Paragraph 2 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
This paragraph applies where, before 30th October 2005—
the licensing authority have been notified of the sponsor’s or investigator’s wish, in accordance with regulation 26(1) or 31(7) of the Clinical Trials Regulations, to make written or oral representations, but the sponsor or investigator has not made those representations; or
the sponsor or investigator has made written representations under regulation 26(1) or 31(7), but a committee established under section 4 of the Act has not considered those representations.
If the sponsor or investigator has notified the licensing authority of his wish to make oral representations, the licensing authority shall afford him an opportunity to make those representations at a hearing before the appropriate committee.
The appropriate committee shall—
take into account such representations as are made; and
report their findings and advice to the licensing authority, together with the reasons for their advice.
The report of the appropriate committee under sub-paragraph (3)(b) shall be treated as the report of the appropriate committee under paragraph 1(6)(b) of Schedule 5 to the Clinical Trials Regulations.