The Medicines (Advisory Bodies) (No. 2) Regulations 2005

PART 4 TRANSITIONAL PROVISIONS APPLICABLE TO THE CLINICAL TRIALS REGULATIONS

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.—(1) This paragraph applies where, before 30th October 2005—

(a) a sponsor has been given a notice as referred to in regulation 26(1) of the Clinical Trials Regulations; or

(b) a sponsor or investigator has been served with a notice in accordance with regulation 31(1) of the Clinical Trials Regulations.

(2) If—

(a) the period of 28 days; or

(b) such longer period as the licensing authority has allowed in the particular case,

has not expired, the sponsor or investigator may, by 30th November 2005, give notice of his wish to make written or oral representations to the appropriate committee.

(3) If the sponsor or investigator gives this notice, he shall be treated as if he had given notice of his wish to make written or oral representations to the appropriate committee in accordance with regulation 26(1) or regulation 31(7) of the Clinical Trials Regulations.

2.—(1) This paragraph applies where, before 30th October 2005—

(a) 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

(b) 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.

(2) 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.

(3) The appropriate committee shall—

(a) take into account such representations as are made; and

(b) report their findings and advice to the licensing authority, together with the reasons for their advice.

(4) 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.

3.—(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.

Procedural provisions relating to proposals to grant, refuse to grant, vary, suspend or revoke manufacturing authorizations

4.—(1) This paragraph applies where, before 30th October 2005—

(a) notification has been given to an applicant for, or holder of, a manufacturing authorization under paragraph 2 of Schedule 8 to the Clinical Trials Regulations;

(b) the person has not given notice of his wish to—

(i) appear before, or be heard by, a person appointed by the licensing authority; or

(ii) make representations in writing to the licensing authority,

with respect to the decision or proposal referred to in the notification; and

(c) the period of 28 days after the notification was given, or such extended period as the licensing authority has allowed, has not expired.

(2) The applicant or holder may, by 30th November 2005—

(a) give notice of his wish to appear before and be heard by a person appointed by the licensing authority; or

(b) make representations in writing to the licensing authority.

(3) If the applicant or holder gives notice under sub-paragraph (2)(a), he shall be treated as if he had given notice under paragraph 4(1)(a) of Schedule 8 to the Clinical Trials Regulations.

5.  If—

(a) the applicant or holder made written representations to the licensing authority before 30th October; or

(b) makes written representations under paragraph 4(2)(b),

the licensing authority shall take those representations into account before determining the application or matter.

6.  Where before 30th October—

(a) an applicant or holder gives notice under paragraph 4 of Schedule 8 to the Clinical Trials Regulations; and

(b) the applicant or holder has not appeared before a person appointed,

the applicant or holder shall be treated as if he had given a notice under paragraph 4(1)(a) of Schedule 8 to the Clinical Trials Regulations.