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

Drugs, Other than Radionuclides, Sold or Represented for Use in the Preparation of Radiopharmaceuticals

C.03.205 The following definitions apply in this section and in sections C.03.206 to C.03.209.

component

component means

• (a) a unit of a drug, other than a radionuclide, separately packaged in a kit; or

• (b) an empty vial or other accessory item in a kit. (constituant)

kit

kit means a package that is intended to be used in the preparation of radiopharmaceuticals and that

• (a) contains one or more separately packaged units of a drug, other than a radionuclide; and

• (b) may contain empty vials or other accessory items. (trousse)

C.03.206 Sections C.01.005 and C.04.019 do not apply to a component or kit.

• C.03.207 (1) Every component shall be labelled to show

  • (a) adequate identification of the component and an adequate description of its function;

  • (b) where applicable, a quantitative list of its ingredients or a reference to the label of the kit that shows such information;

  • (c) the name of the distributor referred to in paragraph C.01A.003(b);

  • (d) the lot number;

  • (e) a statement of any special storage requirements with respect to temperature and light;

  • (f) the date after which the component is not recommended for use, the name of the month being written in full or designated by letter abbreviation; and

  • (g) adequate directions for use or a reference to the accompanying package insert that shows such directions.

• (2) The component of a kit that is intended to contain the prepared radiopharmaceutical shall be labelled to display the drug identification number assigned for the kit, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”.

C.03.208 Every kit shall be labelled to show

• (a) its proper name;

• (b) its brand name, if any;

• (c) a list of its contents;

• (d) the name and address of the distributor referred to in paragraph C.01A.003(b);

• (e) the drug identification number assigned for the kit, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”;

• (f) the lot number;

• (g) a statement of any special storage requirements with respect to temperature and light;

• (h) the date after which the kit is not recommended for use, the name of the month being written in full or designated by letter abbreviation;

• (i) where the label of a component makes reference to the label of the kit that shows information as to the ingredients of the component, a quantitative list of the ingredients of that component;

• (j) a statement of the sterility and apyrogenicity of the components;

• (k) adequate directions for preparing the radiopharmaceutical or a reference to the accompanying package insert that shows such directions;

• (l) a statement of the duration of the useful life of the prepared radiopharmaceutical;

• (m) a statement of the storage requirements for the prepared radiopharmaceutical;

• (n) a statement of the recommended use for the prepared radiopharmaceutical and the recommended radioactivity to be administered for that use, or a reference to the accompanying package insert that shows such information; and

• (o) a statement of the route of administration of the prepared radiopharmaceutical.

• (p) [Repealed, SOR/2001-203, s. 3]

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.

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)