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Medicines Act 1968

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Medicines Act 1968, Section 129 is up to date with all changes known to be in force on or before 25 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. Help about Changes to Legislation

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129 Orders and regulations. U.K.

(1)The Ministers may make regulations for any purpose for which regulations are authorised or required to be made under this Act, other than any purpose for which any provision of this Act authorises or requires regulations to be made otherwise than by the Ministers.

(2)Any power to make orders or regulations under this Act (other than any order made by a court or judge or any order or regulations made in relation to Northern Ireland under [F1section 72A of this Act or] paragraph 1F2... or paragraph 6 of Schedule 4 to this Act F3...) shall be exercisable by statutory instrument.

(3)Any statutory instrument consisting of—

(a)an order made under any of the following provisions of this Act, that is to say, sections [F458, 62, 79 [F5, 84A(5)] and 106] and paragraph 27 of Schedule 3, or

F6(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)any regulations made under any provision, other than section 79, of this Act,

shall be subject to annulment in pursuance of a resolution of either House of Parliament.

(4)Any power to make an order under any provisionF7... of this Act shall include power to revoke or vary the order by a subsequent order made under that provision.

(5)Any power to make[F8 an order or ] regulations under this Act may be exercised so as to make different provision for different areas or in relation to different cases or different circumstances to which the power is applicable, and to make any such provision subject to such exceptions, limitations and conditions (if any) as the authority making the[F9 order or ] regulations considers necessary or expedient.

(6)Before making any regulations under this Act and before making any order under this Act (except an order made in accordance with any provision of this Act under which, in case of urgency, an order can be made with immediate effect) the Ministers proposing to make the regulations or order shall consult such organisations as appear to them to be representative of interests likely to be substantially affected by the regulations or order.

F10(6A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7)Without prejudice to subsection (6) of this section, where any Ministers propose to make any regulations or order under Part III, F11... of this Act, or under section 104 or section 105 of this Act, and they consult [F12an expert committee appointed by themselves, or by one of them acting alone], or the Commission, with respect to that proposal, they shall take the advice of the committee or of the Commission into account before proceeding with those proposals.

Textual Amendments

F2Words in s. 129(2) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 65(a) (with regs. 2(4), 3)

F3Words in s. 129(2) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 30(a) (with Sch. 32)

F7Words in s. 129(4) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 30(c) (with Sch. 32)

F8Words in s. 129(5) inserted (19.7.2006 for specified purposes) by Health Act 2006 (c. 28), ss. 32(a), 83(1)(e)

F9Words in s. 129(5) inserted (19.7.2006 for specified purposes) by Health Act 2006 (c. 28), ss. 32(b), 83(1)(e)

F11Words in s. 129(7) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 30(d)(i) (with Sch. 32)

Modifications etc. (not altering text)

C1Pt. VIII (ss. 104–136) extended by S.I.s 1982/425, art. 3, 1984/187 art. 2; and extended with modifications by S.I. 1985/403, art. 3(1)

C2S. 129 modified (1.1.1995) by S.I. 1994/3144, reg. 9(10)

S. 129 applied (31.3.1997) by S.I. 1997/322, reg. 34, Sch. 5

C4S. 129 amendment to earlier affecting provision SI 1994/3144 reg. 9 (30.10.2005) by Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), regs. 1(a), 2(12)

C5S. 129 amendment to earlier affecting provision SI 2004/1031 reg. 47 Sch. 9 (29.8.2006) by Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 32

C6S. 129(1)(2)(3)(5) applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2), Sch.

C7S. 129(2)(3)(c)(5)(6) extended by Medicines Act 1971 (c. 69), s. 1(3)(b)

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