IV.C.1. Marketing authorisation holders in the EU

IV.C.1.1. Requirement to perform an audit

The marketing authorisation holder in the EU is required to perform regular risk-based audit(s) of their pharmacovigilance system [DIR Art 104(2)], including audit(s) of its quality system to ensure that the quality system complies with the quality system requirements [IR Art 8,10,11,12,13(1)]. The dates and results of audits and follow-up audits shall be documented [IR Art 13(2)].

See IV.C.2. for further details of the requirements for audit reporting by the marketing authorisation holder.

IV.C.1.1.1. The qualified person responsible for pharmacovigilance in the EU (QPPV)

The responsibilities of the QPPV in respect of audit are provided in GVP Module I. Furthermore, the QPPV should receive pharmacovigilance audit reports, and provide information to the auditors relevant to the risk assessment, including knowledge of status of corrective and preventive actions.

The QPPV should be notified of any audit findings relevant to the pharmacovigilance system in the EU, irrespective of where the audit was conducted.

IV.C.1.2. Competent authorities in Member States and the European Medicines Agency

IV.C.1.2.1. Requirement to perform an audit

The Agency shall perform regular independent audits of its pharmacovigilance tasks [REG Art 28f] and competent authorities in Member States shall perform a regular audit of their pharmacovigilance system [DIR Art 101(2)]. Included in their obligation to perform audits of their pharmacovigilance system/tasks, competent authorities in the Member States and the Agency shall perform risk-based audits of the quality system as well, at regular intervals according to a common methodology to ensure that the quality system complies with the requirements [IR Art 8,14,15,16,17(1)]. The dates and results of audits and follow-up audits shall be documented [IR Art 17(2)].

IV.C.1.2.2. Common methodology

In order to have a useful audit system, all audits at the competent authorities in the Member States and the European Medicines Agency should have a common ground in terms of methodology. This should ensure harmonised planning, implementation and reporting by every competent authority in Member States and at the Agency.

IV.C.1.2.3. The Pharmacovigilance Risk Assessment Committee (PRAC)

The mandate of the Pharmacovigilance Risk Assessment Committee (PRAC) shall cover all aspects of the risk management of the use of medicinal products for human use, having due regard to the design and evaluation of pharmacovigilance audits [REG Art 61a(6)].