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.

EMA role

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

Marketing authorisation holders and applicants need to use EMA's IRIS system to communicate with EMA on GVP inspections requested by the Agency’s scientific committees.

Using IRIS for GVP inspections improves efficiency by harmonising and automating processes and re-using master data held by EMA. It also simplifies retrieving and reporting data.

More information on the use of EMA's IRIS system:

Human Pharmacovigilance inspections: questions and answers

EMA and the Pharmacovigilance Inspectors Working Group provide 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.


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