Chapter 3, Article 10 · Commission Implementing Regulation (EU) 2021/1281

Contents

Article 10Record management system#

1.The document management system referred to in Article 5 shall include a record management system for receiving, recording, collating and assessing information on adverse events and for recording safety information.

2.The description of the record management system for recording adverse events and safety information in Section D of the pharmacovigilance system master file shall include the following information:

(a)type of record management system used for adverse event reports, including the name of the database used, if applicable;

(b)location where the record management system is kept;

(c)description of functionality of the record management system;

(d)operational responsibility of the personnel responsible for the record management system;

(e)summary of the assessment of its fitness for purpose.

3.Marketing authorisation holders may use the Union pharmacovigilance database as their electronic record management system for recording adverse events. In that case, Section D of the Pharmacovigilance system master file shall indicate that the record management system being used is the Union pharmacovigilance database.

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.