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
- Directive 2001/82/EC
- Rules Governing Medicinal Products in the European Union (section 2 of the Volume 9B)
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.