Commission Implementing Regulation (EU) No 520/2012Show full title

Section 1 General provisions

Article 8 Quality system

1. Marketing authorisation holders, the national competent authorities and the Agency shall establish and use a quality system that is adequate and effective for the performance of their pharmacovigilance activities.

2. The quality system shall cover organisational structure, responsibilities, procedures, processes and resources, appropriate resource management, compliance management and record management.

3. The quality system shall be based on all of the following activities:

(a) quality planning: establishing structures and planning integrated 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 being carried out;

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

4. All elements, requirements and provisions adopted for the quality system shall be documented in a systematic and orderly manner in the form of written policies and procedures, such as quality plans, quality manuals and quality records.

5. All persons involved in the procedures and processes of the quality systems established by the national competent authorities and the Agency for the performance of pharmacovigilance activities shall be responsible for the good functioning of those quality systems and shall ensure a systematic approach towards quality and towards the implementation and maintenance of the quality system.

Article 9 Performance indicators

1. The marketing authorisation holder, national competent authorities and the Agency may use performance indicators to continuously monitor the good performance of pharmacovigilance activities.

2. The Agency may publish a list of performance indicators on the basis of a recommendation of the Pharmacovigilance Risk Assessment Committee.