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Medicines Act 1968

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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 (2) and (3) and (6) to (10) of section 108 of this Act shall have effect in relation to Scotland as if—

(a)any reference to the appropriate Minister or to the Minister of Health and the Minister of Agriculture, Fisheries and Food acting jointly were a reference to the Secretary of State;

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

[F2[F3(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 ]

F4( d )] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F5(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 [F6 “ a council constituted under section 2 of the Local Government etc. (Scotland) Act 1994 ” ]]

(3)Regulations made by the Secretary of State may provide that, to such extent as may be specified in the regulations—

(a)the Pharmaceutical Society, in respect of Scotland generally, or in respect of such area in Scotland as may be so specified,

(b)a local authority within the meaning of section 26(4) of the M2Food and Drugs (Scotland) Act 1956, in respect of their area,

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

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

Textual Amendments

F1Words 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)

F2S. 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

F6Words 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)

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. 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

C3Ss. 108-114 applied (with modifications) (1.7.1992) by S.I. 1992/1520, reg. 12.

C4Ss. 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)

C5S. 109: Functions transferred (S.) (1.7.1999) by S.I. 1999/1750, art. 2, Sch. 1 (with art. 7)

C6Ss. 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

C8Ss. 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

C9S. 109(1): power to transfer functions conferred (1.5.2000) by S.I. 2000/745, art. 2(1), Sch. para. 1

Marginal Citations

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