Medicines Act 1968

Part I — Administration

Ministers responsible for administration of Act

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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

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General functions of Commission

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Establishment of committees

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Supplementary provisions as to Commission and committees

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Part II — Licences and Certificates Relating to Medicinal Products

General provisions and exemptions

The licensing authority

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General provisions as to dealing with medicinal products

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Provisions as to manufacture and wholesale dealing

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Exemptions for doctors, dentists, veterinary surgeons and veterinary practitioners

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Exemptions for pharmacists

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• (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

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

• (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

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Exemptions in respect of herbal remedies

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Exemptions for imports

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Exemption for re-exports

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Analysis of samples in other cases.

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• (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

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Termination of transitional exemptions

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Applications for, and grant and renewal of, licences

Application for licence

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Factors relevant to determination of application for licence

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Grant or refusal of licence

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Procedure on reference to appropriate committee or Commission

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Procedure in other cases

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Special provisions as to effect of manufacturer's licence

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Duration and renewal of licence

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Licences of right

Entitlement to licence of right

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Scope of licence of right in different cases

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Proceedings on application for licence of right

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Suspension, revocation and variation of licences

General power to suspend, revoke or vary licences

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

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Variation of licence on application of holder

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Clinical trials and medicinal tests on animals

Clinical trials

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Medicinal tests on animals

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Exemptions in respect of medicinal tests on animals

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

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Supplementary provisions as to clinical trials and medicinal tests on animals

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Application for, and issue of, certificate

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Transitional provisions as to clinical trials and medicinal tests on animals

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Duration and renewal of certificate

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Suspension, revocation or variation of certificate

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Medicated animal feeding stuffs

General provisions relating to medicated animal feeding stuffs

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Transitional provisions as to restrictions under s. 40

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• (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

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• (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

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Provision of information to licensing authority

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Offences under Part II

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Special defences under s. 45

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Standard provisions for licences or certificates

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Postponement of restrictions in relation to exports

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Special provisions in respect of exporting certain products

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Certificates for exporters of medicinal products

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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

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Sale or supply of medicinal products not on general sale list

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Sale or supply of medicinal products on general sale list

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Sale of medicinal products from automatic machines

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