The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

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) U.K.

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

(2) In Part 1 M1 , 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”M2 , 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 ”;

[F1 (c) in paragraph 7, after “details of any” insert “manufacturing authorisation or any”;]

(d) in paragraph 8—

[F2 (i) in sub-paragraph (1), after “in accordance with” insert “regulation 43(2) or”;]

[F3 (ii) for sub-paragraph (2) substitute—

“(2) If an investigational medicinal product to be used in the clinical trial has been, or is to be—

(a) imported into Great Britain from a country other than Northern Ireland or imported into Northern Ireland from a country other than an EEA State, a statement from the qualified person at the disposal of the person holding the manufacturing authorisation in relation to that importation specifying—

(i) the address of any premises outside the United Kingdom at which the product was manufactured or assembled; and

(ii) the manufacturing or assembling operations performed at those premises;

(b) imported into Northern Ireland from an EEA State, a statement from the qualified person at the disposal of the person holding the authorisation referred to in Article 13 of the Directive in relation to that importation specifying—

(i) the address of any premises outside the European Economic Area at which the product was manufactured or assembled; and

(ii) the manufacturing or assembling operations performed at those premises.”.]

(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) ”.

Textual Amendments

F1 Reg. 24(3)(c) 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. 1 para. 8(a)

F2 Reg. 24(3)(d)(i) 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. 1 para. 8(b)

F3 Reg. 24(3)(d)(ii) 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. 1 para. 8(c)

Commencement Information

I1 Reg. 24 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M1 Part 1 was amended by S.I. 2008/941.

M2 The words “an EEA State” were substituted by S.I. 2006/1928.