22 Procedure in respect of applications for Minister’s consent

(1)

On receipt of an application for his consent to the distribution of a medicine for the purposes of section 20(2), the Minister shall—

(a)

consider all the particulars and information relating to the medicine submitted under section 21, and such other matters as appear to him to be relevant; and

(b)

as far as practicable, weigh the likely therapeutic value of the medicine against the risk (if any) of the use of the medicine injuriously affecting the health of any person.

(2)

If, after complying with subsection (1), the Minister is not satisfied that he should give his consent to the distribution of the medicine, he shall refer the matter to the appropriate committee, which shall consider the matter, and shall report on it to the Minister with a recommendation as to the decision that the Minister should make.

(3)

On receipt of the recommendation of the appropriate committee under subsection (2), the Minister shall, before making his decision, if the recommendation is to refuse consent to the distribution of the medicine, notify the applicant for consent of the terms of the recommendation, and of the reasons for it.

(4)

The applicant for consent may, within 28 days after being notified under subsection (3) of the recommendation of the appropriate committee, object to the recommendation in writing to the Minister.

(5)

On receipt of an objection under subsection (4), the Minister shall, before making his decision, refer the matter to the Medicines Review Committee, which shall convene such meeting or meetings as may be necessary for it to consider the matter, and shall report on it to the Minister with a recommendation as to the decision that the Minister should make.

Compare: Medicines Act 1968 ss 20(3), 21 (UK)