Title and introductory text
Medicines Act 1968 1968 c.67 An Act to make new provision with respect to medicinal products and related matters, and for purposes connected therewith. [25th October 1968]
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Medicines Act 1968
United Kingdom · statute
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In force since 2025-10-01, as the publisher states.
Copy read on 2026-11-08. The page it was read from
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.
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Contents: 175 provisions
- Title and introductory text
- 1 Ministers responsible for administration of Act.
- 2 Establishment of Medicines Commission.
- 2A Establishment of the Commission on Human Medicines
- 3 Functions of the Commission
- 4 Establishment of committees.
- 5 Supplementary provisions as to Commission and committees.
- 6 The licensing authority.
- 7 General provisions as to dealing with medicinal products.
- 8 Provisions as to manufacture and wholesale dealing.
- 9 Exemptions for doctors and dentists
- 10 Exemptions for pharmacists.
- 11 Exemption for nurses and midwives.
- 12 Exemptions in respect of herbal remedies.
- 13 Exemptions for imports.
- 14 Exemption for re-exports.
- 15 Provision for extending or modifying exemptions.
- 16 Transitional exemptions.
- 17 Termination of transitional exemptions.
- 18 Application for licence.
- 19 Factors relevant to determination of application for licence.
- 20 Grant or refusal of licence.
- 21 Procedure on reference to appropriate committee
- 22 Procedure in other cases.
- 22A Hearing before person appointed
- 23 Special provisions as to effect of manufacturer’s licence.
- 24 Duration and renewal of licence.
- 25 Entitlement to licence of right.
- 26 Scope of licence of right in different cases.
- 27 Proceedings on application for licence of right.
- 28 General power to suspend, revoke or vary licences.
- 29 Procedure where licensing authority propose to suspend, revoke or vary licence under s. 28.
- 30 Variation of licence on application of holder.
- 31 Clinical trials.
- 32 Medicinal tests on animals.
- 33 Exemptions in respect of medicinal tests on animals.
- 34 Restrictions as to animals on which medicinal tests have been carried out.
- 35 Supplementary provisions as to clinical trials and medicinal tests on animals.
- 36 Application for, and issue of, certificate.
- 37 Transitional provisions as to clinical trials and medicinal tests on animals.
- 38 Duration and renewal of certificate.
- 39 Suspension, revocation or variation of certificate.
- 40 Medicated animal feeding stuffs.
- 41–42 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- 43 Extension of s. 7 to certain special circumstances.
- 44 Provision of information to licensing authority.
- 45 Offences under Part II.
- 46 Special defences under s. 45.
- 47 Standard provisions for licences
- 48 Postponement of restrictions in relation to exports.
- 49 Special provisions in respect of exporting certain products.
- 49A Special provisions in respect of exporting certain products to member States
- 49B Special provisions in respect of exporting certain products to EEA State s
- 50 Certificates for exporters of medicinal products.
- 51 General sale lists.
- 52 Sale or supply of medicinal products not on general sale list.
- 53 Sale or supply of medicinal products on general sale list.
- 54 Sale of medicinal products from automatic machines.
- 55 Exemptions for doctors and dentists etc
- 56 Exemptions in respect of herbal remedies.
- 57 Power to extend or modify exemptions.
- 58 Medicinal products on prescription only.
- 58A Requirement to specify certain products as prescription-only products
- 58B Requirement to specify certain products for veterinary use as prescription-only products.
- 59 Special provisions in relation to new medicinal products.
- 60 Restricted sale, supply and administration of certain medicinal products.
- 61 Special restrictions on persons to be supplied with medicinal products.
- 62 Prohibition of sale or supply, or importation, of medicinal products of specified description ....
- 63 Adulteration of medicinal products.
- 64 Protection of purchasers of medicinal products.
- 65 Compliance with standards specified in monographs in certain publications.
- 66 Further powers to regulate dealings with medicinal products.
- 67 Offences under Part III.
- 67A Defence to offence of contravening section 63(a) or (b): product not sold or supplied
- 67B Defence to offence of contravening section 63(a) or (b): product sold or supplied
- 67C Defence to offence of contravening section 64
- 67D Defences under sections 67A, 67B and 67C: evidence etc.
- 67E Sections 67A to 67D: “adulteration” and “registrant”
- 67F Sections 67A to 67D: “relevant pharmacy service”
- 68 Disqualification on conviction of certain offences.
- 69 General provisions.
- 70 Business carried on by individual pharmacist or by partners.
- 71 Business carried on by body corporate
- 72 Representative of pharmacist in case of death or disability.
- 72A The responsible pharmacist
- 72AA The superintendent
- 72B Sections 72A and 72AA: supplementary
- 73 Power to extend or modify conditions.
- 74 Meaning of “registered pharmacy".
- 74A Registration of premises: Great Britain
- 74B Conditions for registration: Great Britain
- 74C Supplementary provision in respect of registration of premises: Great Britain
- 74D Conditional registration: Great Britain
- 74E Supplementary provision in respect of conditional registration: Great Britain
- 74F Giving of notice by registrar: Great Britain
- 74G Voluntary removal from the register: Great Britain
- 74H
- 74I Supplementary provision in respect of change of ownership of retail pharmacy business: Great Britain
- 74J Temporary registration with regard to emergencies involving loss of human life or human illness etc.
- 74K Temporary annotations with regard to emergencies involving loss of human life or human illness etc.
- 74L Evidence of registration: Great Britain
- 75 Registration of premises: Northern Ireland.
- 76 Supplementary provisions as to registration of premises: Northern Ireland.
- 77 Annual return of premises to registrar.
- 78 Restrictions on use of titles, descriptions and emblems.
- 79 Provision for modifying or extending restrictions under s. 78.
- 80 Power for relevant disciplinary committee to disqualify and direct removal from register.
- 81 Grounds for disqualification in certain cases.
- 82 Procedure relating to disqualification.
- 82A Interim measures
- 83 Revocation of disqualification.
- 84 Offences under Part IV.
- 84A Rules by the General Pharmaceutical Council
- 85 Labelling and marking of containers and packages.
- 86 Leaflets.
- 87 Requirements as to containers.
- 88 Distinctive colours, shapes and markings of medicinal products.
- 89 Display of information on automatic machines.
- 90 Provisions as to medicated animal feeding stuffs.
- 91 Offences under Part V, and supplementary provisions.
- 92 Scope of Part VI.
- 93 False or misleading advertisements and representations.
- 94 Advertisements requiring consent of holder of product licence.
- 95 Powers to regulate advertisements and representations.
- 96 Advertisements and representations directed to practitioners.
- 97 Power for licensing authority to require copies of advertisements.
- 98 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- 99 New editions of British Pharmacopoeia, and other compendia.
- 100 Lists of names.
- 101 Other publications.
- 102 Supplementary provisions.
- 103 Construction of references to specified publications.
- 104 Application of the 2012 Regulations to certain articles and substances.
- 105 Application of the 2012 Regulations to certain other substances which are not medicinal products.
- 106 Extension of references to carrying on business.
- 107 Validity of decisions and proceedings relating thereto.
- 108 Enforcement in England and Wales.
- 109 Enforcement in Scotland.
- 110 Enforcement in Northern Ireland.
- 111 Rights of entry.
- 112 Power to inspect, take samples and seize goods and documents.
- 113 Application of sampling procedure to substance or article seized under s. 112.
- 114 Supplementary provisions as to rights of entry and related rights.
- 115 Analysis of samples in other cases.
- 115A Facilities for microbiological examinations.
- 116 Liability to forfeiture under Customs and Excise Act 1952.
- 117 Special enforcement and sampling provisions relating to animal feeding stuffs.
- 118 Restrictions on disclosure of information.
- 119 Protection for officers of enforcement authorities.
- 120 Compensation for loss of employment or loss or diminution of emoluments.
- 121 Contravention due to default of other person.
- 122 Warranty as defence.
- 123 Offences in relation to warranties and certificates of analysis.
- 124 Offences by bodies corporate.
- 125 Prosecutions.
- 126 Presumptions.
- 127 Service of documents.
- 128 Financial provisions.
- 129 Orders and regulations.
- 130 Meaning of “medicinal product" and related expressions.
- 131 Meaning of “wholesale dealing", “retail sale" and related expressions.
- 132 General interpretation provisions.
- 133 General provisions as to operation of Act.
- 134 Special provisions as to Northern Ireland.
- 135 Minor and consequential amendments and repeals.
- 136 Short title, extent and commencement.
- SCHEDULE 1 Provisions Relating to Medicines Commission and Committees
- SCHEDULE 1A PROVISIONS RELATING TO COMMISSION AND COMMITTEES
- SCHEDULE 2 SUSPENSION, REVOCATION OR VARIATION OF LICENCE
- SCHEDULE 3 SAMPLING
- SCHEDULE 4 Provisions relating to Northern Ireland
- SCHEDULE 5 Amendments of Enactments of Parliament of United Kingdom.
- SCHEDULE 6 Enactments of Parliament of United Kingdom Repealed.
- SCHEDULE 7
- SCHEDULE 8 Enactments of Parliament of Northern Ireland Repealed.
Proposed changes to this act
No one has proposed a change to this act yet.
175 provisions
1 Ministers responsible for administration of Act.
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).
Propose a change2 Establishment of Medicines Commission.
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Propose a change2A Establishment of the Commission on Human Medicines
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Propose a change3 Functions of the Commission
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Propose a change4 Establishment of committees.
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Propose a change5 Supplementary provisions as to Commission and committees.
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Propose a change6 The licensing authority.
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Propose a change7 General provisions as to dealing with medicinal products.
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Propose a change8 Provisions as to manufacture and wholesale dealing.
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Propose a change9 Exemptions for doctors and dentists
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Propose a change10 Exemptions for pharmacists.
(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) .
Propose a change11 Exemption for nurses and midwives.
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Propose a change12 Exemptions in respect of herbal remedies.
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Propose a change13 Exemptions for imports.
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Propose a change14 Exemption for re-exports.
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Propose a change15 Provision for extending or modifying exemptions.
(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.
Propose a change16 Transitional exemptions.
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Propose a change17 Termination of transitional exemptions.
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Propose a change18 Application for licence.
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Propose a change19 Factors relevant to determination of application for licence.
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Propose a change20 Grant or refusal of licence.
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Propose a change21 Procedure on reference to appropriate committee
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Propose a change22 Procedure in other cases.
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Propose a change22A Hearing before person appointed
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Propose a change23 Special provisions as to effect of manufacturer’s licence.
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Propose a change24 Duration and renewal of licence.
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Propose a change25 Entitlement to licence of right.
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Propose a change26 Scope of licence of right in different cases.
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Propose a change27 Proceedings on application for licence of right.
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Propose a change28 General power to suspend, revoke or vary licences.
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Propose a change29 Procedure where licensing authority propose to suspend, revoke or vary licence under s. 28.
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Propose a change30 Variation of licence on application of holder.
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Propose a change31 Clinical trials.
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Propose a change32 Medicinal tests on animals.
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Propose a change33 Exemptions in respect of medicinal tests on animals.
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Propose a change34 Restrictions as to animals on which medicinal tests have been carried out.
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Propose a change35 Supplementary provisions as to clinical trials and medicinal tests on animals.
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Propose a change36 Application for, and issue of, certificate.
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Propose a change37 Transitional provisions as to clinical trials and medicinal tests on animals.
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Propose a change