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)I124

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 ”;

F1c

in paragraph 7, after “details of any” insert “manufacturing authorisation or any”;

d

in paragraph 8—

F2i

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

F3ii

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) ”.