UK – Good pharmacovigilance practice

Comply with good pharmacovigilance practice and prepare for an inspection.

Overview

Good Pharmacovigilance Practice (GPvP) is the minimum standard for monitoring the safety of medicines on sale to the public in the EU.

MHRA inspects marketing authorisation holders (MAH) to determine that they comply with pharmacovigilance obligations established within the EU. We have been conducting statutory GPvP inspections since 2003, and any UK MAH or marketing authorisation applicant (for any authorisation procedure) can be subject to GPvP inspection by MHRA, which may also include any of their partners or service providers.

If pharmacovigilance activities are performed outside the UK, MHRA may ask company personnel from other country sites to participate in an inspection at a UK site and/or may request inspectorates in other member states of the EU to perform an inspection at site(s) in their country or to share results from recent inspections.

Types of inspection

Inspections are typically scheduled by pharmacovigilance system than by MAH. A pharmacovigilance system is defined as the system used by an organisation to fulfil its legal tasks and responsibilities in relation to pharmacovigilance and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.

If a group of associated MAHs share the same pharmacovigilance system, all MAHs may be included within the scope of a single inspection of that pharmacovigilance system. Conversely, if an MAH operates more than one pharmacovigilance system, we usually review these through separate inspections…