Paragraph 3 Right to be heard by a person appointedF1

(1)

Subject to sub-paragraph (2), if a sponsor or investigator to whom notice is given under paragraph 2(4) is dissatisfied, he may, within 28 days or such longer period as the licensing authority may in any particular case allow, of the notice being given—

(a)

notify the licensing authority that he wishes to appear before and be heard by a person appointed by the licensing authority with respect to the decision; or

(b)

make representations in writing to the licensing authority with respect to the decision referred to in the notice.

(2)

Sub-paragraph (1)(a) shall not apply where—

(a)

the sponsor or investigator had not made any representations in accordance with paragraph 1(2) to (5); and

(b)

the decision of the licensing authority was in accordance with the advice of the appropriate committee.

(3)

If the sponsor or investigator to whom notice is given under paragraph 2(4) makes written representations in accordance with sub-paragraph (2)(b), the licensing authority shall take those representations into account before deciding whether to confirm or alter their decision.

Annotations

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