Regulation 149 Amendment of regulation 189 (signal detection: licensing authority obligations)I1

United Kingdom

(1)

Regulation 189 is amended as follows.

(2)

In paragraph (1)—

(a)

in sub-paragraph (a), for “in the Eudravigilance database” substitute “ that it collects by virtue of operating its pharmacovigilance system under this Part ”; and

(b)

in sub-paragraph (d), for “regulations 59 to 61” substitute “ regulations 59, 60 and 61 ”.

F1(3)

In paragraphs (2) and (3), for “The licensing” insert “In relation to medicinal products subject to a UKMA(UK), a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation, the licensing”.

Annotations

Textual amendments

F1: Reg. 149(3) substituted (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. 116

Commencement

I1: Reg. 149 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1