Medicines Act 1968

108 Enforcement in England and Wales. U.K.

(1) 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), sections 64 and 65, subsections (3) to (5) of section 85, and sections 87(2), 88(3) and 89(2) 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;

(b) the provisions of subsections (2) and (3) of section 86 of this Act, in their application to the supply, or possession for the purpose of supply, of leaflets with medicinal products sold or to be sold by retail, or supplied or to be supplied in circumstances corresponding to retail sale; and

(c) the provisions of sections 93 and 94 of this Act and any regulations made under section 95 of this Act,

the appropriate Minister shall, in respect of each area for which there is a [F1 drugs authority] make arrangements or give directions whereby the Pharmaceutical Society, or the [F1 drugs authority] for that area, or both the Society and that authority, to such extent as, in the case of that Society 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 paragraphs (a) and (b) of this subsection, in their application as mentioned in those paragraphs, and the provisions and regulations specified in paragraph (c) of this subsection.

(3) Any arrangements made with, or directions given to, the Pharmaceutical Society under subsection (2) of this section, in so far as they relate to the provisions and regulations specified in paragraph (c) of that subsection, shall be limited to the enforcement of those provisions and regulations in respect of—

(a) any advertisement issued or representation made on or in any premises, ship, aircraft, vehicle, stall or place where medicinal products are sold by retail or are supplied in circumstances corresponding to retail sale, and

(b) any advertisement displayed on, or in close proximity to, an automatic machine in which medicinal products are offered or exposed for sale.

(4) Regulations made jointly by the Minister of Health and the Minister of Agriculture, Fisheries and Food may provide that any such body to which this subsection applies as may be specified in the regulations shall, to such extent as in the case of that body may be so specified, and either—

(a) in respect of England and Wales generally, or

(b) in respect of such area in England or Wales as may be so specified,

have power concurrently with the appropriate Minister, or be under a duty concurrently with him, to enforce any regulations made under section 66 of this Act.

(5) Subsection (4) of this section applies to the following bodies, that is to say, the Pharmaceutical Society, any, [F1 drugs authority] the council of any county district which is not a, [F1 drugs authority] and the overseers of the Inner Temple and the Middle Temple.

(6) The Pharmaceutical Society shall be under a duty, concurrently with the appropriate Minister,—

(a) to enforce the provisions of sections F2 ... 52 and 58 of this Act F2 ... in their application to England and Wales;

(b) to enforce the provisions of any regulations made under section 60 or section 61 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 sections 77 and 78 of this Act, and of any regulations made under section 79(2) of this Act, in their application to England and Wales.

(7) Regulations made jointly by the Minister of Health and the Minister of Agriculture, Fisheries and Food may provide that, in respect of each area in England or Wales for which there is a food and drugs authority, the Pharmaceutical Society, or the food and drugs authority for that area, or both the Society and that authority, to such extent as, in the case of that Society or authority, the regulations may provide, shall have power concurrently with the appropriate Minister, or shall be under a duty concurrently with him, to enforce the provisions of sections 53 and 54 of this Act.

F3 (8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(9) Notwithstanding anything in subsections [F4 (2) to (7)] 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, 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 the Pharmaceutical Society or any other body on whom a duty to enforce any provisions is imposed by or under subsections (4) to (8) of this section have in relation to any matter failed to perform that duty, and that the public interest requires that the provisions in question should be enforced in relation to it, he may determine that he will himself enforce those provisions in relation to that matter.

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

F5 (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) F6 ... means the [F7 Secretary of State].

[F8 (12) In this section “ drugs authority ” means—

(a) as respects each London borough, metropolitan district [F9 , county borough] or non-metropolitan county, the council of that borough, district [F9 , county borough] or county; and

(b) as respects the City of London (including the Temples), the Common Council of that City.]

Textual Amendments

F1 Words substituted (E.W.S.) by Food Safety Act 1990 (c. 16, SIF 53:1, 2), ss. 54, 59(1), Sch. 3 para. 8(a)

F2 Words in s. 108(6)(a) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 56(a) (with regs. 2(4), 3)

F3 S. 108(8) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 56(b) (with regs. 2(4), 3)

F4 Words in s. 108(9) substituted (1.10.2006) by The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 56(c) (with regs. 2(4), 3)

F5 S. 108(11)(a) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 56(e)(i) (with regs. 2(4), 3)

F6 Words in s. 108(11)(b) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 56(e)(ii) (with regs. 2(4), 3)

F7 Words substituted by virtue of S.I. 1968/1699, arts. 2, 5(4)(a)

F8 S. 108(12) inserted (E.W.S.) by Food Safety Act 1990 (c. 16, SIF 53:1, 2), ss. 54, 59(1), Sch. 3 para. 8(b)

F9 S. 108(12)(a) words inserted (1.4.1996) by 1994 c. 19, s. 66(6), Sch. 16 para. 33(b); S.I. 1996/396, art. 4, Sch. 2

Modifications etc. (not altering text)

C1 Power to modify s. 108(8)(W.) conferred by Local Government Act 1972 (c. 70), s. 200(3)

C2 Functions of Secretary of State in matters only affecting Wales exercisable by Secretary of State for Wales: S.I. 1969/388, art. 2(1)

C3 Pt. 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)

C4 Ss. 108-114 applied (with modifications) (1.7.1992) by S.I. 1992/1520, reg. 12.

C5 Ss. 108-115 modified (3.4.1992) by S.I. 1992/605, regs. 2(3), 3

Ss. 108-115 applied (3.10.1994) by S.I 1994/2328, reg. 11(c)(ii)(aa)

C6 S. 108 modified (30.1.1992) by S.I. 1992/32, reg. 12(1)(2)

S. 108 extended (with modifications) (14.2.1994) by S.I. 1994/105, reg. 19, Sch.4

S. 108 applied (1.1.1995) by S.I. 1994/3142, reg. 18(2)

s. 108 extended (1.1.1995) by S.I. 1994/3142, reg. 18(7)

S. 108 applied (with modifications) (1.1.1995) by S.I. 1994/3144, reg.10, Sch. 4

S. 108 applied (31.3.1997) by S.I. 1997/322, reg. 34, Sch.5

Ss. 108-110 applied (1.2.2000) by S.I. 2000/7, reg. 5

C7 S. 108: Functions transferred (W.) (1.7.1999) by virtue of S.I. 1999/672, art. 2, Sch. 1

C8 Ss. 107-116 applied (with modifications) (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), regs. 1, 47, Schs. 9

C9 Ss. 107-109 applied (with modifications) (30.10.2005) by Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (S.I. 2005/2750), regs. 1(a), 11, Schs. 4 (with Sch. 6)

C10 Ss. 107-116 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