IV.C.2. Requirements for audit reporting in the EU

IV.C.2.1. Reporting by the marketing authorisation holder

The marketing authorisation holder shall place a note concerning critical and major audit findings of any audit relating to the pharmacovigilance system in the pharmacovigilance system master file (PSMF) (see GVP Module II). Based on the audit findings, the marketing authorisation holder shall ensure that an appropriate plan detailing corrective and preventative action is prepared and implemented. Once the corrective and preventive actions have been fully implemented, the note may be removed [DIR Art 104(2), IR Art 13(2)]. Objective evidence is required in order that any note of audit findings can be removed from the pharmacovigilance system master file (see GVP Module II).

The marketing authorisation holders should ensure that a list of all scheduled and completed audits is kept in the annex to the pharmacovigilance system master file (IR Art 3(5)) and that they comply with reporting commitments in line with the legislation, GVP guidance and their internal reporting policies. The dates and results of audits and follow-up audits shall be documented [IR Art 13(2)].

IV.C.2.2. Reporting by competent authorities in Member States and the Agency

Competent authorities in Member States, and the Agency should ensure that they comply with reporting commitments in line with the legislation, GVP guidance and their internal reporting policies.

Competent authorities in Member States shall report the results [of their pharmacovigilance system audits] to the Commission on 21 September 2013 at the latest and then every 2 years thereafter [DIR Art 101(2)].

The Agency shall report the results [of its pharmacovigilance system audits] to its Management Board on a 2-yearly basis [REG Art 28f].

The reports to the European Commission will follow an agreed format.