Chapter 2, Article 4 · Commission Implementing Regulation (EU) 2021/1281

Contents

Article 4Quality management system for pharmacovigilance#

1.Marketing authorisation holders shall establish and implement an adequate and effective quality management system for the performance of their pharmacovigilance activities.

2.The quality management system shall be described in the pharmacovigilance system master file.

3.Marketing authorisation holders shall ensure that the quality management system includes detailed policies, processes and procedures on document management, training, audits, and change management covering the activities in accordance with Articles 5 to 9. Those policies, processes and procedures shall provide for a review of the quality management system at regular risk-based intervals, based on pre-defined criteria.

4.Marketing authorisation holders shall ensure that the quality management system includes detailed policies, processes and procedures for the record management system and data collection in accordance with Articles 10 to 15, for the following pharmacovigilance activities:

(a)initial recording of any suspected adverse event;

(b)collection of additional data;

(c)collation of reports of suspected adverse events and additional data;

(d)data handling other than mentioned in points (a) to (c);

(e)evaluation of data;

(f)monitoring of quality, integrity and completeness of all information registered in the pharmacovigilance system including information reported to the Union pharmacovigilance database and management of duplicates;

(g)recording of any adverse event in the Union pharmacovigilance database;

(h)archiving of all relevant documents.

5.Marketing authorisation holders shall ensure that the quality management system includes detailed policies, processes and procedures for risk management, monitoring of the benefit-risk balance, signal management and communication to all relevant stakeholders in accordance with Articles 16 to 20.

6.Marketing authorisation holders shall ensure that the quality management system includes detailed policies, processes and procedures for the maintenance and availability of the pharmacovigilance system master file in accordance with Articles 24 and 25.

7.Marketing authorisation holders shall clearly define the roles and responsibilities of those persons involved in pharmacovigilance activities and in documentation in accordance with paragraphs 3 to 6 of this Article.

8.Marketing authorisation holders shall set up a quality management system using the following:

(a)quality planning: establishing structures, integrated planning and consistent processes;

(b)quality adherence: carrying out tasks and responsibilities in accordance with quality requirements;

(c)quality control and assurance: monitoring and evaluating how effectively the structures and processes have been established and how effectively the processes are implemented;

(d)quality improvements: correcting and improving the structures and processes where necessary.