GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — C.04.020
C.04.020 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.050
C.04.050 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.051
C.04.051 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.052
C.04.052 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.053
C.04.053 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.054
C.04.054 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.055
C.04.055 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.060
C.04.060 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.061
C.04.061 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.065
C.04.065 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.066
C.04.066 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.070
C.04.070 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.071
C.04.071 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.072
C.04.072 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.073
C.04.073 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.074
C.04.074 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.075
C.04.075 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.076
C.04.076 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.077
C.04.077 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.078
C.04.078 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.079
C.04.079 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.080
C.04.080 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.081
C.04.081 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.082
C.04.082 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.083
C.04.083 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.084
C.04.084 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.085
C.04.085 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.090
C.04.090 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.091
C.04.091 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.100
C.04.100 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.101
C.04.101 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.102
C.04.102 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.110
C.04.110 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.111
C.04.111 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.112
C.04.112 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.113
C.04.113 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.114
C.04.114 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.115
C.04.115 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.116
C.04.116 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.117
C.04.117 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.118
C.04.118 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.119
C.04.119 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.120
C.04.120 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.121
C.04.121 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.122
C.04.122 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.123
C.04.123 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.124
C.04.124 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.125
C.04.125 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.126
C.04.126 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.127
C.04.127 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.128
C.04.128 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.129
C.04.129 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.130
C.04.130 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.131
C.04.131 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.132
C.04.132 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.133
C.04.133 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.134
C.04.134 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.135
C.04.135 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.136
C.04.136 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.137
C.04.137 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.138
C.04.138 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.140
C.04.140 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.141
C.04.141 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.142
C.04.142 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.143
C.04.143 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.144
C.04.144 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.145
C.04.145 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.146
C.04.146 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.147
C.04.147 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.160
C.04.160 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.161
C.04.161 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.162
C.04.162 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.163
C.04.163 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.164
C.04.164 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.165
C.04.165 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.166
C.04.166 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.167
C.04.167 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.168
C.04.168 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.169
C.04.169 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.170
C.04.170 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.180
C.04.180 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.181
C.04.181 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.182
C.04.182 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.183
C.04.183 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.184
C.04.184 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.185
C.04.185 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.186
C.04.186 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.187
C.04.187 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.188
C.04.188 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.189
C.04.189 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.190
C.04.190 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.210
C.04.210 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.211
C.04.211 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.212
C.04.212 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.213
C.04.213 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.214
C.04.214 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.215
C.04.215 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.216
C.04.216 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.217
C.04.217 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.218
C.04.218 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.219
C.04.219 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.220
C.04.220 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.230
C.04.230 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.231
C.04.231 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.232
C.04.232 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.233
C.04.233 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.234
C.04.234 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.235
C.04.235 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.236
C.04.236 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.237
C.04.237 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.238
C.04.238 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.239
C.04.239 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.240
C.04.240 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.241
C.04.241 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.300 and C.04.301
C.04.300 and C.04.301 [Repealed, SOR/81-335, s. 3]
Food and Drug Regulations — C.04.550
C.04.550 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.551
C.04.551 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.552
C.04.552 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.553
C.04.553 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.554
C.04.554 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.555
C.04.555 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.556
C.04.556 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.557
C.04.557 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.558
C.04.558 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.559
C.04.559 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.560
C.04.560 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.561
C.04.561 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.562
C.04.562 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.563
C.04.563 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.564
C.04.564 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.565
C.04.565 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.566
C.04.566 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.567
C.04.567 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.568
C.04.568 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.569
C.04.569 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.570
C.04.570 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.571
C.04.571 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.572
C.04.572 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.573
C.04.573 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.574
C.04.574 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.575
C.04.575 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.576
C.04.576 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.577
C.04.577 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.578
C.04.578 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.579
C.04.579 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.580
C.04.580 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.581
C.04.581 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.582
C.04.582 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.583
C.04.583 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.584
C.04.584 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.585
C.04.585 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.586
C.04.586 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.587
C.04.587 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.588
C.04.588 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.589
C.04.589 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.590
C.04.590 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.591
C.04.591 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.592
C.04.592 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.593
C.04.593 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.594
C.04.594 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.595
C.04.595 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.596
C.04.596 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.597
C.04.597 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.598
C.04.598 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.599
C.04.599 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.600
C.04.600 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.601
C.04.601 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.602
C.04.602 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.650
C.04.650 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.651
C.04.651 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.652
C.04.652 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.653
C.04.653 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.654
C.04.654 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.655
C.04.655 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.656
C.04.656 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.675
C.04.675 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.676
C.04.676 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.677
C.04.677 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.678
C.04.678 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.679
C.04.679 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.680
C.04.680 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.681
C.04.681 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.682
C.04.682 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.683
C.04.683 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.05.001
 existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life threatening or that results in death. ( réaction indésirable grave à une drogue ) serious unexpected adverse drug reaction means a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information set out in the investigator’s brochure or on the label of the drug. ( réaction indésirable grave et imprévue à une drogue ) sponsor means an individual, corporate body, institution or organization that conducts a clinical trial. ( promoteur ) SOR/2001-203, s. 4; 2001, c. 27, s. 273; SOR/2012-16, s. 1(F); SOR/2013-56, s. 1(F)
Food and Drug Regulations — Food and Drug Regulations
adverse drug reaction means any noxious and unintended response to a drug that is caused by the administration of any dose of the drug. ( réaction indésirable à une drogue )
Food and Drug Regulations — Food and Drug Regulations
adverse event means any adverse occurrence in the health of a clinical trial subject who is administered a drug, that may or may not be caused by the administration of the drug, and includes an adverse drug reaction. ( incident thérapeutique )
Food and Drug Regulations — Food and Drug Regulations
clinical trial means an investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug. ( essai clinique )
Food and Drug Regulations — Food and Drug Regulations
drug means a drug for human use that is to be tested in a clinical trial. ( drogue )
Food and Drug Regulations — Food and Drug Regulations
good clinical practices means generally accepted clinical practices that are designed to ensure the protection of the rights, safety and well-being of clinical trial subjects and other persons, and the good clinical practices referred to in section C.05.010. ( bonnes pratiques cliniques )
Food and Drug Regulations — Food and Drug Regulations
import means to import a drug into Canada for the purpose of sale in a clinical trial. ( importer )
Food and Drug Regulations — Food and Drug Regulations
investigator’s brochure means, in respect of a drug, a document containing the preclinical and clinical data on the drug that are described in paragraph C.05.005(e). ( brochure du chercheur )
Food and Drug Regulations — Food and Drug Regulations
protocol means a document that describes the objectives, design, methodology, statistical considerations and organization of a clinical trial. ( protocole )
Food and Drug Regulations — (a)
qualified investigator means the person responsible to the sponsor for the conduct of the clinical trial at a clinical trial site, who is entitled to provide health care under the laws of the province where that clinical trial site is located, and who is (a) in the case of a clinical trial respecting a drug to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association; and (b) in any other case, a physician and a member in good standing of a professional medical association. ( chercheur qualifié )
Food and Drug Regulations — (a)
research ethics board means a body that is not affiliated with the sponsor, and (a) the principal mandate of which is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being; and (b) that has at least five members, that has a majority of members who are Canadian citizens or permanent residents under the Immigration and Refugee Protection Act , that is composed of both men and women and that includes at least (i) two members whose primary experience and expertise are in a scientific discipline, who have broad experience in the methods and areas of research to be approved and one of whom is from a medical discipline or, if the clinical trial is in respect of a drug to be used for dental purposes only, is from a medical or dental discipline, (ii) one member knowledgeable in ethics, (iii) one member knowledgeable in Canadian laws relevant to the biomedical research to be approved, (iv) one member whose primary experience and expertise are in a non-scientific discipline, and (v) one member who is from the community or is a representative of an organization interested in the areas of research to be approved and who is not affiliated with the sponsor or the site where the clinical trial is to be conducted. ( comité d’éthique de la recherche )
Food and Drug Regulations — Food and Drug Regulations
serious adverse drug reaction means an adverse drug reaction that requires in-patient hospitalization or prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life threatening or that results in death. ( réaction indésirable grave à une drogue )
Food and Drug Regulations — Food and Drug Regulations
serious unexpected adverse drug reaction means a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information set out in the investigator’s brochure or on the label of the drug. ( réaction indésirable grave et imprévue à une drogue )
Food and Drug Regulations — Food and Drug Regulations
sponsor means an individual, corporate body, institution or organization that conducts a clinical trial. ( promoteur )
Food and Drug Regulations — C.05.002
C.05.002 (1) Subject to subsection (2), this Division applies to the sale or importation of drugs to be used for the purposes of clinical trials involving human subjects. (2) Except for paragraph C.05.003(a), subsections C.05.006(2) and (3), paragraphs C.05.010(a) to (i), section C.05.011, subsections C.05.012(1) and (2), paragraphs C.05.012(3)(a) to (d) and (f) to (h), subsection C.05.012(4) and sections C.05.013, C.05.016 and C.05.017, this Division does not apply to the sale or importation of a drug for the purposes of a clinical trial authorized under subsection C.05.006(2). SOR/2001-203, s. 4
Food and Drug Regulations — C.05.003
C.05.003 Despite sections C.01.014, C.08.002, C.08.002.02 and C.08.003, no person shall sell or import a drug for the purposes of a clinical trial unless (a) the person is authorized under this Division; (b) the person complies with this Division and sections C.01.015, C.01.036, C.01.037 to C.01.040, C.01.040.2, C.01.064 to C.01.067, C.01.070, C.01.131, C.01.133 to C.01.136, and C.01.435; and (c) if the drug is to be imported, the person has a representative in Canada who is responsible for the sale of the drug. SOR/2001-203, s. 4; SOR/2011-88, s. 7
Food and Drug Regulations — C.05.004
C.05.004 Despite these Regulations, a sponsor may submit an application under this Division to sell or import a drug for the purposes of a clinical trial that contains a substance the sale of which is prohibited by these Regulations, if the sponsor establishes, on the basis of scientific information, that the inclusion of the substance in the drug may result in a therapeutic benefit for a human being. SOR/2001-203, s. 4
Food and Drug Regulations — C.05.005
 storage requirements for the prepared radiopharmaceutical; (f) if the drug contains a human-sourced excipient, including any used in the placebo, (i) information that indicates the human-sourced excipient has been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a new drug, issued a notice of compliance under subsection C.08.004(1), as the case may be, or (ii) in any other case, sufficient information to support the identity, purity, potency, stability and safety of the human-sourced excipient; (g) if the drug has not been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a new drug, a notice of compliance has not been issued under section C.08.004 or C.08.004.01, the chemistry and manufacturing information in respect of the drug, including its site of manufacture; and (h) the proposed date for the commencement of the clinical trial at each clinical trial site, if known at the time of submitting the application. SOR/2001-203, s. 4; SOR/2011-88, s. 8; SOR/2012-16, s. 2(F)