Medicines Act 1968

109 Enforcement in Scotland. U.K.

(1) [F1 Subject to the provisions of section 108(6C) of this Act as applied by subsection (2) of this section, ]It shall be the duty of the Secretary of State to enforce in Scotland, or to secure the enforcement in Scotland of, the provisions of this Act and of any regulations and orders made under it.

(2) Subsections [F2 (2), (6) to (6D), (9) and (10)] of section 108 of this Act shall have effect in relation to Scotland as if—

(a) any reference to the appropriate Minister F3 ... were a reference to the Secretary of State;

(b) any reference to England and Wales were a reference to Scotland; and

[F4 [F5 (c) references to a food and drugs authority and to the area of any such authority were references respectively to a local authority as defined by section 26(4) of the M1 Food and Drugs (Scotland) Act 1956 and to the area of such an authority; and ]

F6 ( d )] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F7 (2A) Subsection (12) of section 108 of this Act shall have effect in relation to Scotland as if for paragraphs (a) and (b) there were substituted the words [F8 “ a council constituted under section 2 of the Local Government etc. (Scotland) Act 1994 ” ]]

F9 (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) Nothing in this section shall be construed as authorising an enforcement authority to institute proceedings for any offence.

Textual Amendments

F1 Words in s. 109(1) inserted (1.10.2009) by Health Act 2006 (c. 28), ss. 31(2), 83(7); S.I. 2008/2714, art. 2(a)

F2 Words in s. 109(2) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 19(a)(i) (with Sch. 32)

F3 Words in s. 109(2)(a) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 19(a)(ii) (with Sch. 32)

F4 S. 109(2)(c)(d) substituted (S.) for s. 109(2)(c) by Local Government (Scotland) Act 1973 (c. 65), Sch. 27 Pt. II para. 191

F5 S. 109(2)(c) repealed (E.W.S.) by Food Safety Act 1990 (c. 16, SIF 53:1, 2), ss. 54, 59(1), Sch. 3 para. 9(a)

F6 S. 109(2)(d) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 57 (with regs. 2(4), 3)

F7 S. 109(2A) inserted (E.W.S.) by Food Safety Act 1990 (c. 16, SIF 53:1, 2), ss. 54, 59(1), Sch. 3 para. 9(b)

F8 Words in s. 109(2A) substituted (S.) (1.4.1996) by 1994 c. 39, s. 180(1), Sch. 13 para. 79(b);S.I. 1996/323, art. 4(1)(c)

F9 S. 109(3) repealed (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 19(b), Sch. 35 (with Sch. 32)

Modifications etc. (not altering text)

C1 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)

C2 S. 109 modified (30.1.1992) by S.I. 1992/32, reg. 12(1)(2)

S. 109 extended (with modifications) (14.2.1994) by S.I. 1994/105, reg. 19, Sch. 4

S. 109 extended (1.1.1995) by S.I. 1994/3142, reg. 18(7)

S. 109 applied (1.1.1995) by S.I. 1994/3142, reg. 18(2)

S. 109 applied (31.3.1997) by S.I. 1997/322, reg. 34, Sch.5

S. 109 applied (with modifications) (1.1.1995) by S.I. 1994/3144, reg.10, Sch. 4

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

C3 Ss. 108-114 applied (with modifications) (1.7.1992) by S.I. 1992/1520, reg. 12.

C4 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)

C5 S. 109: Functions transferred (S.) (1.7.1999) by S.I. 1999/1750, art. 2, Sch. 1 (with art. 7)

C6 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

C7 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)

C8 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

C9 S. 109(1): power to transfer functions conferred (1.5.2000) by S.I. 2000/745, art. 2(1), Sch. para. 1

Marginal Citations

M1 1956 c. 30.