Medicines Act 1968

Changes over time for: Section 108

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Changes to legislation:

Medicines Act 1968, Section 108 is up to date with all changes known to be in force on or before 29 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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Changes and effects yet to be applied to Section 108:

s. 69(1A)(1B) added (prosp.) by 1997 c. 19 s. 1 Sch. para. 5(b)
s. 84B inserted by S.I. 2016/372 art. 12

Changes and effects yet to be applied to the whole Act associated Parts and Chapters:

Whole provisions yet to be inserted into this Act (including any effects on those provisions):

s. 69(1A)(1B) added (prosp.) by 1997 c. 19 s. 1 Sch. para. 5(b)
s. 84B inserted by S.I. 2016/372 art. 12

108 Enforcement in England and Wales. U.K.

(1)[F1Subject to the provisions of subsection (6C) of this section,] it shall be the duty of the appropriate Minister to enforce in England and Wales, or to secure the enforcement in England and Wales of, the provisions of this Act and any regulations and orders made under it.

(2)For the purpose of performing that duty in relation to—

(a)the provisions of any order made under paragraph (a) of section 62(1) of this Act and of section 63(b), [F2section 64 and sections 87(2) and 88(3)] of this Act, in the application of any of those provisions to the retail sale, offer or exposure for retail sale, or possession for the purpose of retail sale, of medicinal products and to the supply, offer or exposure for supply, or possession for the purpose of supply, of medicinal products in circumstances corresponding to retail sale;

F3(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

the appropriate Minister shall, in respect of each area for which there is a [F4drugs authority] make arrangements or give directions whereby [F5the General Pharmaceutical Council], or the [F4drugs authority] for that area, or both [F6the Council] and that authority, to such extent as, in the case of [F7that Council] or authority, the arrangements or directions may provide, shall have power concurrently with the appropriate Minister, or shall be under a duty concurrently with him, to enforce the provisions specified in [F8paragraph (a)] of this subsection, in their application as mentioned in [F9that paragraph]F10....

F11(3). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F11(4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F11(5). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6)[F12the General Pharmaceutical Council] shall be under a duty, concurrently with the appropriate Minister,—

F13(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)to enforce the provisions of any regulations made under section 60 F14... of this Act in their application to premises in England and Wales at which medicinal products are sold by retail or are supplied in circumstances corresponding to retail sale; and

(c)to enforce the provisions of [F15section 78] of this Act, and of any regulations made under section 79(2) of this Act, in their application to England and Wales.

F16[F17(6A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6B)[F18the General Pharmaceutical Council] shall be under a duty to enforce [F19the provisions of sections 72A and 72AA of this Act, and any rules made under section 72A,] in their application to England and Wales.

(6C)The appropriate Minister shall be under no duty to enforce [F20those provisions, or any rules made under section 72A,] in their application to England and Wales.

(6D)Notwithstanding subsection (6C) of this section the appropriate Minister is to be treated for the purposes of sections 111 to 114 of this Act—

(a)as empowered by this section to enforce [F21those provisions, or any rules made under section 72A,] in their application to England and Wales, and

(b)to that extent as an enforcement authority in relation to [F22those provisions or those rules] in their application to England and Wales.]

F23(7). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F24(8). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(9)Notwithstanding anything in subsections [F25(2) to [F26 (6D)]] of this section, no duty or power conferred or imposed by or under any of those subsections shall be performed or be exercisable in relation to—

(a)any hospital [F27(except in relation to so much of the hospital premises as is a registered pharmacy)], or

(b)so much of any premises as is used by a practitioner for carrying on his practice, or

(c)so much of any premises (not falling within either of the preceding paragraphs) as is used for veterinary medicine or veterinary surgery for the purposes of any institution.

(10)If the appropriate Minister is satisfied, after making such inquiry as he thinks fit, that [F28the General Pharmaceutical Council] [F29has in relation to any matter failed to perform a duty imposed on it by] [F30subsection (6B) to enforce any provisions or rules mentioned in that subsection, and that the public interest requires that the provisions or rules in question should be enforced in relation to it, the appropriate Minister may enforce those provisions or rules in relation to that matter.]

(11)In this section “the appropriate Minister”—

F31(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)F32... means the [F33Secretary of State].

[F34(12) In this section “ drugs authority ” means—

[F35(a)in relation to an area in England other than the City of London, the council of a non-metropolitan county, metropolitan district or London borough;

(b)in relation to the City of London (including the Inner Temple and the Middle Temple), the Common Council of the City of London; and

(c)in relation to an area in Wales, the council of a county or county borough.]]

Textual Amendments

F1 Words in s. 108(1) inserted (1.10.2009) by Health Act 2006 (c. 28), ss. 31(1)(a), 83(7); S.I. 2008/2714, art. 2(a)

F2 Words in s. 108(2)(a) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(2)(a) (with Sch. 32)

F3 S. 108(2)(b)(c) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(2)(b) (with Sch. 32)

F4Words substituted (E.W.S.) by Food Safety Act 1990 (c. 16, SIF 53:1, 2), ss. 54, 59(1), Sch. 3 para. 8(a)

F5 Words in s. 108(2) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(2)(c)(i) (with Sch. 32)

F6 Words in s. 108(2) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(2)(c)(ii) (with Sch. 32)

F7 Words in s. 108(2) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(2)(c)(iii) (with Sch. 32)

F8 Words in s. 108(2) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(2)(c)(iv) (with Sch. 32)

F9 Words in s. 108(2) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(2)(c)(v) (with Sch. 32)