Amendment of regulation 180 (obligation on licensing authority to audit pharmacovigilance system)U.K.
140.—(1) Regulation 180 is amended as follows.
(2) In paragraph (1),
[F1(a)after “its pharmacovigilance system” insert “relating to medicinal products for sale or supply in Great Britain” and]
[F2( b)]omit “and report the results of that audit to the European Commission”.
[F3(2A) After paragraph (1) insert—
“(1A) The licensing authority must perform a regular audit of its pharmacovigilance system relating to medicinal products for sale or supply in Northern Ireland and report the results of that audit to the European Commission.”.]
(3) In paragraph (2)—
(a)omit “results of the”; and
(b)for “reported to the European Commission” substitute “ performed ”.
[F4(4) After paragraph (2) insert—
“(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.”.]
Textual Amendments
F1Reg. 140(2)(a) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 109(a)(i)
F2Words in reg. 140(2) renumbered as reg. 140(2)(b) (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 109(a)(ii)
F3Reg. 140(2A) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 109(b)
F4Reg. 140(4) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 109(c)
Commencement Information
I1Reg. 140 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1