complexity, including:

• Navigating dual regulatory requirements for products supplied to both the EU and UK markets

• Managing duplicate reporting obligations (e.g., expedited ICSRs to both the MHRA and EudraVigilance)

• Increased demand for cross-functional collaboration with clinical, regulatory, and quality teams

• Keeping pace with signal detection requirements in an evolving pharmacovigilance landscape

Conclusion

The QPPV is not just a regulatory requirement; it is a key figure in safeguarding public health and maintaining the integrity of the company’s safety system. Whether managing EU, UK, or dual responsibilities, the QPPV’s role has never been more crucial.

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If you have questions about QPPV responsibilities or need support with pharmacovigilance activities, feel free to contact me at amanda@drugsafetyservices.co.uk or connect via LinkedIn.