CHAPTER II

Minimum requirements for the quality systems for the performance of pharmacovigilance activities
Section 1

General provisions

Performance indicators
Article 9
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.
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)