The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 No. 744

Amendment of Schedule 3 (particulars and documents that must accompany an application for an ethics committee opinion, a request for authorisation, a notice of amendment and a notification of the conclusion of a trial)

24.—(1) Schedule 3 is amended as follows.

(2) In Part 1(1), in paragraph 3(b), after “summary of product characteristics” insert “, or equivalent document,”.

(3) In Part 2—

(a) in paragraph 1(b), for “an EEA State”(2), substitute “the United Kingdom or a country that is included in the list referred to in regulation 3(11A)”;

(b) in paragraph 4, for “another”, substitute “an”;

(c) in paragraph 7—

(i) before “authorisation”, insert “manufacturing”;

(ii) omit “referred to in Article 13 of the Directive”;

(d) in paragraph 8—

(i) in sub-paragraph (1), for “Article 13(3) of the Directive” substitute “regulation 43(2)”;

(ii) in sub-paragraph (2)—

(aa) omit “from a third country”;

(bb) before “authorisation” insert “manufacturing”;

(cc) omit “referred to in Article 13 of the Directive”;

(dd) in paragraph (a), for “European Economic Area”, substitute “United Kingdom”;

(iii) in paragraph 11(4)(a), after “summary of product characteristics” insert “or equivalent document”.

(4) In Part 3, in paragraph 1(b), for “an EEA State”, substitute “the United Kingdom or a country that is included in the list referred to in regulation 3(11A)”.

(5) In Part 4, in paragraph 1(b), for “an EEA State”, substitute “the United Kingdom or a country that is included in the list referred to in regulation 3(11A)”.

(1)

Part 1 was amended by S.I. 2008/941.

(2)

The words “an EEA State” were substituted by S.I. 2006/1928.