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- Point in Time (29/08/2006)
- Original (As enacted)
Version Superseded: 22/04/2011
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Medicines Act 1968, Section 24 is up to date with all changes known to be in force on or before 18 September 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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[F1(1)A licence granted under this Part expires—
(a)in accordance with the provisions of the licence, or
(b)if there is no such provision, at the end of the period of five years beginning with the date on which the licence was granted, or if it has been renewed the date on which it was last renewed.
(1AA)But so far as the licence relates to a medicinal product to which the 2001 Directive applies, it remains in force until—
(a)revoked by the licensing authority; or
(b)surrendered by the holder.]
(2)Any [F2licence granted under this Part of this Act], if it has not been revoked, may, on the application of the holder of the licence, be renewed by the licensing authority for a further period of five years from the date on which it would otherwise expire or such shorter period from that date as the licensing authority may determine.
[F3(2A)Subsection (2) does not apply to a licence insofar as it relates to a medicinal product to which the 2001 Directive applies.]
(3)On an application to the licensing authority for the renewal of a licence under this Part of this Act, the licensing authority—
(a)may renew the licence, with or without modifications, for such a further period as is mentioned in subsection (2) of this section, or
(b)may grant to the applicant a new licence containing such provisions as the licensing authority consider appropriate, or
(c)if, having regard to the provisions of this Act [F4and any Community obligation under [F5the 2001 Directive other than Titles VI, VII and VIII of that Directive]], they consider it necessary or expedient to do so, may refuse to renew the licence or to grant a new licence.
[F6(3A)References to a licence in subsection (3) are to be read as references to a licence only insofar as that licence relates to a medicinal product to which the 2001 Directive does not apply.]
(4)In relation to any such application the provisions of sections 18 and 19, subsections (2) to (5) of section 20 and sections [F721 to 22A] of this Act shall have effect as if in those provisions any reference to refusing a licence included a reference to refusing to renew a licence and any reference to granting a licence included a reference to renewing it.
(5)Every application for the grant or renewal of a licence under this Part of this Act shall, unless it otherwise expressly provides, be taken to be an application for the grant or renewal of the licence for the full period of five years mentioned in subsection (1) or subsection (2) of this section, as the case may be; and in this Part of this Act any reference (including a reference implied by virtue of the last preceding subsection) to the grant or renewal of a licence otherwise than in accordance with the application shall be construed accordingly.
[F8(5A)Subsection (5) does not apply to a licence insofar as it relates to a medicinal product to which the 2001 Directive applies.]
(6)Where an application for the renewal of a licence under this Act has been duly made—
(a)the licence shall not cease to be in force by virtue of the preceding provisions of this section before the licensing authority have determined the application, and
(b)if by an interim order made under section 107(3)(a) of this Act the operation of the decision of the licensing authority on the application is suspended, the licence shall not cease to be in force by virtue of those provisions so long as the operation of the decision continues to be suspended by the order.
F9(7). . .
Textual Amendments
F1S. 24(1)(1AA) substituted for s. 24(1) (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. 4(2) (with Sch. 6)
F2Words substituted by (E.W.)(S.) S.I. 1977/1050, art. 4(4) and (N.I.) S.R. 1977 No. 170, reg. 5(4)
F3S. 24(2A) 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. 4(3) (with Sch. 6)
F4Words in s. 24(3)(c) inserted (13.2.1994) by S.I. 1994/276, reg. 5(b) (which S.I. revoked and replaced defective S.I. 1994/101 before the latter S.I. came into force)
F5Words in “s. 24(3)(C)”substituted (28.2.2002) by virtue of S.I. 2002/236, reg. 2(c)(ii)
F6S. 24(3A) 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. 4(4) (with Sch. 6)
F7Words in s. 24(4) substituted (30.10.2005) by Medicines (Advisory Bodies) Regulations 2005 (S.I. 2005/1094), reg. 1(1), Sch. 1 para. 4
F8S. 24(5A) 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. 4(5) (with Sch. 6)
F9S. 24(7) deleted (28.2.2002) by virtue of S.I. 2002/236, reg. 2(c)(ii)
Modifications etc. (not altering text)
C1Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)
C2S. 24 applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2), Sch.
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