Medicines Act 1968
Medicines Act 1968 (1968 c. 67)
- Medicines Act 1968 (1968 c. 67)
- Part I Administration
- 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.
- Part II Licences and Certificates Relating to Medicinal Products
- General provisions and exemptions
- 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.
- Applications for, and grant and renewal of, licences
- 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.
- Licences of right
- 25 Entitlement to licence of right.
- 26 Scope of licence of right in different cases.
- 27 Proceedings on application for licence of right.
- Suspension, revocation and variation of licences
- 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.
- Clinical trials and medicinal tests on animals
- 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.
- Medicated animal feeding stuffs
- 40 Medicated animal feeding stuffs.
- 41–42 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- Supplementary provisions
- 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.
- Part III Further Provisions relating to Dealings with Medicinal Products
- Provisions as to sale or supply 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.
- Exemptions from sections 52 and 53
- 55 Exemptions for doctors and dentists etc
- 56 Exemptions in respect of herbal remedies.
- 57 Power to extend or modify exemptions.
- Additional provisions
- 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.
- Offences, and provision for disqualification
- 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.
- Part IV Pharmacies
- Persons lawfully conducting retail pharmacy business
- 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.
- Registration of pharmacies
- 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
- 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.
- Provisions as to use of certain titles, descriptions and emblems
- 78 Restrictions on use of titles, descriptions and emblems.
- 79 Provision for modifying or extending restrictions under s. 78.
- Disqualification, and removal of premises from register
- 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.
- Supplementary provisions
- 84 Offences under Part IV.
- 84A. Rules by the General Pharmaceutical Council
- Part V Containers, Packages and Identification of Medicinal Products
- 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.
- Part VI Promotion of Sales of Medicinal Products
- 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.
- Part VII British Pharmacopoeia and Other Publications
- 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.
- Part VIII Miscellaneous and Supplementary Provisions
- 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.
- SCHEDULES
- SCHEDULE 1 Provisions Relating to Medicines Commission and Committees
- SCHEDULE 1A PROVISIONS RELATING TO COMMISSION AND COMMITTEES
- Interpretation
- Co-opted members
- Expert Advisory Groups
- Appointment by the Commission of Expert Advisory Groups
- Delegation of functions by Advisory Bodies
- Terms of office of members
- Staff, premises and facilities
- Validity of proceedings
- Proceedings
- Remuneration and expenses of members
- Expenses of Advisory Bodies and Expert Advisory Groups
- Status
- SCHEDULE 2 SUSPENSION, REVOCATION OR VARIATION OF LICENCE
- Procedure on consultation with appropriate committee
- Procedure in other cases
- Hearing before person appointed
- Procedure in cases of urgency
- Interpretation
- SCHEDULE 3 SAMPLING
- Introductory
- Division of sample
- Notice to person named on container
- Analysis or other examination of sample
- Provisions as to evidence
- Analysis under direction of court
- Proof by written statement
- Power to modify sampling provisions
- Payment for sample taken under compulsory powers
- Application of s. 64 to samples
- SCHEDULE 4 Provisions relating to Northern Ireland
- SCHEDULE 5 Amendments of Enactments of Parliament of United Kingdom.
- The Venereal Disease Act 1917 (c. 21).
- The Cancer Act 1939 (c. 13.)
- The Trade Descriptions Act 1968 (c. 29).
- SCHEDULE 6 Enactments of Parliament of United Kingdom Repealed.
- SCHEDULE 8 Enactments of Parliament of Northern Ireland Repealed.
Feedback