Regulation 24 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)

(1)

Schedule 3 is amended as follows.

(2)

In Part 1^f1, 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”^f2, 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)”.

Annotations

Footnotes

f1: Part 1 was amended by S.I. 2008/941.
f2: The words “an EEA State” were substituted by S.I. 2006/1928.