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

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.
Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(t) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)