UK Pharmacovigilance: QPPV and PSMF Obligations for Marketing Authorisation Holders

Introduction and Legal Basis

Marketing authorisation holders (MAHs) for UK authorised medicinal products must operate a pharmacovigilance system, appoint a Qualified Person for Pharmacovigilance (QPPV), and maintain a Pharmacovigilance System Master File (PSMF). These obligations are set out in regulation 182 of the Human Medicines Regulations 2012 (HMR), as amended. For Category 1 MAs and PLGB licences, requirements mirror those in Schedule 12A of the HMR; for Category 2 MAs and PLNIs, they align with retained EU provisions such as Commission Implementing Regulation (EU) No 520/2012. Statutory guidance is provided in Good Pharmacovigilance Practices (GVP) Modules I and II, with UK-specific exceptions and modifications. The guidance was last updated on 8 January 2025 to reflect Windsor Framework considerations for Category 1 and 2 products. Guidance on qualified person responsible for pharmacovigilance (QPPV), including pharmacovigilance system master files (PSMF) - GOV.UK

Qualified Person for Pharmacovigilance (QPPV)

All UK MAHs must have a permanently and continuously available QPPV who resides and operates in the UK or EU/EEA and is responsible for establishing and maintaining the pharmacovigilance system for UK authorised products.

Qualifications and Responsibilities

The QPPV must possess the necessary qualifications and experience as outlined in Article 10 of Commission Implementing Regulation (EU) No 520/2012 (for Category 2) or paragraph 10 of HMR Schedule 12A (for Category 1/PLGB, mirroring the EU article). Detailed responsibilities are covered in GVP Module I.

Residency and Location

The QPPV must reside and operate in the UK or EU/EEA; there is no temporary exemption from this requirement.

National Contact Person

If the QPPV is based in the EU/EEA (not UK), the MAH must nominate a national contact person for pharmacovigilance residing and operating in the UK. This person reports to the QPPV, has access to adverse reaction reports and the PSMF, and facilitates MHRA responses, including during inspections. Notify the national contact person's details via the MHRA Submissions Portal. For absences exceeding one month, assign a replacement and notify within 2 weeks by updating the portal entry. Guidance on qualified person responsible for pharmacovigilance (QPPV), including pharmacovigilance system master files (PSMF) - GOV.UK

Notification of QPPV Changes

Changes to QPPV details (e.g., name, contact) must be notified within 14 days via a UK-only Summary of the Pharmacovigilance System (SPS) update through the MHRA Submissions Portal (Agency Activity Reference ID G0109, Subactivity H002). Submit a cover letter (PDF), SPS update notification form (Excel), and updated SPS (PDF) including proof of QPPV qualifications, residency country, contact details, signed statement on resources to fulfil tasks, PSMF location, and UK PSMF number. No fee applies; processing occurs within 30 days.

Pharmacovigilance System Master File (PSMF)

MAHs must maintain a PSMF describing the pharmacovigilance system for UK authorised products, accessible electronically from the UK at the same location as adverse reaction reports.

Contents and Format

The PSMF must accurately represent the system (including global aspects and safety information availability) and be up to date when requested by the MHRA. Content and format mirror Chapter I of Commission Implementing Regulation (EU) No 520/2012 (Category 2/PLNI) or Part 1 of HMR Schedule 12A (Category 1/PLGB). Guidance is in GVP Module II, with UK modifications. A single PSMF can cover multiple products if the system is the same; shared systems among MAHs are permitted. Guidance on qualified person responsible for pharmacovigilance (QPPV), including pharmacovigilance system master files (PSMF) - GOV.UK

Location and Accessibility

The PSMF must be electronically accessible from a UK site (same as adverse reaction reports), permanently and immediately available for inspection. The access address must be in the UK.

Requesting a UK PSMF Number

Request a unique UK PSMF number via the MHRA Submissions Portal for each pharmacovigilance system covering UK products (single request for shared systems). The number is assigned immediately by email; contact if delayed. The number remains valid despite changes (e.g., QPPV updates) unless ownership changes.

Updates and Notifications

Notify PSMF location changes via SPS update (as for QPPV). For ownership changes, include in the change of ownership dossier (module 1.8.1) or submit Type IA(IN) variation within 14 days post-grant. Other PSMF number changes require Type IA(IN) variation within 14 days.

Practical Considerations for MAHs

Non-UK based MAHs must comply with residency rules and appoint a UK national contact if needed. A single PSMF suffices for shared/global systems. For MA applications, include SPS details (QPPV proof, residency, contacts, signed statement, PSMF location/number) in the electronic application form. Contact gpvpinspectors@mhra.gov.uk for queries. The guidance supports post-Brexit arrangements, including Windsor Framework alignment for Northern Ireland products. Guidance on qualified person responsible for pharmacovigilance (QPPV), including pharmacovigilance system master files (PSMF) - GOV.UK