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:

Legislation and further guidance

Human medicines

Veterinary medicines

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