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Medicines Act 1968

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Medicines Act 1968 is up to date with all changes known to be in force on or before 07 June 2024. There are changes that may be brought into force at a future date. Help about Changes to Legislation

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You searched for provisions that are applicable to England. The matching provisions are highlighted below. Where no highlighting is shown the matching result may be contained within a footnote.

  1. Introductory TextNext Match

  2. Part I AdministrationPrevious MatchNext Match

    1. 1. Ministers responsible for administration of Act. Previous MatchNext Match

    2. 2. Establishment of Medicines Commission. Previous MatchNext Match

    3. 2A.Establishment of the Commission on Human MedicinesPrevious MatchNext Match

    4. 3. Functions of the Commission Previous MatchNext Match

    5. 4. Establishment of committees. Previous MatchNext Match

    6. 5. Supplementary provisions as to Commission and committees. Previous MatchNext Match

  3. Part II Licences and Certificates Relating to Medicinal ProductsPrevious MatchNext Match

    1. General provisions and exemptionsPrevious MatchNext Match

      1. 6. The licensing authority. Previous MatchNext Match

      2. 7. General provisions as to dealing with medicinal products. Previous MatchNext Match

      3. 8. Provisions as to manufacture and wholesale dealing. Previous MatchNext Match

      4. 9.Exemptions for doctors and dentists Previous MatchNext Match

      5. 10. Exemptions for pharmacists. Previous MatchNext Match

      6. 11. Exemption for nurses and midwives. Previous MatchNext Match

      7. 12. Exemptions in respect of herbal remedies. Previous MatchNext Match

      8. 13. Exemptions for imports. Previous MatchNext Match

      9. 14. Exemption for re-exports. Previous MatchNext Match

      10. 15. Provision for extending or modifying exemptions. Previous MatchNext Match

      11. 16. Transitional exemptions. Previous MatchNext Match

      12. 17. Termination of transitional exemptions. Previous MatchNext Match

    2. Applications for, and grant and renewal of, licencesPrevious MatchNext Match

      1. 18. Application for licence. Previous MatchNext Match

      2. 19. Factors relevant to determination of application for licence. Previous MatchNext Match

      3. 20. Grant or refusal of licence. Previous MatchNext Match

      4. 21. Procedure on reference to appropriate committee Previous MatchNext Match

      5. 22. Procedure in other cases. Previous MatchNext Match

      6. 22A.Hearing before person appointedPrevious MatchNext Match

      7. 23. Special provisions as to effect of manufacturer’s licence. Previous MatchNext Match

      8. 24. Duration and renewal of licence. Previous MatchNext Match

    3. Licences of rightPrevious MatchNext Match

      1. 25. Entitlement to licence of right. Previous MatchNext Match

      2. 26. Scope of licence of right in different cases. Previous MatchNext Match

      3. 27. Proceedings on application for licence of right. Previous MatchNext Match

    4. Suspension, revocation and variation of licencesPrevious MatchNext Match

      1. 28. General power to suspend, revoke or vary licences. Previous MatchNext Match

      2. 29. Procedure where licensing authority propose to suspend, revoke or vary licence under s. 28.Previous MatchNext Match

      3. 30. Variation of licence on application of holder. Previous MatchNext Match

    5. Clinical trials and medicinal tests on animalsPrevious MatchNext Match

      1. 31. Clinical trials. Previous MatchNext Match

      2. 32. Medicinal tests on animals. Previous MatchNext Match

      3. 33. Exemptions in respect of medicinal tests on animals. Previous MatchNext Match

      4. 34. Restrictions as to animals on which medicinal tests have been carried out. Previous MatchNext Match

      5. 35. Supplementary provisions as to clinical trials and medicinal tests on animals.Previous MatchNext Match

      6. 36. Application for, and issue of, certificate. Previous MatchNext Match

      7. 37. Transitional provisions as to clinical trials and medicinal tests on animals. Previous MatchNext Match

      8. 38. Duration and renewal of certificate. Previous MatchNext Match

      9. 39. Suspension, revocation or variation of certificate. Previous MatchNext Match

    6. Medicated animal feeding stuffsPrevious MatchNext Match

      1. 40. Medicated animal feeding stuffs. Previous MatchNext Match

      2. 41–42.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Previous MatchNext Match

    7. Supplementary provisionsPrevious MatchNext Match

      1. 43. Extension of s. 7 to certain special circumstances. Previous MatchNext Match

      2. 44. Provision of information to licensing authority. Previous MatchNext Match

      3. 45. Offences under Part II. Previous MatchNext Match

      4. 46. Special defences under s. 45. Previous MatchNext Match

      5. 47. Standard provisions for licences Previous MatchNext Match

      6. 48. Postponement of restrictions in relation to exports. Previous MatchNext Match

      7. 49. Special provisions in respect of exporting certain products. Previous MatchNext Match

      8. 49A. Special provisions in respect of exporting certain products to member States Previous MatchNext Match

      9. 49B. Special provisions in respect of exporting certain products to EEA State s Previous MatchNext Match

      10. 50. Certificates for exporters of medicinal products. Previous MatchNext Match

  4. Part III Further Provisions relating to Dealings with Medicinal ProductsPrevious MatchNext Match

    1. Provisions as to sale or supply of medicinal productsPrevious MatchNext Match

      1. 51. General sale lists. Previous MatchNext Match

      2. 52. Sale or supply of medicinal products not on general sale list. Previous MatchNext Match

      3. 53. Sale or supply of medicinal products on general sale list. Previous MatchNext Match

      4. 54. Sale of medicinal products from automatic machines.Previous MatchNext Match

    2. Exemptions from sections 52 and 53Previous MatchNext Match

      1. 55. Exemptions for doctors and dentists etcPrevious MatchNext Match

      2. 56. Exemptions in respect of herbal remedies.Previous MatchNext Match

      3. 57. Power to extend or modify exemptions. Previous MatchNext Match

    3. Additional provisionsPrevious MatchNext Match

      1. 58. Medicinal products on prescription only. Previous MatchNext Match

      2. 58A. Requirement to specify certain products as prescription-only productsPrevious MatchNext Match

      3. 58B. Requirement to specify certain products for veterinary use as prescription-only products.Previous MatchNext Match

      4. 59. Special provisions in relation to new medicinal products.Previous MatchNext Match

      5. 60. Restricted sale, supply and administration of certain medicinal products.Previous MatchNext Match

      6. 61. Special restrictions on persons to be supplied with medicinal products. Previous MatchNext Match

      7. 62. Prohibition of sale or supply, or importation, of medicinal products of specified description .... Previous MatchNext Match

      8. 63. Adulteration of medicinal products. Previous MatchNext Match

      9. 64. Protection of purchasers of medicinal products. Previous MatchNext Match

      10. 65. Compliance with standards specified in monographs in certain publications. Previous MatchNext Match

      11. 66. Further powers to regulate dealings with medicinal products. Previous MatchNext Match

    4. Offences, and provision for disqualificationPrevious MatchNext Match

      1. 67. Offences under Part III. Previous MatchNext Match

      2. 67A.Defence to offence of contravening section 63(a) or (b): product not sold or suppliedPrevious MatchNext Match

      3. 67B.Defence to offence of contravening section 63(a) or (b): product sold or suppliedPrevious MatchNext Match

      4. 67C.Defence to offence of contravening section 64Previous MatchNext Match

      5. 67D.Defences under sections 67A, 67B and 67C: evidence etc.Previous MatchNext Match

      6. 67E.Sections 67A to 67D: “adulteration” and “registrant” Previous MatchNext Match

      7. 67F.Sections 67A to 67D: “relevant pharmacy service”Previous MatchNext Match

      8. 68. Disqualification on conviction of certain offences.Previous MatchNext Match

  5. Part IV PharmaciesPrevious MatchNext Match

    1. Persons lawfully conducting retail pharmacy businessPrevious MatchNext Match

      1. 69. General provisions.Previous MatchNext Match

      2. 70.Business carried on by individual pharmacist or by partners.Previous MatchNext Match

      3. 71.Business carried on by body corporatePrevious MatchNext Match

      4. 72. Representative of pharmacist in case of death or disability.Previous MatchNext Match

      5. 72A.The responsible pharmacistPrevious MatchNext Match

      6. 72AA.The superintendentPrevious MatchNext Match

      7. 72B.Sections 72A and 72AA: supplementaryPrevious MatchNext Match

      8. 73. Power to extend or modify conditions.Previous MatchNext Match

    2. Registration of pharmaciesPrevious MatchNext Match

      1. 74. Meaning of “registered pharmacy".Previous MatchNext Match

      2. 74A.Registration of premises: Great BritainPrevious MatchNext Match

      3. 74B.Conditions for registration: Great BritainPrevious MatchNext Match

      4. 74C.Supplementary provision in respect of registration of premises: Great BritainPrevious MatchNext Match

      5. 74D.Conditional registration: Great BritainPrevious MatchNext Match

      6. 74E.Supplementary provision in respect of conditional registration: Great BritainPrevious MatchNext Match

      7. 74F.Giving of notice by registrar: Great BritainPrevious MatchNext Match

      8. 74G.Voluntary removal from the register: Great BritainPrevious MatchNext Match

      9. 74H.(1) Subject to subsection (2), where a change occurs in...Previous MatchNext Match

      10. 74I.Supplementary provision in respect of change of ownership of retail pharmacy business: Great BritainPrevious MatchNext Match

      11. 74J.Temporary registration with regard to emergencies involving loss of human life or human illness etc.Previous MatchNext Match

      12. 74K.Temporary annotations with regard to emergencies involving loss of human life or human illness etc.Previous MatchNext Match

      13. 74L.Evidence of registration: Great BritainPrevious MatchNext Match

      14. 75. Registration of premises: Northern Ireland. Previous MatchNext Match

      15. 76. Supplementary provisions as to registration of premises: Northern Ireland.Previous MatchNext Match

      16. 77. Annual return of premises to registrar.Previous MatchNext Match

    3. Provisions as to use of certain titles, descriptions and emblemsPrevious MatchNext Match

      1. 78. Restrictions on use of titles, descriptions and emblems.Previous MatchNext Match

      2. 79. Provision for modifying or extending restrictions under s. 78.Previous MatchNext Match

    4. Disqualification, and removal of premises from registerPrevious MatchNext Match

      1. 80. Power for relevant disciplinary committee to disqualify and direct removal from register.Previous MatchNext Match

      2. 81. Grounds for disqualification in certain cases.Previous MatchNext Match

      3. 82. Procedure relating to disqualification.Previous MatchNext Match

      4. 82A.Interim measuresPrevious MatchNext Match

      5. 83. Revocation of disqualification.Previous MatchNext Match

    5. Supplementary provisionsPrevious MatchNext Match

      1. 84. Offences under Part IV.Previous MatchNext Match

      2. 84A.Rules by the General Pharmaceutical CouncilPrevious MatchNext Match

  6. Part V Containers, Packages and Identification of Medicinal ProductsPrevious MatchNext Match

    1. 85. Labelling and marking of containers and packages. Previous MatchNext Match

    2. 86. Leaflets. Previous MatchNext Match

    3. 87. Requirements as to containers. Previous MatchNext Match

    4. 88. Distinctive colours, shapes and markings of medicinal products. Previous MatchNext Match

    5. 89. Display of information on automatic machines. Previous MatchNext Match

    6. 90. Provisions as to medicated animal feeding stuffs. Previous MatchNext Match

    7. 91. Offences under Part V, and supplementary provisions. Previous MatchNext Match

  7. Part VI Promotion of Sales of Medicinal ProductsPrevious MatchNext Match

    1. 92. Scope of Part VI. Previous MatchNext Match

    2. 93. False or misleading advertisements and representations.Previous MatchNext Match

    3. 94. Advertisements requiring consent of holder of product licence.Previous MatchNext Match

    4. 95. Powers to regulate advertisements and representations. Previous MatchNext Match

    5. 96. Advertisements and representations directed to practitioners.Previous MatchNext Match

    6. 97. Power for licensing authority to require copies of advertisements.Previous MatchNext Match

  8. Part VII British Pharmacopoeia and Other PublicationsPrevious MatchNext Match

    1. 98. British Pharmacopoeia and Other PublicationsPrevious MatchNext Match

    2. 99. New editions of British Pharmacopoeia, and other compendia.Previous MatchNext Match

    3. 100. Lists of names.Previous MatchNext Match

    4. 101. Other publications.Previous MatchNext Match

    5. 102. Supplementary provisions.Previous MatchNext Match

    6. 103. Construction of references to specified publications.Previous MatchNext Match

  9. Part VIII Miscellaneous and Supplementary ProvisionsPrevious MatchNext Match

    1. 104. Application of the 2012 Regulations to certain articles and substances. Previous MatchNext Match

    2. 105. Application of the 2012 Regulations to certain other substances which are not medicinal products. Previous MatchNext Match

    3. 106. Extension of references to carrying on business. Previous MatchNext Match

    4. 107. Validity of decisions and proceedings relating thereto.Previous MatchNext Match

    5. 108. Enforcement in England and Wales. Previous MatchNext Match

    6. 109. Enforcement in Scotland. Previous MatchNext Match

    7. 110. Enforcement in Northern Ireland. Previous MatchNext Match

    8. 111. Rights of entry. Previous MatchNext Match

    9. 112. Power to inspect, take samples and seize goods and documents. Previous MatchNext Match

    10. 113. Application of sampling procedure to substance or article seized under s. 112. Previous MatchNext Match

    11. 114. Supplementary provisions as to rights of entry and related rights. Previous MatchNext Match

    12. 115. Analysis of samples in other cases. Previous MatchNext Match

    13. 115A. Facilities for microbiological examinations. Previous MatchNext Match

    14. 116. Liability to forfeiture under Customs and Excise Act 1952. Previous MatchNext Match

    15. 117. Special enforcement and sampling provisions relating to animal feeding stuffs. Previous MatchNext Match

    16. 118. Restrictions on disclosure of information. Previous MatchNext Match

    17. 119. Protection for officers of enforcement authorities. Previous MatchNext Match

    18. 120. Compensation for loss of employment or loss or diminution of emoluments. Previous MatchNext Match

    19. 121. Contravention due to default of other person. Previous MatchNext Match

    20. 122. Warranty as defence. Previous MatchNext Match

    21. 123. Offences in relation to warranties and certificates of analysis. Previous MatchNext Match

    22. 124. Offences by bodies corporate. Previous MatchNext Match

    23. 125. Prosecutions. Previous MatchNext Match

    24. 126. Presumptions. Previous MatchNext Match

    25. 127. Service of documents. Previous MatchNext Match

    26. 128. Financial provisions. Previous MatchNext Match

    27. 129. Orders and regulations. Previous MatchNext Match

    28. 130. Meaning of “medicinal product" and related expressions. Previous MatchNext Match

    29. 131. Meaning of “wholesale dealing", “retail sale" and related expressions. Previous MatchNext Match

    30. 132. General interpretation provisions. Previous MatchNext Match

    31. 133. General provisions as to operation of Act. Previous MatchNext Match

    32. 134. Special provisions as to Northern Ireland. Previous MatchNext Match

    33. 135. Minor and consequential amendments and repeals. Previous MatchNext Match

    34. 136. Short title, extent and commencement. Previous MatchNext Match

  10. SCHEDULES

    1. SCHEDULE 1Previous MatchNext Match

      Provisions Relating to Medicines Commission and CommitteesPrevious MatchNext Match

      1. 1.The Ministers may make provision by regulations with respect to...Previous MatchNext Match

      2. 2.The Ministers shall provide the Commission and each committee established...Previous MatchNext Match

      3. 3.The validity of any proceedings of the Commission or of...Previous MatchNext Match

      4. 4.The Commission and any such committee or sub-committee shall have...Previous MatchNext Match

      5. 5.The Ministers may pay to the members of the Commission...Previous MatchNext Match

      6. 6.The Ministers shall defray any expenses incurred with their approval...Previous MatchNext Match

      7. 7.Neither the Commission nor any such committee or sub-committee shall...Previous MatchNext Match

    2. SCHEDULE 1APrevious MatchNext Match

      PROVISIONS RELATING TO COMMISSION AND COMMITTEESPrevious MatchNext Match

      1. 1.InterpretationPrevious MatchNext Match

      2. 2.Co-opted membersPrevious MatchNext Match

      3. 3.Expert Advisory GroupsPrevious MatchNext Match

      4. 4.Appointment by the Commission of Expert Advisory GroupsPrevious MatchNext Match

      5. 5.Delegation of functions by Advisory BodiesPrevious MatchNext Match

      6. 6.Terms of office of membersPrevious MatchNext Match

      7. 7.Staff, premises and facilitiesPrevious MatchNext Match

      8. 8.Validity of proceedingsPrevious MatchNext Match

      9. 9.ProceedingsPrevious MatchNext Match

      10. 10.Remuneration and expenses of membersPrevious MatchNext Match

      11. 11.Expenses of Advisory Bodies and Expert Advisory GroupsPrevious MatchNext Match

      12. 12.StatusPrevious MatchNext Match

    3. SCHEDULE 2Previous MatchNext Match

      SUSPENSION, REVOCATION OR VARIATION OF LICENCEPrevious MatchNext Match

      1. Procedure on consultation with appropriate committeePrevious MatchNext Match

        1. 1.SUSPENSION, REVOCATION OR VARIATION OF LICENCEPrevious MatchNext Match

        2. 2.SUSPENSION, REVOCATION OR VARIATION OF LICENCEPrevious MatchNext Match

        3. 3.SUSPENSION, REVOCATION OR VARIATION OF LICENCEPrevious MatchNext Match

        4. 4.SUSPENSION, REVOCATION OR VARIATION OF LICENCEPrevious MatchNext Match

        5. 5.SUSPENSION, REVOCATION OR VARIATION OF LICENCEPrevious MatchNext Match

      2. Procedure in other casesPrevious MatchNext Match

        1. 6.SUSPENSION, REVOCATION OR VARIATION OF LICENCEPrevious MatchNext Match

      3. Hearing before person appointedPrevious MatchNext Match

        1. 7.SUSPENSION, REVOCATION OR VARIATION OF LICENCEPrevious MatchNext Match

      4. Procedure in cases of urgencyPrevious MatchNext Match

        1. 8.SUSPENSION, REVOCATION OR VARIATION OF LICENCEPrevious MatchNext Match

        2. 9.SUSPENSION, REVOCATION OR VARIATION OF LICENCEPrevious MatchNext Match

        3. 10.SUSPENSION, REVOCATION OR VARIATION OF LICENCEPrevious MatchNext Match

        4. 11.SUSPENSION, REVOCATION OR VARIATION OF LICENCEPrevious MatchNext Match

      5. InterpretationPrevious MatchNext Match

        1. 12.SUSPENSION, REVOCATION OR VARIATION OF LICENCEPrevious MatchNext Match

    4. SCHEDULE 3Previous MatchNext Match

      SAMPLINGPrevious MatchNext Match

      1. IntroductoryPrevious MatchNext Match

        1. 1.(1) The provisions of this Schedule shall have effect where...Previous MatchNext Match

      2. Division of samplePrevious MatchNext Match

        1. 2.The sampling officer shall forthwith divide the sample into three...Previous MatchNext Match

        2. 3.If the sample was purchased by the sampling officer, otherwise...Previous MatchNext Match

        3. 4.If the sampling officer obtained the sample from an automatic...Previous MatchNext Match

        4. 5.If the sample is of goods consigned from outside the...Previous MatchNext Match

        5. 6.If, in a case not falling within any of paragraphs...Previous MatchNext Match

        6. 7.If, in a case not falling within any of paragraphs...Previous MatchNext Match

        7. 8.In any case not falling within any of paragraphs 3...Previous MatchNext Match

        8. 9.In every case falling within any of paragraphs 3, 4,...Previous MatchNext Match

        9. 10.Of the remaining parts of the sample into which the...Previous MatchNext Match

        10. 11.Where a sample consists of substances or articles enclosed in...Previous MatchNext Match

        11. 12.Section 127 of this Act shall have effect in relation...Previous MatchNext Match

        12. 13.If after reasonable inquiry the sampling officer is unable to...Previous MatchNext Match

      3. Notice to person named on containerPrevious MatchNext Match

        1. 14.(1) Where it appears to the sampling officer that a...Previous MatchNext Match

      4. Analysis or other examination of samplePrevious MatchNext Match

        1. 15.If the sampling officer decides to submit the sample for...Previous MatchNext Match

        2. 16.Where the relevant enforcement authority is a Minister or the...Previous MatchNext Match

        3. 17.Any such arrangements as are mentioned in paragraph 15(b) or...Previous MatchNext Match

        4. 18.(1) Subject to the following sub-paragraph, the person to whom...Previous MatchNext Match

        5. 19.(1) A public analyst who has analysed a sample submitted...Previous MatchNext Match

        6. 20.(1) Any person to whom, in accordance with paragraphs 2...Previous MatchNext Match

      5. Provisions as to evidencePrevious MatchNext Match

        1. 21.In any proceedings for an offence under this Act a...Previous MatchNext Match

        2. 22.In any proceedings for an offence under this Act a...Previous MatchNext Match

        3. 23.(1) If in any such proceedings before a magistrates’ court...Previous MatchNext Match

      6. Analysis under direction of courtPrevious MatchNext Match

        1. 24.(1) In any proceedings for an offence under this Act,...Previous MatchNext Match

        2. 25.The costs of any analysis or examination under paragraph 24...Previous MatchNext Match

      7. Proof by written statementPrevious MatchNext Match

        1. 26.In relation to England and Wales section 9 of the...Previous MatchNext Match

      8. Power to modify sampling provisionsPrevious MatchNext Match

        1. 27.The Ministers may by order provide that, in relation to...Previous MatchNext Match

      9. Payment for sample taken under compulsory powersPrevious MatchNext Match

        1. 28.(1) Where a sampling officer takes a sample in the...Previous MatchNext Match

      10. Application of s. 64 to samplesPrevious MatchNext Match

        1. 29.Where a medicinal product is taken as a sample by...Previous MatchNext Match

    5. SCHEDULE 4Previous MatchNext Match

      Provisions relating to Northern Ireland Previous MatchNext Match

      1. 1.(1) the Minister for Health, Social Services and Public Safety...Previous MatchNext Match

      2. 2. Provisions relating to Northern Ireland Previous MatchNext Match

      3. 3. Provisions relating to Northern Ireland Previous MatchNext Match

      4. 4. Provisions relating to Northern Ireland Previous MatchNext Match

      5. 5. Provisions relating to Northern Ireland Previous MatchNext Match

      6. 6.The appropriate Northern Ireland Minister may in relation to Northern...Previous MatchNext Match

      7. 7.Where an order is made by virtue of paragraph 6...Previous MatchNext Match

      8. 8.Every order or regulation under this Act made by the...Previous MatchNext Match

      9. 9.In this Schedule “the appropriate Northern Ireland Minister”— Previous MatchNext Match

      10. 10.In this Act any reference to the Department of Health,...Previous MatchNext Match

      11. 11.The Statutory Rules (Northern Ireland) Order 1979, except article 5(2)(a)...Previous MatchNext Match

    6. SCHEDULE 5Previous MatchNext Match

      Amendments of Enactments of Parliament of United Kingdom.Previous MatchNext Match

      1. 1.The Venereal Disease Act 1917 (c. 21). Previous MatchNext Match

      2. 2, 9.. . . . . . . . . ....Previous MatchNext Match

      3. 10.The Cancer Act 1939 (c. 13.)Previous MatchNext Match

      4. 11.. . . . . . . . . ....Previous MatchNext Match

      5. 12.. . . . . . . . . ....Previous MatchNext Match

      6. 13.. Previous MatchNext Match

      7. 14, 15.. . . . . . . . . ....Previous MatchNext Match

      8. 16.The Trade Descriptions Act 1968 (c. 29). Previous MatchNext Match

      9. 17.In section 22, in subsection (2), after the words “the...Previous MatchNext Match

    7. SCHEDULE 6Previous MatchNext Match

      Enactments of Parliament of United Kingdom Repealed.Previous MatchNext Match

    8. SCHEDULE 7Previous MatchNext Match

      1. . . . . . . . . . ....

    9. SCHEDULE 8Previous MatchNext Match

      Enactments of Parliament of Northern Ireland Repealed.Previous MatchNext Match

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