Food and Drug Regulations (C.R.C., c. 870)

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.

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)