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The Medicines for Human Use (Clinical Trials) Regulations 2004

S.I. 2004/1031 · Made 31 March 2004 · Extends to United Kingdom

Not fully up to date. 4 changes made by later legislation have not yet been written into this text, which is revised to 28 April 2026.

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reg. 2(1)words insertedHuman Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) 2025 art. 11
reg. 37(2)(a)word omittedHuman Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) 2025 art. 6(2)(a)
reg. 37(2)(a)(ii)words insertedHuman Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) 2025 art. 6(2)(b)
reg. 37(3)-(10)insertedHuman Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) 2025 art. 6(3)

MEDICINES

Made 31st March 2004

Laid before Parliament 1st April 2004

Coming into force 1st May 2004

The Secretary of State, being a Minister designated M1 for the purposes of section 2(2) of the European Communities Act 1972 M2 in relation to medicinal products, in exercise of the powers conferred by the said section 2(2), and of all other powers enabling him in that behalf, hereby makes the following Regulations:

Annotations to the whole text

Marginal citations

M1

S.I. 1972/1811.

M2

1972 c. 68.

Contents

  1. Part 1: INTRODUCTORY PROVISIONS
  2. 1Citation and commencement
  3. 2Interpretation
  4. 2AList of countries for the purpose of the definition of “marketing authorization”
  5. 3Sponsor of a clinical trial
  6. 3ASponsor’s responsibility for the investigator’s brochure
  7. 3BInvestigator in a clinical trial
  8. 4Responsibility for functions under the Directive Repealed
  9. Part 2: ETHICS COMMITTEES
  10. 5United Kingdom Ethics Committees Authority
  11. 6Establishment and abolition of ethics committees
  12. 7Recognition of ethics committees Repealed
  13. 8Revocation of recognition Repealed
  14. 9Operation of ethics committees
  15. 10Other functions of the Authority
  16. Part 3: AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE OPINION
  17. 11Interpretation of Part 3
  18. 11ADefinition of notifiable trial
  19. 11BDefinition of Route B substantial modification
  20. 12Requirement for authorisation and ethics committee opinion
  21. 13Supply of investigational medicinal products for the purpose of clinical trials
  22. 14Request for authorisation to conduct a clinical trial
  23. 15Application for ethics committee opinion
  24. 16Request for approval and combined procedure
  25. 17Assessment of request for approval
  26. 18Approval procedure for clinical trials
  27. 18ARequest for further information regarding a request for approval
  28. 18BApproval procedure for amended requests for approval
  29. 18CApproval procedure time periods in special circumstances
  30. 19Clinical trials conducted in countries other than the United Kingdom
  31. 20Modifications to clinical trial approval
  32. 21Modifications by the licensing authority or the ethics committee
  33. 22Modifications by the sponsor
  34. 22AApproval procedure for substantial modifications
  35. 22BRequest for further information regarding proposed substantial modifications
  36. 22CApproval procedure for amended requests regarding substantial modifications
  37. 23Reference to the appropriate committee or the Medicines Commission
  38. 24Review and appeal relating to ethics committee opinion
  39. 25Transparency requirements
  40. 26Lapse of clinical trial approval
  41. 27Conclusion of clinical trial
  42. 27AInformation sharing
  43. 27BPublication of information
  44. Part 4: GOOD CLINICAL PRACTICE AND THE CONDUCT OF CLINICAL TRIALS
  45. 28Good clinical practice and protection of clinical trial participants
  46. 29Conduct of trial in accordance with clinical trial authorisation etc.
  47. 29ANotification of serious breaches
  48. 30Urgent safety measures
  49. 31Suspension or termination of clinical trial
  50. 31ATrial master file and archiving
  51. Part 5: PHARMACOVIGILANCE
  52. A32Record keeping
  53. 32Notification of adverse events
  54. 33Notification of suspected unexpected serious adverse reactions
  55. 34Clinical trials conducted in countries other than the United Kingdom
  56. 35Annual ... safety report
  57. Part 6: MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS
  58. 36Requirement for authorisation to manufacture or import investigational medicinal products
  59. 36AManufacture of MM investigational medicinal products
  60. 36BManufacture of POC investigational medicinal products
  61. 37Exemption for hospitals and health centres
  62. 37AExemption for radiopharmaceuticals used for diagnostic purposes
  63. 38Application for manufacturing authorisation
  64. 39Consideration of application for manufacturing authorisation
  65. 40Grant or refusal of manufacturing authorisation
  66. 41Application and effect of manufacturing authorisation
  67. 42Obligations of manufacturing authorisation holder
  68. 43Qualified persons
  69. 43AApproved country for import
  70. 44Variation of manufacturing authorisation
  71. 44AVariation of MM (IMP) master file
  72. 44BVariation of POC (IMP) master file
  73. 45Suspension and revocation of manufacturing authorisation
  74. Part 6A: NON-INVESTIGATIONAL MEDICINAL AND NON-MEDICINAL PRODUCTS
  75. 45ANon-investigational medicinal and non-medicinal products
  76. Part 7: LABELLING
  77. 46Labelling of investigational medicinal products
  78. 46ALabelling of non-investigational medicinal products
  79. 46BLabelling of certain POC investigational medicinal products
  80. Part 8: ENFORCEMENT AND RELATED PROVISIONS
  81. 47Application of enforcement provisions of the 2012 Regulations
  82. 48Infringement notices
  83. 49Offences
  84. 50False or misleading information
  85. 51Defence of due diligence
  86. 52Penalties
  87. Part 9: MISCELLANEOUS PROVISIONS
  88. 53Construction of references to specified publications
  89. 54Consequential and other amendments to enactments
  90. 55Revocations
  91. 56Transitional provisions
  92. 57Functions in relation to good clinical practice
  93. 58Detailed guidance
  94. Signature
  95. Schedule 1: CONDITIONS AND PRINCIPLES OF GOOD CLINICAL PRACTICE AND FOR THE PROTECTION OF CLINICAL TRIAL PARTICIPANTS
  96. Part 1: APPLICATION AND INTERPRETATION
  97. 1Paragraph 1
  98. 2Paragraph 2
  99. 3Paragraph 3
  100. Part 2: CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS
  101. 1Paragraph 1
  102. 2Paragraph 2
  103. 3Paragraph 3
  104. 4Paragraph 4
  105. Part 3: CONDITIONS WHICH APPLY IN RELATION TO AN ADULT ABLE TO CONSENT OR WHO HAS GIVEN CONSENT PRIOR TO THE ONSET OF INCAPACITY
  106. 1Paragraph 1
  107. 2Paragraph 2
  108. 3Paragraph 3
  109. 4Paragraph 4
  110. 5Paragraph 5
  111. Part 4: CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO A MINOR
  112. 1Conditions
  113. 2Paragraph 2
  114. 3Paragraph 3
  115. 4Paragraph 4
  116. 5Paragraph 5
  117. 6Paragraph 6
  118. 7Paragraph 7
  119. 8Paragraph 8
  120. 9Paragraph 9
  121. 10Paragraph 10
  122. 11Paragraph 11
  123. 12Paragraph 12
  124. 13Principles
  125. 14Paragraph 14
  126. 15Paragraph 15
  127. 16Paragraph 16
  128. Part 5: CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO AN INCAPACITATED ADULT
  129. 1Conditions
  130. 2Paragraph 2
  131. 3Paragraph 3
  132. 4Paragraph 4
  133. 5Paragraph 5
  134. 6Paragraph 6
  135. 7Paragraph 7
  136. 8Paragraph 8
  137. 9Paragraph 9
  138. 10Paragraph 10
  139. 11Paragraph 11
  140. 12Principles
  141. 13Paragraph 13
  142. 14Paragraph 14
  143. 15Paragraph 15
  144. Schedule 2: ADDITIONAL PROVISIONS RELATING TO ETHICS COMMITTEES Repealed
  145. 1Paragraph 1 Repealed
  146. 2Paragraph 2 Repealed
  147. 3Membership Repealed
  148. 4Paragraph 4 Repealed
  149. 5Paragraph 5 Repealed
  150. 6Paragraph 6 Repealed
  151. 7Deputies and co-opted members Repealed
  152. 8Paragraph 8 Repealed
  153. 9Paragraph 9 Repealed
  154. 10Expenses Repealed
  155. 11Paragraph 11 Repealed
  156. 12Paragraph 12 Repealed
  157. 13Paragraph 13 Repealed
  158. Schedule 3: PARTICULARS AND DOCUMENTS THAT MUST ACCOMPANY A REQUEST FOR APPROVAL, A MODIFICATION REQUEST AND A NOTIFICATION OF THE CONCLUSION OF A TRIAL
  159. Part A1: REQUEST FOR APPROVAL
  160. 1Paragraph 1
  161. 2Paragraph 2
  162. 3Paragraph 3
  163. 4Paragraph 4
  164. 5Paragraph 5
  165. Part 1: APPLICATION FOR ETHICS COMMITTEE OPINION Repealed
  166. 1Paragraph 1 Repealed
  167. 2Paragraph 2 Repealed
  168. 3Paragraph 3 Repealed
  169. Part 2: REQUEST FOR AUTHORISATION Repealed
  170. 1Paragraph 1 Repealed
  171. 2Paragraph 2 Repealed
  172. 3Paragraph 3 Repealed
  173. 4Paragraph 4 Repealed
  174. 5Paragraph 5 Repealed
  175. 6Paragraph 6 Repealed
  176. 7Paragraph 7 Repealed
  177. 8Paragraph 8 Repealed
  178. 9Paragraph 9 Repealed
  179. 10Paragraph 10 Repealed
  180. 11Paragraph 11 Repealed
  181. 12Paragraph 12 Repealed
  182. Part 3: MODIFICATION REQUEST
  183. 1Paragraph 1 Repealed
  184. 2Paragraph 2
  185. 3Paragraph 3
  186. 4Paragraph 4
  187. 5Paragraph 5
  188. 6Paragraph 6
  189. Part 4: NOTIFICATION OF CONCLUSION OF A CLINICAL TRIAL
  190. 1Paragraph 1 Repealed
  191. 2Paragraph 2
  192. 3Paragraph 3
  193. 4Paragraph 4
  194. 5Paragraph 5
  195. Schedule 4: APPEAL AGAINST UNFAVOURABLE ETHICS COMMITTEE OPINION
  196. 1Paragraph 1
  197. 2Paragraph 2
  198. 3Paragraph 3 Repealed
  199. 4Paragraph 4 Repealed
  200. 5Paragraph 5 Repealed
  201. 6Paragraph 6 Repealed
  202. Schedule 5: PROCEDURAL PROVISIONS RELATING TO THE REFUSAL OR AMENDMENT OF, OR IMPOSITION OF CONDITIONS RELATING TO, CLINICAL TRIAL AUTHORISATIONS AND THE SUSPENSION OR TERMINATION OF CLINICAL TRIALS
  203. 1Hearing before the appropriate committee
  204. 2Licensing authority decision
  205. 3Right to be heard by a person appointed
  206. 4Hearing before person appointed
  207. Schedule 6: PARTICULARS THAT MUST ACCOMPANY AN APPLICATION FOR A MANUFACTURING AUTHORISATION
  208. 1Paragraph 1
  209. 2Paragraph 2
  210. 3Paragraph 3
  211. 3AParagraph 3A
  212. 4Paragraph 4
  213. 5Paragraph 5
  214. 6Paragraph 6
  215. 7Paragraph 7
  216. 8Paragraph 8
  217. 9Paragraph 9
  218. 10Paragraph 10
  219. 11Paragraph 11
  220. Schedule 7: STANDARD PROVISIONS FOR MANUFACTURING AUTHORISATIONS
  221. Part 1: INTERPRETATION
  222. Paragraph
  223. Part 2: PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE MANUFACTURE OR ASSEMBLY OF INVESTIGATIONAL MEDICINAL PRODUCTS
  224. 1Paragraph 1
  225. 2Paragraph 2
  226. 2AParagraph 2A
  227. 2BParagraph 2B
  228. 3Paragraph 3
  229. 4Paragraph 4
  230. 5Paragraph 5
  231. 6Paragraph 6
  232. 6AParagraph 6A
  233. 6BParagraph 6B
  234. 7Paragraph 7
  235. 8Paragraph 8
  236. 9Paragraph 9
  237. 10Paragraph 10
  238. 11Paragraph 11
  239. 12Paragraph 12
  240. 13Paragraph 13
  241. 14Paragraph 14
  242. 14AParagraph 14A
  243. Part 2A: Manufacturing authorisation (MM)
  244. 14BParagraph 14B
  245. 14CParagraph 14C
  246. 14DParagraph 14D
  247. 14EParagraph 14E
  248. 14FParagraph 14F
  249. 14GParagraph 14G
  250. 14HParagraph 14H
  251. 14IParagraph 14I
  252. Part 2B: Manufacturing authorisation (POC)
  253. 14JParagraph 14J
  254. 14KParagraph 14K
  255. 14LParagraph 14L
  256. 14MParagraph 14M
  257. 14NParagraph 14N
  258. 14OParagraph 14O
  259. 14PParagraph 14P
  260. 14QParagraph 14Q
  261. Part 3: PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS
  262. 1Paragraph 1
  263. 2Paragraph 2
  264. 3Paragraph 3
  265. 4Paragraph 4
  266. 5Paragraph 5
  267. 6Paragraph 6
  268. 7Paragraph 7
  269. 8Paragraph 8
  270. 9Paragraph 9
  271. 9AParagraph 9A
  272. Schedule 8: PROCEDURAL PROVISIONS RELATING TO PROPOSALS TO GRANT, REFUSE TO GRANT, VARY, SUSPEND OR REVOKE MANUFACTURING AUTHORISATIONS
  273. 1Paragraph 1
  274. 2Paragraph 2
  275. 3Paragraph 3
  276. 4Paragraph 4
  277. 5Paragraph 5
  278. 6Paragraph 6
  279. Schedule 9: MODIFICATIONS OF THE ENFORCEMENT PROVISIONS OF THE 2012 REGULATIONS SUBJECT TO WHICH THOSE PROVISIONS ARE APPLIED FOR THE PURPOSES OF THESE REGULATIONS
  280. 1Paragraph 1
  281. 2Paragraph 2
  282. 2Paragraph 2
  283. 3Paragraph 3
  284. 4Paragraph 4
  285. 5Paragraph 5
  286. Schedule 10: CONSEQUENTIAL AND OTHER AMENDMENTS OF ENACTMENTS
  287. Part 1: ACTS OF PARLIAMENT
  288. 1The Act
  289. 2Paragraph 2
  290. 3Paragraph 3
  291. 4Paragraph 4
  292. 5Paragraph 5
  293. 6Paragraph 6
  294. 7Paragraph 7
  295. 8Paragraph 8
  296. 9Paragraph 9
  297. 10Paragraph 10
  298. 11Paragraph 11
  299. 12Paragraph 12
  300. 13Paragraph 13
  301. 14Paragraph 14
  302. 15Paragraph 15 Repealed
  303. 16Paragraph 16
  304. 17Paragraph 17
  305. 18Paragraph 18
  306. 19Paragraph 19
  307. 20Paragraph 20
  308. 21Paragraph 21
  309. Part 2: ORDERS AND REGULATIONS
  310. 1Paragraph 1
  311. 2Paragraph 2
  312. 3Paragraph 3
  313. 4Paragraph 4
  314. 5Paragraph 5
  315. 6Paragraph 6
  316. 7Paragraph 7
  317. 8Paragraph 8
  318. 9Paragraph 9
  319. 10Paragraph 10
  320. 11Paragraph 11
  321. 12Paragraph 12
  322. 13Paragraph 13
  323. 14Paragraph 14
  324. 15Paragraph 15
  325. 16Paragraph 16
  326. 17Paragraph 17
  327. 18Paragraph 18
  328. Schedule 11REVOCATIONS
  329. Schedule 12: TRANSITIONAL PROVISIONS
  330. 1Paragraph 1
  331. 2Paragraph 2
  332. 3Clinical trial exemptions or notifications prior to 1st May 2004
  333. 4Paragraph 4
  334. 5Paragraph 5
  335. 6Paragraph 6
  336. 7Paragraph 7
  337. Schedule 13: Transitional provisions relating to EU Exit
  338. 1List of countries for the purpose of the definition of “marketing authorization” on IP completion day (regulation 2A)
  339. 2List of countries where a sponsor of a clinical trial, or their legal representative, may be established on IP completion day (regulation 3(11A))
  340. 3Import of investigational medicinal products into Great Britain from EEA States during the transitional period
  341. 4Approved country for import list on IP completion day (regulation 43A)
  342. Schedule 14: Transitional provisions relating to the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
  343. 1Interpretation
  344. 2Application of the old rules to the authorisation etc of existing clinical trials
  345. 3Application of Good Clinical Practice to old rules clinical trials
  346. 4Pharmacovigilance in respect of old rules clinical trials
  347. 5Manufacture and importation of investigational medicinal products used in old rules clinical trials
  348. 6Labelling of investigational medicinal products used in old rules clinical trials
  349. 7Enforcement etc
  350. Explanatory note