Regulation 179 Obligation on licensing authority to operate pharmacovigilance system

(1)

The licensing authority must operate a pharmacovigilance system F1in relation to medicinal products for sale or supply in Great Britain.

F2(1A)

The licensing authority must operate a pharmacovigilance system in relation to medicinal products for sale or supply in Northern Ireland.

(2)

F3Each pharmacovigilance system must in particular enable the collection of information on the risks that medicinal products present to patients' health or public health, including information on—

(a)

adverse reactions in humans arising from use of a medicinal product (irrespective of whether the use was within the terms of an authorisation or registration); and

(b)

adverse reactions associated with occupational exposure.

(3)

The licensing authority must on an ongoing basis—

(a)

evaluate scientifically the information collected under F4each pharmacovigilance system;

(b)

consider options for minimising and preventing risks presented by medicinal products; and

(c)

take appropriate regulatory action, if any.

Annotations

Textual amendments

F1: Words in reg. 179(1) inserted (31.12.2020) by S.I. 2019/775, reg. 139A(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 108)
F2: Reg. 179(1A) inserted (31.12.2020) by S.I. 2019/775, reg. 139A(b) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 108)
F3: Words in reg. 179(2) substituted (31.12.2020) by S.I. 2019/775, reg. 139A(c) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 108)
F4: Words in reg. 179(3)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 139A(d) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 108)