The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

[F1 Amendment of regulation 196 (urgent action) U.K.

156ZA.   In regulation 196—

(a) in the italic heading immediately preceding it, after “Urgent action” insert “and major safety review”;

(b) in paragraph (1), for “The licensing authority must initiate the Section 4 procedure by informing” substitute “In the case of a medicinal product authorised for sale or supply under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation, the licensing authority must inform”;

(c) omit sub-paragraph (2B);

(d) omit paragraphs (4) to (7);

(e) in paragraph (8), omit the definition of “EU urgent action procedure” and “Section 4 procedure”.]

Textual Amendments

F1 Reg. 156ZA 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. 123

Commencement Information

I1 Reg. 156ZA in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1