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

Applicant has given notice of wish to appear before person appointed prior to 30th October

19.—(1) This paragraph applies where, before 30th October 2005, an applicant for, or holder of, a licence has given notice to the licensing authority of his wish to appear before, or be heard by, a person appointed by the licensing authority under—

(a) section 21(5), or 22(3) of, or

(b) paragraph 6 or 8 of Schedule 2 to,

the Act.

(2) If, before 30th October 2005, the licensing authority—

(a) have not made that appointment—

(i) they shall do so; and

(ii) the person so appointed shall not, except with the consent of the applicant or holder, be an officer or servant of any of the Ministers specified in paragraphs (a) and (b) of section 1(1) of the Act;

(b) have made that appointment, the person appointed shall be treated as if he had been appointed under paragraph (a).

(3) Where this paragraph applies—

(a) the provisions of—

(i) section 22A of the Act; or

(ii) paragraph 7 of Schedule 2 to, the Act

shall not apply;

(b) the licensing authority shall arrange for the applicant to have an opportunity of appearing before and being heard by the person appointed;

(c) if the applicant or holder so requests—

(i) the hearing shall be in public, and

(ii) the licensing authority shall furnish to him a copy of the report of the person so appointed;

(d) the hearing before the person appointed shall be conducted in accordance with the Medicines Act 1968 (Hearings by Persons Appointed) Rules 1986(1); and

(e) the licensing authority shall take into account the report of the person so appointed before determining the application or matter.

(1)

S.I. 1986/1761.