9.—(1) The Minister shall, as soon as may be after the establishment day, appoint—

(a) a committee to be known as the Advisory Committee for Human Medicines to assist and advise the Board in relation to any matters pertaining to the safety, quality or efficacy of medicinal products for human use as are referred to it by the Board and to perform the functions assigned to it by subsection (8), and

(b) a committee to be known as the Advisory Committee for Veterinary Medicines to assist and advise the Board in relation to any matters pertaining to the safety, quality or efficacy of medicinal products for animal use as are referred to it by the Board and to perform the functions assigned to it by subsection (8).

F19[(c) a committee to be known as the Advisory Committee for Medical Devices to assist and advise the Board in relation to any matters pertaining to the safety, quality and efficacy of medical devices as are referred to it by the Board.]

(2) The members of a committee shall be appointed by the Minister, with, in the case of the committee referred to in paragraph (b), the consent of the Minister for Agriculture, Food and Forestry, and the number of such members shall be not less than 6 nor more than 12.

(3) The Minister shall appoint a chairperson of a committee from amongst the members of the committee.

(4) The Minister when appointing a member shall fix such member's period of membership which shall not exceed 5 years and, subject to this section, membership shall be on such terms as the Minister determines.

(5) A committee shall regulate, by standing orders or otherwise, the procedure and business of the committee.

(6) (a) A committee may from time to time establish subcommittees to advise it in relation to the performance of its functions.

(b) A committee may appoint to a subcommittee established under this subsection persons who have a special knowledge and experience related to the purposes of the subcommittee.

(c) The appointment of a person to a subcommittee established under this subsection shall be subject to such terms and conditions as a committee may determine.

(d) A committee may at any time dissolve a subcommittee established under this subsection.

(e) The acts of a subcommittee established under this subsection shall be subject to confirmation by a committee unless the committee dispenses with the necessity for confirmation.

(f) A committee may regulate the procedure of subcommittees established under this subsection, but, subject to any such regulation, subcommittees established under this subsection may regulate their own procedure.

(g) A committee shall notify the Minister of the establishment of a subcommittee, of the purpose of the subcommittee and of the names of the members thereof.

(h) The Minister may, if he or she considers it appropriate, appoint additional persons to be members of any subcommittee.

(7) There may be paid by the Board to members of a committee and to members of any subcommittee established under this section such allowances for expenses incurred by them as the Board may, with the consent of the Minister and the Minister for Finance, determine.

F20[(8) The Board shall not refuse to grant a licence or authorisation in respect of—

(a) a medicinal product or class of medicinal products, or

(b) the manufacture or wholesale of a medicinal product or class of medicinal products,

on any ground relating to the safety, quality or efficacy of the medicinal product or class of medicinal products, as the case may be, unless the Board has requested the advice of the appropriate committee in relation thereto and considered the advice given pursuant to the request.

(9) Whenever the Board grants, suspends, renews or revokes a licence or other authorisation in respect of a medicinal product, it shall notify the appropriate committee of such grant, suspension, renewal or revocation.]

F21[(10) In subsections (8) and (9), any reference to a medicinal product includes a reference to a medicinal product for animal use.]