GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — C.03.307
C.03.307 (1) The sponsor shall submit to the Minister an application for authorization to sell or import a study drug that contains the information set out in subsection (2) as well as sufficient information to demonstrate that all of the following criteria are met: (a) the use of the study drug will not endanger the health of any study subject or other person; (b) the study is not contrary to the best interests of the study subjects; and (c) the objectives of the study can reasonably be achieved. (2) The application shall contain all of the following information: (a) the title of the study and the protocol code or identification; (b) the purposes and a concise description of the study; (c) the number of study subjects; (d) the brand name, if any, of the study drug; (e) the chemical or generic name of the active ingredients in the study drug; (f) a qualitative list of the non-active ingredients of the study drug; (g) the maximum mass of the study drug to be administered to each study subject; (h) the radioactive dose range of the study drug, expressed in MBq or mCi; (i) the effective dose or effective dose equivalent of the study drug, expressed in mSv/MBq or rem/mCi; (j) the sponsor’s name and civic address, its postal address if different, and its telephone number, fax number and email address; (k) the manufacturer’s name and civic address, its postal address if different, and its telephone number, fax number and email address; (l) in the case of an application for importation, the name and civic address, the postal address if different, and the telephone number, fax number and email address of the manufacturer’s representative in Canada who is responsible for the sale of the study drug; (m) the name and civic address of each study site; (n) for each study site, the name, civic address, telephone number, fax number and email address of the qualified investigator; (o) the proposed starting date for the study at each study site, if known; (p) for each study site, the name, civic address, telephone number, fax number and email address of the research ethics board; (q) a statement, dated and signed by the research ethics board for each study site, that certifies that it has reviewed and approved the study, the protocol and the statement of the risks and anticipated benefits arising to the health of study subjects as a result of participating in the study that is set out in the informed consent form; (r) a list of any previous applications for an authorization to sell or import a drug for a study related to the current study; and (s) a statement, dated and signed by the sponsor’s senior medical or scientific officer in Canada and senior executive officer, that certifies both of the following: (i) the study will be conducted in accordance with these Regulations, and (ii) all of the information contained or referred to in the application is complete and accurate and is not false or misleading. SOR/2012-129, s. 5
Food and Drug Regulations — C.03.308
C.03.308 If the information submitted under section C.03.307 is insufficient to enable the Minister to determine whether the sale or importation of the study drug should be authorized, the Minister may, by notice in writing, request the sponsor to provide any additional information that is necessary to make the determination and that is relevant to the study drug, the study or the protocol, by the date specified in the notice. SOR/2012-129, s. 5
Food and Drug Regulations — C.03.309
C.03.309 After examining the application and any additional information, the Minister shall authorize the sponsor to sell or import the study drug if she or he determines that the application complies with the requirements of section C.03.307, and shall send a notice of that decision to the sponsor that specifies the study sites in respect of which the sale or importation are authorized. SOR/2012-129, s. 5
Food and Drug Regulations — C.03.310
C.03.310 The sponsor shall notify the Minister in writing of the day on which the sale or importation of the study drug is intended to start in respect of each study site, not later than 15 days before that day. SOR/2012-129, s. 5
Food and Drug Regulations — C.03.311
C.03.311 A sponsor shall ensure that each study is conducted in accordance with good clinical practices and that (a) the study is scientifically sound and clearly described in its protocol; (b) the study is conducted, and the study drug is used, in accordance with the protocol and with these Regulations; (c) systems and procedures are implemented that assure the quality of every aspect of the study; (d) at each study site, there is only one qualified investigator; (e) at each study site, medical care and medical decisions, in respect of the study, are under the supervision of the qualified investigator; (f) each individual who is involved in the conduct of the study is qualified by their education, training and experience to perform their respective tasks; (g) before a study subject participates in the study, a copy of their signed consent form is included in the records for the study; (h) the requirements respecting information and records set out in section C.03.315 are met; and (i) the study drug is manufactured, handled and stored in accordance with Division 2, other than sections C.02.019, C.02.025 and C.02.026. SOR/2012-129, s. 5
Food and Drug Regulations — C.03.312
C.03.312 Despite any other provision of these Regulations respecting labelling, the sponsor shall ensure that the study drug (a) bears an inner label that sets out both of the following: (i) the unique batch number for the study drug, and (ii) the radiation warning symbol set out in Schedule 3 to the Radiation Protection Regulations and the words “ RAYONNEMENT — DANGER — RADIATION”; and (b) is accompanied by a package insert that sets out all of the following information: (i) a statement that indicates that the study drug is to be used only under the supervision of a qualified investigator, (ii) the chemical or generic name of the active ingredients in the study drug, (iii) the name and civic address of the manufacturer, (iv) the name and civic address of the sponsor, (v) the code or other identification of the protocol, (vi) the warnings and precautions in respect of the use of the study drug, and (vii) a list of the possible adverse reactions that are associated with the use of the study drug. SOR/2012-129, s. 5; SOR/2018-69, s. 24(F) SOR/2021-46, s. 9(F)
Food and Drug Regulations — C.03.313
C.03.313 (1) On the Minister’s written request, a sponsor shall submit, within the period specified in the request, information to establish the safety of the study drug if the Minister has reason to believe any of the following: (a) the use of the study drug may endanger the health of a study subject or other person; (b) the study may be contrary to the best interests of the study subjects; (c) a qualified investigator is not respecting their undertaking made under paragraph C.03.315(3)(f); or (d) information submitted in respect of the study drug or study is false or misleading. (2) The Minister may, by notice in writing, require the sponsor to provide the Minister with any information or records referred to in subsection C.03.315(3) to assess the safety of the study drug or the health of the study subjects or other persons, by the date specified in the notice. SOR/2012-129, s. 5
Food and Drug Regulations — C.03.314
C.03.314 (1) During the course of a study, the sponsor shall notify the Minister of any serious adverse reaction or serious unexpected adverse reaction that occurs inside or outside Canada, within the following period: (a) if the adverse reaction is fatal or life-threatening, within seven days after becoming aware of it; or (b) if the adverse reaction is not fatal or life-threatening, within 15 days after becoming aware of it. (2) The sponsor shall, within eight days after having notified the Minister under subsection (1), file with the Minister a complete report in respect of the adverse reaction, including an assessment of the importance and implication of the findings. (3) Sections C.01.016 to C.01.020 do not apply to study drugs. SOR/2012-129, s. 5
Food and Drug Regulations — C.03.315
C.03.315 (1) The sponsor shall record, handle and store all information in respect of a study in a way that allows it to be reported completely and accurately and to be interpreted and verified. (2) The sponsor shall maintain complete and accurate records to establish that the study is conducted in accordance with these Regulations. (3) The sponsor shall maintain all of the following records in respect of the use of the study drug in each study: (a) records respecting all adverse reactions that occur inside or outside Canada, including the indications for use and the dosage form of the study drug at the time of the adverse reaction; (b) written procedures for subject monitoring and for the documentation and reporting of adverse reactions; (c) articles from scientific journals or other publications that were used in support of the safety profile of the study drug in respect of humans; (d) records in respect of each study subject, including respecting their enrolment, a copy of their signed consent form and sufficient information to enable them to be identified and contacted in the event that the sale of the study drug may endanger their health or that of another person; (e) records respecting the shipment, receipt, sale, return and destruction or other disposition of the study drug; (f) for each study site, an undertaking, dated and signed by the qualified investigator before the start of the study, that they will (i) conduct the study in accordance with good clinical practices, and (ii) on discontinuance of the study by the sponsor, for any reason related to health or safety, immediately inform both the study subjects and the research ethics board of the discontinuance, provide them with the reasons for the discontinuance and advise them in writing of any potential risks to the health of study subjects or other persons; (g) for each study site, a copy of the informed consent form; and (h) for each study site, a copy of the certifying statement described in paragraph C.03.307(2)(q), of the protocol for the study and of the statement of the risks and anticipated benefits arising to the health of study subjects as a result of participating in the study that is set out in the informed consent form. (4) The sponsor shall maintain all records for five years after the day on which the study ends. SOR/2012-129, s. 5
Food and Drug Regulations — C.03.316
C.03.316 (1) If a sponsor discontinues a study in its entirety or at a study site, the sponsor shall notify all qualified investigators of the discontinuance as soon as possible in writing, and include in the notice the reasons for the discontinuance and whether the study presented any risks to the health of study subjects or other persons. (2) If the discontinuance is for reasons that would affect the health or safety of study subjects or other persons, the sponsor shall notify the Minister in writing within 15 days after the discontinuance, and include in the notice the reasons for the discontinuance and whether it will have an impact on any proposed or ongoing studies in respect of the study drug in Canada by the sponsor. SOR/2012-129, s. 5
Food and Drug Regulations — C.03.317
C.03.317 (1) The Minister shall suspend an authorization to sell or import a study drug, in its entirety or in respect of a study site, in any of the following circumstances: (a) information provided by the sponsor under section C.03.307, C.03.308 or C.03.313 proves to be inaccurate or incomplete; (b) the sponsor fails to provide the Minister with sufficient information to establish the safety of the study drug pursuant to a written request under section C.03.313, by the date specified in the request; (c) the sponsor fails to notify the Minister of an adverse reaction or file a report in respect of an adverse reaction in accordance with section C.03.314; or (d) the sponsor contravenes a provision of these Regulations or any provision of the Act in relation to the study drug. (2) In determining whether to suspend an authorization in its entirety or in respect of a study site, the Minister shall consider whether the reason for the suspension affects the study in its entirety or affects only a certain study site. (3) Before suspending an authorization, the Minister shall send the sponsor a notice that (a) specifies whether the suspension is of the study authorization in its entirety or in respect of a study site and sets out the reasons for the proposed suspension and the effective date; (b) if applicable, specifies the corrective action that the sponsor must take and the period within which it must be taken; and (c) gives the sponsor a reasonable opportunity to be heard in writing concerning the proposed suspension. (4) Despite subsection (3), the Minister shall immediately suspend an authorization if she or he has reason to believe that it is necessary to do so to prevent injury to the health of a study subject or any other person. (5) When the Minister suspends an authorization under subsection (4), the Minister must send the sponsor a notice that (a) sets out the reasons for the suspension; (b) if applicable, specifies the corrective action that the sponsor must take and the period within which it must be taken; and (c) gives the sponsor a reasonable opportunity to be heard in writing concerning the suspension. SOR/2012-129, s. 5
Food and Drug Regulations — C.03.318
C.03.318 (1) Subject to subsection (2), the Minister shall reinstate the authorization if the sponsor provides the Minister with sufficient evidence to establish that the study does not present a risk of injury to the health of study subjects or other persons, within the following periods: (a) in the case of a suspension under subsection C.03.317(1), 30 days after the day on which the suspension is effective; or (b) in the case of a suspension under subsection C.03.317(4), the period specified in the notice sent under subsection C.03.317(5). (2) If the Minister does not reinstate any part of an authorization that was suspended, the Minister shall amend the authorization to remove that part. SOR/2012-129, s. 5
Food and Drug Regulations — C.03.319
C.03.319 (1) The Minister shall cancel an authorization, in its entirety or in respect of a study site, in either of the following circumstances: (a) the study is discontinued in its entirety or at that study site by the sponsor under section C.03.316; or (b) the sponsor fails to provide the Minister with the evidence required by subsection C.03.318(1) within the specified period. (2) When the Minister cancels all or part of an authorization, she or he shall send the sponsor a notice that sets out the reasons for the cancellation and the effective date. SOR/2012-129, s. 5
Food and Drug Regulations — C.04.001
C.04.001 The following definitions apply in this Division. biological source material means (a) biological material sourced or derived from humans; (b) animals, including insects, or any biological material sourced or derived from them; (c) plants or any biological material sourced or derived from them; or (d) micro-organisms, including bacteria, viruses, fungi and bacteriophages, or any biological material sourced or derived from them. ( matériel d’origine biologique ) drug means a drug that is listed in Schedule D to the Act that is in dosage form or an active ingredient that can be used in the preparation of a drug listed in that Schedule. ( drogue ) holder , in respect of a drug identification number assigned for a drug, means the manufacturer to whom a document setting out the number was issued under subsection C.01.014.2(1). ( titulaire ) SOR/97-12, s. 31; SOR/2013-74, s. 16 SOR/2024-238, s. 23
Food and Drug Regulations — (a)
biological source material means (a) biological material sourced or derived from humans; (b) animals, including insects, or any biological material sourced or derived from them; (c) plants or any biological material sourced or derived from them; or (d) micro-organisms, including bacteria, viruses, fungi and bacteriophages, or any biological material sourced or derived from them. ( matériel d’origine biologique )
Food and Drug Regulations — Food and Drug Regulations
drug means a drug that is listed in Schedule D to the Act that is in dosage form or an active ingredient that can be used in the preparation of a drug listed in that Schedule. ( drogue )
Food and Drug Regulations — Food and Drug Regulations
holder , in respect of a drug identification number assigned for a drug, means the manufacturer to whom a document setting out the number was issued under subsection C.01.014.2(1). ( titulaire )
Food and Drug Regulations — C.04.001.1
C.04.001.1 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.002
C.04.002 It is prohibited for a distributor or importer of a drug to sell the drug unless it has been fabricated, packaged/labelled and tested in accordance with this Division. SOR/97-12, s. 33 SOR/2024-238, s. 23
Food and Drug Regulations — C.04.003
C.04.003 It is prohibited for a person to sell a drug that they have fabricated, packaged/labelled or tested unless they have fabricated, packaged/labelled or tested it, as the case may be, in accordance with this Division. SOR/2024-238, s. 23
Food and Drug Regulations — C.04.004
C.04.004 (1) It is prohibited for a person to use biological source material in the fabrication of a drug unless (a) the biological source material is (i) prepared and stored in a manner that ensures its suitability for use in the fabrication of the drug, and (ii) collected, in the case of material of human or animal origin, under medical or veterinary supervision, as the case may be; (b) the person collects the information that is necessary to allow the tracing of the biological source material; and (c) any human from whom, or animal from which, the biological source material is collected — or any animal that is such material — is free from any disease that would make the material unsuitable for use in the fabrication of the drug. (2) A person who uses biological source material in the fabrication of a drug must ensure that the material meets any specifications for the material that have been provided to the Minister in connection with the drug. (3) A person who uses biological source material in the fabrication of a drug must retain any documents containing the information referred to in paragraph (1)(b) for a period that they determine after taking into account the following factors, but the period must end no earlier than five years after the day on which the biological source material was last used in the fabrication of the drug: (a) the nature of the biological source material; (b) the risks associated with the biological source material; (c) the manner in which the biological source material is used in the fabrication of the drug; and (d) if the fabricated drug is in dosage form, the intended use of the drug. SOR/2024-238, s. 23
Food and Drug Regulations — C.04.005
C.04.005 (1) Every person who fabricates a drug and every person who packages a drug in an immediate container must (a) segregate all work involving infectious agents that require special handling, including spore-bearing pathogenic micro-organisms; and (b) minimize the possibility of contamination of biological source material and drugs at the premises where the person fabricates or packages the drug, including by taking measures to protect against infection any individual who has access to the area where the person fabricates or packages the drug. (2) It is prohibited for a person to conduct laboratory procedures of a diagnostic nature in their premises unless the conduct of those procedures is segregated from the fabrication, packaging/labelling and testing of drugs. SOR/2024-238, s. 23
Food and Drug Regulations — C.04.006
C.04.006 Reference preparations that are used to test the purity or potency of a drug must allow for the control of the quality of the drug. SOR/2024-238, s. 23
Food and Drug Regulations — C.04.007
C.04.007 (1) In this section, suitable for sale , in respect of a lot of a drug, means that the lot has been fabricated, packaged/labelled and tested in accordance with these Regulations and in a manner that is consistent with information provided to the Minister regarding the quality and safety of the drug. (2) The Minister may, for the purpose of assessing whether a lot of a drug in dosage form is suitable for sale, request that the following persons provide the Minister with any information, samples of the drug or its active ingredients, or material to be used to test the samples: (a) a fabricator of the drug; (b) a packager/labeller of the drug; (c) an importer of the drug; or (d) the holder of the drug identification number. (3) It is prohibited for a person who is requested to provide information, samples or material under subsection (2), and any other person whom the Minister notifies of the request, to sell drugs from the lot to which the request relates unless the Minister notifies the person that the lot is suitable for sale. SOR/2024-238, s. 23
Food and Drug Regulations — C.04.008
C.04.008 The holder of the drug identification number for a drug in dosage form must, at the request of the Minister, provide the Minister, on an annual basis or at any longer interval specified by the Minister, with information regarding the quality of the drug and its active ingredients, including information regarding the consistency of the fabrication and packaging processes for the drug and the ingredients. SOR/2024-238, s. 23
Food and Drug Regulations — C.04.009
rug’s potency, if applicable, unless the drug contains more than one medicinal ingredient and the drug’s brand name is unique for a particular potency of the drug, (viii) the drug’s lot number, (ix) the drug’s expiration date, (x) the drug’s route of administration, and (xi) any other information that is necessary to prevent injury to human health; and (b) the outer label meets the applicable requirements of these Regulations. (7) The expiration date referred to in paragraph (2)(e) and subparagraph (6)(a)(ix) may be omitted from the label of a drug that is to be stockpiled by the following entities for use in emergency situations if the date is communicated by an alternative means to the individuals who administer the drug: (a) the Government of Canada or the government of a province for the use of a department or agency of that government; or (b) a municipal government or an institution of a municipal government. SOR/2024-238, s. 23
Food and Drug Regulations — Food and Drug Regulations
SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE NOUVELLE POUR USAGE EXCEPTIONNEL AUX FINS DE [indication de la fin] EN SE FONDANT SUR DES ESSAIS CLINIQUES RESTREINTS CHEZ L’ÊTRE HUMAIN. ”
Food and Drug Regulations — C.04.010
C.04.010 (1) In the case of a drug in dosage form that is a prescription drug, the symbol “Pr” must be shown on (a) the upper left quarter of the principal display panel of both the inner and the outer labels; or (b) if the drug is packaged in a single-dose container, on the upper left quarter of the principal display panel of the outer label. (2) Subsection (1) does not apply to a drug that is (a) sold to a person who holds an establishment licence under Division 1A; or (b) sold by a pharmacist under a prescription or by a practitioner, if its label shows suitable directions for use and meets the requirements set out in section C.01.005. SOR/2024-238, s. 23
Food and Drug Regulations — C.04.011 and C.04.012
C.04.011 and C.04.012 [Repealed, SOR/97-12, s. 36]
Food and Drug Regulations — C.04.013
C.04.013 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.014
C.04.014 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.015
C.04.015 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.016
C.04.016 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.017
C.04.017 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.018
C.04.018 [Repealed, SOR/2024-238, s. 23]
Food and Drug Regulations — C.04.019
C.04.019 [Repealed, SOR/2024-238, s. 23]