Coordination of Pharmacovigilance inspections

This content applies to human and veterinary medicines.

Pharmacovigilance inspections are conducted to ensure that requirements for monitoring the safety of medicines are met. The responsibility for carrying out the inspections rests with the national competent authorities.

Role of the European Medicines Agency

The European Medicines Agency (EMA) plays an important role in the harmonisation and coordination of pharmacovigilance (PhV) inspections at the Union level. It is involved in:

  • preparing a risk based programme of routine PhV inspections in relation to centrally authorised products (CAPs);
  • co-ordinating PhV inspections requested by the Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use;
  • preparing new and revised guidance on PhV inspection, through the work of the PHV Inspections Working Group;
  • coordinating advice on the interpretation of PhV requirements and related technical issues;
  • developing of European Union-wide guidelines relating to PhV inspections.

Legislation and further guidance

Human medicines

Veterinary medicines

Human Pharmacovigilance inspections: questions and answers

The European Medicines Agency (EMA) and the Pharmacovigilance Inspectors Working Group provides guidance on human pharmacovigilance obligations in the form of questions and answers (Q&As).

These Q&As are based on the Pharmacovigilance Inspectors Working Group's interpretation of pharmacovigilance legislation.

Level of validation/qualification needed to be performed by a MAH when using an electronic system previously qualified by a provider and what documentation is required to be available for inspections

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