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Medicines Act 1968

1968 c. 67 · Enacted 25 October 1968 · Extends to United Kingdom

Not fully up to date. 15 changes made by later legislation have not yet been written into this text, which is revised to 1 October 2025.

See the changes not yet applied
ProvisionChangeMade by
s. 52amended (prosp.)Pharmacists (Fitness to Practise) Act 1997 s. 1 Sch. para. 2(adding1954 c 61 s. 13A-13M)
s. 10 23 31 33amended (prosp.)Pharmacists (Fitness to Practise) Act 1997 s. 1 Sch. para. 2(adding1954 c 61 s. 13A-13M)
s. 69(1A)(1B)added (prosp.)Pharmacists (Fitness to Practise) Act 1997 s. 1 Sch. para. 5(b)
s. 69(1)amended (prosp.)Pharmacists (Fitness to Practise) Act 1997 s. 1 Sch. para. 5(a)
s. 75(4)-(6)omittedThe Pharmacy (Premises Standards, Information Obligations, etc.) Order 2016 art. 8
s. 84BinsertedThe Pharmacy (Premises Standards, Information Obligations, etc.) Order 2016 art. 12
s. 10(4)words insertedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 4(2)(d)(i)
s. 10(4)words insertedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 4(2)(d)(ii)
s. 10(7A)words insertedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 4(2)(e)
s. 10(7B)words insertedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 4(2)(f)
s. 10AinsertedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 4(3)
s. 10(3)words substitutedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 4(2)(c)
s. 10(1A)(1B)insertedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 4(2)(b)
s. 10(1)words substitutedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 4(2)(a)(ii)
s. 10(1)words insertedThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 art. 4(2)(a)(i)

C1C2C3C4C5C6C7C8An Act to make new provision with respect to medicinal products and related matters, and for purposes connected therewith.

[25th October 1968]C9C10C11

Annotations to the whole text

Modifications

C1

References 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

C2

Functions 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

C3

Functions 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)

C4

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

C5

Act 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

C6

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

C7

Act 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)

C8

Act: 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)

C9

Act excluded (30.10.2005) by The Veterinary Medicines Regulations 2005 (S.I. 2005/2745), reg. 44(1)

C10

Act amendment to earlier affecting provision SI 1994/3144 reg. 10 Sch. 4 para. 10(b) (1.10.2006) by The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 11(b) (with regs. 2(4), 3)

C11

Act amendment to earlier affecting provision SI 1994/3144 reg. 10 Sch. 4 para. 9(b) (1.10.2006) by The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 11(a) (with regs. 2(4), 3)

Contents

  1. Part I: Administration
  2. 1Ministers responsible for administration of Act.
  3. 2Establishment of Medicines Commission. Repealed
  4. 2AEstablishment of the Commission on Human Medicines Repealed
  5. 3Functions of the Commission Repealed
  6. 4Establishment of committees. Repealed
  7. 5Supplementary provisions as to Commission and committees. Repealed
  8. Part II: Licences and Certificates Relating to Medicinal Products
  9. General provisions and exemptions
  10. 6The licensing authority. Repealed
  11. 7General provisions as to dealing with medicinal products. Repealed
  12. 8Provisions as to manufacture and wholesale dealing. Repealed
  13. 9Exemptions for doctors and dentists Repealed
  14. 10Exemptions for pharmacists.
  15. 11Exemption for nurses and midwives. Repealed
  16. 12Exemptions in respect of herbal remedies. Repealed
  17. 13Exemptions for imports. Repealed
  18. 14Exemption for re-exports. Repealed
  19. 15Provision for extending or modifying exemptions.
  20. 16Transitional exemptions. Repealed
  21. 17Termination of transitional exemptions. Repealed
  22. Applications for, and grant and renewal of, licences
  23. 18Application for licence. Repealed
  24. 19Factors relevant to determination of application for licence. Repealed
  25. 20Grant or refusal of licence. Repealed
  26. 21Procedure on reference to appropriate committee Repealed
  27. 22Procedure in other cases. Repealed
  28. 22AHearing before person appointed Repealed
  29. 23Special provisions as to effect of manufacturer’s licence. Repealed
  30. 24Duration and renewal of licence. Repealed
  31. Licences of right
  32. 25Entitlement to licence of right. Repealed
  33. 26Scope of licence of right in different cases. Repealed
  34. 27Proceedings on application for licence of right. Repealed
  35. Suspension, revocation and variation of licences
  36. 28General power to suspend, revoke or vary licences. Repealed
  37. 29Procedure where licensing authority propose to suspend, revoke or vary licence under s. 28. Repealed
  38. 30Variation of licence on application of holder. Repealed
  39. Clinical trials and medicinal tests on animals
  40. 31Clinical trials. Repealed
  41. 32Medicinal tests on animals. Repealed
  42. 33Exemptions in respect of medicinal tests on animals. Repealed
  43. 34Restrictions as to animals on which medicinal tests have been carried out. Repealed
  44. 35Supplementary provisions as to clinical trials and medicinal tests on animals. Repealed
  45. 36Application for, and issue of, certificate. Repealed
  46. 37Transitional provisions as to clinical trials and medicinal tests on animals. Repealed
  47. 38Duration and renewal of certificate. Repealed
  48. 39Suspension, revocation or variation of certificate. Repealed
  49. Medicated animal feeding stuffs
  50. 40Medicated animal feeding stuffs. Repealed
  51. 41–42. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Repealed
  52. Supplementary provisions
  53. 43Extension of s. 7 to certain special circumstances. Repealed
  54. 44Provision of information to licensing authority. Repealed
  55. 45Offences under Part II. Repealed
  56. 46Special defences under s. 45. Repealed
  57. 47Standard provisions for licences Repealed
  58. 48Postponement of restrictions in relation to exports. Repealed
  59. 49Special provisions in respect of exporting certain products. Repealed
  60. 49ASpecial provisions in respect of exporting certain products to member States Repealed
  61. 49BSpecial provisions in respect of exporting certain products to EEA State s Repealed
  62. 50Certificates for exporters of medicinal products. Repealed
  63. Part III: Further Provisions relating to Dealings with Medicinal Products
  64. Provisions as to sale or supply of medicinal products
  65. 51General sale lists. Repealed
  66. 52Sale or supply of medicinal products not on general sale list. Repealed
  67. 53Sale or supply of medicinal products on general sale list. Repealed
  68. 54Sale of medicinal products from automatic machines. Repealed
  69. Exemptions from sections 52 and 53
  70. 55Exemptions for doctors and dentists etc Repealed
  71. 56Exemptions in respect of herbal remedies. Repealed
  72. 57Power to extend or modify exemptions. Repealed
  73. Additional provisions
  74. 58Medicinal products on prescription only.
  75. 58ARequirement to specify certain products as prescription-only products
  76. 58BRequirement to specify certain products for veterinary use as prescription-only products. Repealed
  77. 59Special provisions in relation to new medicinal products. Repealed
  78. 60Restricted sale, supply and administration of certain medicinal products. Repealed
  79. 61Special restrictions on persons to be supplied with medicinal products. Repealed
  80. 62Prohibition of sale or supply, or importation, of medicinal products of specified description ....
  81. 63Adulteration of medicinal products.
  82. 64Protection of purchasers of medicinal products.
  83. 65Compliance with standards specified in monographs in certain publications. Repealed
  84. 66Further powers to regulate dealings with medicinal products. Repealed
  85. Offences, and provision for disqualification
  86. 67Offences under Part III.
  87. 67ADefence to offence of contravening section 63(a) or (b): product not sold or supplied
  88. 67BDefence to offence of contravening section 63(a) or (b): product sold or supplied
  89. 67CDefence to offence of contravening section 64
  90. 67DDefences under sections 67A, 67B and 67C: evidence etc.
  91. 67ESections 67A to 67D: “adulteration” and “registrant”
  92. 67FSections 67A to 67D: “relevant pharmacy service”
  93. 68Disqualification on conviction of certain offences. Repealed
  94. Part IV: Pharmacies
  95. Persons lawfully conducting retail pharmacy business
  96. 69General provisions.
  97. 70Business carried on by individual pharmacist or by partners.
  98. 71Business carried on by body corporate
  99. 72Representative of pharmacist in case of death or disability.
  100. 72AThe responsible pharmacist
  101. 72AAThe superintendent
  102. 72BSections 72A and 72AA: supplementary
  103. 73Power to extend or modify conditions.
  104. Registration of pharmacies
  105. 74Meaning of “registered pharmacy".
  106. 74ARegistration of premises: Great Britain
  107. 74BConditions for registration: Great Britain
  108. 74CSupplementary provision in respect of registration of premises: Great Britain
  109. 74DConditional registration: Great Britain
  110. 74ESupplementary provision in respect of conditional registration: Great Britain
  111. 74FGiving of notice by registrar: Great Britain
  112. 74GVoluntary removal from the register: Great Britain
  113. 74HSection 74H
  114. 74ISupplementary provision in respect of change of ownership of retail pharmacy business: Great Britain
  115. 74JTemporary registration with regard to emergencies involving loss of human life or human illness etc.
  116. 74KTemporary annotations with regard to emergencies involving loss of human life or human illness etc.
  117. 74LEvidence of registration: Great Britain
  118. 75Registration of premises: Northern Ireland.
  119. 76Supplementary provisions as to registration of premises: Northern Ireland.
  120. 77Annual return of premises to registrar.
  121. Provisions as to use of certain titles, descriptions and emblems
  122. 78Restrictions on use of titles, descriptions and emblems.
  123. 79Provision for modifying or extending restrictions under s. 78.
  124. Disqualification, and removal of premises from register
  125. 80Power for relevant disciplinary committee to disqualify and direct removal from register.
  126. 81Grounds for disqualification in certain cases.
  127. 82Procedure relating to disqualification.
  128. 82AInterim measures
  129. 83Revocation of disqualification.
  130. Supplementary provisions
  131. 84Offences under Part IV.
  132. 84ARules by the General Pharmaceutical Council
  133. Part V: Containers, Packages and Identification of Medicinal Products
  134. 85Labelling and marking of containers and packages. Repealed
  135. 86Leaflets. Repealed
  136. 87Requirements as to containers.
  137. 88Distinctive colours, shapes and markings of medicinal products.
  138. 89Display of information on automatic machines. Repealed
  139. 90Provisions as to medicated animal feeding stuffs. Repealed
  140. 91Offences under Part V, and supplementary provisions.
  141. Part VI: Promotion of Sales of Medicinal Products
  142. 92Scope of Part VI. Repealed
  143. 93False or misleading advertisements and representations. Repealed
  144. 94Advertisements requiring consent of holder of product licence. Repealed
  145. 95Powers to regulate advertisements and representations. Repealed
  146. 96Advertisements and representations directed to practitioners. Repealed
  147. 97Power for licensing authority to require copies of advertisements. Repealed
  148. Part VII: British Pharmacopoeia and Other Publications
  149. 98. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Repealed
  150. 99New editions of British Pharmacopoeia, and other compendia. Repealed
  151. 100Lists of names. Repealed
  152. 101Other publications. Repealed
  153. 102Supplementary provisions. Repealed
  154. 103Construction of references to specified publications. Repealed
  155. Part VIII: Miscellaneous and Supplementary Provisions
  156. 104Application of the 2012 Regulations to certain articles and substances.
  157. 105Application of the 2012 Regulations to certain other substances which are not medicinal products.
  158. 106Extension of references to carrying on business.
  159. 107Validity of decisions and proceedings relating thereto.
  160. 108Enforcement in England and Wales.
  161. 109Enforcement in Scotland.
  162. 110Enforcement in Northern Ireland.
  163. 111Rights of entry.
  164. 112Power to inspect, take samples and seize goods and documents.
  165. 113Application of sampling procedure to substance or article seized under s. 112.
  166. 114Supplementary provisions as to rights of entry and related rights.
  167. 115Analysis of samples in other cases. Repealed
  168. 115AFacilities for microbiological examinations.
  169. 116Liability to forfeiture under Customs and Excise Act 1952. Repealed
  170. 117Special enforcement and sampling provisions relating to animal feeding stuffs. Repealed
  171. 118Restrictions on disclosure of information.
  172. 119Protection for officers of enforcement authorities.
  173. 120Compensation for loss of employment or loss or diminution of emoluments. Repealed
  174. 121Contravention due to default of other person.
  175. 122Warranty as defence.
  176. 123Offences in relation to warranties and certificates of analysis.
  177. 124Offences by bodies corporate.
  178. 125Prosecutions.
  179. 126Presumptions.
  180. 127Service of documents.
  181. 128Financial provisions.
  182. 129Orders and regulations.
  183. 130Meaning of “medicinal product" and related expressions.
  184. 131Meaning of “wholesale dealing", “retail sale" and related expressions. Repealed
  185. 132General interpretation provisions.
  186. 133General provisions as to operation of Act.
  187. 134Special provisions as to Northern Ireland.
  188. 135Minor and consequential amendments and repeals.
  189. 136Short title, extent and commencement.
  190. Schedule 1: Provisions Relating to Medicines Commission and Committees
  191. 1Paragraph 1 Repealed
  192. 2Paragraph 2 Repealed
  193. 3Paragraph 3 Repealed
  194. 4Paragraph 4 Repealed
  195. 5Paragraph 5 Repealed
  196. 6Paragraph 6 Repealed
  197. 7Paragraph 7 Repealed
  198. Schedule 1A: PROVISIONS RELATING TO COMMISSION AND COMMITTEES
  199. 1Interpretation Repealed
  200. 2Co-opted members Repealed
  201. 3Expert Advisory Groups Repealed
  202. 4Appointment by the Commission of Expert Advisory Groups Repealed
  203. 5Delegation of functions by Advisory Bodies Repealed
  204. 6Terms of office of members Repealed
  205. 7Staff, premises and facilities Repealed
  206. 8Validity of proceedings Repealed
  207. 9Proceedings Repealed
  208. 10Remuneration and expenses of members Repealed
  209. 11Expenses of Advisory Bodies and Expert Advisory Groups Repealed
  210. 12Status Repealed
  211. Schedule 2: SUSPENSION, REVOCATION OR VARIATION OF LICENCE
  212. Procedure on consultation with appropriate committee Repealed
  213. 1Paragraph 1 Repealed
  214. 2Paragraph 2 Repealed
  215. 3Paragraph 3 Repealed
  216. 4Paragraph 4 Repealed
  217. 5Paragraph 5 Repealed
  218. Procedure in other cases Repealed
  219. 6Paragraph 6 Repealed
  220. Hearing before person appointed Repealed
  221. 7Paragraph 7 Repealed
  222. Procedure in cases of urgency Repealed
  223. 8Paragraph 8 Repealed
  224. 9Paragraph 9 Repealed
  225. 10Paragraph 10 Repealed
  226. 11Paragraph 11 Repealed
  227. Interpretation Repealed
  228. 12Paragraph 12 Repealed
  229. Schedule 3: SAMPLING
  230. Introductory
  231. 1Paragraph 1
  232. Division of sample
  233. 2Paragraph 2
  234. 3Paragraph 3
  235. 4Paragraph 4
  236. 5Paragraph 5 Repealed
  237. 6Paragraph 6 Repealed
  238. 7Paragraph 7 Repealed
  239. 8Paragraph 8
  240. 9Paragraph 9
  241. 10Paragraph 10
  242. 11Paragraph 11
  243. 12Paragraph 12
  244. 13Paragraph 13
  245. Notice to person named on container
  246. 14Paragraph 14
  247. Analysis or other examination of sample
  248. 15Paragraph 15
  249. 16Paragraph 16
  250. 17Paragraph 17
  251. 18Paragraph 18
  252. 19Paragraph 19
  253. 20Paragraph 20
  254. Provisions as to evidence
  255. 21Paragraph 21
  256. 22Paragraph 22
  257. 23Paragraph 23
  258. Analysis under direction of court
  259. 24Paragraph 24
  260. 25Paragraph 25
  261. Proof by written statement
  262. 26Paragraph 26
  263. Power to modify sampling provisions
  264. 27Paragraph 27
  265. Payment for sample taken under compulsory powers
  266. 28Paragraph 28
  267. Application of s. 64 to samples
  268. 29Paragraph 29
  269. Schedule 4: Provisions relating to Northern Ireland
  270. 1Paragraph 1
  271. 2Paragraph 2 Repealed
  272. 3Paragraph 3 Repealed
  273. 4Paragraph 4 Repealed
  274. 5Paragraph 5 Repealed
  275. 6Paragraph 6
  276. 7Paragraph 7 Repealed
  277. 8Paragraph 8
  278. 9Paragraph 9
  279. 10Paragraph 10
  280. 11Paragraph 11
  281. Schedule 5: Amendments of Enactments of Parliament of United Kingdom.
  282. 1The Venereal Disease Act 1917 (c. 21). Repealed
  283. 2, 9Paragraph 2, 9 Repealed
  284. 10The Cancer Act 1939 (c. 13.)
  285. 11Paragraph 11 Repealed
  286. 12Paragraph 12 Repealed
  287. 13Paragraph 13 Repealed
  288. 14, 15Paragraph 14, 15 Repealed
  289. 16The Trade Descriptions Act 1968 (c. 29).
  290. 17Paragraph 17
  291. Schedule 6Enactments of Parliament of United Kingdom Repealed.
  292. Schedule 7Schedule 7
  293. Schedule 8Enactments of Parliament of Northern Ireland Repealed.