Qualified Person Responsible for Pharmacovigilance (QPPV) in the UK & EU

Do you know? As per the EU Regulation 2025/1466 and evolving signal-monitoring expectations, accountability of the Qualified Person Responsible for Pharmacovigilance (QPPV) towards EudraVigilance monitoring, PSMF data accuracy, audit-readiness, etc., is becoming significant and mandatory. On the other hand, MHRA’s recent GPvP inspections highlight weaknesses in risk management and gaps in reference safety information, where the QPPVs should be more visible.

Both scenarios discussed above emphasize the evolving role of QPPV in the UK and the EU and how it blends with regulatory accountability, procedural oversight, and the strategic factors that influence drug safety decisions. Given that, who is QPPV in actual terms? Is there any difference between QPPV, EU QPPV, and Local QPPV?​

QPPV Vs. EU QPPV Vs. Local QPPV

• QPPV – A QPPV is an individual responsible for establishing and maintaining a pharmacovigilance system for a company. Collating, analysing, and reporting safety data of all authorized products comes under the purview of a QPPV.

• • A QPPV is also accountable for the timely submission of various Pharmacovigilance documents, including ICSRs, PSURs, PBRERs, RMPs, and related documents.
  • As per Module I in GVP, QPPV is positioned as the owner of PV system oversight and benefit–risk thinking. But in the UK and EU, it goes beyond signing cover pages of PSMF.
• EU QPPV – For all authorized products in the EU/EEA, the EU QPPV serves as the legally accountable safety lead. He is a primary contact available 24/7 and owns the PSMF documentation and accuracy, and ensures it is followed across organizations and vendors.
• Local QPPV – Often referred to as LRP-PV, LPPV, or national PV contact, a local QPPV oversees operations at the country level. Reporting to the EU QPPV, a Local QPPV checks whether the global processes align with national legislation, thereby ensuring meticulous implementation. The responsibilities typically include language checks, literature monitoring, alignment with national authority expectations, and healthy interactions with the authority.   ​​

Regulatory expectations – UK-authorized Products Vs. EU-authorized Products 

UK‑authorised products:

• An MAH (Marketing Authorisation Holder) must have a QPPV that resides and operates in the UK or EU/EEA
• If the QPPV is outside the UK, a UK‑based national PV contact is a must-have.
• The UK PSMF must be electronically accessible from the UK and accurately describe the global PV system as it relates to UK products.​

EU‑authorised products:

• The EU QPPV must be located in the EEA, and should be accessible at all times.
• EU QPPV should be clearly linked to a PSMF that reflects the EU PV system, including shared systems and multiple MAHs where relevant. ​​​

With the responsibilities and regulatory expectations clearly set out, it might seem that acting as a QPPV is a cakewalk, but in real life, making it work requires facing many pragmatic setbacks. Right from designing PV governance around the QPPV to establishing a robust LPPV/local QPPV network, it is recommended to navigate strategic partnerships with experienced QPPV service providers who don’t see it as a checklist activity but treat it as a leadership mandate for end-to-end compliance.