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Revised Statute from The UK Statute Law Database

Medicines Act 1968 (c.67)

This version of this statute is extracted from the UK Statute Law Database (SLD). It is not necessarily in the form in which it was originally enacted but is a revised version, which means that any subsequent amendments to the text and other effects are incorporated with annotations.

There are effects on this legislation that have not yet been applied to SLD for the following years: 2003, 2004, 2005, 2006, 2007, 2008 and 2009. See the Tables of Legislative effects and the Update status of legislation page on the SLD website.

Royal arms

Medicines Act 1968

1968 CHAPTER 67

Contents

Go to Preamble

  1. Part I

    Administration

    1. 1. Ministers responsible for administration of Act

    2. 2. Establishment of Medicines Commission

    3. 3. General functions of Commission

    4. 4. Establishment of committees

    5. 5. Supplementary provisions as to Commission and committees

  2. Part II

    Licences and Certificates Relating to Medicinal Products

    1. General provisions and exemptions

      1. 6. The licensing authority

      2. 7. General provisions as to dealing with medicinal products

      3. 8. Provisions as to manufacture and wholesale dealing

      4. 9. Exemptions for doctors, dentists, veterinary surgeons and veterinary practitioners

      5. 10. Exemptions for pharmacists

      6. 11. Exemption for nurses and midwives

      7. 12. Exemptions in respect of herbal remedies

      8. 13. Exemptions for imports

      9. 14. Exemption for re-exports

      10. 15. Provision for extending or modifying exemptions

      11. 16. Transitional exemptions

      12. 17. Termination of transitional exemptions

    2. Applications for, and grant and renewal of, licences

      1. 18. Application for licence

      2. 19. Factors relevant to determination of application for licence

      3. 20. Grant or refusal of licence

      4. 21. Procedure on reference to appropriate committee or Commission

      5. 22. Procedure in other cases

      6. 23. Special provisions as to effect of manufacturer’s licence

      7. 24. Duration and renewal of licence

    3. Licences of right

      1. 25. Entitlement to licence of right

      2. 26. Scope of licence of right in different cases

      3. 27. Proceedings on application for licence of right

    4. Suspension, revocation and variation of licences

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

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

      3. 30. Variation of licence on application of holder

    5. Clinical trials and medicinal tests on animals

      1. 31. Clinical trials

      2. 32. Medicinal tests on animals

      3. 33. Exemptions in respect of medicinal tests on animals

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

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

      6. 36. Application for, and issue of, certificate

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

      8. 38. Duration and renewal of certificate

      9. 39. Suspension, revocation or variation of certificate

    6. Medicated animal feeding stuffs

      1. 40. Medicated animal feeding stuffs

      2. 41–42.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    7. Supplementary provisions

      1. 43. Extension of s. 7 to certain special circumstances

      2. 44. Provision of information to licensing authority

      3. 45. Offences under Part II

      4. 46. Special defences under s. 45

      5. 47. Standard provisions for licences or certificates

      6. 48. Postponement of restrictions in relation to exports

      7. 49. Special provisions in respect of exporting certain products

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

      9. 50. Certificates for exporters of medicinal products

  3. Part III

    Further Provisions relating to Dealings with Medicinal Products

    1. Provisions as to sale or supply of medicinal products

      1. 51. General sale lists

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

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

      4. 54. Sale of medicinal products from automatic machines

    2. Exemptions from sections 52 and 53

      1. 55. Exemptions for doctors, dentists, veterinary surgeons and veterinary practitioners

      2. 56. Exemptions in respect of herbal remedies

      3. 57. Power to extend or modify exemptions

    3. Additional provisions

      1. 58. Medicinal products on prescription only

      2. 58A. Requirement to specify certain products for human use as prescription-only products

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

      4. 59. Special provisions in relation to new medicinal products

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

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

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

      8. 63. Adulteration of medicinal products

      9. 64. Protection of purchasers of medicinal products

      10. 65. Compliance with standards specified in monographs in certain publications

      11. 66. Further powers to regulate dealings with medicinal products

    4. Offences, and provision for disqualification

      1. 67. Offences under Part III

      2. 68. Disqualification on conviction of certain offences

  4. Part IV

    Pharmacies

    1. Persons lawfully conducting retail pharmacy business

      1. 69. General provisions

      2. 70. Business carried on by individual pharmacist or by partners

      3. 71. Bodies corporate

      4. 72. Representative of pharmacist in case of death or disability

      5. 73. Power to extend or modify conditions

    2. Registration of pharmacies

      1. 74. Meaning of “registered pharmacy"

      2. 75. Registration of premises

      3. 76. Supplementary provisions as to registration of premises

      4. 77. Annual return of premises to registrar

    3. Provisions as to use of certain titles, descriptions and emblems

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

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

    4. Disqualification, and removal of premises from register

      1. 80. Power for Statutory Committee to disqualify and direct removal from register

      2. 81. Grounds for disqualification in certain cases

      3. 82. Procedure relating to disqualification

      4. 83. Revocation of disqualification

    5. Supplementary provisions

      1. 84. Offences under Part IV

  5. Part V

    Containers, Packages and Identification of Medicinal Products

    1. 85. Labelling and marking of containers and packages

    2. 86. Leaflets

    3. 87. Requirements as to containers

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

    5. 89. Display of information on automatic machines

    6. 90. Provisions as to medicated animal feeding stuffs

    7. 91. Offences under Part V, and supplementary provisions

  6. Part VI

    Promotion of Sales of Medicinal Products

    1. 92. Scope of Part VI

    2. 93. False or misleading advertisements and representations

    3. 94. Advertisements requiring consent of holder of product licence

    4. 95. Powers to regulate advertisements and representations

    5. 96. Advertisements and representations directed to practitioners

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

  7. Part VII

    British Pharmacopoeia and Other Publications

    1. 98.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

    3. 100. Lists of names

    4. 101. Other publications

    5. 102. Supplementary provisions

    6. 103. Construction of references to specified publications

  8. Part VIII

    Miscellaneous and Supplementary Provisions

    1. 104. Application of Act to certain articles and substances

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

    3. 106. Extension of references to carrying on business

    4. 107. Validity of decisions and proceedings relating thereto

    5. 108. Enforcement in England and Wales

    6. 109. Enforcement in Scotland

    7. 110. Enforcement in Northern Ireland

    8. 111. Rights of entry

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

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

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

    12. 115. Analysis of samples in other cases

    13. 115A. Facilities for microbiological examinations

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

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

    16. 118. Restrictions on disclosure of information

    17. 119. Protection for officers of enforcement authorities

    18. 120. Compensation for loss of employment or loss or diminution of emoluments

    19. 121. Contravention due to default of other person

    20. 122. Warranty as defence

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

    22. 124. Offences by bodies corporate

    23. 125. Prosecutions

    24. 126. Presumptions

    25. 127. Service of documents

    26. 128. Financial provisions

    27. 129. Orders and regulations

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

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

    30. 132. General interpretation provisions

    31. 133. General provisions as to operation of Act

    32. 134. Special provisions as to Northern Ireland

    33. 135. Minor and consequential amendments and repeals

    34. 136. Short title, extent and commencement

  9. SCHEDULE 1

    Provisions Relating to Medicines Commission and Committees

  10. SCHEDULE 2

    Suspension, Revocation or Variation of Licence

  11. SCHEDULE 3

    SAMPLING

  12. SCHEDULE 4

    Provisions relating to Northern Ireland

  13. SCHEDULE 5

    Amendments of Enactments of Parliament of United Kingdom

  14. SCHEDULE 6

    Enactments of Parliament of United Kingdom Repealed

  15. SCHEDULE 7

  16. SCHEDULE 8

    Enactments of Parliament of Northern Ireland Repealed

An Act to make new provision with respect to medicinal products and related matters, and for purposes connected therewith.

[25th October 1968]

Annotations:

Modifications etc. (not altering text)

C1References to Ministers of Northern Ireland to be construed as references to heads of Northern Ireland departments: Northern Ireland Constitution Act 1973 (c. 36), Sch. 5 para. 7

C2Functions of Ministry of Home Affairs for Northern Ireland transferred to Department of Health and Social Services for Northern Ireland by S.R. & O. (N.I.) 1973 No. 504, art. 5, Sch. 2 Pt. I

C3Functions exercisable by Ministers jointly under this Act (except s. 108(4)(7) now exercisable by those Ministers and Secretary of State for Wales jointly: S.I. 1978/272, art. 2(3), Sch. 1; references to Minister of Agriculture, Fisheries and Food amended (W.): ibid., art. 11(6)

C4Act restricted by S.I. 1985/273, reg. 3(3)

C5Act amended (N.I.) (1.4.1992) by S.I. 1991/194 (N.I. 1), art. 7(2), Sch. 2 para. 5(1); S.R. 1991/131, art. 2(e), Sch. Pt. III

C6Certain provisions of the Act extended and modified (14.2.1994) by S.I. 1994/105, reg. 19, Sch. 4

C7Act excluded in part (6.5.1998) by S.I. 1998/1046, reg. 43

Act excluded in part (6.5.1998) by S.I. 1998/1047, reg. 74

Act excluded in part (2.8.1999) by S.I. 1999/1871, reg. 92(1)

C8Act: functions transferred (27.12.1999) by S.I. 1999/3142, art. 2(1)(2) (with art. 4)

Act: functions transferred (27.3.2002) by S.I. 2002/794, art. 3(1)(c)(2)(7) (with art. 6)

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