The Medicines for Human Use (Clinical Trials) Regulations 2004

[F1 Hearing before the appropriate committee U.K.

1.— (1) Where the licensing authority are notified of the wish of a sponsor or investigator to make representations in accordance with regulation 26(1) or 31(7), the authority shall inform the appropriate committee and the committee shall give the sponsor or investigator an opportunity to make such representations in accordance with sub-paragraphs (2) to (5).

(2) Subject to sub-paragraph (3), the sponsor or investigator shall provide the appropriate committee with—

(a) his written representations or a written summary of the oral representations he intends to make; and

(b) any documents on which he wishes to rely in support of those representations,

before the end of the period of six months beginning with the date of the notice referred to in sub-paragraph (1), or within such shorter period as the licensing authority may specify in the notification referred to in sub-paragraph (1).

(3) If the sponsor or investigator so requests, the appropriate committee may extend the time limit referred to in sub-paragraph (2), up to a maximum period of twelve months beginning with the date of the notice referred to in sub-paragraph (1).

(4) The sponsor or investigator may not submit any additional written representations or documents once the time limit referred to in sub-paragraphs (2) and (3) has expired, except with the permission of the appropriate committee.

(5) If the sponsor or investigator gave notice of his wish to make oral representations, the appropriate committee shall, after receiving a written summary and any other documents in accordance with sub-paragraph (3), arrange for the sponsor or investigator to make such representations at a hearing before the committee.

(6) The appropriate committee shall—

(a) take into account such representations as are made in accordance with this paragraph; and

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

Textual Amendments

F1 Sch. 5 substituted (30.10.2005) by The Medicines (Advisory Bodies) (No. 2) Regulations 2005 (S.I. 2005/2754), reg. 1(2)(b), Sch. 3 para. 5