Regulation 180 Obligation on licensing authority to audit pharmacovigilance system

(1)

The licensing authority must perform a regular audit of its pharmacovigilance system F1relating to medicinal products for sale or supply F2pursuant to a UKMA(GB) or a UKMA(UK)(Category 1) F3....

F4(1A)

The licensing authority must perform a regular audit of its pharmacovigilance system relating to medicinal products for sale or supply in Northern Ireland F5pursuant to a UKMA(NI) or a UKMA(UK)(Category 2) and report the results of that audit to the European Commission.

(2)

The F6... audit referred to in paragraph (1) must be F7performed—

(a)

on the first occasion no later than 21st September 2013; and

(b)

every two years after the first occasion.

F8(3)

The results of the audit referred to in paragraph (1A) must be reported to the European Commission—

(a)

on the first occasion no later than 21st September 2021;

(b)

every two years after the first occasion.

Annotations

Textual amendments

F1: Words in reg. 180(1) inserted (31.12.2020) by S.I. 2019/775, reg. 140(2)(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 109(a)(i))
F2: Words in reg. 180(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 75(a)
F3: Words in reg. 180(1) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 140(2)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 109(a)(ii)); 2020 c. 1, Sch. 5 para. 1(1)
F4: Reg. 180(1A) inserted (31.12.2020) by S.I. 2019/775, reg. 140(2A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 109(b))
F5: Words in reg. 180(1A) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 75(b)
F6: Words in reg. 180(2) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 140(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
F7: Word in reg. 180(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 140(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
F8: Reg. 180(3) inserted (31.12.2020) by S.I. 2019/775, reg. 140(4) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 109(c))