Article 13: Audit

1.   Marketing authorisation holders shall perform risk-based audits of the quality system at regular intervals to ensure that it complies with the requirements set out in Articles 8, 10, 11 and 12 and to determine its effectiveness. The audits shall, individually or taken together, cover all pharmacovigilance activities for a defined period and verify those activities’ conformity with the policies, processes and procedures of the quality system. Those audits shall be conducted by individuals who have no direct involvement in or responsibility for the matters or processes being audited.

1a.   Any third party subcontracted to conduct pharmacovigilance tasks in whole or in part on behalf of or in conjunction with marketing authorisation holders shall be audited by or on behalf of marketing authorisation holders taking into account the risk of the subcontracted activity and may be inspected by the competent authorities, even if the obligation pursuant to Article 6(3) has not yet been included in the subcontract.

2.   Corrective action(s), including a follow-up audit of deficiencies, shall be taken where necessary. A report on the results of the audit shall be drawn up for each audit and follow-up audit. The audit report shall be sent to the management responsible for the matters audited. The dates and results of audits and follow-up audits shall be documented in accordance with the second subparagraph of Article 104(2) of Directive 2001/83/EC.