CHAPTER II

Minimum requirements for the quality systems for the performance of pharmacovigilance activities
Section 3

Minimum requirements for the quality systems for the performance of pharmacovigilance activities by national competent authorities and the Agency

Management of human resources
Article 14
1
The national competent authorities and the Agency shall have sufficient competent and appropriately qualified and trained personnel available for the performance of pharmacovigilance activities.
The organisational structures and the distribution of tasks and responsibilities shall be clear and, to the extent necessary, accessible. Contact points shall be established.
2
All personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training. The national competent authorities and the Agency shall keep training plans and records for documenting, maintaining and developing the competences of personnel and shall make them available for audit.
3
Appropriate instructions on the processes to be used in case of urgency, including business continuity, shall be provided by the national competent authorities and by the Agency to their personnel.

Compliance management
Article 15
1
The national competent authorities and the Agency shall establish specific procedures and processes in order to achieve all of the following objectives:
a
ensuring the evaluation of the quality, including completeness, of pharmacovigilance data submitted;
b
ensuring the assessment of pharmacovigilance data and its processing within the timelines provided by Directive 2001/83/EC and Regulation (EC) No 726/2004;
c
ensuring independence in the performance of pharmacovigilance activities;
d
ensuring effective communication among national competent authorities and between the national competent authorities and the Agency as well as with patients, healthcare professionals, marketing authorisation holders and the general public;
e
guaranteeing that the national competent authorities and the Agency inform each other and the Commission of their intention to make announcements relating to the safety of a medicinal product authorised in several Member States or an active substance contained in such a medicinal product in accordance with Article 106a of Directive 2001/83/EC;
f
conducting inspections, including pre-authorisation inspections.
2
In addition to the procedures referred to in paragraph 1, national competent authorities shall establish procedures for collecting and recording all suspected adverse reactions that occur in their territory.
3
The Agency shall establish procedures for the monitoring of medical literature in accordance with Article 27 of Regulation (EC) No 726/2004.

Record management and data retention
Article 16
1
The national competent authorities and the Agency shall record all pharmacovigilance information and ensure that it is handled and stored so as to allow for accurate reporting, interpretation and verification of that information.
They shall put in place a record management system for all documents used for pharmacovigilance activities that ensures the retrievability of those documents as well as the traceability of the measures taken to investigate safety concerns, of the timelines for those investigations and of decisions on safety concerns, including their date and the decision-making process.
2
The national competent authorities and the Agency shall arrange for the essential documents describing their pharmacovigilance system to be kept for at least five years after the system has been formally terminated.
Pharmacovigilance data and documents relating to individual authorised medicinal products shall be retained as long as the product is authorised and for at least 10 years after the marketing authorisation has expired. However, the documents shall be retained for a longer period where Union law or national law so requires.

Audit
Article 17
1
Risk-based audits of the quality system shall be performed at regular intervals according to a common methodology to ensure that the quality system complies with the requirements set out in Articles 8, 14, 15 and 16 and to ensure its effectiveness.
2
Corrective action, including a follow-up audit of deficiencies, shall be taken where necessary. 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.