Paragraph 3 Procedural provisions relating to the refusal or amendment of, or imposition of conditions relating to, clinical trial authorizations and the suspension or termination of clinical trials
(1)
This paragraph applies where, before 30th October 2005—
(a)
a committee established under section 4 of the Act—
(i)
has considered written or oral representations of the sponsor or investigator; and
(ii)
has reported findings and advice to the licensing authority; and
(b)
the licensing authority have not made a decision under paragraph 1(3), (4), or (5) of Schedule 5 to the Clinical Trials Regulations.
(2)
The report of the committee referred to in sub-paragraph 1(a)(ii) shall be treated as the report of the appropriate committee under paragraph 1(6)(b) of Schedule 5 to those regulations.