GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — Food and Drug Regulations
drug means a drug that is listed in Schedule C to the Act that is in dosage form or a drug that is an active ingredient of biological origin that can be used in the preparation of a drug listed in that Schedule; ( drogue )
Food and Drug Regulations — Food and Drug Regulations
licence or Canadian licence [Repealed, SOR/97-12, s. 22]
Food and Drug Regulations — Food and Drug Regulations
manufacturer [Repealed, SOR/97-12, s. 22]
Food and Drug Regulations — Food and Drug Regulations
master lot means a quantity of a drug from which a lot is prepared for sale by subsequent dilution or mixture; ( maître-lot )
Food and Drug Regulations — (a)
radionuclide generator means a radioactive parent and daughter (a) contained in an ion-exchange column, or (b) dissolved in a suitable solvent in a liquid-liquid extraction system where the radioactive daughter is separated from its parent by (c) elution from the ion exchange column, or (d) a solvent extraction procedure. ( générateur de radionucléide )
Food and Drug Regulations — C.03.001.1
C.03.001.1 No distributor referred to in paragraph C.01A.003(b) or importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with this Division. SOR/97-12, s. 23
Food and Drug Regulations — C.03.002 to C.03.005
C.03.002 to C.03.005 [Repealed, SOR/97-12, s. 24]
Food and Drug Regulations — C.03.007 to C.03.011
C.03.007 to C.03.011 [Repealed, SOR/97-12, s. 26]
Food and Drug Regulations — C.03.012
C.03.012 On written request from the Minister, every fabricator, packager/labeller, tester, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall submit protocols of tests together with samples of any lot or master lot of the drug before it is sold, and no person shall sell a lot of which the protocol or sample fails to meet the requirements of these Regulations. SOR/97-12, s. 27; SOR/2018-69, s. 27
Food and Drug Regulations — C.03.013
C.03.013 No person shall fabricate or import a drug that is derived from animal tissue unless the tissue is obtained from a healthy animal free from infectious disease. SOR/97-12, s. 27
Food and Drug Regulations — C.03.014
C.03.014 (1) Section C.01.004 does not apply to a drug. (2) and (3) [Repealed, SOR/97-12, s. 28] SOR/79-236, s. 1; SOR/93-202, s. 15; SOR/97-12, s. 28
Food and Drug Regulations — C.03.015
C.03.015 (1) Every package of a drug that is a prescription drug shall carry the symbol “Pr” on the upper left quarter of the principal display panel of both its inner and outer labels or, in the case of a single dose container, on the upper left quarter of its outer label. (2) Subsection (1) does not apply to (a) a drug sold to a drug fabricator; (b) a drug sold under a prescription; (c) a radiopharmaceutical as defined in section C.03.201; or (d) a component or kit as defined in section C.03.205. SOR/80-543, s. 9; SOR/97-12, s. 61; SOR/2001-181, s. 4; SOR/2013-122, s. 16
Food and Drug Regulations — C.03.030 to C.03.045
C.03.030 to C.03.045 [Repealed, SOR/81-335, s. 2]
Food and Drug Regulations — C.03.201
C.03.201 In these Regulations, radiopharmaceutical means a drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons. SOR/97-12, s. 29
Food and Drug Regulations — C.03.203
C.03.203 (1) Every radionuclide generator shall carry on the inner label (a) the proper name of the radionuclide generator, which proper name, where there is a brand name, shall immediately precede or follow the brand name; (b) the name and address of the distributor referred to in paragraph C.01A.003(b); (c) the lot number; (d) the standard that the radionuclide generator professes to meet, if that standard is referred to in any publication mentioned in Schedule B to the Act; (e) the drug identification number assigned for the radionuclide generator, preceded by the expression “Drug Identification Number” or “ Drogue : identification numérique ”, or both, or the abbreviation “DIN”; (f) the radiation warning symbol set out in Schedule 3 to the Radiation Protection Regulations and the words “ RAYONNEMENT — DANGER — RADIATION”; (g) a statement of the total parent radioactivity contained in the radionuclide generator; (h) a statement of the hour and date at which the radioactivity value mentioned in paragraph (g) is valid, the name of the month being written or designated by letter abbreviation; (i) a statement of the recommended useful life or the date after which the radionuclide generator is not recommended for use, the name of the month being written or designated by letter abbreviation; (j) a statement of the recommended useful life of the drug after removal from the radionuclide generator; (k) a statement of special storage requirements with reference to temperature or shielding; (l) complete directions for use or a reference to an accompanying package insert that sets out such directions; and (m) a statement cautioning against the dismantling of the radionuclide generator. (2) Paragraphs (1)(i) and (j) of this section do not apply where the information referred to in those subparagraphs is shown on a package insert that accompanies the radionuclide generator. (3) Section C.01.005 does not apply to a radionuclide generator. SOR/79-236, s. 3; SOR/93-202, s. 17; SOR/97-12, ss. 54, 58, 62; SOR/2012-129, s. 3; SOR/2017-259, s. 17; SOR/2018-69, ss. 21(F), 22(F)
Food and Drug Regulations — C.03.204
C.03.204 (1) No person shall sell a drug that contains technetium-99m at any time during its useful life if it also contains a radionuclidic impurity set out in the monograph for Sodium Pertechnetate Tc-99m Injection referred to in the publication set out in item 8 of Schedule B to the Act, in an amount greater than that shown in the monograph. (2) No person shall sell a radionuclide generator from which can be removed a drug that contains technetium-99m, at any time during the useful life of the drug, if the drug also contains a radionuclidic impurity set out in the monograph for Sodium Pertechnetate Tc-99m Injection referred to in the publication set out in item 8 of Schedule B to the Act, in an amount greater than that shown in the monograph. SOR/97-12, s. 30; SOR/2012-129, s. 4
Food and Drug Regulations — C.03.205
C.03.205 The following definitions apply in this section and in sections C.03.206 to C.03.209. 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 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 ) SOR/79-236, s. 4; SOR/2017-259, s. 19
Food and Drug Regulations — (a)
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 )
Food and Drug Regulations — (a)
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 )
Food and Drug Regulations — C.03.206
C.03.206 Sections C.01.005 and C.04.009 do not apply to a component or kit. SOR/79-236, s. 4 SOR/2024-238, s. 22
Food and Drug Regulations — C.03.207
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”. SOR/79-236, s. 4; SOR/97-12, s. 58; SOR/2017-259, s. 20; SOR/2018-69, s. 23(F)
Food and Drug Regulations — C.03.208
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] SOR/79-236, s. 4; SOR/93-202, s. 18; SOR/97-12, ss. 58, 62; SOR/2001-203, s. 3; SOR/2017-259, s. 21; SOR/2018-69, s. 36(F)
Food and Drug Regulations — C.03.209
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; SOR/2018-69, s. 36(F)
Food and Drug Regulations — C.03.301
C.03.301 The following definitions apply in this section and in sections C.03.302 to C.03.319. 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 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 means, in respect of a study drug, to import it into Canada for sale for the purpose of a study. ( importer ) other person means an individual who comes into physical contact with a study subject. ( autre personne ) protocol means a document that describes the objectives, design, methodology, statistical considerations and organization of a study. ( protocole ) 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 means a body described in section C.03.306. ( comité d’éthique de la recherche ) 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 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 means a person who is responsible for the conduct of a study. ( promoteur ) 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 means a positron-emitting radiopharmaceutical that is used in a study. ( drogue destinée à l’étude ) study site means the location where all or part of a study is conducted. ( lieu d’étude ) SOR/2012-129, s. 5
Food and Drug Regulations — Food and Drug Regulations
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 )
Food and Drug Regulations — Food and Drug Regulations
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 )
Food and Drug Regulations — Food and Drug Regulations
import means, in respect of a study drug, to import it into Canada for sale for the purpose of a study. ( importer )
Food and Drug Regulations — Food and Drug Regulations
other person means an individual who comes into physical contact with a study subject. ( autre personne )
Food and Drug Regulations — Food and Drug Regulations
protocol means a document that describes the objectives, design, methodology, statistical considerations and organization of a study. ( protocole )
Food and Drug Regulations — Food and Drug Regulations
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 )
Food and Drug Regulations — Food and Drug Regulations
research ethics board means a body described in section C.03.306. ( comité d’éthique de la recherche )
Food and Drug Regulations — (a)
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 )
Food and Drug Regulations — Food and Drug Regulations
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 )
Food and Drug Regulations — Food and Drug Regulations
sponsor means a person who is responsible for the conduct of a study. ( promoteur )
Food and Drug Regulations — Food and Drug Regulations
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 )
Food and Drug Regulations — Food and Drug Regulations
study drug means a positron-emitting radiopharmaceutical that is used in a study. ( drogue destinée à l’étude )
Food and Drug Regulations — Food and Drug Regulations
study site means the location where all or part of a study is conducted. ( lieu d’étude )
Food and Drug Regulations — C.03.302
C.03.302 (1) Sections C.03.303 to C.03.319 apply to the sale and importation of study drugs. (2) Sections C.03.001 to C.03.209 and Divisions 5 and 8 do not apply to study drugs. (3) Sections C.03.303 to C.03.319 do not apply to a study drug manufactured from a bulk process intermediate that is of biological origin. SOR/2012-129, s. 5
Food and Drug Regulations — C.03.303
C.03.303 No person shall sell or import a study drug unless all of the following requirements are met: (a) the study drug is for use only in a study; (b) the study drug has been previously tested in human subjects and its safety in humans has been demonstrated; (c) if the study drug is to be imported, the manufacturer of the drug has a representative in Canada who is responsible for its sale; (d) the sponsor is authorized under section C.03.309 to sell or import the study drug; and (e) the sponsor complies with sections C.03.310 to C.03.316. SOR/2012-129, s. 5
Food and Drug Regulations — C.03.304
C.03.304 (1) The purpose of a study is to obtain data on any of the following: (a) the pharmacokinetics or metabolism of the study drug; (b) normal human biochemistry or physiology; or (c) changes caused to human biochemistry or physiology by aging, disease or medical interventions. (2) A study is not primarily intended to do any of the following: (a) discover, identify or verify the pharmacodynamic effects of the study drug; (b) identify adverse reactions; (c) fulfil an immediate therapeutic or diagnostic purpose; or (d) ascertain the safety or efficacy of the study drug. SOR/2012-129, s. 5
Food and Drug Regulations — C.03.305
C.03.305 (1) A study shall meet all of the following requirements: (a) before the study drug is used in the study, there is sufficient data from testing it in animals and humans to demonstrate its safety in humans; (b) the amount of active ingredients or combination of active ingredients in the study drug has been shown not to cause any clinically detectable pharmacodynamic effect in humans; (c) the total radiation dose incurred annually by a study subject, including from multiple administrations of the study drug, from significant contaminants or from impurities and from the use of other procedures for the purposes of the study, will be not more than 50 mSv; (d) any concomitant drug used in the study has been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a concomitant drug that is a new drug, has been issued a notice of compliance under section C.08.004; (e) study subjects shall be at least 18 years old and have legal capacity at the time of the study; (f) female study subjects shall (i) be confirmed at the outset of the study, on the basis of a pregnancy test, as not being pregnant or state in writing that they are not pregnant, and (ii) be advised that if they are lactating, they are to suspend lactation for 24 hours after the administration of the study drug; and (g) the study shall not involve more than 30 study subjects. (2) Despite paragraph (1)(g), a study may involve more than 30 study subjects if the sponsor provides the Minister with a scientific rationale for the increase and the Minister approves it. SOR/2012-129, s. 5
Food and Drug Regulations — C.03.306
C.03.306 A research ethics board has all of the following characteristics: (a) its principal mandate is to approve the initiation of and to periodically review biomedical research that involves human subjects in order to protect their rights, safety and well-being; (b) it has at least five members, a majority of whom are Canadian citizens or permanent residents under the Immigration and Refugee Protection Act , is composed of both men and women and includes at least the following: (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, (ii) one member knowledgeable in ethics, (iii) one member knowledgeable in Canadian laws relevant to the 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 with the study site; and (c) it has no affiliations with the sponsor that could compromise its ability to fulfil its principal mandate, or that could be perceived to do so. SOR/2012-129, s. 5