Regulation 29 Amendment of Schedule 3 to the principal Regulations

In Schedule 3 to the principal Regulations (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)—

(a)

in Part 2 (request for authorisation), in paragraph 1, in sub-paragraph (b), for “the European Community” substitute “an EEA State”;

(b)

in Part 3 (notice of amendment)—

(i)

in paragraph 1, in sub-paragraph (b), for “the European Community” substitute “an EEA State”, and

(ii)

in paragraph 2, in sub-paragraph (b), for “the number” substitute “any number”; and

(c)

in Part 4 (notification of conclusion of a clinical trial)—

(i)

in paragraph 1, in sub-paragraph (b), for “the European Community” substitute “an EEA State”, and

(ii)

in paragraph 2, in sub-paragraph (b), for “the number” substitute “any number”.