Amendment of Schedule 3 to the principal Regulations29

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”.