Medicines Act 1968

[F1 22 Procedure in other cases. U.K.

(1) This section applies when—

(a) an application is made for the grant of a licence under this Part of this Act; and

(b) the appropriate committee—

(i) is not consulted under subsection (3) of section 20, or

(ii) is consulted under that subsection but does not give a provisional opinion in accordance with section 21(1).

(2) If the licensing authority propose—

(a) to refuse to grant the licence, or

(b) to grant it otherwise than in accordance with the application,

they shall notify the applicant of their proposals and the reasons for them.

(3) If the applicant is so notified, he may, within the time allowed—

(a) notify the licensing authority of his wish to appear before and be heard by a person appointed by the licensing authority with respect to the proposal; or

(b) make representations in writing to the licensing authority with respect to the proposal referred to in the notification.

(4) If the applicant makes written representations in accordance with subsection (3)(b) of this section, the licensing authority shall take those representations into account before determining the application.]

Textual Amendments

F1 Ss. 22, 22A substituted for s. 22 (30.10.2005) by Medicines (Advisory Bodies) Regulations 2005 (S.I. 2005/1094), reg. 1(1), Sch. 1 para. 3

Modifications etc. (not altering text)

C1 Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)

C2 Ss. 20-22 applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2),Sch.

C3 Definitions in ss. 18-22 applied (N.I.) (1.4.1992) by S.I. 1991/194 (N.I. 1), art. 7(2), Sch. 2 para. 5(4); S.R. 1991/131, art. 2(e), Sch. Pt.III

C4 s. 22 extended (with modifications) (14.2.1994) by S.I. 1994/105, reg. 19, Sch.4

C5 S. 22 amendment to earlier affecting provision SI 1994/105 Sch. 4 (30.10.2005) by Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005 (S.I. 2005/2753), regs. 1(1), 19(2)