UK Pharmacovigilance Services

UK Local Contact Person for Pharmacovigilance

The Local Contact Person for Pharmacovigilance (LCPPV) in UK meets the national obligations of the MAH for UK Marketing Authorisations (MAs) where an EU Qualified Person for Pharmacovigilance (QPPV) is also in place. Integral Pharma Solutions covers all UK LCPPV responsibilities:
• Primary point of contact for the MHRA on PV matters in the UK.
• Ensuring timely reporting of adverse drug reactions (ADRs) to the MHRA.
• Oversight of localised implementation of risk management plans and safety communication requirements.
• Up-to-date knowledge of UK-specific PV regulations.
• Preparation and leading MHRA PV inspections.
• Training UK-based employees in PV procedures and requirements.

UK Qualified Person for PV (QPPV) and UK PV System

The UK Qualified Person for Pharmacovigilance (UK QPPV) holds ultimate responsibility for ensuring that the company’s pharmacovigilance (PV) system complies with all legal and regulatory requirements for UK Marketing Authorisations (MAs). Integral Pharma Solutions provides full UK QPPV services, including end-to-end management of the UK Pharmacovigilance System Master File (PSMF):
• Creation and oversight of end-to-end UK pharmacovigilance system to ensure continuous regulatory compliance.
• Full lifecycle management of the UK PSMF, including creation, maintenance, and regular updates to reflect system changes, activities, and compliance metrics.
• Coordination and validation of safety data collection, evaluation, and timely submission of adverse drug reaction (ADR) reports to the MHRA.
• Development and implementation of risk management plans and safety communication strategies tailored to the UK market.
• In-depth and up-to-date knowledge of UK-specific pharmacovigilance legislation and MHRA expectations.
• Preparation for and leadership during MHRA PV inspections, including audit readiness and corrective/preventive actions.
• Training and support for UK-based staff to ensure adherence to current pharmacovigilance procedures and regulatory obligations.

We also offer a full EU and UK Marketing Authorisation Holder service covering all elements of Pharmacovigilance, Regulatory and Quality Assurance, so get in touch to see how we can free-up your team to focus on growth.