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The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

Draft. This instrument was laid in draft and may differ from the one made. Look for the made version under its title.

Draft 2020, ISBN 9780348213980

Original text. legislation.gov.uk does not revise statutory instruments, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Draft Regulations laid before Parliament under paragraphs 1(1), 8F(1) and 12(1) of Schedule 7 to the European Union (Withdrawal) Act 2018, for approval by resolution of each House of Parliament.

Exiting The European Union

Medicines

Made ***

Coming into force in accordance with regulation 1

The Secretary of State makes these Regulations in exercise of the powers conferred by sections 8(1) and 8C of, and paragraphs 1(1) and 7(2) of Schedule 4 and 21 of Schedule 7 to, the European Union (Withdrawal) Act 2018f1.

The Treasury has consented to the making of these Regulations as required by paragraphs 3(1) and 10 of Schedule 4 to the European Union (Withdrawal) Act 2018.

In accordance with paragraphs 1(1), 8F(1) and 12(1) of Schedule 7 to the European Union (Withdrawal) Act 2018, a draft of these Regulations has been laid before, and approved by, a resolution of each House of Parliament.

Annotations to the whole text

Footnotes

f1

2018 c.16. Section 8C was inserted by section 21 of the European Union (Withdrawal Agreement) Act 2020 (c.1) and paragraph 21 of Schedule 7 was amended by paragraph 53(2) of Schedule 5 to that Act.

Contents

  1. 1Citation and commencement
  2. 2Amendment of the Good Laboratory Practice Regulations 1999
  3. 3Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019
  4. 4Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
  5. 5Amendment of the Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
  6. Signature
  7. Schedule 1: Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019
  8. 1Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019
  9. 2Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019
  10. 3Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019
  11. 4Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019
  12. 5Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019
  13. 6Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019
  14. 7Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019
  15. 8Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019
  16. 9Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019
  17. 10Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019
  18. Schedule 2: Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
  19. Part 1: Amendment of Part 2 (amendment of Part 1 (General))
  20. 1Paragraph 1
  21. 2Paragraph 2
  22. 3Paragraph 3
  23. 4Paragraph 4
  24. 5Paragraph 5
  25. 6Paragraph 6
  26. 7Paragraph 7
  27. Part 2: Amendment of Part 3 (amendment of Part 3 (manufacture and distribution of medicinal products and active substances))
  28. 8Paragraph 8
  29. 9Paragraph 9
  30. 10Paragraph 10
  31. 11Paragraph 11
  32. 12Paragraph 12
  33. 13Paragraph 13
  34. 14Paragraph 14
  35. 15Paragraph 15
  36. 16Paragraph 16
  37. 17Paragraph 17
  38. 18Paragraph 18
  39. 19Paragraph 19
  40. 20Paragraph 20
  41. 21Paragraph 21
  42. 22Paragraph 22
  43. 23Paragraph 23
  44. 24Paragraph 24
  45. 25Paragraph 25
  46. 26Paragraph 26
  47. 27Paragraph 27
  48. 28Paragraph 28
  49. 29Paragraph 29
  50. 30Paragraph 30
  51. 31Paragraph 31
  52. 32Paragraph 32
  53. Part 3: Amendment of Part 4 (amendment of Part 4 (requirement for authorisation))
  54. 33Paragraph 33
  55. 34Paragraph 34
  56. Part 4: Amendment of Part 5 (amendment of Part 5 (marketing authorisations))
  57. 35Paragraph 35
  58. 36Paragraph 36
  59. 37Paragraph 37
  60. 38Paragraph 38
  61. 39Paragraph 39
  62. 40Paragraph 40
  63. 41Paragraph 41
  64. 42Paragraph 42
  65. 43Paragraph 43
  66. 44Paragraph 44
  67. 45Paragraph 45
  68. 46Paragraph 46
  69. 47Paragraph 47
  70. 48Paragraph 48
  71. 49Paragraph 49
  72. 50Paragraph 50
  73. 51Paragraph 51
  74. 52Paragraph 52
  75. 53Paragraph 53
  76. 54Paragraph 54
  77. 55Paragraph 55
  78. 56Paragraph 56
  79. 57Paragraph 57
  80. 58Paragraph 58
  81. 59Paragraph 59
  82. 60Paragraph 60
  83. 61Paragraph 61
  84. 62Paragraph 62
  85. 63Paragraph 63
  86. 64Paragraph 64
  87. 65Paragraph 65
  88. 66Paragraph 66
  89. 67Paragraph 67
  90. 68Paragraph 68
  91. 69Paragraph 69
  92. 70Paragraph 70
  93. 71Paragraph 71
  94. 72Paragraph 72
  95. 73Paragraph 73
  96. 74Paragraph 74
  97. 75Paragraph 75
  98. 76Paragraph 76
  99. 77Paragraph 77
  100. 78Paragraph 78
  101. 79Paragraph 79
  102. Part 5: Amendment of Part 6 (amendment of Part 6 (certification of homoeopathic products))
  103. 80Paragraph 80
  104. 81Paragraph 81
  105. Part 6: Amendment of Part 7 (amendment of Part 7 (Traditional Herbal Registrations))
  106. 82Paragraph 82
  107. 83Paragraph 83
  108. 84Paragraph 84
  109. 85Paragraph 85
  110. 86Paragraph 86
  111. 87Paragraph 87
  112. 88Paragraph 88
  113. 89Paragraph 89
  114. 90Paragraph 90
  115. 91Paragraph 91
  116. 92Paragraph 92
  117. 93Paragraph 93
  118. 94Paragraph 94
  119. 95Paragraph 95
  120. 96Paragraph 96
  121. 97Paragraph 97
  122. 98Paragraph 98
  123. Part 7: Amendment of Part 8 (omission of Part 8 (Article 126a authorisations))
  124. 99Paragraph 99
  125. Part 8: Amendment of Part 9 (amendment of Part 9 (borderline products))
  126. 100Paragraph 100
  127. 101Paragraph 101
  128. Part 9: Amendment of Part 10 (amendment of Part 10 (exceptions to requirement for marketing authorisations etc))
  129. 102Paragraph 102
  130. 103Paragraph 103
  131. 104Paragraph 104
  132. 105Paragraph 105
  133. 106Paragraph 106
  134. Part 10: Amendment of Part 11 (amendment of Part 11 (Pharmacovigilance))
  135. 107Paragraph 107
  136. 108Paragraph 108
  137. 109Paragraph 109
  138. 110Paragraph 110
  139. 111Paragraph 111
  140. 112Paragraph 112
  141. 113Paragraph 113
  142. 114Paragraph 114
  143. 115Paragraph 115
  144. 116Paragraph 116
  145. 117Paragraph 117
  146. 118Paragraph 118
  147. 119Paragraph 119
  148. 120Paragraph 120
  149. 121Paragraph 121
  150. 122Paragraph 122
  151. 123Paragraph 123
  152. 124Paragraph 124
  153. 125Paragraph 125
  154. 126Paragraph 126
  155. 127Paragraph 127
  156. 128Paragraph 128
  157. 129Paragraph 129
  158. 130Paragraph 130
  159. 131Paragraph 131
  160. 132Paragraph 132
  161. 133Paragraph 133
  162. 134Paragraph 134
  163. 135Paragraph 135
  164. 136Paragraph 136
  165. 137Paragraph 137
  166. 138Paragraph 138
  167. 139Paragraph 139
  168. 140Paragraph 140
  169. Part 11: Amendment of Part 12 (amendment of Part 12 (dealings with medicinal products))
  170. 141Paragraph 141
  171. 142Paragraph 142
  172. 143Paragraph 143
  173. 144Paragraph 144
  174. 145Paragraph 145
  175. 146Paragraph 146
  176. 147Paragraph 147
  177. 148Paragraph 148
  178. 149Paragraph 149
  179. 150Paragraph 150
  180. Part 12: Amendment of Part 13 (omission of Part 12A (sale of medicines to the public at a distance))
  181. 151Paragraph 151
  182. Part 13: Amendment of Part 14 (amendment of Part 13 (packaging and leaflets))
  183. 152Paragraph 152
  184. 153Paragraph 153
  185. 154Paragraph 154
  186. 155Paragraph 155
  187. 156Paragraph 156
  188. 157Paragraph 157
  189. 158Paragraph 158
  190. 159Paragraph 159
  191. 160Paragraph 160
  192. 161Paragraph 161
  193. 162Paragraph 162
  194. 163Paragraph 163
  195. 164Paragraph 164
  196. 165Paragraph 165
  197. 166Paragraph 166
  198. Part 14: Amendment of Part 15 (amendment of Part 14 (advertising))
  199. 167Paragraph 167
  200. 168Paragraph 168
  201. 169Paragraph 169
  202. 170Paragraph 170
  203. 171Paragraph 171
  204. 172Paragraph 172
  205. 173Paragraph 173
  206. 174Paragraph 174
  207. 175Paragraph 175
  208. 176Paragraph 176
  209. 177Paragraph 177
  210. Part 15: Amendment of Part 16 (amendment of Part 15 (British Pharmacopoeia))
  211. 178Paragraph 178
  212. Part 16: Amendment of Part 17 (amendment of Part 16 (enforcement))
  213. 179Paragraph 179
  214. 180Paragraph 180
  215. 181Paragraph 181
  216. 182Paragraph 182
  217. Part 17: Amendment of Part 18 (amendment of Part 17 (miscellaneous and general))
  218. 183Paragraph 183
  219. 184Paragraph 184
  220. 185Paragraph 185
  221. 186Paragraph 186
  222. 187Paragraph 187
  223. Part 18: Amendment of Schedule 1 (amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016)
  224. 188Paragraph 188
  225. 189Paragraph 189
  226. Part 19: Insertion of Schedule 2A (insertion of new Schedule 8C (material to accompany an application for a UK marketing authorisation under the unfettered access route))
  227. 190Paragraph 190
  228. Part 20: Amendment of Schedule 4 (insertion of new Schedule 9A)
  229. 191Paragraph 191
  230. Part 21: Amendment of Schedule 6 (insertion of new Schedule 12A (further provision as to the performance of pharmacovigilance activities))
  231. 192Paragraph 192
  232. Part 22: Amendment of Schedule 7 (insertion of new Schedule 33A (Transitional Provision))
  233. 193Paragraph 193
  234. Part 23: Amendment of Schedule 8 (consequential provision)
  235. 194Paragraph 194
  236. Part 24: Amendment of Schedule 9 (retained EU law: revocations)
  237. 195Paragraph 195
  238. Schedule 3: Amendment of the Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
  239. 1Amendment of the Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
  240. Explanatory note