Chapter 2, Article 8 · Commission Implementing Regulation (EU) 2021/1281

Contents

Article 8Audits#

1.Marketing authorisation holders shall perform audits of the pharmacovigilance system at regular risk-based intervals to ensure that it complies with the requirements set out in this Regulation and to determine its effectiveness. The audits shall be planned to cover all pharmacovigilance activities for a defined period and verify their conformity with the policies, processes and procedures of the quality management system. They shall be conducted by individuals who have no direct involvement in or responsibility for the matters or processes audited.

2.Any third party contracted to carry out pharmacovigilance activities in whole or in part, on behalf of or in conjunction with marketing authorisation holders, shall accept to be audited by or on behalf of marketing authorisation holders.

3.Marketing authorisation holders shall draw up a risk-based schedule for auditing. The process for risk-based planning shall be described and the rationale for the risk-based schedule shall be documented. A list of scheduled and completed audits, including outstanding critical and major findings, shall be documented in Annex IV, point (ii) to the pharmacovigilance system master file.

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Defined terms · 3

Show every defined term

performance indicator
means an item of information collected at regular intervals to monitor the performance of a system;
quality management system
means a formalised system that provides for comprehensive processes, procedures, and responsibilities for achieving quality policies and objectives to coordinate and direct an organisation’s activities and improve its effectiveness and efficiency in this regard on a continuous basis;
signal
means information that arises from one or multiple sources, including observations and experiments, which suggests a potentially new causal association, or a new aspect of a known causal association between an intervention and an adverse event or a set of related adverse events, that is judged likely to justify further investigation of possible causality.