Food and Drug Regulations (C.R.C., c. 870)
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Regulations are current to 2013-06-10 and last amended on 2013-05-31. Previous Versions
C.03.209. A package insert shall be included in every kit and shall show
(a) the proper name and the brand name, if any, of the kit and a description of its use;
(b) a list of the contents of the kit;
(c) the name and address of the distributor referred to in paragraph C.01A.003(b) of the kit;
(d) identification of the radionuclides that can be used to prepare the radiopharmaceutical;
(e) directions for preparing the radiopharmaceutical and a statement of the storage requirements for the prepared radiopharmaceutical;
(f) a statement of the duration of the useful life of the prepared radiopharmaceutical;
(g) a description of the biological actions of the prepared radiopharmaceutical;
(h) indications and contraindications in respect of the prepared radiopharmaceutical;
(i) warnings and precautions in respect of the components and the prepared radiopharmaceutical;
(j) the adverse reactions, if any, associated with the prepared radiopharmaceutical;
(k) where applicable, the pharmacology and toxicology of the prepared radiopharmaceutical or a statement that such information is available on request;
(l) the radiation dosimetry in respect of the prepared radiopharmaceutical;
(m) a statement of the recommended use for the prepared radiopharmaceutical and the recommended radioactivity to be administered for that use;
(n) a statement of the route of administration of the prepared radiopharmaceutical; and
(o) a recommendation that the radiochemical purity and radioactivity content of the prepared radiopharmaceutical be checked prior to administration.
- SOR/79-236, s. 4;
- SOR/93-202, s. 19;
- SOR/97-12, s. 58.
Positron-emitting Radiopharmaceuticals
Interpretation
C.03.301. The following definitions apply in this section and in sections C.03.302 to C.03.319.
- “adverse reaction”
“adverse reaction” means an undesirable and unintended response in a study subject or other person to a study drug that is caused by the administration of any dose of the study drug. (réaction indésirable)
- “good clinical practices”
“good clinical practices” means generally accepted clinical practices that are designed to protect the rights, safety and well-being of study subjects and other persons. (bonnes pratiques cliniques)
- “import”
“import” means, in respect of a study drug, to import it into Canada for sale for the purpose of a study. (importer)
- “other person”
“other person” means an individual who comes into physical contact with a study subject. (autre personne)
- “protocol”
“protocol” means a document that describes the objectives, design, methodology, statistical considerations and organization of a study. (protocole)
- “qualified investigator”
“qualified investigator” means the physician and member in good standing of a professional medical association in Canada to whom a sponsor gives the responsibility for the proper conduct of the study at a given study site, who is entitled to practise their profession under the laws of the province where the study site is located. (chercheur qualifié)
- “research ethics board”
“research ethics board” means a body described in section C.03.306. (comité d’éthique de la recherche)
- “serious adverse reaction”
“serious adverse reaction” means an adverse reaction that results in any of the following consequences for the study subject or other person:
(a) their in-patient hospitalization or its prolongation;
(b) a congenital malformation;
(c) persistent or significant disability or incapacity;
(d) a life-threatening condition; or
(e) death. (réaction indésirable grave)
- “serious unexpected adverse reaction”
“serious unexpected adverse reaction” means a serious adverse reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the study drug. (réaction indésirable grave et imprévue)
- “sponsor”
“sponsor” means a person who is responsible for the conduct of a study. (promoteur)
- “study”
“study” means a basic clinical research study that involves human subjects and that is described in sections C.03.304 and C.03.305. (étude)
- “study drug”
“study drug” means a positron-emitting radiopharmaceutical that is used in a study. (drogue destinée à l’étude)
- “study site”
“study site” means the location where all or part of a study is conducted. (lieu d’étude)
- SOR/2012-129, s. 5.
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