SOP: EU-QPPV and Back-up Coverage

This Standard Operating Procedure (SOP) template describes the roles, responsibilities, and oversight of the EU Qualified Person for Pharmacovigilance (EU-QPPV) and the procedures ensuring continuous availability of the EU-QPPV in accordance with EU pharmacovigilance legislation.
 
The template provides a structured framework to ensure that the Marketing Authorisation Holder maintains appropriate pharmacovigilance oversight and regulatory compliance within the EU/EEA.
 
The SOP includes procedures covering key elements such as:
EU-QPPV roles and responsibilities
EU-QPPV registration in EudraVigilance
Oversight of the pharmacovigilance system
Continuous 24/7 availability of the EU-QPPV
Availability testing and documentation
Delegation of pharmacovigilance tasks
Appointment and responsibilities of the Deputy QPPV (dQPPV)
Procedures for back-up coverage during planned or unplanned absence
 
The procedure ensures that the EU-QPPV remains continuously available as the primary pharmacovigilance contact point for regulatory authorities and supports compliance with EU Good Pharmacovigilance Practice (GVP) requirements.
OZQA_EU-QPPV and back-up covera…
 
Typical use cases
Establishing procedures for EU-QPPV oversight and governance
Implementing EU GVP-compliant pharmacovigilance systems
Preparing for PV inspections by EU competent authorities
Supporting Marketing Authorisation Holders operating in the EU
 
Document format
Editable template provided in Word format, allowing easy customization to fit the company’s pharmacovigilance system and internal procedures.