SCHEDULES

SCHEDULE 2 U.K. Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 4 U.K. Amendment of Part 5 (amendment of Part 5 (marketing authorisations))

66.  In regulation 89 (amendment of regulation 80 (urgent safety restrictions))— U.K.

(a) for paragraph (3) substitute—

“(3) For paragraph (a) substitute—

“(a) fails—

(i) in respect of a UKMA(GB) or UKMA(UK), to inform the licensing authority in accordance with paragraph 14(1) of Schedule 10A, or

(ii) in respect of a UKMA(NI), UKMA(UK) or EU marketing authorisation, to inform the European Commission in accordance with Article 22(1) of Regulation (EC) No 1234/2008,

that the holder has taken urgent safety restrictions on the holder's own initiative;”.”;

(b) for paragraph (4) substitute—

“(4) For paragraph (b) substitute—

“(b) fails—

(i) in respect of a UKMA(GB), to implement an urgent safety restriction imposed on the holder by the licensing authority in accordance with paragraph 14(3) of Schedule 10A, or

(ii) in respect of a UKMA(NI) or UKMA(UK), to implement an urgent safety restriction imposed on the holder by the European Commission under Article 22(2) of Regulation (EC) No 1234/2008; or”.”;

(c) after paragraph (4) insert—

“(4A) In paragraph (c) after “fails” insert “ in respect of a UKMA(NI) ”.”;

(d) in paragraph (5)—

(i) for “For sub-paragraph (c) substitute” substitute “ After paragraph (c) insert ”;

(ii) renumber the paragraph inserted as sub-paragraph (d);

(iii) in the paragraph inserted, after “fails” insert “ in respect of a UKMA(GB) ”.

Commencement Information

I1 Sch. 2 para. 66 in force at 31.12.2020 immediately before IP completion day, see reg. 1