Medicines Act 1968

20 Grant or refusal of licence. U.K.

(1) Subject to [F1 sections 8(2E) and (3E) and 19,], and to the following provisions of this Act, on any application to the licensing authority for a licence under this Part of this Act the licensing authority—

(a) may grant a licence containing such provisions as they consider appropriate, or

(b) if, having regard to the provisions of this Act [F2 and any [F3 EU] obligation], they consider it necessary or expedient to do so, may refuse to grant a licence.

[F4 (1A) The licensing authority must either grant or refuse any application for a licence under this Part, before the end of a period of 90 days from the date upon which they receive the application.]

[F4 (2B) If there are requirements in force under section 18 that apply to the application, subsection (1A) applies only if the requirements have been met]

[F4 (2C) If a notice under section 44 requires the applicant to provide the licensing authority with information, the period specified in subsection (1) stops running when the notice is given, and does not start running again until—

(a) the licensing authority receives the information; or

(b) the applicant has shown to the reasonable satisfaction of the licensing authority why he is unable to provide it.]

(2) The licensing authority shall not refuse to grant such a licence on any grounds relating to the price of any product, and shall not insert in any such licence any provisions as to the price at which any product may be sold, supplied, imported or exported.

(3) The licensing authority shall not refuse to grant such a licence on any grounds relating to the safety, quality or efficacy of medicinal products of any description, except after consultation with the appropriate committee F5 ....

F6 (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) Where on an application for a licence under this Part of this Act—

(a) the licensing authority refuse to grant a licence, or

(b) the licensing authority grant a licence otherwise than in accordance with the application, and the applicant requests the licensing authority to state their reasons,

the licensing authority shall serve on the applicant a notice stating the reasons for their decision.

Textual Amendments

F1 Words in s. 20(1) substituted (30.10.2005) by The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (S.I. 2005/2789), reg. 1(1), Sch. 5 para. 3(a) (with Sch. 6)

F2 Words inserted by (E.W.) S.I. 1977/1050, art. 4(3) and (N.I.) S.R. 1977 No. 170, reg. 5(3)

F3 Words in Act substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2, 3, 6 (with art. 3(2)(3)4(2)6(4)6(5))

F4 S. 20(1A)(2B)(2C) inserted (30.10.2005) by The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (S.I. 2005/2789), reg. 1(1), Sch. 5 para. 3(b) (with Sch. 6)

F5 Words in s. 20(3) omitted (30.10.2005) by virtue of Medicines (Advisory Bodies) Regulations 2005 (S.I. 2005/1094), reg. 1(1), Sch. 1 para. 1(a)

F6 S. 20(4) omitted (30.10.2005) by virtue of Medicines (Advisory Bodies) Regulations 2005 (S.I. 2005/1094), reg. 1(1), Sch. 1 para. 1(b)

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