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The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006

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Amendment of Schedule 3 to the principal Regulations

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29.  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”.

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