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Medicines Act 1968
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Changes over time for: Section 20
Version Superseded: 22/04/2011
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Medicines Act 1968, Section 20 is up to date with all changes known to be in force on or before 26 December 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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20 Grant or refusal of licence. U.K.
(1)Subject to [F1sections 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 [F2and any Community obligation], they consider it necessary or expedient to do so, may refuse to grant a licence.
[F3(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.]
[F3(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]
[F3(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 F4....
F5(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
F1Words 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)
F2Words inserted by (E.W.) S.I. 1977/1050, art. 4(3) and (N.I.) S.R. 1977 No. 170, reg. 5(3)
F3S. 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)
F4Words 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)
F5S. 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)
C1Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)
C2Ss. 20-22 applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2),Sch.
C3Definitions 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
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