Legalize / United Kingdom / Public General Act

Medicines Act 1968

Type Public General Act

Publication 1968-10-25

Last updated 2025-10-01

State In force

Department Statute Law Database

Source legislation.gov.uk

articles Not indexed

Reform history JSON API

Part I — Administration

Ministers responsible for administration of Act

1

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).

Establishment of Medicines Commission

2

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General functions of Commission

3

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Establishment of committees

4

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Supplementary provisions as to Commission and committees

5

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Part II — Licences and Certificates Relating to Medicinal Products

General provisions and exemptions

The licensing authority

6

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General provisions as to dealing with medicinal products

7

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Provisions as to manufacture and wholesale dealing

8

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Exemptions for doctors, dentists, veterinary surgeons and veterinary practitioners

9

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Exemptions for pharmacists

10

(1) ... The restrictions imposed by regulations 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 , 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 an appropriate practitioner, or

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

(i) it shall be in a registered pharmacy at or 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 or from that registered pharmacy or at or from any other such registered pharmacy ..., 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.

(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, ...

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

(4) Without prejudice to the preceding subsections, the restrictions imposed by regulations 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 provided 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 or from that registered pharmacy or at or 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.

(5) Without prejudice to the preceding subsections, the restrictions imposed by 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 or from the registered pharmacy at which it is prepared, and

(6) Without prejudice to the preceding subsections, the restrictions imposed by regulation 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 or from that registered pharmacy.

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

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

(7A) The ... 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 regulation 7 (advertisements relating to medicinal products) of the 2012 Regulations.

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

Exemption for nurses and midwives

11

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Exemptions in respect of herbal remedies

12

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Exemptions for imports

13

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Exemption for re-exports

14

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Analysis of samples in other cases.

15

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

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

(3) The ... Ministers may by order provide that any of the provisions of 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.

Transitional exemptions

16

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Termination of transitional exemptions

17

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Applications for, and grant and renewal of, licences

Application for licence

18

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Factors relevant to determination of application for licence

19

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Grant or refusal of licence

20

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Procedure on reference to appropriate committee or Commission

21

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Procedure in other cases

22

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Special provisions as to effect of manufacturer's licence

23

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Duration and renewal of licence

24

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Licences of right

Entitlement to licence of right

25

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Scope of licence of right in different cases

26

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Proceedings on application for licence of right

27

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Suspension, revocation and variation of licences

General power to suspend, revoke or vary licences

28

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

29

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Variation of licence on application of holder

30

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Clinical trials and medicinal tests on animals

Clinical trials

31

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Medicinal tests on animals

32

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Exemptions in respect of medicinal tests on animals

33

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Restrictions as to animals on which medicinal tests have been carried out

34

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Supplementary provisions as to clinical trials and medicinal tests on animals

35

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Application for, and issue of, certificate

36

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Transitional provisions as to clinical trials and medicinal tests on animals

37

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Duration and renewal of certificate

38

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Suspension, revocation or variation of certificate

39

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Medicated animal feeding stuffs

General provisions relating to medicated animal feeding stuffs

40

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Transitional provisions as to restrictions under s. 40

41

(1) The provisions of section 40 of this Act shall have effect subject to the following provisions of this section.

(2) The restrictions imposed by that section do not apply to anything done before the first appointed day.

(3) The restrictions imposed by subsection (1) of that section do not apply to anything done on or after the first appointed day in relation to any animal feeding stuff in which a medicinal product of any description has been incorporated, and the restrictions imposed by subsection (3) of that section do not apply to anything done on or after that day which consists of incorporating a medicinal product of any description in any animal feeding stuff, if (in either case) it is done—

(a) before the date on which, by virtue of one or more orders under section 17 of this Act, section 16(2) of this Act ceases to have any effect in relation to medicinal products of that description, or

(b) before the end of the period of twelve months beginning with that date.

(4) The restriction imposed by section 40(2) of this Act does not apply to the importation on or after the first appointed day of any animal feeding stuff in which a medicinal product of any description has been incorporated if it is imported—

(a) before the date on which, by virtue of one or more orders under section 17 of this Act, section 16(3) of this Act ceases to have any effect in relation to medicinal products of that description, or

(b) before the end of the period of twelve months beginning with that date.

Supplementary provisions as to incorporation of substances and articles in animal feeding stuffs

42

(1) Where in the course of a business carried on by him a person incorporates a substance or article, other than a medicinal product, in any animal feeding stuff with a view to—

(a) feeding it, with the substance or article incorporated in it, to one or more animals, or

(b) selling, supplying or exporting it with the substance or article incorporated in it,

and the substance or article is so incorporated by him for a medicinal purpose, sections 40(3) and 41 of this Act shall have effect in relation to the incorporation of that substance or article as if it were a medicinal product.

(2) Where in the course of a business carried on by him a person proposes—

(a) to sell or supply a substance or article, other than a medicinal product, to persons who for a medicinal purpose may require to incorporate it in animal feeding stuffs to be fed to one or more animals, or

(b) to manufacture a substance or article, other than a medicinal product, for sale or supply as mentioned in the preceding paragraph,

he may, if he so desires, apply for a product licence in respect of that substance or article, and the licensing authority (subject to the provisions of sections 19 to 22 of this Act) may grant to him a product licence in respect of it, as if it were a medicinal product and he were proposing to sell or supply it in circumstances to which section 7(2) of this Act applies; and a product licence so granted may be renewed, suspended, revoked or varied accordingly.

(3) Where a person proposes to sell, supply or manufacture a substance or article, other than a medicinal product, in the circumstances specified in paragraph (a) or paragraph (b) of subsection (2) of this section, any person who proposes, by purchase or otherwise, to obtain from him a supply of the substance or article with a view to incorporating it for a medicinal purpose in any animal feeding stuff may, if he so desires, apply for a product licence in respect of that substance or article, and the licensing authority (subject to the provisions of sections 19 to 22 of this Act) may grant to him a product licence in respect of it, as if it were a medicinal product and he were proposing to procure the sale or supply, or the manufacture for sale or supply, of that product in circumstances to which section 7(2) of this Act applies; and a product licence so granted may be renewed, suspended revoked or varied accordingly.

(4) On the grant, renewal or variation (whether by virtue of subsection (2) or subsection (3) of this section or otherwise) of a product licence, in so far as it relates to any substance or article which is to be incorporated in animal feeding stuffs, the licence may (without prejudice to the generality of section 20(1) of this Act) include provisions as to the manner in which the substance or article in question may be so incorporated, whether by the holder of the licence or by any other person to whom those provisions of the licence have been communicated.

(5) Without prejudice to the operation of section 130(7) of this Act, a substance manufactured, sold, supplied or exported as an animal feeding stuff shall not be taken to be a medicinal product for the purposes of this Act by reason only that any of the preceding provisions of this section has effect in relation to a substance or article incorporated in it.

(6) The appropriate Ministers may by order provide that any of the provisions of section 40 of this Act or of subsections (1) to (5) of this section shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be specified in the order.

(7) No order shall be made under subsection (6) of this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

Supplementary provisions

Extension of s.7 to certain special circumstances

43

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Provision of information to licensing authority

44

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Offences under Part II

45

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Special defences under s. 45

46

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Standard provisions for licences or certificates

47

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Postponement of restrictions in relation to exports

48

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Special provisions in respect of exporting certain products

49

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Certificates for exporters of medicinal products

50

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Part III — Further Provisions relating to Dealings with Medicinal Products

Provisions as to sale or supply of medicinal products

General sale lists

51

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Sale or supply of medicinal products not on general sale list

52

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Sale or supply of medicinal products on general sale list

53

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Sale of medicinal products from automatic machines

54

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Exemptions from sections 52 and 53

Exemptions for doctors, dentists, veterinary surgeons and veterinary practitioners

55

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Exemptions in respect of herbal remedies

56

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Power to extend or modify exemptions

57

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Additional provisions

Medicinal products on prescription only

58

(1) The Ministers may by order specify descriptions or classes of medicinal products as prescription only medicines

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

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

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

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

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

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

(a) that regulation 214(1) or (2) of the 2012 Regulations shall have effect subject to such exemptions as may be specified in the order 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 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.

(4A) An order under this section may provide, in relation to an 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

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.

(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.

(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 regulation 214(1) or (2) of the 2012 Regulations .

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

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

(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.

Special provisions in relation to new medicinal products

59

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Restricted sale, supply and administration of certain medicinal products

60

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Special restrictions on persons to be supplied with medicinal products

61

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Prohibition of sale or supply, or importation, of medicinal products of specified description, or of animal feeding stuffs incorporating such products

62

(1) Subject to the following provisions of this section, the ... 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;

(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 Ministers , unless in their opinion it is essential to make the order with immediate effect to avoid serious danger to health ..., shall consult the appropriate committee ....

(4) Where an order is made under this section without prior consultation with the appropriate committee ... 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 Ministers of their desire to be heard under this subsection, or have made representations in writing to the 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 Ministers shall arrange for them to have an opportunity of appearing before, and being heard by, the appropriate committee, or

(b) if they have made representations in writing, the Ministers shall refer those representations to the appropriate 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 Ministers and the 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 ... Ministers it is essential to make the order with immediate effect as mentioned in subsection (3) of this section.

(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.

(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.

Adulteration of medicinal products

63

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.

Protection of purchasers of medicinal products

64

(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 an 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".

Compliance with standards specified in monographs in certain publications

65

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Further powers to regulate dealings with medicinal products

66

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Offences, and provision for disqualification

Offences under Part III

67

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

(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 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 63 and 64, or who contravenes ... 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.

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

(4) Any person guilty of an offence under subsection (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.

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

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

Disqualification on conviction of certain offences

68

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Part IV — Pharmacies

Persons lawfully conducting retail pharmacy business

General provisions

69

(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.

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

(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—

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

“the register” means—in relation to Great Britain, the register established and maintained under article 19 of the Pharmacy Order 2010; andin relation to Northern Ireland, the register kept for the purposes of section 75;

“the registrar” means—in relation to Great Britain, the person appointed under article 18 of the Pharmacy Order 2010 as registrar for the purposes of that Order; andin 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;

“the relevant disciplinary committee” means—in relation to Great Britain, the Fitness to Practise Committee established under article 4(6) of the Pharmacy Order 2010; andin 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.

Business carried on by individual pharmacist or by partners

70

(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 at 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 the requirement of subsection (4) of this section is in charge of the business carried on at or from those premises, so far as concerns—

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

(b) the supply at or 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,

(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

(4) The responsible pharmacist must be—

(a) the person carrying on the business, or

(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

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

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

Bodies corporate

71

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

(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 at 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 the requirement of subsection (4) of this section is in charge of the 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 or from those premises of medicinal products (whether they are on a general sale list or not), and

(b) the supply at or 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,

(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

(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.

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

(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,

(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 ..., has been sent to the registrar ...

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

(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.

(8) If 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 be the superintendent in relation to the business.

(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Representative of pharmacist in case of death or disability

72

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

and a representative of his thereafter carries on his business.

(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.

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

(b) the supply at or 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) 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

(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 deputy, curator bonis, judicial factor, committee or guardian or 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, the 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 donee, deputy, curator bonis, judicial factor, controller or guardian ; 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 voluntary arrangement proposed for the purposes of, and approved under, Part VIII of the Insolvency Act 1986 or Chapter II of Part VIII of the Insolvency (Northern Ireland) Order 1989.

Power to extend or modify conditions

73

(1) The ... 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 ... 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.

Registration of pharmacies

Meaning of " registered pharmacy "

74

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

(1A) If the entry of a registered pharmacy in the register is suspended under paragraph (4)(b) of article 14 section 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 of that Order as the General Pharmaceutical Council may prescribe by rules in 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.

(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 apart from that Order except for a purpose prescribed by the rules or regulations mentioned in subsection (1A) .

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

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

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

Registration of premises

75

(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 ... 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 or 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”—

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

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

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.

Supplementary provisions as to registration of premises

76

(1) Where any premises have been entered in the register under 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 or from those premises.

(2) If, on demand being made to him in the prescribed manner, the person carrying on a retail pharmacy business at or from any premises entered in the register under 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, the 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 the 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 the appropriate Minister so directs, 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 or 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.

(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 or 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.

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

(7) A document purporting to be a certificate signed by the registrar and stating that, on a specified date, specified premises in 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.

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

(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.

Annual return of premises to registrar

77

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

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

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

Provisions as to use of certain titles, descriptions and emblems

Restrictions on use of titles, descriptions and emblems

78

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

(2) ... 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 or 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 or from which any goods are sold by retail, or are supplied in circumstances corresponding to retail sale, unless those premises are a registered pharmacy ....

(4) ... 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.

(5) A person who is not registered in the register of pharmaceutical chemists for Northern Ireland ... 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 or 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 ... 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 or 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) ... 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 or 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, who is in charge of the 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.

Provision for modifying or extending restrictions under s. 78

79

(1) The ... 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 ... 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 ... Ministers shall consult the 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.

Disqualification, and removal of premises from register

Power for Statutory Committee to disqualify and direct removal from register

80

(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 in Great Britain that are entered in the register as premises at or from which the body corporate carries on that business, there is a failure to meet the standards that are provided for in rules made under 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 body corporate is to be disqualified for the purposes of this Part of this Act.

(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 within the preceding subsection within subsection (1) or (1A) —

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

(b) if the the relevant disciplinary committee do not give a direction under the preceding subsection the 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.

(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) or (1A) of this section and under paragraph (a) of the last preceding subsection subsection (2), and any direction under paragraph (b) of the last preceding subsection subsection (2), may, if the the 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 the last preceding subsection subsection (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 the 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 the 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 the 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.

Grounds for disqualification in certain cases

81

(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) The facts referred to in subsection (1A)(a) of this section are-

(a) that the 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;

(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 offence, 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.

Procedure relating to disqualification

82

(1) The 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, 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, 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 General 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 Council 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 the 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 Court of Judicature of Northern Ireland.

Revocation of disqualification

83

(1) At any time while a direction under section 80 of this Act is in force the 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 the relevant disciplinary committee to revoke such a direction, the 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 Court of Judicature of Northern Ireland.

Supplementary provisions

Offences under Part IV

84

(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 level 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 level 3 on the standard scale.

Part V — Containers, Packages and Identification of Medicinal Products

Labelling and marking of containers and packages

85

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

Leaflets

86

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

Requirements as to containers

87

(1) The ... Ministers may make regulations prohibiting the sale or supply of medicinal products otherwise than in containers which comply with such requirements as the Ministers consider necessary or expedient for any of the purposes specified in subsection (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.

(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;

Distinctive colours, shapes and markings of medicinal products

88

(1) Regulations made by the ... Ministers may impose such requirements as, for any of the purposes specified in section 87(3) of this Act, the 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

(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.

Display of information on automatic machines

89

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

Provisions as to medicated animal feeding stuffs

90

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

Offences under Part V, and supplementary provisions

91

(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 ... section 87(2) of this Act ..., 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 section 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 regulations....

(4) In this Part of this Act “requirements” includes restrictions.

Part VI — Promotion of Sales of Medicinal Products

Scope of Part VI

92

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

False or misleading advertisements and representations

93

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

94

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

Powers to regulate advertisements and representations

95

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

Advertisements and representations directed to practitioners

96

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

Power for licensing authority to require copies of advertisements

97

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

Part VII — British Pharmacopoeia and Other Publications

Copyright in British Pharmacopoeia

98

New editions of British Pharmacopoeia, and other compendia

99

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

Lists of names

100

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

Other publications

101

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

Supplementary provisions

102

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

Construction of references to specified publications

103

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

Part VIII — Miscellaneous and Supplementary Provisions

Application of Act to certain articles and substances

104

(1) The Ministers... 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 the 2012 Regulations, 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.

Application of Act to certain other substances which are not medicinal products

105

(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...,

and direct that, subject to such exceptions and modifications as may be specified in the order, such provisions of the 2012 Regulations, or the Clinical Trials Regulations, as may be so specified (including any provisions so specified which relate to offences or penalties) shall have effect in relation to that substance as those provisions have effect in relation to medicinal products.

(2) The power conferred by the preceding subsection may be exercised in relation to a class of substances if it appears to the Ministers that the conditions specified in paragraph (a) or paragraph (b) of that subsection are fulfilled in relation to all substances falling within that class.

(3) No order shall be made under this section—

(a) in relation to a substance as being a substance in respect of which the condition specified in subsection (1)(b) of this section is fulfilled, or

(b) in relation to a class of substances as being substances in respect of which that condition is fulfilled,

unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

Extension of references to carrying on business

106

(1) The Ministers may by order direct that such provisions of this Act as may be specified in the order, in so far as they relate to things done by a person in the course of a business carried on by him, shall have effect, subject to such exceptions and modifications as may be specified in the order, as if in those provisions any reference to a business included a reference to an activity (other than a business) of a description specified in the order.

(2) Without prejudice to the preceding subsection, the Ministers may by order direct that such provisions of this Act as may be specified in the order, in so far as they relate to things done by a person in the course of a business carried on by him, shall have effect, subject to such exceptions and modifications as may be specified in the order, as if, in such circumstances as may be so specified, a business carried on by a person’s employer were a business carried on by that person.

Validity of decisions and proceedings relating thereto

107

(1) Except as provided by the following provisions of this section, the validity of any decision ... of a Minister under section 75 of this Act, and the validity of any certificate issued or other thing done in pursuance of any such decision, shall not be questioned in any legal proceedings.

(2) If the person to whom such a decision relates desires to question the validity of the decision on the grounds—

(a) that it is not within the powers of this Act, or

(b) that any of the requirements of this Act or of any regulations made under this Act, which are applicable to the matter to which the decision relates, have not been complied with,

that person may, at any time within the period of three months from the date on which notice of the decision is served on him, make an application to the High Court under this section.

(3) On any application under this section the High Court—

(a) may by interim order suspend the operation of the decision to which the application relates until the final determination of the proceedings;

(b) if satisfied that the decision is not within the powers of this Act, or that the interests of the person making the application have been substantially prejudiced by a failure to comply with any of the requirements mentioned in subsection (2)(b) of this section, may quash the decision.

(4) Where a decision to issue a certificate is quashed under this section, any certificate issued in pursuance of that decision shall be void, and any proceedings on the application for the issue of the certificate may be continued as if no such decision had been made.

(5) 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.

(6) 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 High Court ... in Northern Ireland.

Enforcement in England and Wales

108

(1) Subject to the provisions of subsection (6C) of this section, it shall be the duty of the appropriate Minister to enforce in England and Wales, or to secure the enforcement in England and Wales of, the provisions of this Act and any regulations and orders made under it.

(2) For the purpose of performing that duty in relation to—

(a) the provisions of any order made under paragraph (a) of section 62(1) of this Act and of section 63(b), section 64 and sections 87(2) and 88(3) of this Act, in the application of any of those provisions to the retail sale, offer or exposure for retail sale, or possession for the purpose of retail sale, of medicinal products and to the supply, offer or exposure for supply, or possession for the purpose of supply, of medicinal products in circumstances corresponding to retail sale;

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