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Legislation Crest

Medicines Act 1968

1968 CHAPTER 67

An Act to make new provision with respect to medicinal products and related matters, and for purposes connected therewith.

[25th October 1968]

Modifications etc. (not altering text)

C1References to Ministers of Northern Ireland to be construed as references to heads of Northern Ireland departments: Northern Ireland Constitution Act 1973 (c. 36), Sch. 5 para. 7

C2Functions of Ministry of Home Affairs for Northern Ireland transferred to Department of Health and Social Services for Northern Ireland by S.R. & O. (N.I.) 1973 No. 504, art. 5, Sch. 2 Pt. I

C3Functions exercisable by Ministers jointly under this Act (except s. 108(4)(7) now exercisable by those Ministers and Secretary of State for Wales jointly: S.I. 1978/272, art. 2(3), Sch. 1; references to Minister of Agriculture, Fisheries and Food amended (W.): ibid., art. 11(6)

C4Act restricted by S.I. 1985/273, reg. 3(3)

C6Certain provisions of the Act extended and modified (14.2.1994) by S.I. 1994/105, reg. 19, Sch. 4

C7Act excluded in part (6.5.1998) by S.I. 1998/1046, reg. 43

Act excluded in part (6.5.1998) by S.I. 1998/1047, reg. 74

Act excluded in part (2.8.1999) by S.I. 1999/1871, reg. 92(1)

C8Act: functions transferred (27.12.1999) by S.I. 1999/3142, art. 2(1)(2) (with art. 4)

Act: functions transferred (27.3.2002) by S.I. 2002/794, art. 3(1)(c)(2)(7) (with art. 6)

C10Act amendment to earlier affecting provision SI 1994/3144 reg. 10 Sch. 4 para. 10(b) (1.10.2006) by The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 11(b) (with regs. 2(4), 3)

C11Act amendment to earlier affecting provision SI 1994/3144 reg. 10 Sch. 4 para. 9(b) (1.10.2006) by The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 11(a) (with regs. 2(4), 3)

Part IU.K. Administration

Modifications etc. (not altering text)

C12Pt. I (ss. 1-5) modified (3.4.1992) by S.I. 1992/605, regs. 2(3), 3

[F1 1 Ministers responsible for administration of Act. U.K.

In this Act, “the Ministers” has the meaning given by regulation 6(6) to (8) of the 2012 Regulations (but as if references in that regulation to those Regulations were references to this Act). ]

Textual Amendments

Modifications etc. (not altering text)

C13Pt. I(ss. 1–5) extended by S.I. 1984/187, art. 2

C14S. 1 extended (3.4.1992) by S.I. 1992/605, regs. 2(4), 3

F22 Establishment of Medicines Commission. U.K.

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Textual Amendments

F32A.Establishment of the Commission on Human MedicinesU.K.

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Textual Amendments

F3 3 Functions of the Commission U.K.

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Textual Amendments

F34 Establishment of committees. U.K.

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Textual Amendments

F35 Supplementary provisions as to Commission and committees. U.K.

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Textual Amendments

Part IIU.K. Licences and Certificates Relating to Medicinal Products

General provisions and exemptionsU.K.

F36 The licensing authority. U.K.

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Textual Amendments

F37 General provisions as to dealing with medicinal products. U.K.

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Textual Amendments

F38 Provisions as to manufacture and wholesale dealing. U.K.

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Textual Amendments

F3 9 Exemptions for doctors and dentists U.K.

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Textual Amendments

10 Exemptions for pharmacists. U.K.

(1)F4 ... The restrictions imposed by [F5regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations] do not apply to anything which is done in a registered pharmacy, a hospital [F6, a care home service ] or a health centre and is done there by or under the supervision of a pharmacist and consists of—

(a)preparing or dispensing a medicinal product in accordance with a prescription given by [F7an appropriate practitioner], or

(b)assembling a medicinal product [F8provided that where the assembling takes place in a registered pharmacy—

(i)it shall be in a registered pharmacy at [F9or from] which the business in medicinal products carried on is restricted to retail sale or to supply in circumstances corresponding to retail sale and the assembling is done with a view to such sale or supply either at [F9or from] that registered pharmacy or at [F9or from] any other such registered pharmacy forming part of the same retail pharmacy business, and

(ii)the medicinal product has not been the subject of an advertisement]; and those restrictions do not apply to anything done by or under the supervision of a pharmacist which consists of procuring the preparation or dispensing of a medicinal product in accordance with a prescription given by a practitioner, or of procuring the assembly of a medicinal product.

F10(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3)Those restrictions do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist in accordance with a specification furnished by the person to whom the product is or is to be sold or supplied, where—

(a)the product is prepared or dispensed for administration to that person or to a person under his care, F11 ...

F11(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4)Without prejudice to the preceding subsections, the restrictions imposed by [F12regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations] do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of—

(a)preparing or dispensing a medicinal product for administration to a person where the pharmacist is requested by or on behalf of that person to do so in accordance with the pharmacist’s own judgment as to the treatment required, and that person is present in the pharmacy at the time of the request in pursuance of which that product is prepared or dispensed, or

(b)preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) or subsection (3) of this section or in paragraph (a) of this subsection [F13provided that such stock is prepared with a view to retail sale or to supply in circumstances corresponding to retail sale and the preparation is done with a view to such sale or supply either at [F14or from] that registered pharmacy or at [F14or from] any other registered pharmacy forming part of the same retail pharmacy business];

and those restrictions do not apply to anything which is done in a hospital or a health centre by or under the supervision of a pharmacist and consists of preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) of this section.

[F15(5)Without prejudice to the preceding subsections, the restrictions imposed by [F16 regulation 46 of the 2012 Regulations] do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist where—

(a)the medicinal product is prepared or dispensed otherwise than in pursuance of an order from any other person, and

(b)the medicinal product is prepared with a view to retail sale or supply in circumstances corresponding to retail sale at [F17or from] the registered pharmacy at which it is prepared, and

(c)the medicinal product has not been the subject of an advertisement.

(6)Without prejudice to the preceding subsections, the restrictions imposed by [F18regulation 17(1) of the 2012 Regulations] do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of preparing a medicinal product with a view to retail sale or to supply in circumstances corresponding to retail sale at [F19or from] that registered pharmacy.

F20(6A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F21(7). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F22(7A)The F23 ... Ministers may make regulations prescribing conditions which must be complied with if a thing is to be considered for the purposes of this section as done under the supervision of a pharmacist.

(7B)Conditions prescribed under subsection (7A) may relate to supervision in the case where the pharmacist is not at the place where the thing is being done, and in that case the thing is not to be so considered if no such conditions are prescribed.

(7C)In any case, compliance with any applicable conditions is sufficient for the thing to be so considered.]

(8)For the purposes of this section “advertisement" shall have the meaning assigned to it by [F24regulation 7 (advertisements relating to medicinal products) of the 2012 Regulations].]

[F25(9)In subsection (1) of this section, “care home service" has the meaning given by [F26paragraph 2 of schedule 12 to the Public Services Reform (Scotland) Act 2010 (asp 8) ]. ]

Textual Amendments

F4Words in s. 10(1) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 10(a) (with regs. 2(4), 3)

F6Words in s. 10(1) inserted (S.) (1.4.2002) by 2001 asp 8, s. 79, Sch. 3 para. 5(a); S.S.I. 2002/162, art. 2(h) (subject to arts. 3-13)

F8Words added by S.I. 1971/1445, art. 3(a)

F15S. 10(5)–(8) added by S.I. 1971/1445, art. 3(c)

F21S. 10(7) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 3(e) Sch. 35 (with Sch. 32)

F22S. 10(7A)-(7C) inserted (19.7.2006 for specified purposes) by Health Act 2006 (c. 28), ss. 26(1), 83(1)(e)

F23Word in s. 10(7A) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 10(e) (with regs. 2(4), 3)

F25S. 10(9) added (S.) (1.4.2002) by 2001 asp 8, ss. 79, Sch. 3 para. 5(b); S.S.I. 2002/162, art. 2(h) (subject to arts. 3-13)

Modifications etc. (not altering text)

C15Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)

C16S. 10 amended (E.W.S.) (prosp) by 1954 c. 61, s. 13I(1)(b) (as inserted (prosp.) by 1997 c. 19, ss. 1, 2(1), Sch. para. 2)

F2711 Exemption for nurses and midwives. U.K.

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Textual Amendments

F2712 Exemptions in respect of herbal remedies. U.K.

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Textual Amendments

F2713 Exemptions for imports. U.K.

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Textual Amendments

F27 14 Exemption for re-exports. U.K.

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Textual Amendments

15 Provision for extending or modifying exemptions. U.K.

F28(1). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F28(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) The F29 ... Ministers may by order provide that any of the provisions of [F30 section 10 ] of this Act specified in the order shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be so specified.

(4)No order shall be made under subsection (3) of this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

Textual Amendments

F28S. 15(1)(2) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 4(a) Sch. 35 (with Sch. 32)

F29Word in s. 15(3) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 11(b) (with regs. 2(4), 3)

F30Words in s. 15(3) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 4(b) Sch. 35 (with Sch. 32)

Modifications etc. (not altering text)

C17 Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403 , art. 3(1)

F3116 Transitional exemptions. U.K.

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Textual Amendments

F3117 Termination of transitional exemptions. U.K.

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Textual Amendments

Applications for, and grant and renewal of, licencesU.K.

F3118 Application for licence. U.K.

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Textual Amendments

F3119 Factors relevant to determination of application for licence. U.K.

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Textual Amendments

F3120 Grant or refusal of licence. U.K.

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Textual Amendments

F31 21 Procedure on reference to appropriate committee U.K.

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Textual Amendments

F31 22 Procedure in other cases. U.K.

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Textual Amendments

F31 22A .Hearing before person appointedU.K.

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Textual Amendments

F3123 Special provisions as to effect of manufacturer’s licence. U.K.

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Textual Amendments

F3124 Duration and renewal of licence. U.K.

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Textual Amendments

Licences of rightU.K.

F3125 Entitlement to licence of right. U.K.

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Textual Amendments

F3226 Scope of licence of right in different cases. U.K.

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Textual Amendments

F32S. 26 repealed (22.7.2004) by Statute Law (Repeals) Act 2004 (c. 14), Sch. 1 Pt. 17 Group 7

F3127 Proceedings on application for licence of right. U.K.

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Textual Amendments

Suspension, revocation and variation of licencesU.K.

F3128 General power to suspend, revoke or vary licences. U.K.

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Textual Amendments

F3129 Procedure where licensing authority propose to suspend, revoke or vary licence under s. 28.U.K.

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Textual Amendments

F3130 Variation of licence on application of holder. U.K.

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Textual Amendments

Clinical trials and medicinal tests on animalsU.K.

F3331 Clinical trials. U.K.

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F3432 Medicinal tests on animals. U.K.

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Textual Amendments

F3433 Exemptions in respect of medicinal tests on animals. U.K.

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Textual Amendments

F3434 Restrictions as to animals on which medicinal tests have been carried out. U.K.

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Textual Amendments

F3435 Supplementary provisions as to clinical trials and medicinal tests on animals.U.K.

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Textual Amendments

F3436 Application for, and issue of, certificate. U.K.

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Textual Amendments

F3537 Transitional provisions as to clinical trials and medicinal tests on animals. U.K.

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Textual Amendments

F35S. 37 repealed (22.7.2004) by Statute Law (Repeals) Act 2004 (c. 14), Sch. 1 Pt. 17 Group 7

F3638 Duration and renewal of certificate. U.K.

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Textual Amendments

F3639 Suspension, revocation or variation of certificate. U.K.

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Textual Amendments

Medicated animal feeding stuffsU.K.

F3640 Medicated animal feeding stuffs. U.K.

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Textual Amendments

41–42. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F37U.K.

Supplementary provisionsU.K.

F3143 Extension of s. 7 to certain special circumstances. U.K.

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Textual Amendments

F3144 Provision of information to licensing authority. U.K.

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Textual Amendments

F3145 Offences under Part II. U.K.

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Textual Amendments

F3146 Special defences under s. 45. U.K.

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Textual Amendments

F3147 Standard provisions for licences U.K.

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Textual Amendments

F3148 Postponement of restrictions in relation to exports. U.K.

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Textual Amendments

F3149 Special provisions in respect of exporting certain products. U.K.

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Textual Amendments

F38 49A Special provisions in respect of exporting certain products to member States U.K.

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F3149B. Special provisions in respect of exporting certain products to EEA State s U.K.

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Textual Amendments

F3150 Certificates for exporters of medicinal products. U.K.

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Textual Amendments

Part IIIU.K. Further Provisions relating to Dealings with Medicinal Products

Modifications etc. (not altering text)

C18Part III (ss.51-68) modified (1.1.1995) by S.I. 1994/3144, reg. 9(9)

C19Pt. III amendment to earlier affecting provision SI 1994/3144 reg. 9 (30.10.2005) by Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), regs. 1(a), 2(12)

Provisions as to sale or supply of medicinal productsU.K.

F3151 General sale lists. U.K.

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Textual Amendments

F3152 Sale or supply of medicinal products not on general sale list. U.K.

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Textual Amendments

F3153 Sale or supply of medicinal products on general sale list. U.K.

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Textual Amendments

F3154 Sale of medicinal products from automatic machines.U.K.

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Textual Amendments

Exemptions from sections 52 and 53U.K.

F3155 Exemptions for doctors and dentists etcU.K.

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Textual Amendments

F3156 Exemptions in respect of herbal remedies.U.K.

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Textual Amendments

F3157 Power to extend or modify exemptions. U.K.

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Textual Amendments

Additional provisionsU.K.

58 Medicinal products on prescription only. U.K.

(1)The [F39Ministers] may by order specify descriptions or classes of medicinal products [F40as prescription only medicines]

F41(1A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F42(1ZA). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F43(1B). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F44(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F45(3). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) Without prejudice to [F46 regulation 223(1) of the 2012 Regulations] , any order made by the [F47 Ministers ] for the purposes of this section may provide—

(a) that [F48 regulation 214(1) or (2) of the 2012 Regulations] shall have effect subject to such exemptions as may be specified in the order [F49[F50 or, in the case of an appropriate practitioner, other than a doctor or dentist, ] such modifications as may be so specified ] ;

(b) that, for the purpose of [F51 regulation 214(1) of the 2012 Regulations] , a medicinal product shall not be taken to be sold or supplied in accordance with a prescription given by an appropriate practitioner unless such conditions as are prescribed by the order are fulfilled.

[F52(4A)An order under this section may provide, in relation to [F53an appropriate practitioner, other than a doctor or dentist], that such a person may—

(a)give a prescription for a medicinal product falling within a description or class specified in the order;

(b)administer any such medicinal product; or

(c)give directions for the administration of any such medicinal product,

only where he complies with such conditions as may be specified in the order in respect of the cases or circumstances in which he may do so.

F52( 4B )An order under this section may provide, in relation to a condition specified by virtue of subsection (4A), for the condition to have effect subject to such exemptions as may be specified in the order.

F52( 4C ) Where a condition is specified by virtue of subsection (4A), any prescription or direction given by a person in contravention of the condition is not (subject to such exemptions or modifications as may be specified in the order by virtue of subsection (4)(a) of this section) given by an appropriate practitioner for the purposes of [F54 regulation 214(1) or (2) of the 2012 Regulations] . ]

(5)Any exemption conferred [F55or modification made] by an order in accordance with subsection (4)(a) of this section may be conferred [F56or made] subject to such conditions or limitations as may be specified in the order.

( 6 ) Before making an order under this section the [F57 Ministers ] shall consult the appropriate committee F58 ....

[F59(7)In subsection (6) “the appropriate committee” means whichever the Ministers consider appropriate of—

(a)the Commission; or

(b)an expert committee appointed by the Ministers, or by one of them acting alone.]

Textual Amendments

F41S. 58(1A) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 5(b) Sch. 35 (with Sch. 32)

F44S. 58(2) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 5(b) Sch. 35 (with Sch. 32)

F45S. 58(3) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 5(b) Sch. 35 (with Sch. 32)

F46Words in s. 58(4) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 5(c) (with Sch. 32)

F49Words in s. 58(4)(a) inserted (3.10.1994) by Medicinal Products: Prescription by Nurses etc. Act 1992 (c. 28), s. 1(2); S.I. 1994/2408, art. 2

F51Words in s. 58(4)(b) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 5(e) (with Sch. 32)

F52S. 58(4A)-(4C) inserted (6.3.2002 for certain purposes and 1.4.2002 otherwise) by 2001 c. 15, s. 63(5); S.I. 2002/1095, art. 2(1)

F55Words in s. 58(5) inserted (3.10.1994) by Medicinal Products: Prescription by Nurses etc. Act 1992 (c. 28), s. 1(3)(a); S.I. 1994/2408, art. 2

F56Words in s. 58(5) inserted (3.10.1994) by Medicinal Products: Prescripion by Nurses etc. Act 1992 (c. 28), s. 1(3)(b); S.I. 1994/2408, art. 2

Modifications etc. (not altering text)

C20Ss. 57, 58, 61 extended by S.I. 1984/187, art. 2

S. 58 applied (31.3.1997) by S.I. 1997/322, reg. 34, Sch. 5

C21S. 58 applied (1.1.1995) by S.I. 1994/3142, reg. 18(2)

S. 58 modified (1.1.1995) by S.I. 1994/3144, reg. 9(10)

C22 Ss. 58 58A amendment to earlier affecting provision SI 1994/3144 reg. 9 (30.10.2005) by Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759) , regs. 1(a) , 2(12)

C23S. 58(1) restricted (1.1.1995) by S.I. 1994/3144, reg. 8(4)

[F60 58A [F61Requirement to specify certain products as prescription-only products]U.K.

(1) The F62 ... Ministers shall, subject to subsection (4) of this section, so exercise their powers under section 58(1) of this Act as to secure that every product—

F63(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F63(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)to which subsection (2) of this section applies;

[F64is specified as a prescription only medicine].

(2)This subsection applies to any product which—

(a)is likely to present a direct or indirect danger to human health, even when used correctly, if used without the supervision of a doctor or dentist; or

(b)is frequently and to a very wide extent used incorrectly, and as a result is likely to present a direct or indirect danger to human health; or

(c)contains substances or preparations of substances of which the activity requires, or the side-effects require, further investigation; or

(d)is normally prescribed by a doctor or dentist for parenteral administration.

(3) In considering whether subsection (2) of this section applies to a product the F65 ... Ministers shall take into account whether the product—

(a) contains a substance which is listed in any of Schedules I, II or IV to the Narcotic Drugs Convention (where the product is not a preparation listed in Schedule III to that Convention); or

(b) contains a substance which is listed in any of Schedules I to IV of the Psychotropic Substances Convention (where the pro duct is not a preparation which may be exempted from measures of control in accordance with paragraphs 2 and 3 of article 3 of that Convention); or

(c)is likely, if incorrectly used—

(i)to present a substantial risk of medicinal abuse, or

(ii)to lead to addiction, or

(iii)to be used for illegal purposes; or

(d)contains a substance which, by reason of its novelty or properties, might fall within paragraph (c) above, but as to which there is insufficient information available to determine whether it does so fall; or

(e)by reason of its pharmaceutical characteristics or novelty, or in the interests of public health, is reserved for treatments which can only be followed in a hospital; or

(f)is used in the treatment of conditions which must be diagnosed in a hospital or in an institution with special diagnostic facilities (although administration and subsequent supervision may be carried out elsewhere); or

(g)is intended for outpatients but may produce very serious sideeffects which would require a prescription drawn up as required by a specialist and special supervision throughout the treatment.

(4) Subsection (1) of this section shall not apply in relation to any product if the F66 ... Ministers so determine having regard to—

(a)the maximum single dose;

(b)the maximum daily dose;

(c)the strength of the product;

(d)its pharmaceutical form;

(e)its packaging; or

(f)such other circumstances relating to its use as may be specified in the determination.

(5) In this section F67 ...—

“the Narcotic Drugs Convention" means the Single Convention on Narcotic Drugs signed by the United Kingdom on 30th March 1961 as amended by the Protocol Amending the Single Convention on Narcotic Drugs signed by the United Kingdom on 25th March 1972 X1 ; and

“the Psychotropic Substances Convention" means the Convention on Psychotropic Substances signed by the United Kingdom on 21st February 1971 X2 . ]

Editorial Information

X1The Convention, as amended by the Protocol, is published as Cmnd. 7466.

X2Cmnd. 7330.

Textual Amendments

F60 S. 58A inserted (1.1.1993) by S.I. 1992/3271 , regs. 1(1) , 2

F61Words in s. 58A heading substituted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 30

F62Word in s. 58A(1) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 30(a) (with regs. 2(4), 3)

F63S. 58A(1)(a)(b) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 6(a) (with Sch. 32)

F65Word in s. 58A(3) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 30(b) (with regs. 2(4), 3)

F66Word in s. 58A(4) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 30(c) (with regs. 2(4), 3)

F67Words in s. 58A(5) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 30(d) (with regs. 2(4), 3)

Modifications etc. (not altering text)

C22 Ss. 58 58A amendment to earlier affecting provision SI 1994/3144 reg. 9 (30.10.2005) by Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759) , regs. 1(a) , 2(12)

C25 S. 58A extended (with modifications) (14.2.1994) by S.I. 1994/105 , reg. 19 , Sch. 4

C26 S. 58A modified (1.1.1995) by S.I. 1994/3144 , reg. 9(4)(10)

S. 58A applied (1.1.1995) by 1994/3142, reg. 18

F6858B Requirement to specify certain products for veterinary use as prescription-only products.U.K.

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

Textual Amendments

F6959 Special provisions in relation to new medicinal products.U.K.

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

Textual Amendments

F6960 Restricted sale, supply and administration of certain medicinal products.U.K.

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

Textual Amendments

F6961 Special restrictions on persons to be supplied with medicinal products. U.K.

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

Textual Amendments

62 Prohibition of sale or supply, or importation, of medicinal products of specified description F70 .... U.K.

(1) Subject to the following provisions of this section, the F71 ... Ministers, where it appears to them to be necessary to do so in the interests of safety, may by order—

(a)prohibit the sale or supply, or the importation, of medicinal products of any description, or falling within any class, specified in the order, or (in such manner as may appear to them to be sufficient to identify the products in question) designate particular medicinal products and prohibit the sale or supply, or the importation, of those particular products;

F72(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2)A prohibition imposed by order under this section may be a total prohibition or may be imposed subject to such exceptions as may be specified in the order.

(3) Before making an order under this section the [F73 Ministers ] , unless in their opinion it is essential to make the order with immediate effect to avoid serious danger to health F74 ..., shall consult the appropriate committee F75 ....

(4) Where an order is made under this section without prior consultation with the appropriate committee F76 ... in accordance with subsection (3) of this section, the prohibition imposed by the order shall not have effect after the end of such period, not exceeding three months from the date on which it comes into operation, as may be specified in the order, but without prejudice to the making of any further order in accordance with the provisions of this section (including this subsection).

(5)If any organisation consulted in pursuance of section 129(6) of this Act with respect to a proposal to make an order under this section have given notice to the [F77Ministers] of their desire to be heard under this subsection, or have made representations in writing to [F78the Ministers] with respect to that proposal, then before making the order—

(a)if the organisation have given notice of their desire to be heard, the [F77Ministers] shall arrange for them to have an opportunity of appearing before, and being heard by, the [F79appropriate committee], or

(b)if they have made representations in writing, the [F77Ministers] shall refer those representations to the [F79appropriate committee],

and, where the organisation have availed themselves of the opportunity of being heard, or after considering the representations, as the case may be, the Commission shall report their findings and conclusions to the [F77Ministers] and [F78the Ministers] shall take that report into account in determining whether to make the order.

(6) Subsection (5) of this section shall not have effect where in the opinion of the F80 ... Ministers it is essential to make the order with immediate effect as mentioned in subsection (3) of this section.

[F81(7)If an order is made under this section and either—

(a)the appropriate committee have not considered the proposal to make the order, or

(b)the order is made contrary to the advice of the appropriate committee,

the order shall include a statement of the fact that it has been so made.]

[F82(8)In this section “the appropriate committee” means whichever the Ministers consider appropriate of—

(a)the Commission; or

(b)an expert committee appointed by the Ministers, or by one of them acting alone.]

Textual Amendments

F70 Words in s. 62 heading omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407) , reg. 1 , Sch. 8 para. 35(a) (with regs. 2(4) , 3 )

F80Word in s. 62(6) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 35(e) (with regs. 2(4), 3)

Modifications etc. (not altering text)

C27S. 62 extended by S.I. 1984/187, art. 2

C28S. 62 extended with modifications by S.I. 1985/1403, art. 3(1)

S. 62 applied (1.1.1995) by S.I. 1994/3142, reg. 18(2)

C29S. 62 (1)(a), (2)–(7) extended by S.I.s 1982/425, art. 3, 1984/187, art. 2 and extended with modifications by S.I. 1985/1403, art. 3(1)

63 Adulteration of medicinal products. U.K.

No person shall—

(a)add any substance to, or abstract any substance from, a medicinal product so as to affect injuriously the composition of the product, with intent that the product shall be sold or supplied in that state, or

(b)sell or supply, or offer or expose for sale or supply, or have in his possession for the purpose of sale or supply, any medicinal product whose composition has been injuriously affected by the addition or abstraction of any substance.

Modifications etc. (not altering text)

C31Ss. 63–65 extended by S.I. 1984/187, art. 2

C32S. 63 applied (1.1.1995) by S.I 1994/3142, reg. 18(2)

64 Protection of purchasers of medicinal products. U.K.

(1)No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser.

(2)For the purposes of this section the sale of a medicinal product shall not be taken to be otherwise than to the prejudice of the purchaser by reason only that the purchaser buys the product for the purpose of analysis or examination.

(3)Subsection (1) of this section shall not be taken to be contravened by reason only that a medicinal product contains some extraneous matter, if it is proved that the presence of that matter was an inevitable consequence of the process of manufacture of the product.

(4)Subsection (1) of this section shall not be taken to be contravened by reason only that a substance has been added to, or abstracted from, the medicinal product, if it is proved that—

(a)the addition or abstraction was not carried out fraudulently, and did not injuriously affect the composition of the product, and

(b)the product was sold having attached to it, or to a container or package in which it was sold, a conspicuous notice of adequate size and legibly printed, specifying the substance added or abstracted.

(5)Where a medicinal product is sold or supplied in pursuance of a prescription given by [F83an appropriate practitioner], the preceding provisions of this section shall have effect as if—

(a)in those provisions any reference to sale included a reference to supply and (except as provided by the following paragraph) any reference to the purchaser included a reference to the person (if any) for whom the product was prescribed by the practitioner, and

(b)in subsection (1) of this section, for the words “demanded by the purchaser", there were substituted the words “specified in the prescription".

Textual Amendments

Modifications etc. (not altering text)

C33 Ss. 63–65 extended by S.I. 1984/187 , art. 2

F8465 Compliance with standards specified in monographs in certain publications. U.K.

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

Textual Amendments

F8466 Further powers to regulate dealings with medicinal products. U.K.

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

Textual Amendments

Offences, and provision for disqualificationU.K.

67 Offences under Part III. U.K.

(1)The following provisions of this section shall have effect subject to sections 121 and 122 of this Act.

[F85(1A)Any person who gives a prescription or directions or administers a medicinal product in contravention of a condition imposed by an order under section 58 of this Act by virtue of subsection (4A) of that section shall be guilty of an offence.

(1B)Any person who—

(a) is an appropriate practitioner [F86 within the meaning of regulation 214 of the 2012 Regulations] ; and

(b)gives a prescription or directions in respect of a medicinal product of a description or class in relation to which he is not an appropriate practitioner,

shall be guilty of an offence.]

(2)Any person who contravenes any of the following provisions of this Part of this Act, that is to say, sections [F8763 and 64], or who contravenes F88... any order made under section 62 of this Act, shall be guilty of an offence.

(3)Where a medicinal product is sold, supplied or imported in contravention of an order made under section 62 of this Act, any person who, otherwise than for the purpose of performing or exercising a duty or power imposed or conferred by or under this Act or any other enactment, is in possession of the medicinal product, knowing or having reasonable cause to suspect that it was sold, supplied or imported in contravention of the order, shall be guilty of an offence.

F89(3A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4)Any person guilty of an offence under [F90subsection (1A), (1B), (2) or (3)] of this section shall be liable—

(a)on summary conviction, to a fine not exceeding £400;

(b)on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both.

F91(5). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F91(6). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F85S. 67(1A)(1B) inserted (6.3.2002 for certain purposes and 1.4.2002 otherwise) by 2001 c. 15, s. 63(7)(a) (with ss. 64(9), 65(4)); S.I. 2002/1095, art. 2(1) (with transitional provisions in art. 3)

F86Words in s. 67(1B)(a) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 9(2) (with Sch. 32)

F88Words in s. 67(2) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 9(3)(b) (with Sch. 32)

F89S. 67(3A) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 9(4), Sch. 35 (with Sch. 32)

F91S. 67(5)(6) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 9(6), Sch. 35 (with Sch. 32)

Modifications etc. (not altering text)

C34S. 67 extended by S.I.s 1982/425, art. 3, 1984/187, art. 2 and extended with modifications by S.I. 1985/1403, art. 3(1)

S. 67 applied (1.1.1995) by S.I. 1994/3142, reg. 18(2)

S. 67 applied (31.3.1997) by S.I. 1997/322, reg. 34, Sch. 5

[F9267A.Defence to offence of contravening section 63(a) or (b): product not sold or suppliedU.K.

(1)This section applies in a case where—

(a)a person (“the defendant”) is charged with an offence under section 67(2) of contravening section 63(a) or (b) in respect of a medicinal product; and

(b)the product is not sold or supplied in its adulterated state.

(2)Where the defendant is charged with contravening section 63(a), it is a defence for the defendant to prove that—

[F93(a)the adulteration took place—

(i)at a registered pharmacy, or

(ii)in the course of the provision of a relevant pharmacy service;]

(b)the defendant—

(i)was a registrant acting in the course of his or her profession, or

(ii)was acting under the supervision of a person who was a registrant acting in the course of his or her profession; and

(c)at the time of the alleged contravention, the defendant did not know that the product was being adulterated.

(3)Where the defendant is charged with contravening section 63(b), it is a defence for the defendant to prove that—

[F94(a)the adulteration took place—

(i)at a registered pharmacy, or

(ii)in the course of the provision of a relevant pharmacy service;]

(b)the person who adulterated the product—

(i)was a registrant acting in the course of his or her profession, or

(ii)was acting under the supervision of a person who was a registrant acting in the course of his or her profession; and

(c)at the time of the alleged contravention, the defendant did not know that the product had been adulterated.

67B.Defence to offence of contravening section 63(a) or (b): product sold or suppliedU.K.

(1)This section applies in a case where—

(a)a person (“the defendant”) is charged with an offence under section 67(2) of contravening section 63(a) or (b) in respect of a medicinal product; and

(b)the product was sold or supplied in its adulterated state.

(2)It is a defence for the defendant to prove that—

[F95(a)the adulteration took place—

(i)at a registered pharmacy, or

(ii)in the course of the provision of a relevant pharmacy service;]

(b)the person who adulterated the product—

(i)was a registrant acting in the course of his or her profession, or

(ii)was acting under the supervision of a person (“the supervising registrant”) who was a registrant acting in the course of his or her profession;

(c)the product was—

(i)sold or supplied in pursuance of a prescription or directions given by a relevant prescriber or a patient group direction, or

(ii)a prescription only medicine that was sold or supplied in circumstances where there was an immediate need for it to be sold or supplied and a prescription could not have been obtained without undue delay; and

(d)Condition A or B is met.

(3)Condition A is that before the defendant was charged—

(a)the defendant did not know that the product had been adulterated; and

(b)if the defendant is a person within subsection (4), neither the person who adulterated the product nor (in a case within subsection (2)(b)(ii)) the supervising registrant knew that the product had been adulterated.

(4)A defendant is a person within this subsection if the defendant is any of the following—

(a)the person who adulterated the product;

(b)(in a case within subsection (2)(b)(ii)) the supervising registrant;

(c)the person carrying on the retail pharmacy business [F96, or the relevant pharmacy service,] in the course of which the product was sold or supplied.

(5)Condition B is that—

(a)before the defendant was charged, an appropriate person, on becoming aware that the product had been adulterated—

(i)promptly ensured that all reasonable steps were taken to ensure that the person to whom the product was intended to be administered was notified that the product had been adulterated, or

(ii)reasonably formed the view that it was not necessary or appropriate to do so, in the circumstances of the case; and

(b)the defendant did not know at the time that the product was sold or supplied that it had been adulterated.

(6)In subsection (5), “appropriate person” means any of the following—

(a)the person who adulterated the product or (in a case within subsection (2)(b)(ii)) the supervising registrant;

(b)the person carrying on the retail pharmacy business [F97, or the relevant pharmacy service,] in the course of which the product was sold or supplied, or any person acting on that person’s behalf.

67C.Defence to offence of contravening section 64U.K.

(1)This section applies in a case where a person (“the defendant”) is charged with an offence under section 67(2) of contravening section 64 in respect of a medicinal product.

(2)It is a defence for the defendant to prove that—

[F98(a)the product was dispensed—

(i)at or from a registered pharmacy, or

(ii)in the course of the provision of a relevant pharmacy service;]

(b)the person who dispensed the product—

(i)was a registrant acting in the course of his or her profession, or

(ii)was acting under the supervision of a person (“the supervising registrant”) who was a registrant acting in the course of his or her profession;

(c)the product was—

(i)sold or supplied in pursuance of a prescription or directions given by a relevant prescriber or a patient group direction, or

(ii)a prescription only medicine that was sold or supplied in circumstances where there was an immediate need for it to be sold or supplied and a prescription could not have been obtained without undue delay; and

(d)Condition A or B is met.

(3)Condition A is that before the defendant was charged—

(a)the defendant did not know that the product was not of the required nature or quality; and

(b)if the defendant is a person within subsection (4), neither the person who dispensed the product nor (in a case within subsection (2)(b)(ii)) the supervising registrant knew that the product was not of the required nature or quality.

(4)A defendant is a person within this subsection if the defendant is any of the following—

(a)the person who dispensed the product;

(b)(in a case within subsection (2)(b)(ii)) the supervising registrant;

(c)the person carrying on the retail pharmacy business [F99, or the relevant pharmacy service,] in the course of which the product was sold or supplied.

(5)Condition B is that—

(a)before the defendant was charged, an appropriate person, on becoming aware that the product was not of the required nature or quality—

(i)promptly ensured that all reasonable steps were taken to ensure that the person to whom the product was intended to be administered was notified that the product was not of the required nature or quality, or

(ii)reasonably formed the view that it was not necessary or appropriate to do so, in the circumstances of the case; and

(b)the defendant did not know at the time the product was sold or supplied that it was not of the required nature or quality.

(6)In subsection (5), “appropriate person” means any of the following—

(a)the person who dispensed the product or (in a case within subsection (2)(b)(ii)) the supervising registrant;

(b)the person carrying on the retail pharmacy business [F100, or the relevant pharmacy service,] in the course of which the product was sold or supplied, or any person acting on that person’s behalf.

(7)In this section, “the required nature or quality”, in relation to a product, means—

(a)where the product is sold or supplied in pursuance of a prescription, the nature or quality specified in the prescription; or

(b)in any other case, the nature or quality demanded by the purchaser of the product.

67D.Defences under sections 67A, 67B and 67C: evidence etc.U.K.

(1)This section applies for the purposes of sections 67A to 67C.

(2)If evidence is adduced that is sufficient to raise an issue with respect to the doing of an act by a person in the course of his or her profession, the court must assume that the person did that act in the course of his or her profession unless the prosecution proves the contrary beyond reasonable doubt.

(3)The court must assume that the prosecution has proved the contrary beyond reasonable doubt if the prosecution proves beyond reasonable doubt that, in doing that act—

(a)the person used his or her professional skills for an improper purpose; or

(b)the person deliberately failed to have due regard for patient safety.

(4)Proof that a registrant failed to comply with a procedure established in relation to a registered pharmacy [F101or a relevant pharmacy service] does not of itself constitute proof that the registrant was not acting in the course of his or her profession.

(5)Knowledge acquired after a product is sold or supplied does not count if it is acquired only as a result of an investigation into whether an offence has been committed in respect of a product.

(6)If evidence is adduced that is sufficient to raise an issue with respect to doing of an act promptly, the court must assume that the act was done promptly unless the prosecution proves the contrary beyond reasonable doubt.

(7)A medicinal product is taken to be sold or supplied to a person in pursuance of a prescription or direction even if that person is not the person for whom it was dispensed in pursuance of the prescription or direction.

67E.Sections 67A to 67D: [F102“adulteration” and “registrant”] U.K.

In sections 67A to 67D—

  • “adulteration”, in relation to a medicinal product, means the addition of a substance to, or the abstraction of a substance from, the product, so as to affect injuriously its composition (and related expressions are to be construed accordingly);

  • “registrant” means—

    (a)

    where it is alleged that the offence in question took place in Great Britain, a person who is entered in Part 1, [F103or 2] of the register of pharmacists and pharmacy technicians established and maintained under article 19 of the Pharmacy Order 2010 (SI 2010/231); or

    (b)

    where it is alleged that the offence in question took place in Northern Ireland, a person registered in the register of pharmaceutical chemists for Northern Ireland F104... maintained under articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 (SI 1976/1213 (NI 22)).]

[F10567FSections 67A to 67D: “relevant pharmacy service”U.K.

(1)For the purposes of sections 67A to 67D a pharmacy service is a relevant pharmacy service if conditions A and B are met in respect of it.

(2)Condition A is met in respect of a pharmacy service if—

(a)the service is provided in England by a person in the course of carrying on a regulated activity in respect of which the person is registered under Chapter 2 of Part 1 of the Health and Social Care Act 2008;

(b)the service is provided in Wales—

(i)in the course of the business of a hospital,

(ii)in a prison or youth detention accommodation within the meaning of sections 185 to 187 of the Social Services and Well-being (Wales) Act 2014 (anaw 4) (see section 188 of that Act),

(iii)in a removal centre, short-term holding facility or pre-departure accommodation within the meaning of Part 8 of the Immigration and Asylum Act 1999 (see section 147 of that Act),

(iv)by a person in the course of carrying on or managing an establishment in respect of which the person is registered under Part 2 of the Care Standards Act 2000, or

(v)by a person in the course of providing a regulated service in respect of which the person is registered under Chapter 2 of Part 1 of the Regulation and Inspection of Social Care (Wales) Act 2016 (anaw 2);

(c)the service is provided in Scotland—

(i)in the course of the business of a hospital,

(ii)in a prison within the meaning of section 49C of the Criminal Law (Consolidation) (Scotland) Act 1995 (see subsection (7) of that section),

(iii)in a removal centre, short-term holding facility or pre-departure accommodation within the meaning of Part 8 of the Immigration and Asylum Act 1999 (see section 147 of that Act),

(iv)by a person in the course of providing an independent health care service which is registered under section 10P of the National Health Service (Scotland) Act 1978, or

(v)by a person in the course of carrying on a care service which is registered under Chapter 3 of Part 5 of the Public Services Reform (Scotland) Act 2010 (asp 8); or

(d)the service is provided in Northern Ireland—

(i)in the course of the business of a hospital,

(ii)in a prison or other institution for the treatment of offenders, including a place mentioned in section 2 of the Treatment of Offenders Act (Northern Ireland) 1968 (c. 29 (N.I.)) and a juvenile justice centre within the meaning of the Criminal Justice (Children) (Northern Ireland) Order 1998 (S.I. 1998/1504 (N.I. 9)) (see Article 51(1) of that Order),

(iii)in a removal centre, short-term holding facility or pre-departure accommodation within the meaning of Part 8 of the Immigration and Asylum Act 1999 (see section 147 of that Act), or

(iv)by a person in the course of carrying on or managing an establishment in respect of which the person is registered under Part 3 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 (S.I. 2003/431 (N.I. 9)).

(3)Condition B is met in respect of a pharmacy service if it has a chief pharmacist.

(4)A chief pharmacist, in relation to a pharmacy service, is a pharmacist who—

(a)plays a significant role (irrespective of whether other individuals also do so) in—

(i)the making of decisions about how the whole or a substantial part of the activities of the pharmacy service are to be managed or organised, or

(ii)the actual managing or organising of the whole or a substantial part of those activities,

(b)has the authority to make decisions that affect the running of the pharmacy service so far as concerns the sale or supply of medicinal products, and

(c)is responsible for securing that the pharmacy service is carried on safely and effectively.

(5)For the purposes of subsection (4)(c) a pharmacy service is carried on safely and effectively if it is carried on in ways that ensure its safe and effective running so far as concerns the sale or supply of medicinal products.]

F10668 Disqualification on conviction of certain offences.U.K.

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

Textual Amendments

Part IVU.K. Pharmacies

Modifications etc. (not altering text)

C35Pt. IV: Power to amend conferred (N.I.) (2.4.2001) by 2001 c. 3 (N.I.), s. 60, Sch. 4 para. 2(2); S.R. 2001/128, art. 2(4), Sch.

C36Pt. IV amendment to earlier affecting provision SI 1994/3144 reg. 9 (30.10.2005) by Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), regs. 1(a), 2(12)

C37Pt. IV modified (E.W.S.) (coming into force in accordance with art. 1(2)(3)) by Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), art. 1(2)(3), Sch. 2 para. 13(7)

C38Pt. IV (except ss. 80-83): Power to amend conferred (15.3.2000) by 1999 c. 8, ss. 60(1)(2)(4), 67(1), Sch. 3 para. 2(3)(b); S.I. 2000/779, art. 2

Persons lawfully conducting retail pharmacy businessU.K.

69 General provisions.U.K.

(1)Subject to the provisions of any order made under section 73 of this Act, a person carrying on a retail pharmacy business shall be taken to be a person lawfully conducting such a business if, not being disqualified by virtue of section 80 of this Act,—

(a)that person (or, if the business is carried on by a partnership, each, or, in Scotland, one or more, of the partners) is a pharmacist and the conditions specified in section 70 of this Act are fulfilled in relation to the business, or

(b)that person is a body corporate and the conditions specified in section 71 of this Act are fulfilled in relation to the business, or

(c)that person is a representative of a pharmacist (as defined by section 72 of this Act) and the conditions specified in subsection (2) of that section are fulfilled in relation to him and in relation to the business and the period applicable in accordance with subsection (3) of that section has not expired.

F107(1ZA). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F108(2)For the purposes of the application of this Part of this Act to a business which—

(a)is or is to be carried on in one or more separate or distinct parts (but not the whole) of a building, whether it is or is to be also carried on elsewhere or not, or

(b)so far as concerns the retail sale of medicinal products, or the supply of such products in circumstances corresponding to retail sale, is or is to be carried on in one or more separate or distinct parts (but not the whole) of a building, whether it is or is to be carried on elsewhere or not,

each such part of that building shall be taken to be separate premises.

(3)In this Part of this Act—

  • F109...

  • the board”, in relation to a body corporate, means the body of persons controlling the body corporate, by whatever name called;

  • F110...

  • [F111“the register” means—

    (a)

    in relation to Great Britain, the register established and maintained under article 19 of the Pharmacy Order 2010; and

    (b)

    in relation to Northern Ireland, the register kept for the purposes of section 75;]

  • [F112“the registrar” means—

    (a)

    in relation to Great Britain, the person appointed under article 18 of the Pharmacy Order 2010 as registrar for the purposes of that Order; and

    (b)

    in relation to Northern Ireland, the person appointed under Article 9(1) of the Pharmacy (Northern Ireland) Order 1976 as registrar for the purposes of that Order;]

  • [F113“the relevant disciplinary committee” means—

    (a)

    in relation to Great Britain, the Fitness to Practise Committee established under article 4(6) of the Pharmacy Order 2010; and

    (b)

    in relation to Northern Ireland, the Statutory Committee appointed under Article 19 of the Pharmacy (Northern Ireland) Order 1976;]

  • relevant European State ” means either an EEA State other than the United Kingdom or Switzerland.

  • F114...]

Textual Amendments

F109Definition in s. 69(3) repealed (5.11.1993) by 1993 c. 50, s. 1(1), Sch. 1 Pt.XII

F114Words in s. 69(3) omitted (coming into force in accordance with art. 1(2)(3)) by virtue of Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), art. 1(2)(3), Sch. 1 para. 2(4)(c)

Modifications etc. (not altering text)

C39S. 69(3) amendment continued (11.2.2010) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(2)(c), Sch. 6 para. 1(1)

[F115 70 Business carried on by individual pharmacist or by partners.U.K.

(1)The conditions referred to in section 69(1)(a) of this Act are that subsections (2) and (3) of this section are both satisfied as respects each of the premises [F116at or from which] the retail pharmacy business is carried on and medicinal products, other than medicinal products on a general sale list, are sold by retail.

(2)This subsection is satisfied if a responsible pharmacist who satisfies [F117the requirement of subsection (4)] of this section is in charge of [F118the business carried on at or from] those premises, so far as concerns—

(a)the retail sale at [F119or from] those premises of medicinal products (whether they are on a general sale list or not), and

(b)the supply at [F120or from] those premises of such products in circumstances corresponding to retail sale.

(3)This subsection is satisfied if a notice is conspicuously displayed at those premises stating—

(a)the name of the responsible pharmacist for the time being,

[F121(b)the number of his registration under Part 4 of the Pharmacy Order 2010 or, in relation to Northern Ireland, under the Pharmacy (Northern Ireland) Order 1976, and]

(c)the fact that he is for the time being in charge of [F122the business carried on at or from] those premises.

(4)The responsible pharmacist must be—

(a)the person carrying on the business, or

[F123(b)if the business is carried on by a partnership, one of the partners or, in Scotland, one of the partners who is a person registered in Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 (pharmacists other than visiting practitioners), or]

(c)another pharmacist.

F124(5). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F124(6). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

[F125 71 Business carried on by body corporateU.K.

(1)The conditions referred to in section 69(1)(b) of this Act are—

[F126(a)that there is a superintendent in relation to the retail pharmacy business in respect of whom the requirements specified in subsection (6) are fulfilled, and]

(b)that subsections (2) and (3) of this section are both satisfied as respects each of the premises [F127at or from which] the business is carried on and medicinal products, other than medicinal products on a general sale list, are sold by retail.

(2)This subsection is satisfied if a responsible pharmacist who satisfies [F128the requirement of subsection (4)] of this section is in charge of [F129the business carried on at or from] the premises mentioned in subsection (1)(b) of this section, so far as concerns—

(a)the retail sale at [F130or from] those premises of medicinal products (whether they are on a general sale list or not), and

(b)the supply at [F131or from] those premises of such products in circumstances corresponding to retail sale.

(3)This subsection is satisfied if a notice is conspicuously displayed at those premises stating—

(a)the name of the responsible pharmacist for the time being,

[F132(b)the number of his registration under Part 4 of the Pharmacy Order 2010 or, in relation to Northern Ireland, under the Pharmacy (Northern Ireland) Order 1976, and]

(c)the fact that he is for the time being in charge of [F133the business carried on at or from] those premises.

(4)The responsible pharmacist must be—

(a)the superintendent mentioned in subsection (1)(a) of this section, or

(b)a manager or assistant subject to the directions of the superintendent and who is a pharmacist.

F134(5). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F134(5A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6)The requirements referred to in subsection (1)(a) of this section in relation to a superintendent are that—

(a)he is a pharmacist,

[F135(aa)he is a senior manager of the retail pharmacy business who has the authority to make decisions that affect the running of the retail pharmacy business so far as concerns—

(i)the retail sale of medicinal products (whether they are on a general sale list or not), and

(ii)the supply of such products in circumstances corresponding to retail sale,

and]

(b)a statement in writing signed by him, and signed on behalf of the body corporate, specifying his name F136..., has been sent to the registrar F136...

F137(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F138(7). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F139(7A)For the purposes of subsection (6)(aa), a person is a senior manager of a retail pharmacy business if the person plays a significant role (irrespective of whether other individuals also do so) in—

(a)the making of decisions about how the whole or a substantial part of its activities are to be managed or organised, or

(b)the actual managing or organising of the whole or a substantial part of those activities.]

[F140(8)[F141If a person who has been the superintendent in relation to a retail pharmacy business ceases to be the superintendent in relation to the business] (otherwise than by reason of death) the person must notify the registrar in writing of that fact within the period of 28 days beginning with the day on which the person ceases to [F142be the superintendent in relation to the business].]

F143(9). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

72 Representative of pharmacist in case of death or disability.U.K.

(1)The provisions of this section shall have effect where a pharmacist carries on a retail pharmacy business and—

(a)he dies, or

(b)he is adjudged bankrupt or enters into a composition or scheme or deed of arrangement with his creditors, or, in Scotland, sequestration of his estate is awarded or he makes a trust deed for behoof of his creditors or a composition contract, or

(c)[F144he becomes a person who lacks capacity (within the meaning of the Mental Capacity Act 2005) to carry on the business], or, in Scotland, a [F145guardian] or judicial factor is appointed for him on the ground that he suffers from mental disorder, or, in Northern Ireland, [F146a controller is appointed in his case under the Mental Health (Northern Ireland) Order 1986],

and a representative of his thereafter carries on his business.

[F147(1A)In subsection (1)(c), the reference to a person who lacks capacity to carry on the business is to a person—

(a)in respect of whom there is a donee of an enduring power of attorney or lasting power of attorney (within the meaning of the Mental Capacity Act 2005), or

(b)for whom a deputy is appointed by the Court of Protection,

and in relation to whom the donee or deputy has power for the purposes of this Act.]

[F148(2)The conditions referred to in section 69(1)(c) of this Act are—

(a)that the name and address of the representative, and the name of the pharmacist whose representative he is, have been notified to the registrar, and

(b)that subsections (2A) and (2B) of this section are both satisfied as respects each of the premises at [F149or from] which the business is carried on and medicinal products, other than medicinal products on a general sale list, are sold by retail.

(2A)This subsection is satisfied if a responsible pharmacist is in charge of [F150the business carried on at or from] the premises mentioned in subsection (2)(b) of this section, so far as concerns—

(a)the retail sale at [F151or from] those premises of medicinal products (whether they are on a general sale list or not), and

(b)the supply at [F152or from] those premises of such products in circumstances corresponding to retail sale.

(2B)This subsection is satisfied if a notice is conspicuously displayed at those premises stating—

(a)the name of the responsible pharmacist for the time being,

(b)[F153the number of his registration under Part 4 of the Pharmacy Order 2010 or, in relation to Northern Ireland, under the Pharmacy (Northern Ireland) Order 1976, and]

(c)the fact that he is for the time being in charge of [F154the business carried on at or from] those premises.]

(3)The period referred to in section 69(1)(c) of this Act—

(a)in the case of the death of a pharmacist, is a period of five years from the date of his death;

(b)in the case of the bankruptcy or sequestration of the estate of a pharmacist, is a period of three years from the date on which he is adjudged bankrupt or the date of the award of sequestration, as the case may be;

(c)in the case of a composition or scheme or deed of arrangement, or of a trust deed or composition contract, is a period of three years from the date on which the trustee appointed thereunder becomes entitled to carry on the business; and

(d)in a case falling within subsection (1)(c) of this section, is a period of three years from the date of the appointment of the [F155deputy], [F156curator bonis,] judicial factor, committee or guardian [F157or from the date of registration of the instrument appointing the donee],

or, in any such case, is such longer period as, on the application of the representative, [F158the relevant disciplinary committee], having regard to all the circumstances of the case, may direct.

(4)In this section “representative”—

(a)in relation to a pharmacist who has died, means his executor or administrator and, in respect of a period of three months from the date of his death, if he has died leaving no executor who is entitled and willing to carry on the business, includes any person beneficially interested in his estate;

(b)in a case falling within paragraph (b) of subsection (1) of this section, means the trustee in bankruptcy or the trustee in the sequestration or any trustee appointed under the composition scheme, deed of arrangement, trust deed or composition contract; and

(c)in a case falling within paragraph (c) of that subsection, means the [F159donee, deputy], [F156curator bonis,] judicial factor, [F160controller] or guardian [F161; and in paragraph (b) above the reference to a trustee appointed under a composition, scheme or deed of arrangement includes a reference to the supervisor of a [F162voluntary arrangement proposed for the purposes of, and approved under, Part VIII of the Insolvency Act 1986] [F163or Chapter II of Part VIII of the Insolvency (Northern Ireland) Order 1989].]

Textual Amendments

F144Words in s. 72(1)(c) substituted (1.10.2007) by Mental Capacity Act 2005 (c. 9), s. 68(1), Sch. 6 para. 14(a) (with ss. 27-29, 62); S.I. 2007/1897, art. 2(1)(d)

F145Words in s. 72(1) substituted (S.) (1.4.2002) by 2000 asp 4, s. 88(2), Sch. 5 para. 12(a); S.S.I. 2001/81, art. 3, Sch. 2

F148S. 72(2)-(2B) substituted for s. 72(2) (1.10.2009) by Health Act 2006 (c. 28), ss. 29, 83(7); S.I. 2008/2714, art. 2(a)

F156Words in s. 72(3)(d)(4)(c) repealed (S.) (1.4.2002) by 2000 asp 4, s. 88(2)(3), Sch. 5 para. 12(b), Sch. 6; S.S.I. 2001/81, art. 3, Sch. 2

F158Words in s. 72(3) substituted (coming into force in accordance with art. 1(2)(3)) by Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), art. 1(2)(3), Sch. 1 para. 2(9)(b)

F159Words in s. 72(4)(c) substituted (1.10.2007) by Mental Capacity Act 2005 (c. 9), s. 68(1), Sch. 6 para. 14(d) (with ss. 27-29, 62); S.I. 2007/1897, art. 2(1)(d)

F163Words in s. 72(4) added (N.I.) (1.10.1991) by S.I. 1989/2405 (N.I. 19), art. 381, Sch. 9 Pt. II para. 24; S.R. 1991/411, art. 2

Modifications etc. (not altering text)

C40S. 72(3) amendments continued (11.2.2010) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(2)(c), Sch. 6 para. 1(2)(a)

[F16472AThe responsible pharmacistU.K.

[F165(A1)Nothing in this Part is to be taken as requiring there to be a responsible pharmacist in respect of premises at or from which a retail pharmacy business is carried on at a time when no medicinal products (whether they are on a general sale list or not) are being—

(a)offered or exposed for sale by retail or supply in circumstances corresponding to retail sale at or from the premises, or

(b)assembled, prepared or dispensed at or from the premises with a view to such sale or supply.]

(1)It is the duty of the responsible pharmacist mentioned in sections 70, 71 and 72 of this Act to secure the safe and effective running of the pharmacy [F166business carried on at or from] the premises in question so far as concerns—

(a)the retail sale at [F167or from] those premises of medicinal products (whether they are on a general sale list or not), and

(b)the supply at [F168or from] those premises of such products in circumstances corresponding to retail sale.

(2)A person may not be the responsible pharmacist in respect of more than one set of premises at the same time, except in circumstances specified by [F169the General Pharmaceutical Council in rules in relation to premises in Great Britain or the Council of the Pharmaceutical Society of Northern Ireland in regulations in relation to premises in Northern Ireland], and then only if such conditions as may be so specified are complied with.

F170(3). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F170(4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F170(5). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F171(6)The General Pharmaceutical Council may make further provision in rules in relation to the responsible pharmacist in respect of premises in Great Britain, and the Council of the Pharmaceutical Society of Northern Ireland may make further provision in regulations in relation to the responsible pharmacist in respect of premises in Northern Ireland.

(6A)In making any such provision, the General Pharmaceutical Council and the Council of the Pharmaceutical Society of Northern Ireland must have regard to the principle that the burdens imposed on businesses by rules or regulations should be the minimum necessary to secure the benefits, considered in general terms, which are expected to result from the rules or regulations.

(7)The rules and regulations mentioned in subsection (6) may (amongst other things)—

(a)make further provision about the matters mentioned in subsection (1);

(b)make provision about the responsible pharmacist’s absence from the premises.

(7A)If such rules or regulations make provision about the responsible pharmacist’s absence from the premises, they must also provide that the retail sale of medicinal products on a general sale list may continue at or from the premises during any period in which the responsible pharmacist is absent from the premises.]

F172(8). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

F164Ss. 72A, 72B inserted (19.7.2006 for specified purposes) by Health Act 2006 (c. 28), ss. 30(1), 83(1)(e)

[F17372AA.The superintendentU.K.

It is the duty of the superintendent in relation to a retail pharmacy business to secure that the business is at all times carried on in ways that ensure its safe and effective running so far as concerns—

(a)the retail sale of medicinal products (whether they are on a general sale list or not), and

(b)the supply of such products in circumstances corresponding to retail sale.]

[F16472B[F174Sections 72A and 72AA: supplementary]U.K.

[F175(1)The failure by a person to comply with any requirements of [F176section 72A or 72AA of this Act, or of rules or regulations made under section 72A,] may constitute misconduct for the purposes of section 80 of this Act, article 51(1)(a) of the Pharmacy Order 2010 and Article 20 of the Pharmacy (Northern Ireland) Order 1976 and the relevant disciplinary committee may deal with such a failure accordingly.]

F177(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3)Subsection (4) of this section applies if a person—

(a)fails to comply with the requirements of subsection (2) of section 72A of this Act, or of [F178rules or] regulations made under that subsection,

(b)fails to comply with any requirements as to absence from the premises contained in [F179rules or] regulations made by virtue of [F180subsection (7)] of that section.

(4)If this subsection applies, the person in question is not to be considered while the failure continues as being in charge of [F181the business carried on at or from] the premises in question (or in a subsection (3)(a) case at any of them) for the purposes of sections 70 to 72 of this Act.]

Textual Amendments

F164Ss. 72A, 72B inserted (19.7.2006 for specified purposes) by Health Act 2006 (c. 28), ss. 30(1), 83(1)(e)

73 Power to extend or modify conditions.U.K.

(1)The F182... Ministers may by order add to, revoke or vary any of the provisions of sections 70 to 72 of this Act, so as either—

(a)to modify, or provide new conditions in substitution for, the conditions referred to in any of the paragraphs of section 69(1) of this Act, or

(b)for the purposes of any of those paragraphs, to provide alternative conditions compliance with which is to have the like effect as compliance with the conditions referred to in that paragraph.

(2)Any provision made by an order in accordance with subsection (1) of this section may be made either generally or in relation to any particular circumstances specified in the order.

(3)Any order made under this section may direct that subsection (1) or subsection (2) of section 69 of this Act shall have effect subject to such exceptions or modifications as appear to the F183... Ministers to be necessary or expedient in consequence of the provision made by the order in accordance with subsection (1) of this section.

(4)Where an order under this section is for the time being in force, any reference to section 69 of this Act in any other enactment as amended by this Act shall be construed as a reference to that section as modified by the order.

(5)No order shall be made under this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

Textual Amendments

Registration of pharmaciesU.K.

74 Meaning of “registered pharmacy".U.K.

(1)F184. . . In this Act “registered pharmacy” means premises for the time being entered in the register F185....

[F186(1A)If the entry of a registered pharmacy in the register is suspended under [F187paragraph (4)(b) of article 14] [F187section 82A of this Act, paragraph 8 of Schedule 3 to the Pharmacy (Northern Ireland) Order 1976 or article 14(4)(b) or 56] of the Pharmacy Order 2010 then, except for such purposes [F188of that Order] as the General Pharmaceutical Council may prescribe by rules [F189in relation to Great Britain or the Council of the Pharmaceutical Society of Northern Ireland may prescribe by regulations in relation to Northern Ireland], that registered pharmacy must be treated as not being entered in the register notwithstanding that the register still includes the address of that pharmacy.]

[F186(1B)Accordingly, premises whose entry in the register is suspended are not to be treated as a registered pharmacy for the purposes of this Act or any other enactment [F190apart from that Order] [F190except for a purpose prescribed by the rules or regulations mentioned in subsection (1A)] .]

F191(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F192(3). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F191(4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F184Words in s. 74(1) repealed (5.11.1993) by 1993 c. 50, s. 1(1), Sch. 1Pt. XII

F186S. 74(1A)(1B) inserted (10.2.2010 for specified purposes, 27.9.2010 in so far as not already in force) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(3), Sch. 4 para. 1(7)(b); S.I. 2010/1621, art. 2(1), Sch.

F191S. 74(2)(4) repealed (5.11.1993) by 1993 c. 50, s. 1(1), Sch. 1 Pt. XII

[F19374A.Registration of premises: Great BritainU.K.

(1)This section applies in relation to premises in Great Britain.

(2)If the registrar is satisfied that the conditions in section 74B are met in relation to premises that are not entered in the register, the registrar must enter the premises in Part 3 of the register unless the registrar considers that doing so would prejudice the health, safety or well-being of members of the public.

(3)Subject to subsection (5) and to section 74H, the entry of premises entered in Part 3 of the register under subsection (2) is valid for the period of one year beginning with the date on which the entry was made.

(4)If the registrar is satisfied that the conditions in section 74B are met in relation to premises entered in Part 3 of the register under subsection (2), the registrar must renew the entry of the premises unless the registrar considers that doing so would prejudice the health, safety or well-being of members of the public.

(5)Subject to subsection (7) and to section 74H, each renewal of the entry of premises entered in Part 3 of the register under subsection (2) extends the validity of the entry for the period of one year beginning with the day on which the entry would otherwise have ceased to be valid.

(6)The registrar may, except in such circumstances as may be prescribed by the General Pharmaceutical Council in rules, renew the entry of premises in Part 3 of the register for a period exceeding one year beginning with the day on which the entry would otherwise have ceased to be valid in which case the renewal of the entry of premises entered in that part of the register under subsection (2) extends the validity of the entry for that period.

(7)If the entry of premises entered in Part 3 of the register under this section ceases to be valid then, except in such circumstances as may be prescribed by the General Pharmaceutical Council in rules, the premises are to be treated for all purposes as no longer being entered in Part 3 of the register and accordingly the registrar must remove the entry from that part of the register.]

Textual Amendments

F193Ss. 74A-74L inserted (10.2.2010 for specified purposes, 27.9.2010 in so far as not already in force) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(3), Sch. 4 para. 1(8) (with Sch. 5 para. 10); S.I. 2010/1621, art. 2(1), Sch.

[F19374B.Conditions for registration: Great BritainU.K.

(1)The conditions referred to in section 74A are as follows.

(2)Condition A is that an application for the entry of the premises in Part 3 of the register or, as the case may be, for the renewal of the entry of the premises in Part 3 of the register is made—

(a)in such form and manner as is prescribed in rules made by the General Pharmaceutical Council; and

(b)if the application is an application for renewal, by such time prior to the entry ceasing to be valid as is so prescribed.

(3)Condition B is that the appropriate fee prescribed in rules made by the General Pharmaceutical Council under article 36(1) of the Pharmacy Order 2010 is paid.

(4)Condition C—

(a)if the application is an application for the entry of the premises in Part 3 of the register, is that either—

(i)the applicant is lawfully conducting a retail pharmacy business, or

(ii)if the premises are entered in Part 3 of the register, and the applicant begins to carry on a retail pharmacy business at [F194or from] the premises, the applicant will, from the time the applicant begins to do so, be a person lawfully conducting a retail pharmacy business; or

(b)if the application is an application for the renewal of the entry of the premises in Part 3 of the register, is that the applicant is lawfully conducting a retail pharmacy business at [F195or from] the premises.

(5)Condition D—

(a)if the application is an application for the entry of the premises in Part 3 of the register, is that the standards that are [F196provided for in rules made] [F196set] under article 7(1) of the Pharmacy Order 2010 are met, or are capable of being met, in connection with the carrying on of a retail pharmacy business at [F197or from] the premises; or

(b)if the application is an application for the renewal of the entry of the premises in Part 3 of the register, is—

(i)that the standards that are [F198provided for in rules made] [F198set] under article 7(1) of the Pharmacy Order 2010 are met in connection with the carrying on of a retail pharmacy business at [F199or from] the premises, and

(ii)that the requirements of rules [F200(if any)] made under article 7(4) of that Order are met by the person carrying on a retail pharmacy business at [F201or from] the premises.]

Textual Amendments

F193Ss. 74A-74L inserted (10.2.2010 for specified purposes, 27.9.2010 in so far as not already in force) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(3), Sch. 4 para. 1(8) (with Sch. 5 para. 10); S.I. 2010/1621, art. 2(1), Sch.

[F19374C.Supplementary provision in respect of registration of premises: Great BritainU.K.

(1)The registrar may restore to Part 3 of the register the entry of premises removed from that part of the register by virtue of section 74A(7) if an application is made to the registrar in accordance with this section.

(2)An entry restored under this section to Part 3 of the register—

(a)is still to be treated as having been entered in that part of the register under section 74A;

(b)is valid for the period of one year beginning with the day on which the entry would otherwise have ceased to be valid by virtue of section 74A(7) or is valid for such longer period beginning with that day as the registrar may in any particular case allow; and

(c)may be subject to the same conditions as those to which the entry was subject immediately before it was removed from Part 3 of the register by virtue of section 74A(7) or may be subject to such other conditions as the registrar may impose under section 74D(1).

(3)An application for restoration may be made to the registrar by the person who is the owner of the retail pharmacy business previously carried on at [F202or from] the premises and that person must be—

(a)a person who is lawfully conducting a retail pharmacy business; or

(b)a person who, if the entry of the premises is restored to Part 3 of the register and the person begins to carry on a retail pharmacy business at [F203or from] the premises, will, from the time the person begins to do so, be a person lawfully conducting a retail pharmacy business.

(4)The General Pharmaceutical Council may make rules in connection with applications under this section.

(5)Rules under subsection (4) may, in particular, include provision—

(a)about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the General Pharmaceutical Council may determine from time to time);

(b)about the information to be provided in respect of applications; and

(c)about the circumstances in which applications must or, as the case may be, may be refused (including where an application for renewal under this section was not received by the registrar by the time prescribed by the General Pharmaceutical Council in rules under section 74B(2)(b)).

(6)Where the registrar restores the entry of premises to Part 3 of the register pursuant to an application under this section, the registrar must give notice in writing of that restoration to the applicant.

(7)The notice under subsection (6) must specify—

(a)the period for which the entry restored to Part 3 of the register is valid;

(b)any conditions to which that entry is subject by virtue of subsection (2)(c).

(8)The notice under subsection (6) must be sent—

(a)where the retail pharmacy business was carried on by an individual, to that individual at that individual’s home address in the register;

(b)where the retail pharmacy business was carried on by a partnership, to that partnership at its principal office;

(c)where the retail pharmacy business was carried on by a body corporate, to that body corporate at its registered or principal office.]

[F19374D.Conditional registration: Great BritainU.K.

(1)The registrar may make the entry of premises entered in Part 3 of the register under section 74A subject to such conditions as the registrar considers it necessary to impose for the purpose of securing the safe and effective practice of pharmacy [F204in the course of the business carried on at or from] those premises.

(2)The power under subsection (1)—

(a)may be exercised on the making of the entry or subsequently (whether on a renewal of the entry or otherwise);

(b)includes power to vary the conditions to which the entry of the premises in Part 3 of the register is subject, including by adding to the conditions or revoking any of them.

(3)Except as provided in subsection (4), the registrar may not under subsection (1)—

(a)impose a new condition in respect of premises already entered in Part 3 of the register; or

(b)vary or revoke any conditions to which the entry of premises entered in Part 3 of the register is subject,

unless the registrar has given reasonable notice in writing of the condition to be imposed or, as the case may be, of the variation or revocation of an existing condition, to the person carrying on the retail pharmacy business at [F205or from] the premises and of the date from which that condition, variation or revocation is to have effect.

(4)The registrar may, with immediate effect—

(a)impose a new condition in respect of premises already entered in Part 3 of the register; or

(b)vary or revoke any conditions to which the entry of premises entered in Part 3 of the register is subject,

if, in the registrar’s opinion, the giving of reasonable notice as required by subsection (3) would prejudice the health, safety or well-being of members of the public.

(5)The registrar must give notice in writing of any decision under subsection (4) to the person carrying on a retail pharmacy business at [F206or from] the premises.

(6)The notice under subsection (5) must be sent—

(a)where the retail pharmacy business is carried on by an individual, to that individual at that individual’s home address in the register;

(b)where the retail pharmacy business is carried on by a partnership, to that partnership at its principal office; or

(c)where the retail pharmacy business is carried on by a body corporate, to that body corporate at its registered or principal office.

(7)Where premises are entered in the register because condition C in section 74B is met by virtue of subsection (4)(a)(ii) of that section, the registrar may, on making the entry of the premises in the register, also make that entry subject to a condition that the applicant for registration will be a person lawfully conducting a retail pharmacy business within such period as the registrar reasonably determines beginning with the date on which the entry is made.]

[F19374E.Supplementary provision in respect of conditional registration: Great BritainU.K.

(1)Where the entry of premises entered in Part 3 of the register is subject to conditions imposed under section 74D(1), the person carrying on the business at [F207or from] the premises may apply to the registrar for any of the conditions imposed to be varied or revoked.

(2)The General Pharmaceutical Council may make rules in connection with applications under subsection (1).

(3)Rules under subsection (2) may, in particular, include provision—

(a)about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the General Pharmaceutical Council may determine from time to time);

(b)about the information to be provided in respect of applications;

(c)about the circumstances in which applications may be refused by the registrar;

(d)about the giving of notice of the decision in respect of the application to the applicant by the registrar.

(4)The registrar may vary a condition imposed under section 74D(7) by extending the period within which the applicant for registration must become a person lawfully conducting a retail pharmacy business.

(5)Where premises are entered in the register subject to a condition imposed under subsection (7) of section 74D, the registrar may remove the entry if the applicant is not a person lawfully conducting a retail pharmacy business at [F208or from] the premises within the period determined by the registrar in accordance with that subsection or within such longer period as the registrar may, by virtue of subsection (4), allow.

(6)Where the registrar—

(a)varies a condition under subsection (5); or

(b)removes an entry of premises in Part 3 of the register under subsection (4),

the registrar must send to the person who applied for registration a statement in writing giving that person notice of the decision and the reasons for it.

(7)The notice under subsection (6) must be sent—

(a)where the person who applied for registration is an individual, to that individual at that individual’s home address in the register;

(b)where that person is a partnership, to that partnership at its principal office;

(c)where that person is a body corporate, to that body corporate at its registered or principal office.]

[F19374F.Giving of notice by registrar: Great BritainU.K.

(1)Where, in pursuance of an application, the registrar enters premises in Part 3 of the register under section 74A, the registrar must give to the applicant a written confirmation of the entry.

(2)The written confirmation under subsection (1) must include—

(a)the number of the entry;

(b)the date on which the entry was made;

(c)the period for which the entry is valid; and

(d)details of any conditions to which the entry is subject by virtue of section 74D.

(3)Where, in pursuance of an application, the registrar renews the entry of premises in Part 3 of the register under section 74A, the registrar must give to the applicant a written confirmation of the renewal.

(4)The written confirmation under subsection (3) must include—

(a)the number of the entry;

(b)the date on which the renewal of the entry was made;

(c)the period for which the renewal of the entry is valid; and

(d)details of any conditions to which the renewal of the entry is subject by virtue of section 74D.

(5)Where the registrar refuses an application for the entry of premises in Part 3 of the register under section 74A, or for the renewal of an entry of premises in the register under that section, the registrar must give to the applicant written notice of that refusal and the reasons for it and of the right of appeal to the Appeals Committee under article 40 of the Pharmacy Order 2010.

(6)Where, under section 74J, the registrar enters premises or a group of premises in Part 3 of the register, the registrar must give written confirmation of the entry to the person who will be carrying on a retail pharmacy business at [F209or from the premises, or at or from] each set of premises in the group of premises.

(7)The written confirmation under subsection (6) must include—

(a)the number of the entry;

(b)the date on which the entry was made; and

(c)details of any conditions to which the entry is subject by virtue of section 74J(4).]

Textual Amendments

F193Ss. 74A-74L inserted (10.2.2010 for specified purposes, 27.9.2010 in so far as not already in force) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(3), Sch. 4 para. 1(8) (with Sch. 5 para. 10); S.I. 2010/1621, art. 2(1), Sch.

[F19374G.Voluntary removal from the register: Great BritainU.K.

(1)An application may be made to the registrar by the person carrying on a retail pharmacy business at [F210or from] any premises entered in Part 3 of the register under section 74A or 74J for the premises to be removed from the register.

(2)The General Pharmaceutical Council may make rules in connection with applications under subsection (1).

(3)Rules under subsection (2) may, in particular, include provision—

(a)about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the Council may determine from time to time);

(b)about the information to be provided by the applicant;

(c)about the circumstances in which applications may be refused; and

(d)for written notice of the outcome of the application to be given to the applicant by the registrar.]

Textual Amendments

F193Ss. 74A-74L inserted (10.2.2010 for specified purposes, 27.9.2010 in so far as not already in force) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(3), Sch. 4 para. 1(8) (with Sch. 5 para. 10); S.I. 2010/1621, art. 2(1), Sch.

[F19374H.(1)Subject to subsection (2), where a change occurs in the ownership of a retail pharmacy business carried on at [F211or from] premises entered in Part 3 of the register under section 74A, the entry of the premises in the register ceases to be valid at the end of the relevant period unless the registrar is notified in writing of the change prior to the end of the relevant period by the person who, as a result of the change, will be the person carrying on the business at [F212or from] the premises.U.K.

(2)Subsection (1) only applies if the relevant period is shorter than the period for which the entry would otherwise have remained valid under section 74A.

(3)Where, before the end of the relevant period, the registrar is notified of a change in the ownership of a retail pharmacy business carried on at [F213or from] premises entered in Part 3 of the register, the registrar must, on receipt of a fee of the amount prescribed in rules under article 36(1)(c) of the Pharmacy Order 2010, amend the entry relating to the premises in Part 3 of the Register to record the name and address of the person who, as a result of the change, will be the person carrying on the retail pharmacy business at [F214or from] the premises.

(4)For the purposes of subsections (1) to (3), the relevant period—

(a)if the change occurs on the death of the person carrying on the business or, in the case of a partnership, on the death of one of the partners, means the period of three months beginning with the date of death; and

(b)in any other case, means the period of 28 days beginning with the date on which the change occurred.

(5)If the entry of premises entered in Part 3 of the register under section 74A ceases to be valid under this section, the premises are to be treated for all purposes as no longer being entered in the register and accordingly the registrar must remove the entry from the register.

(6)The registrar must restore the entry of the premises to Part 3 of the register if—

(a)an application for restoration is made to the registrar in accordance with section 74I(1) and with rules made under section 74I(3);

(b)a fee of an amount prescribed in rules under article 36(1)(b) of the Pharmacy Order 2010 (fees in connection with entry) is paid; and

(c)the registrar is satisfied that the standards that are [F215provided for in rules made] [F215set] under article 7(1) of the Pharmacy Order 2010 are met in connection with the carrying on of a retail pharmacy business at [F216or from] the premises.

(7)Subject to subsection (8), an entry restored to the register under subsection (6)—

(a)is still to be treated as having been entered in Part 3 of the register under section 74A;

(b)is subject to the same conditions as those to which the entry was subject immediately before it was removed from Part 3 of the register by virtue of subsection (5);

(c)is valid for the same period as the period for which the entry would have been valid under section 74A had it not been removed from Part 3 of the register by virtue of subsection (5) of this section.

(8)Where an entry of premises in Part 3 of the register is restored by the registrar under subsection (6) and the applicant is a person falling within section 74I(2)(b), the registrar may—

(a)on restoring the entry of the premises to the register, make that entry subject to a condition that the applicant for restoration will be a person lawfully conducting a retail pharmacy business within such period as the registrar reasonably determines beginning with the date on which the entry is restored; and

(b)subsequently remove the entry of the premises from Part 3 of the register if the applicant is not a person lawfully conducting a retail pharmacy business within the period determined by the registrar in accordance with paragraph (a).

(9)Where under subsection (8)(b) the registrar removes an entry of premises from Part 3 of the register, the registrar must give to the person who was carrying on a retail pharmacy business at [F217or from] the premises immediately prior to the removal written notice of the removal and the reasons for it.

(10)The notice under subsection (9) must be sent—

(a)where the retail pharmacy business is carried on by an individual, to that individual at that individual’s home address in the register;

(b)where the retail pharmacy business is carried on by a partnership, to the principal office of that partnership;

(c)where the retail pharmacy business is carried on by a body corporate, to the registered or principal office of that body corporate.]

Textual Amendments

F193Ss. 74A-74L inserted (10.2.2010 for specified purposes, 27.9.2010 in so far as not already in force) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(3), Sch. 4 para. 1(8) (with Sch. 5 para. 10); S.I. 2010/1621, art. 2(1), Sch.

[F19374I.Supplementary provision in respect of change of ownership of retail pharmacy business: Great BritainU.K.

(1)An application may be made to the registrar for the entry of premises removed from Part 3 of the register by virtue of section 74H(5) to be restored to the register.

(2)An application under subsection (1) must be made by the person who, in consequence of the change of ownership, has become the owner of the business and that person must be—

(a)a person who is lawfully conducting a retail pharmacy business; or

(b)a person who, if the entry of the premises is restored to Part 3 of the register and the person begins to carry on a retail pharmacy business at [F218or from] those premises, will, from the time the person begins to do so, be a person lawfully conducting a retail pharmacy business.

(3)The General Pharmaceutical Council may make rules in connection with applications under subsection (1).

(4)Rules under subsection (3) may, in particular, include provision—

(a)about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the Council may determine from time to time);

(b)about the information to be provided in respect of applications;

(c)about the circumstances in which an application for restoration under subsection (1) may be treated by the registrar as an application for the renewal of registration under section 74A(4) as well as an application for restoration.

(5)Where the registrar restores the entry of premises to Part 3 of the register pursuant to an application under subsection (1), the registrar must send to the applicant for restoration a statement in writing giving the applicant notice of the restoration.

(6)The notice given by the registrar under subsection (5) must specify—

(a)the period for which the entry restored to Part 3 of the register is valid;

(b)any conditions to which the entry of the premises restored to Part 3 of the register is subject.

(7)Where the registrar refuses an application under this section for the restoration to Part 3 of the register of an entry relating to any premises, the registrar must send to the applicant for restoration a statement in writing giving the applicant notice of the decision and the reasons for it.

(8)The notice under subsections (5) and (7) must be sent—

(a)where the applicant is an individual, to that individual at that individual’s home address in the register;

(b)where the applicant is a partnership, to the principal office of that partnership;

(c)where the applicant is a body corporate, to the registered or principal office of that body corporate.]

Textual Amendments

F193Ss. 74A-74L inserted (10.2.2010 for specified purposes, 27.9.2010 in so far as not already in force) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(3), Sch. 4 para. 1(8) (with Sch. 5 para. 10); S.I. 2010/1621, art. 2(1), Sch.

[F19374J.Temporary registration with regard to emergencies involving loss of human life or human illness etc.U.K.

(1)This section applies in relation to premises in Great Britain.

(2)If the Secretary of State advises the registrar that an emergency has occurred, is occurring or is about to occur and that action should be considered under this section, the registrar may under this section enter in Part 3 of the register—

(a)premises; or

(b)premises comprising a specified group of premises,

with regard to the emergency.

(3)The registrar may enter in Part 3 of the register by virtue of subsection (2)(b) all of the premises in a specified group of premises without first identifying each set of premises in the group.

(4)The registrar may make the entry of premises entered in Part 3 of the register under this section subject to such conditions as the registrar considers necessary to impose for the purpose of securing the safe and effective practice of pharmacy [F219in the course of the business carried on at or from] those premises.

(5)The power in subsection (4)—

(a)may be exercised on the making of the entry or subsequently;

(b)includes power to vary the conditions to which the entry of the premises in Part 3 of the register is subject, including by adding to the conditions or revoking any of them.

(6)The entry of premises entered in Part 3 of the register under this section by virtue of subsection (2)(b) as one of a specified group may be subject to the same conditions as the entry of the other premises in the group or it may be subject to different conditions.

(7)The conditions to which the entry of premises entered in Part 3 of the register under this section is subject may include conditions relating to their physical state, safety and security and the conditions in which medicinal products (including controlled drugs) are stored at those premises.

(8)The registrar may not under subsection (4)—

(a)impose a new condition in respect of the entry of premises already entered in Part 3 of the register; or

(b)vary or revoke any conditions to which the entry of premises entered in Part 3 of the register is subject,

unless the registrar has given reasonable notice in writing of the condition to be imposed or, as the case may be, of the variation or revocation of an existing condition, to the person carrying on a retail pharmacy business at [F220or from] the premises and of the date from which that condition, variation or revocation is to have effect.

(9)The entry of premises entered in Part 3 of the register under this section may be removed by the registrar, which—

(a)the registrar must do if the Secretary of State advises the registrar that the circumstances that led the Secretary of State to advise the registrar as mentioned in subsection (2) no longer exist;

(b)the registrar may do for any other reason at any time including where the registrar has grounds for suspecting that there is a failure to comply with any conditions to which the entry of the premises in Part 3 of the register is subject.

(10)The entry of premises entered in Part 3 of the register under this section by virtue of subsection (2)(b) as one of a specified group of premises may be removed without removing the entries of the other premises in the group, or it may be removed by virtue of a decision to remove the entries of all of the premises in the group.

(11)In this section, and in section 74K, “emergency” means an emergency of the type described in subsection (1)(a) of section 19 of the Civil Contingencies Act 2004 (meaning of “emergency”), read with subsection (2)(a) and (b) of that section.]

[F19374K.Temporary annotations with regard to emergencies involving loss of human life or human illness etc.U.K.

(1)If the Secretary of State advises the registrar that an emergency has occurred, is occurring or is about to occur and that action should be considered under this section, the registrar may annotate—

(a)the entry of a registered pharmacy entered in Part 3 of the register under section 74J to designate that pharmacy as a pharmacy from which drugs, medicines and appliances may be ordered in a specified capacity; or

(b)the entries of a specified group of registered pharmacies entered in Part 3 of the register under section 74J to designate that group as a group of pharmacies from which drugs, medicines and appliances may be ordered in a specified capacity.

(2)The registrar may make an annotation, by virtue of subsection (1), to the entry of a registered pharmacy entered in Part 3 of the register under section 74J in such a way as to distinguish that annotation from an annotation in respect of a registered pharmacy made otherwise than by virtue of subsection (1).

(3)Annotations made by virtue of subsection (1)—

(a)must be removed by the registrar if the Secretary of State advises the registrar that the circumstances that led the Secretary of State to advise the registrar as mentioned in subsection (1) no longer exist;

(b)may be removed by the registrar for any other reason at any time.

(4)An annotation of the entry of a registered pharmacy made by virtue of subsection (1)(b) as one of a specified group may be removed without removing the annotations of the entries of the other registered pharmacies in the group, or it may be removed by virtue of a decision to remove the annotations of the entries of all the registered pharmacies in the group.]

Textual Amendments

F193Ss. 74A-74L inserted (10.2.2010 for specified purposes, 27.9.2010 in so far as not already in force) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(3), Sch. 4 para. 1(8) (with Sch. 5 para. 10); S.I. 2010/1621, art. 2(1), Sch.

[F19374L.Evidence of registration: Great BritainU.K.

A document purporting to be a certificate signed by the registrar and stating that, on a specified date, specified premises in Great Britain were, or were not, entered in Part 3 of the register (whether under section 74A or section 74J) is admissible in any proceedings as evidence (or in Scotland, as sufficient evidence) that those premises were, or were not, entered in the register on that date.]

Textual Amendments

F193Ss. 74A-74L inserted (10.2.2010 for specified purposes, 27.9.2010 in so far as not already in force) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(3), Sch. 4 para. 1(8) (with Sch. 5 para. 10); S.I. 2010/1621, art. 2(1), Sch.

75 Registration of premises[F221: Northern Ireland]. U.K.

[F222(A1)This section applies in relation to premises in Northern Ireland.]

(1)It shall be the duty of the registrar to keep a register for the purposes of this section F223... and, subject to the following provisions of this section, on payment of the prescribed fee to enter in the register any premises in respect of which an application is made under this section.

(2)Any application for the registration of premises under this section shall be made in the prescribed manner and shall specify the premises to which the application relates and shall contain such other particulars as may be prescribed.

(3)On the making of any such application the registrar shall notify the appropriate Minister, specifying the premises to which the application relates and the date on which the application was made, and shall not enter those premises in the register before the end of the period of two months from that date, unless before the end of that period the appropriate Minister consents to his doing so.

(4)If it appears to the appropriate Minister that in a material respect the premises do not comply with the requirements of regulations made under section 66 of this Act which are for the time being in force, and accordingly he proposes to certify that the premises are unsuitable for registration under this section, he shall, before the end of the period referred to in subsection (3) of this section, serve on the applicant a notice stating his proposals and the reasons for them, and shall serve a copy of that notice on the registrar; and, where a copy of such a notice is served on him, the registrar shall not enter the premises in the register except where required to do so in accordance with the following provisions of this section.

(5)If, within the time allowed after the service on him of a notice under subsection (4) of this section, the applicant gives notice to the appropriate Minister of his desire to be heard with respect to the proposals, or makes representations in writing to the appropriate Minister with respect to the proposals, then, before determining whether to issue a certificate under this section in respect of the premises,—

(a)if the applicant has given notice of his desire to be heard, the appropriate Minister shall afford to him an opportunity of appearing before, and being heard by, a person appointed by that Minister for the purpose, or

(b)if he has made representations in writing, that Minister shall consider those representations.

(6)Where the appropriate Minister has served a notice under subsection (4) of this section, then—

(a)if he determines not to issue a certificate certifying that the premises are unsuitable for registration under this section, he shall notify the applicant and the registrar of his decision and (subject to subsection (7) of this section) the registrar shall forthwith enter the premises in the register;

(b)if the appropriate Minister issues such a certificate, he shall transmit the certificate to the registrar and shall notify the applicant that he has done so, and, if so required by the applicant, shall inform him of the reasons for his decision to issue such a certificate.

(7)Notwithstanding anything in the preceding provisions of this section, the registrar shall not enter any premises in the register in pursuance of an application under this section unless it is shown to his reasonable satisfaction either—

(a)that at the time of the application the applicant is a person lawfully conducting a retail pharmacy business, or

(b)that, if the premises are entered in the register, and the applicant begins to carry on a retail pharmacy business at [F224or from] those premises, then as from the time when he begins to do so he will be a person lawfully conducting a retail pharmacy business.

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

F225(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F225(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)F226... means the Minister of Health and Social Services for Northern Ireland,

and “the time allowed” means the period of twenty-eight days or such extended period as the appropriate Minister may in any particular case allow.

Textual Amendments

Modifications etc. (not altering text)

C41Functions of Secretary of State in matters only affecting Wales exercisable by Secretary of State for Wales: S.I. 1969/388, art. 2(1)

76 Supplementary provisions as to registration of premises[F227: Northern Ireland].U.K.

(1)Where any premises have been entered in the register [F228under section 75], then, in respect of each year subsequent to the year in which the premises were so entered, a further fee (in this section referred to as a “retention fee") of the prescribed amount shall be payable by the person carrying on a retail pharmacy business at [F229or from] those premises.

(2)If, on demand being made to him in the prescribed manner, the person carrying on a retail pharmacy business at [F230or from] any premises entered in the register [F231under section 75] fails to pay a retention fee in respect of those premises within two months from the date on which the demand is made, [F232the appropriate Minister] may direct the registrar to remove the premises from the register; but if, before the end of the year in respect of which the retention fee is payable or such longer period as in any particular case [F232the appropriate Minister] may allow, the person carrying on the business pays to the registrar the retention fee in respect of that year, together with such additional sum (if any) by way of penalty as may be prescribed,—

(a)the registrar shall restore the premises to the register, and

(b)if [F232the appropriate Minister] so [F233directs], the restoration shall be deemed to have had effect as from the date on which the premises were removed from the register.

(3)Where a change occurs in the ownership of a retail pharmacy business carried on at [F234or from] any premises registered under section 75 of this Act, the registration of the premises under that section—

(a)if the change occurs on the death of the person carrying on the business, or, in the case of a partnership, on the death of one of the partners, shall become void at the end of the period of three months from the date of the death, and

(b)in any other case, shall become void at the end of the period of twenty-eight days from the date on which the change occurs.

F235(4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5)Where the registration of any premises under section 75 of this Act in respect of a business becomes void by virtue of subsection (3) of this section, an application for the premises to be restored to the register may be made by the person who, in consequence of the change of ownership, has become the owner of the business; and where such an application is made, and it is shown to the reasonable satisfaction of the registrar either—

(a)that at the time of the application the applicant is a person lawfully conducting a retail pharmacy business, or

(b)that, if the premises are restored to the register, and the applicant thereafter carries on a retail pharmacy business at [F236or from] those premises, then as from the time when he begins to do so he will be a person lawfully conducting a retail pharmacy business,

and (in a case where, if the registration had not become void, a retention fee would have become payable) a fee equal to a retention fee has been paid, the registrar shall restore the premises to the register.

F237(6). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7)A document purporting to be a certificate signed by the registrar and stating that, on a specified date, specified premises [F238in Northern Ireland] were, or were not, entered in the register shall be admissible in any proceedings as evidence (and, in Scotland, shall be sufficient evidence) that those premises were, or were not, entered in the register on that date.

F239(8). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F240(9)In this section—

  • “the appropriate Minister” means the Minister of Health, Social Services and Public Safety for Northern Ireland;

  • “year” means a period of 12 months beginning with such date as the appropriate Minister may from time to time determine.]

Textual Amendments

F235S. 76(4) repealed (5.11.1993) by 1993 c. 50, s. 1(1), Sch. 1Pt. XII

77 Annual return of premises to registrar.U.K.

Every person who carried on a retail pharmacy business [F241at [F242or from] premises in Northern Ireland] shall, in the month of January in each year, send to the registrar—

(a)a list of all [F243such] premises at [F244or from] which his business, so far as it consists of the retail sale of medicinal products, is carried on, and

F245(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Provisions as to use of certain titles, descriptions and emblemsU.K.

78 Restrictions on use of titles, descriptions and emblems.U.K.

(1)The provisions of this section shall have effect subject to section 79 of this Act.

(2)F246... No person shall—

(a)take or use any of the following titles, that is to say, chemist and druggist, druggist, dispensing chemist, and dispensing druggist, or

(b)take or use the title of chemist in connection with the sale of any goods by retail or the supply of any goods in circumstances corresponding to retail sale,

unless the conditions specified in the next following subsection are fulfilled.

(3)Those conditions are—

(a)in the case of an individual, that he is a person lawfully conducting a retail pharmacy business (either alone or as a member of a partnership) and that he does not take or use the title in question in connection with any premises at [F247or from] which any goods are sold by retail, or are supplied in circumstances corresponding to retail sale, unless those premises are a registered pharmacy, and

(b)in the case of a body corporate, that the body is a person lawfully conducting a retail pharmacy business and that the title in question is not taken or used by that body in connection with any premises at [F248or from] which any goods are sold by retail, or are supplied in circumstances corresponding to retail sale, unless those premises are a registered pharmacy F249....

(4)F246... No person shall, in connection with a business carried on by him which consists of or includes the retail sale of any goods, or the supply of any goods in circumstances corresponding to retail sale, use the description “pharmacy” except in respect of a registered pharmacy or in respect of the pharmaceutical department of a hospital or a health centre.

[F250(5)A person who is not registered in the register of pharmaceutical chemists for Northern Ireland F251... made out and maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 may not—

(a)take or use the title pharmaceutical chemist, pharmaceutist, pharmacist, member of the Pharmaceutical Society of Northern Ireland or Fellow of the Pharmaceutical Society of Northern Ireland; or

(b)take or use any of the titles mentioned in paragraph (a) in connection with a business carried on (whether by him or by some other person) at [F252or from] any premises which consists of or includes the retail sale of any goods, or the supply of any goods in circumstances corresponding to retail sale, unless those premises are a registered pharmacy or a hospital or health centre.

(5A)A person who is not registered as a pharmacist in Part 1 F253... of the register maintained under article 19 of the Pharmacy Order 2010 may not take or use the title pharmacist or fferyllydd (its equivalent in the Welsh language) in connection with a business carried on (whether by him or by some other person) at [F254or from] any premises which consists of or includes the retail sale of any goods, or the supply of any goods in circumstances corresponding to retail sale, unless those premises are a registered pharmacy or a hospital or health centre.

(5B)Subsection (5) extends to Northern Ireland only; and subsection (5A) does not extend there.]

(6)F246... No person shall, in connection with any business, use any title, description or emblem likely to suggest—

(a)that he possesses any qualification with respect to the sale, manufacture or assembly of medicinal products which he does not in fact possess, or

(b)that any person employed in the business possesses any such qualification which that person does not in fact possess.

(7)For the purposes of the last preceding subsection the use of the description “pharmacy", in connection with a business carried on at [F255or from] any premises, shall be taken to be likely to suggest that the person carrying on the business (where that person is not a body corporate) is a pharmacist and that any other person, [F256 who is in charge of [F257the business carried on at or from] those premises (so far as concerns the retail sale of medicinal products or the supply of such products in circumstances corresponding to retail sale) is also a pharmacist].

(8)Where a person is lawfully conducting a retail pharmacy business as being a representative of a pharmacist in the circumstances specified in section 69(1)(c) of this Act, subsections (5) to (7) of this section shall not have effect so as to prevent the representative from taking or using, in connection with that business, any title, description or emblem which the pharmacist himself could have used in accordance with those subsections.

Textual Amendments

F246Words in s. 78 repealed (5.11.1993) by 1993 c. 50, s. 1(1), Sch. 1 Pt. XII

F256Words in s. 78(7) substituted (1.10.2009) by Health Act 2006 (c. 28), ss. 27(2), 83(7); S.I. 2008/2714, art. 2(a)

79 Provision for modifying or extending restrictions under s. 78.U.K.

(1)The F258... Ministers may by order provide that any of the restrictions imposed by section 78 of this Act shall cease to have effect, or shall have effect subject to such exceptions as may be specified in the order.

(2)Without prejudice to the preceding subsection, regulations made by the F259... Ministers may (in addition to the restrictions for the time being having effect by virtue of section 78 of this Act) impose such further restrictions or other requirements with respect to the use of titles, descriptions and emblems as may be specified in the regulations.

(3)Without prejudice to the application of section 129(6) of this Act, before making any order or regulations under this section the F260... Ministers shall consult [F261the General Pharmaceutical Council and the Council of the Pharmaceutical Society of Northern Ireland].

(4)Regulations made under this section shall be of no effect unless a draft of the regulations has been laid before Parliament and approved by a resolution of each House of Parliament.

Textual Amendments

Disqualification, and removal of premises from registerU.K.

80 Power for [F262relevant disciplinary committee] to disqualify and direct removal from register.U.K.

[F263(1)Where a body corporate carries on a retail pharmacy business and—

(a)that body is convicted of an offence under one of the relevant Acts;

(b)any member of the board or any officer of, or person employed by, that body is convicted of an offence, or has been guilty of misconduct, and the offence or misconduct is such as in the opinion of the relevant disciplinary committee renders him, or would if he were a pharmacist, render him unfit to be a pharmacist; or

(c)in respect of premises [F264in Great Britain] that are entered in the register as premises at [F265or from] which the body corporate carries on that business, there is a failure to meet the standards that are [F266provided for in rules made under] [F266set under Article 5A(1) of the Pharmacy (Northern Ireland) Order 1976 or] article 7(1) of the Pharmacy Order 2010 in connection with the carrying on of the business at [F267or from] those premises,

then, subject to the following provisions of this Part of this Act, the relevant disciplinary committee, after inquiring into the case, may direct that the body corporate is to be disqualified for the purposes of this Part of this Act.]

[F268(1A)Where—

(a)a pharmacist or partnership carries on a retail pharmacy business, and

(b)in respect of premises that are entered in the register as premises at or from which that pharmacist or partnership carries on that business, there is a failure to meet the standards that are set under Article 5A(1) of the Pharmacy (Northern Ireland) Order 1976 or article 7(1) of the Pharmacy Order 2010 in connection with the carrying on of the business at or from those premises,

then, subject to the following provisions of this Part of this Act, the relevant disciplinary committee, after inquiring into the case, may direct that the pharmacist or partnership is to be disqualified for the purposes of this Part of this Act.

(1B)But, in a case falling within subsection (1)(c) or (1A), the relevant disciplinary committee may only give a direction under the subsection in question if they are satisfied that the body corporate, the pharmacist or the partnership is unfit to carry on a retail pharmacy business safely and effectively, so far as concerns—

(a)the retail sale of medicinal products (whether they are on a general sale list or not), or

(b)the supply of such products in circumstances corresponding to retail sale.]

(2)In any case falling [F269within the preceding subsection] [F269within subsection (1) or (1A)]

(a)if the [F270the relevant disciplinary committee] give a direction under [F271that subsection] [F271the subsection in question], they shall direct the registrar to remove from the register all premises entered in the register as being premises at [F272or from] which the body corporate[F273, the pharmacist or the partnership] carries on a retail pharmacy business;

(b)if the [F270the relevant disciplinary committee] do not give a direction under [F274the preceding subsection] [F274the subsection in question], they may, if they think fit, direct the registrar to remove from the register all those premises, or such of them as may be specified in the direction under this paragraph.

[F275(2A)But, in a case falling within subsection (1)(c) or (1A), the relevant disciplinary committee may only direct the registrar under subsection (2)(b) to remove premises from the register if they are satisfied that the body corporate, the pharmacist or the partnership is unfit to carry on a retail pharmacy business safely and effectively at or from those premises, so far as concerns—

(a)the retail sale of medicinal products (whether they are on a general sale list or not), or

(b)the supply of such products in circumstances corresponding to retail sale.]

(3)Directions under subsection (1) [F276or (1A)] of this section and under paragraph (a) of [F277the last preceding subsection] [F277subsection (2)], and any direction under paragraph (b) of [F277the last preceding subsection] [F277subsection (2)], may, if the [F278the relevant disciplinary committee] think fit, be given so as to have effect for a limited period; and in that case the registrar, at the end of that period, shall restore to the register any premises removed from it in compliance with the direction given under paragraph (a) or paragraph (b) of [F277the last preceding subsection] [F277subsection (2)].

(4)Where, in any such case as is mentioned in subsection (1) of section 72 of this Act, a representative, or a person employed by a representative in the business referred to in that subsection,—

(a)is convicted of an offence, or

(b)has been guilty of misconduct,

and the offence or misconduct is such as in the opinion of the [F279the relevant disciplinary committee] renders him, or would if he were a pharmacist render him, unfit to be a pharmacist, then, subject to the following provisions of this Part of this Act, the [F279the relevant disciplinary committee], after inquiring into the case, may direct that the representative shall be disqualified for the purposes of this Part of this Act.

(5)In this and the next following section “the relevant Acts” means [F280the Pharmacy Act 1954, this Act, the Misuse of Drugs Act 1971, the Pharmacy (Northern Ireland) Order 1976, the Pharmacists and Pharmacy Technicians Order 2007 and the Pharmacy Order 2010], and “representative” has the same meaning as in section 72 of this Act.

Textual Amendments

F262Words in heading substituted (coming into force in accordance with art. 1(2)(3)) by Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), art. 1(2)(3), Sch. 1 para. 2(12)

F270Words in s. 80(2) substituted (coming into force in accordance with art. 1(2)(3)) by Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), art. 1(2)(3), Sch. 1 para. 2(12)(a)

F278Words in s. 80(3) substituted (coming into force in accordance with art. 1(2)(3)) by Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), art. 1(2)(3), Sch. 1 para. 2(12)(a)

F279Words in s. 80(4) substituted (coming into force in accordance with art. 1(2)(3)) by Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), art. 1(2)(3), Sch. 1 para. 2(12)(a)

Modifications etc. (not altering text)

C42S. 80 heading; amendments continued (11.2.2010) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(2)(c), Sch. 6 para. 1(2)(b)

C43S. 80: Power to amend conferred (15.3.2000) by 1999 c. 8, s. 60(1)(2)(4), Sch. 3 para. 2(3)(a); S.I. 2000/779, art. 2(1)

C44S. 80(2)(3)(4) amendments continued (11.2.2010) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(2)(c), Sch. 6 para. 1(2)(c)

81 Grounds for disqualification in certain cases.U.K.

[F281(1)Unless the conditions specified in subsection (1A) are satisfied, the relevant disciplinary committee may not do any of the following—

(a)give a direction under subsection (1) of section 80 of this Act—

(i)in a case falling within paragraph (b) of that subsection, or

(ii)in a case falling within paragraph (c) of that subsection, where the failure in question is by a member of the board or any officer of, or person employed by, the body in question; or

(b)give a direction under subsection (4) of that section.

(1A)The conditions are that—

(a)one or more of the facts specified in subsection (2) are proved to the satisfaction of the relevant disciplinary committee; and

(b)the committee are of the opinion, having regard to those facts, that the board of the body corporate or, as the case may be, the representative, is to be regarded as responsible for the offence, misconduct or failure in question.]

(2)[F282The facts referred to in subsection (1A)(a) of this section are]-

(a)that [F283the offence, misconduct or failure in question] was instigated or connived at by the board or by a member of the board, or by the representative, as the case may be;

[F284(b)that, in the case of a body corporate, a member of the board, or an officer of, or person employed by, the body corporate had, at some time within the twelve months immediately preceding the date on which the offence, misconduct or failure occurred, been guilty of a similar offence or failure or of similar misconduct and that the board had, or with the exercise of reasonable care would have had, knowledge of that previous offence, misconduct or failure;]

(c)that, in the case of the representative, he or a person employed by him had, at some time within twelve months before the date on which the offence or misconduct in question occurred, been guilty of a similar offence or similar misconduct and (where it was a similar offence or similar misconduct on the part of an employee) that the representative had, or with the exercise of reasonable care would have had, knowledge of that previous offence or misconduct;

(d)if [F285offence, misconduct or failure in question is a continuing offence or failure or is continuing misconduct], that the board, or the representative, had, or with the exercise of reasonable care would have had, knowledge of its continuance;

(e)in the case of an offence in respect of a contravention of an enactment contained in any of the relevant Acts, that the board, or the representative, had not exercised reasonable care to secure that the enactment was complied with.

Textual Amendments

Modifications etc. (not altering text)

C45S. 81: Power to amend conferred (15.3.2000) by 1999 c. 8, s. 60(1)(2)(4), Sch. 3 para. 2(3)(a); S.I. 2000/779, art. 2(1)

82 Procedure relating to disqualification.U.K.

(1)[F286The relevant disciplinary committee] shall not give a direction under section 80 of this Act except with the assent of the chairman of the Committee.

(2)A direction under that section shall not take effect until the end of the period of three months from the date on which notice of the direction is given to the body corporate[F287, pharmacist, partnership] or other person to whom it relates, and, if an appeal against the direction is brought under this section, shall not take effect until that appeal has been determined or withdrawn.

(3)Where any such direction is given, the body corporate[F288, pharmacist, partnership] or other person to whom it relates may, at any time before the end of the period of three months specified in subsection (2) of this section, appeal against the direction to the High Court.

(4)The [F289General Pharmaceutical Council or, in Northern Ireland, the Pharmaceutical Society of Northern Ireland] may appear as respondent on any such appeal; and, for the purpose of enabling directions to be given as to costs on any such appeal, the [F290Council or the Society] shall be deemed to be a respondent to the appeal whether they appear on the hearing of the appeal or not.

(5)On any such appeal, the High Court may give such directions in the matter as appear to the Court to be appropriate; and it shall be the duty of [F291the relevant disciplinary committee] to comply with any such directions and (where appropriate) of the registrar to make such alterations in the register as are necessary to give effect to them.

(6)No appeal shall lie from any decision of the High Court under this section.

(7)In the application of this section to Scotland, any reference to the High Court shall be construed as a reference to the Court of Session, and any reference to costs shall be construed as a reference to expenses.

(8)In the application of this section to Northern Ireland, any reference to the High Court shall be construed as a reference to a judge of the [F292 Court of Judicature ] of Northern Ireland.

Textual Amendments

F286Words in s. 82(1) substituted (coming into force in accordance with art. 1(2)(3)) by Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), art. 1(2)(3), Sch. 1 para. 2(14)

F291Words in s. 82(5) substituted (coming into force in accordance with art. 1(2)(3)) by Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), art. 1(2)(3), Sch. 1 para. 2(14)

Modifications etc. (not altering text)

C42S. 80 heading; amendments continued (11.2.2010) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(2)(c), Sch. 6 para. 1(2)(b)

C46s. 82: Power to amend conferred (15.3.2000) by 1999 c. 8, s. 60(1)(2)(4), Sch. 3 para. 2(3)(a); S.I. 2000/779, art. 2(1)

C47S. 82(1) amendments continued (11.2.2010) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(2)(c), Sch. 6 para. 1(2)(d)

C48S. 82(5) amendments continued (11.2.2010) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(2)(c), Sch. 6 para. 1(2)(d)

[F29382A.Interim measuresU.K.

(1)Subsection (2) applies where—

(a)the relevant disciplinary committee have given a direction (“the principal direction”) under section 80(1), (1A) or (2) in relation to a body corporate, pharmacist or partnership; and

(b)the direction has not yet taken effect.

(2)Where the committee are satisfied that to do so is necessary for the protection of members of the public or is otherwise in the public interest, the committee may direct the registrar to suspend from the register, until the principal direction takes effect or an appeal under section 82(3) against the principal direction is successful—

(a)all entries of premises entered in the register as premises at or from which the body corporate, pharmacist or partnership carries on a retail pharmacy business; or

(b)entries of such of those premises as may be specified in the direction under this subsection.

(3)Where the committee give a direction under subsection (2), the registrar must send to the body corporate, pharmacist or partnership to whom the direction relates a statement in writing giving that person notice of—

(a)the contents of the direction; and

(b)the right of appeal under subsection (5).

(4)The statement must be sent—

(a)in the case of a body corporate, to the body corporate at its registered or principal office;

(b)in the case of a pharmacist, to the pharmacist at the pharmacist’s home address in the register;

(c)in the case of a partnership, to the partnership at its principal office.

(5)A body corporate, pharmacist or partnership to whom a direction under subsection (2) relates may appeal against the direction to the High Court.

(6)Subsections (4) to (6) of section 82 apply in relation to an appeal under subsection (5) as they apply in relation to an appeal under section 82(3).

(7)Subsections (7) and (8) of section 82 apply in the application of this section to Scotland or Northern Ireland as they apply in the application of section 82 to Scotland or Northern Ireland.]

83 Revocation of disqualification.U.K.

(1)At any time while a direction under section 80 of this Act is in force [F294the relevant disciplinary committee], either on the application of the person to whom it relates or without any such application, may revoke the direction.

(2)If, on an application to [F295the relevant disciplinary committee] to revoke such a direction, [F296the committee] refuse to revoke it, the applicant, at any time before the end of the period of three months from the date on which notice of the refusal is given to him, may appeal to the High Court against the refusal.

(3)Subsections (4) to (6) of section 82 of this Act shall have effect in relation to any appeal under this section as they have effect in relation to appeals under that section.

(4)In the application of this section to Scotland, any reference to the High Court shall be construed as a reference to the Court of Session; and in the application of this section to Northern Ireland, any reference to the High Court shall be construed as a reference to a judge of the [F292 Court of Judicature ] of Northern Ireland.

Textual Amendments

F294Words in s. 83(1) substituted (coming into force in accordance with art. 1(2)(3)) by Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), art. 1(2)(3), Sch. 1 para. 2(15)(a)

F295Words in s. 83(2) substituted (coming into force in accordance with art. 1(2)(3)) by Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), art. 1(2)(3), Sch. 1 para. 2(15)(a)

F296Words in s. 83(2) substituted (coming into force in accordance with art. 1(2)(3)) by Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), art. 1(2)(3), Sch. 1 para. 2(15)(b)

Modifications etc. (not altering text)

C42S. 80 heading; amendments continued (11.2.2010) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(2)(c), Sch. 6 para. 1(2)(b)

C49S. 83: Power to amend conferred (15.3.2000) by 1999 c. 8, s. 60(1)(2)(4), Sch. 3 para. 2(3)(a); S.I. 2000/779, art. 2(1)

C50S. 83(1)(2) amendments continued (11.2.2010) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(2)(c), Sch. 6 para. 1(2)(e)

Supplementary provisionsU.K.

84 Offences under Part IV.U.K.

F297(A1). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(1)Any person who contravenes section 77 of this Act shall be guilty of an offence and liable on summary conviction to a fine not exceeding [F298level 3 on the standard scale].

(2)Any person who contravenes section 78 of this Act or who contravenes any regulations made under section 79(2) of this Act shall be guilty of an offence and liable on summary conviction to a fine not exceeding [F299level 3 on the standard scale].

[F30084A.Rules by the General Pharmaceutical CouncilU.K.

(1)The General Pharmaceutical Council may make such provision as it considers appropriate in rules for any purpose for which rules are authorised or required to be made by it under Part 4 of this Act.

(2)Article 66 of the Pharmacy Order 2010 (rules) applies to the making of rules by the General Pharmaceutical Council under [F301any provision of Part 4 of this Act other than section 72A] as it applies to the making of rules by the General Pharmaceutical Council under Part 3 of that Order (registered pharmacies: standards in retail pharmacies).]

[F302(3)The power of the General Pharmaceutical Council to make rules under section 72A may be exercised so as to make different provision for different areas or in relation to different cases or different circumstances to which the power is applicable, and to make any such provision subject to such exceptions, limitations and conditions (if any) as the General Pharmaceutical Council considers necessary or expedient.

(4)Before making rules under section 72A, the General Pharmaceutical Council must publish draft rules and invite representations to be made to it about the draft by—

(a)the Secretary of State, the Scottish Ministers and the Welsh Ministers, and

(b)any other persons appearing to it appropriate to consult about the draft.

(5)No rules made under section 72A by the General Pharmaceutical Council are to come into force until approved by order of the Privy Council.

(6)The power vested in the Privy Council to make an order under subsection (5) may be exercised by any two or more members of the Privy Council.

(7)The making of an order under subsection (5) is sufficiently signified by an instrument signed by the Clerk of the Privy Council.

(8)Where an order under subsection (5) is signified by an instrument purporting to be signed by the Clerk of the Privy Council, that is evidence and in Scotland sufficient evidence of—

(a)the fact that the order was duly made, and

(b)the order’s terms.]

Part VU.K. Containers, Packages and Identification of Medicinal Products

F30385 Labelling and marking of containers and packages. U.K.

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

Textual Amendments

F30386 Leaflets. U.K.

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

Textual Amendments

87 Requirements as to containers. U.K.

(1)The F304... Ministers may make regulations prohibiting the sale or supply of medicinal products otherwise than in containers which comply with such requirements as [F305the Ministers] consider necessary or expedient for any of the purposes specified in [F306subsection (3)], or for the purpose of preserving the quality of the products, and in particular, may by the regulations require such containers to be of such strength, to be made of such materials, and to be of such shapes or patterns, as may be prescribed.

(2)No person shall, in the course of a business carried on by him, sell or supply, or have in his possession for the purpose of sale or supply, any medicinal product in such circumstances as to contravene any requirements imposed by regulations under this section which are applicable to that product.

[F307(3)The purposes mentioned in subsection (1) are—

(a)securing that medicinal products are correctly described and readily identifiable;

(b)securing that any appropriate warning or other appropriate instruction or information is given, and that false or misleading information is not given, with respect to medicinal products;

(c)promoting safety in relation to medicinal products.]

Textual Amendments

Modifications etc. (not altering text)

C51Pt. V (ss. 85–91) extended with modifications by S.I. 1985/1403, art. 3(1)

C52Ss. 85–88, 91 extended by S.I. 1984/187, art. 2

88 Distinctive colours, shapes and markings of medicinal products. U.K.

(1)Regulations made by the F308... Ministers may impose such requirements as, for any of the purposes specified in [F309section 87(3)] of this Act, [F310the Ministers] consider necessary or expedient with respect to any one or more of the following matters, that is to say—

(a)the colour of the products;

(b)the shape of the products; and

(c)distinctive marks to be displayed on the products.

(2)Regulations made under this section may provide that medicinal products of any such description, or falling within any such class, as may be specified in the regulations shall not except in such circumstances (if any) as may be so specified, be of any such colour or shape, or display any such mark, as may be so specified.

(3)No person shall, in the course of a business carried on by him, sell or supply, or have in his possession for the purpose of sale or supply, any medicinal product which contravenes any requirements imposed by regulations under this section.

Textual Amendments

Modifications etc. (not altering text)

C53Pt. V (ss. 85–91) extended with modifications by S.I. 1985/1403, art. 3(1)

C54Ss. 85–88, 91 extended by S.I. 1984/187, art. 2

F31189 Display of information on automatic machines. U.K.

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

Textual Amendments

Modifications etc. (not altering text)

C55Pt. V (ss. 85–91) extended with modifications by S.I. 1985/1403, art. 3(1)

F31290 Provisions as to medicated animal feeding stuffs. U.K.

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

Textual Amendments

Modifications etc. (not altering text)

C56Pt. V (ss. 85–91) extended with modifications by S.I. 1985/1403, art. 3(1)

91 Offences under Part V, and supplementary provisions. U.K.

F313(1). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2)Any regulations made under this Part of this Act may provide that any person who contravenes the regulations, or who contravenes the provisions of F314... section 87(2) of this Act F315..., shall be guilty of an offence and—

(a)shall be liable on summary conviction to a fine not exceeding £400 or such lesser sum as may be specified in the regulations, and

(b)if the regulations so provide, shall be liable on conviction on indictment to a fine or to imprisonment for a term not exceeding two years or to both.

(3)Without prejudice to the application of section 129(5) of this Act, any power to make regulations conferred by [F316section] 87 of this Act may be exercised so as to impose requirements either in relation to medicinal products generally or in relation to medicinal products of a particular description, or falling within a particular class, specified in the regulationsF317....

(4)In this Part of this Act “requirements” includes restrictions.

Textual Amendments

F313S. 91(1) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 14(a) Sch. 35 (with Sch. 32)

F314Words in s. 91(2) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 14(b) (with Sch. 32)

F315Words in s. 91(2) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 48(b) (with regs. 2(4), 3)

F317Words in s. 91(3) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 48(c) (with regs. 2(4), 3)

Modifications etc. (not altering text)

C57Pt. V (ss. 85–91) extended with modifications by S.I. 1985/1403, art. 3(1)

C58Ss. 85–88, 91 extended by S.I. 1984/187, art. 2

C59S. 91 applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2), Sch.

C60Criminal Justice Act 1982 (c. 48, SIF 39:1), ss. 38 (increase of fines) and 46 (substitution of references to levels on the standard scale) apply (E.W.) and Criminal Procedure (Scotland) Act 1975 (c. 21, SIF 39:1), ss. 289F, 289G (increase of fines and substitution of references to levels on the standard scale) apply (S.) and S.I. 1984/703 (N.I. 3), art. 5 (substitution of references to levels on the standard scale) and art. 6 (increase of fines) apply (N.I.)

Part VIU.K. Promotion of Sales of Medicinal Products

F31892 Scope of Part VI. U.K.

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

Textual Amendments

F31893 False or misleading advertisements and representations.U.K.

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

Textual Amendments

F31894 Advertisements requiring consent of holder of product licence.U.K.

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

Textual Amendments

F31895 Powers to regulate advertisements and representations. U.K.

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

Textual Amendments

F31896 Advertisements and representations directed to practitioners.U.K.

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

Textual Amendments

F31897 Power for licensing authority to require copies of advertisements.U.K.

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

Textual Amendments

Part VIIU.K. British Pharmacopoeia and Other Publications

98. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F319U.K.

F31899 New editions of British Pharmacopoeia, and other compendia.U.K.

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

Textual Amendments

F318100 Lists of names.U.K.

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

Textual Amendments

F318101 Other publications.U.K.

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

Textual Amendments

F318102 Supplementary provisions.U.K.

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

Textual Amendments

F318103 Construction of references to specified publications.U.K.

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

Textual Amendments

Part VIII U.K. Miscellaneous and Supplementary Provisions

Modifications etc. (not altering text)

C61Pt. 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)

104 Application of [F320the 2012 Regulations] to certain articles and substances. U.K.

(1)The MinistersF321... may by order specify any description or class of articles or substances appearing to them to be articles or substances which are not medicinal products but are manufactured, sold, supplied, imported or exported for use wholly or partly for a medicinal purpose, and may by the order direct that, subject to such exceptions and modifications as may be specified in the order, such provisions of [F322the 2012 Regulations][F323, or the Clinical Trials Regulations,] as may be so specified (including provisions so specified which relate to offences or penalties) shall have effect in relation to articles or substances of that description or class as those provisions have effect in relation to medicinal products.

(2)No order shall be made under this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

Textual Amendments

F321Words in s. 104(1) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 54 (with regs. 2(4), 3)

Modifications etc. (not altering text)

C62Pt. 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)

105 Application of [F324the 2012 Regulations] to certain other substances which are not medicinal products. U.K.

(1)The Ministers may by order specify any substance appearing to the Ministers to be a substance which is not itself a medicinal product but—

(a)is used as an ingredient in the manufacture of medicinal products, or

(b)if used without proper safeguards, is capable of causing danger to the health of the community