OpenLegislation

Section 108 Enforcement in England and Wales.C10C1C2C3C4C5C6C7C8C9

United Kingdom

(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)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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 drugs 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 paragraphF10....

F11(3)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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(F176A)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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—

(F35a)

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.

Annotations

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)

F4

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)

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)

F10

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

F11

S. 108(3)-(5) repealed (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(3), Sch. 35 (with Sch. 32)

F12

Words in s. 108(6) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(4)(a) (with Sch. 32)

F13

S. 108(6)(a) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(4)(b) (with Sch. 32)

F14

Words in s. 108(6)(b) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(4)(c) (with Sch. 32)

F15

Words in s. 108(6)(c) substituted (27.9.2010) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(5), Sch. 4 para. 1(17); S.I. 2010/1621, art. 2(1), Sch.

F16

S. 108(6A) omitted (1.12.2022) by virtue of The Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022 (S.I. 2022/849), art. 1(3), Sch. 1 para. 6(a); S.I. 2022/1023, art. 2

F17

S. 108(6A)-(6D) inserted (1.10.2009) by Health Act 2006 (c. 28), ss. 31(1)(b), 83(7); S.I. 2008/2714, art. 2(a)

F18

Words in s. 108(6A)(6B) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(5) (with Sch. 32)

F19

Words in s. 108(6B) substituted (1.12.2022) by The Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022 (S.I. 2022/849), art. 1(3), Sch. 1 para. 6(b) (with art. 8(3)); S.I. 2022/1023, art. 2

F20

Words in s. 108(6C) substituted (1.12.2022) by The Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022 (S.I. 2022/849), art. 1(3), Sch. 1 para. 6(c) (with art. 8(3)); S.I. 2022/1023, art. 2

F21

Words in s. 108(6D)(a) substituted (1.12.2022) by The Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022 (S.I. 2022/849), art. 1(3), Sch. 1 para. 6(d)(i) (with art. 8(3)); S.I. 2022/1023, art. 2

F22

Words in s. 108(6D)(b) substituted (1.12.2022) by The Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022 (S.I. 2022/849), art. 1(3), Sch. 1 para. 6(d)(ii) (with art. 8(3)); S.I. 2022/1023, art. 2

F23

S. 108(7) repealed (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(6), Sch. 35 (with Sch. 32)

F24

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)

F25

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)

F26

Word in s. 108(9) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(7) (with Sch. 32)

F27

Words in s. 108(9)(a) inserted (1.10.2009) by Health Act 2006 (c. 28), ss. 31(1)(c), 83(7); S.I. 2008/2714, art. 2(a)

F28

Words in s. 108(10) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(8)(i) (with Sch. 32)

F29

Words in s. 108(10) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(8)(ii) (with Sch. 32)

F30

Words in s. 108(10) substituted (1.12.2022) by The Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022 (S.I. 2022/849), art. 1(3), Sch. 1 para. 6(e) (with art. 8(3)); S.I. 2022/1023, art. 2

F31

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)

F32

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)

F33

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

F34

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)

F35

S. 108(12)(a)-(c) substituted for s. 108(12)(a)(b) (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 18(9) (with Sch. 32)

Modifications

C1

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

C2

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)

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)(ii)(aa)

C5

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

C6

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

C7

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

C8

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)

C9

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

C10

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

Notes on Part VIII

Modifications

C1

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