GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — C.05.006
C.05.006 (1) Subject to subsection (3), a sponsor may sell or import a drug, other than a drug described in subsection (2), for the purposes of a clinical trial if (a) the sponsor has submitted to the Minister an application in accordance with section C.05.005; (b) the Minister does not, within 30 days after the date of receipt of the application, send to the sponsor a notice in respect of the drug indicating that the sponsor may not sell or import the drug for any of the following reasons: (i) that the information and documents in respect of the application (A) were not provided in accordance with these Regulations, or (B) are insufficient to enable the Minister to assess the safety and risks of the drug or the clinical trial, or (ii) that based on an assessment of the application, an assessment of any information submitted under section C.05.009 or a review of any other information, the Minister has reasonable grounds to believe that (A) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person, (B) the clinical trial is contrary to the best interests of a clinical trial subject, or (C) the objectives of the clinical trial will not be achieved; (c) for each clinical trial site, the sponsor has obtained the approval of the research ethics board in respect of the protocol referred to in paragraph C.05.005(a) and in respect of an informed consent form that contains the statement referred to in paragraph C.05.005(b); and (d) before the sale or importation of the drug at a clinical trial site, the sponsor submits to the Minister the information referred to in subparagraphs C.05.005(c)(ix) and (x) and paragraphs C.05.005(d) and (h), if it was not submitted in respect of that clinical trial site at the time of submitting the application. (2) Subject to subsection (3), a sponsor may sell or import a drug for the purposes of a clinical trial in respect of (a) a new drug that has been issued a notice of compliance under subsection C.08.004(1), if the clinical trial is in respect of a purpose or condition of use for which the notice of compliance was issued; or (b) a drug, other than a new drug, that has been assigned a drug identification number under subsection C.01.014.2(1), if the clinical trial is in respect of a use or purpose for which the drug identification number was assigned. (3) A sponsor may not sell or import a drug for the purposes of a clinical trial (a) during the period of any suspension made under section C.05.016 or C.05.017; or (b) after a cancellation made under section C.05.016 or C.05.017. SOR/2001-203, s. 4; SOR/2012-16, s. 3(F)
Food and Drug Regulations — C.05.007
C.05.007 If the sale or importation of a drug is authorized under this Division, the sponsor may make one or more of the following changes if the sponsor notifies the Minister in writing within 15 days after the date of the change: (a) a change to the chemistry and manufacturing information that does not affect the quality or safety of the drug, other than a change for which an amendment is required by section C.05.008; and (b) a change to the protocol that does not alter the risk to the health of a clinical trial subject, other than a change for which an amendment is required by section C.05.008. SOR/2001-203, s. 4; SOR/2012-16, s. 4(F)
Food and Drug Regulations — C.05.008
h C.05.005(a), and the rationale for the amendment; (b) if the application is in respect of an amendment referred to in paragraph (2)(e), a copy of the amended investigator’s brochure or an addendum to the investigator’s brochure that indicates the new information, including supporting toxicological studies and clinical trial safety data; (c) if the application is in respect of an amendment referred to in any of paragraphs (2)(a) to (f) and, as a result of that amendment, it is necessary to amend the statement referred to in paragraph C.05.005(b), a copy of the amended statement that indicates the amendment; and (d) if the application is in respect of an amendment referred to in paragraph (2)(f), a copy of the amended chemistry and manufacturing information that indicates the amendment, and the rationale for that amendment. (4) If the sponsor is required to immediately make one or more of the amendments referred to in subsection (2) because the clinical trial or the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person, the sponsor may immediately make the amendment and shall provide the Minister with the information referred to in subsection (3) within 15 days after the date of the amendment. (5) A sponsor may not sell or import a drug for the purposes of a clinical trial (a) during the period of any suspension made under section C.05.016 or C.05.017; or (b) after a cancellation made under section C.05.016 or C.05.017. SOR/2001-203, s. 4; SOR/2012-16, s. 5
Food and Drug Regulations — C.05.009
C.05.009 If the information and documents submitted in respect of an application under section C.05.005 or an application for amendment under section C.05.008 are insufficient to enable the Minister to determine whether any of the reasons referred to in paragraph C.05.006(1)(b) or C.05.008(1)(b) exist, the Minister may require the sponsor to submit, within two days after receipt of the request, samples of the drug or additional information relevant to the drug or the clinical trial that are necessary to make the determination. SOR/2001-203, s. 4; SOR/2012-16, s. 6(F)
Food and Drug Regulations — C.05.010
C.05.010 Every sponsor shall ensure that a clinical trial is conducted in accordance with good clinical practices and, without limiting the generality of the foregoing, shall ensure that (a) the clinical trial is scientifically sound and clearly described in a protocol; (b) the clinical trial is conducted, and the drug is used, in accordance with the protocol and this Division; (c) systems and procedures that assure the quality of every aspect of the clinical trial are implemented; (d) for each clinical trial site, the approval of a research ethics board is obtained before the clinical trial begins at the site; (e) at each clinical trial site, there is no more than one qualified investigator; (f) at each clinical trial site, medical care and medical decisions, in respect of the clinical trial, are under the supervision of the qualified investigator; (g) each individual involved in the conduct of the clinical trial is qualified by education, training and experience to perform his or her respective tasks; (h) written informed consent, given in accordance with the applicable laws governing consent, is obtained from every person before that person participates in the clinical trial but only after that person has been informed of (i) the risks and anticipated benefits to his or her health arising from participation in the clinical trial, and (ii) all other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial; (i) the requirements respecting information and records set out in section C.05.012 are met; and (j) the drug is manufactured, handled and stored in accordance with the applicable good manufacturing practices referred to in Divisions 2 to 4 except sections C.02.019, C.02.025 and C.02.026. SOR/2001-203, s. 4; SOR/2012-16, s. 7(F)
Food and Drug Regulations — C.05.011
C.05.011 Despite any other provision of these Regulations respecting labelling, the sponsor shall ensure that the drug bears a label that sets out the following information in both official languages: (a) a statement indicating that the drug is an investigational drug to be used only by a qualified investigator; (b) the name, number or identifying mark of the drug; (c) the expiration date of the drug; (d) the recommended storage conditions for the drug; (e) the lot number of the drug; (f) the name and address of the sponsor; (g) the protocol code or identification; and (h) if the drug is a radiopharmaceutical as defined in section C.03.201, the information required by subparagraph C.03.202(1)(b)(vi). SOR/2001-203, s. 4; SOR/2012-16, s. 8(F)
Food and Drug Regulations — C.05.012
C.05.012 (1) The sponsor shall record, handle and store all information in respect of a clinical trial in a way that allows its complete and accurate reporting as well as its interpretation and verification. (2) The sponsor shall maintain complete and accurate records to establish that the clinical trial is conducted in accordance with good clinical practices and these Regulations. (3) The sponsor shall maintain complete and accurate records in respect of the use of a drug in a clinical trial, including (a) a copy of all versions of the investigator’s brochure for the drug; (b) records respecting each change made to the investigator’s brochure, including the rationale for each change and documentation that supports each change; (c) records respecting all adverse events in respect of the drug that have occurred inside or outside Canada, including information that specifies the indication for use and the dosage form of the drug at the time of the adverse event; (d) records respecting the enrolment of clinical trial subjects, including information sufficient to enable all clinical trial subjects to be identified and contacted in the event that the sale of the drug may endanger the health of the clinical trial subjects or other persons; (e) records respecting the shipment, receipt, disposition, return and destruction of the drug; (f) for each clinical trial site, an undertaking from the qualified investigator that is signed and dated by the qualified investigator prior to the commencement of his or her responsibilities in respect of the clinical trial, that states that (i) the qualified investigator will conduct the clinical trial in accordance with good clinical practices, and (ii) the qualified investigator will immediately, on discontinuance of the clinical trial by the sponsor, in its entirety or at a clinical trial site, inform both the clinical trial 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 clinical trial subjects or other persons; (g) for each clinical trial site, a copy of the protocol, informed consent form and any amendment to the protocol or informed consent form that have been approved by the research ethics board for that clinical trial site; and (h) for each clinical trial site, an attestation, signed and dated by the research ethics board for that clinical trial site, stating that it has reviewed and approved the protocol and informed consent form and that the board carries out its functions in a manner consistent with good clinical practices. (4) The sponsor shall maintain all records referred to in this Division for a period of 15 years. SOR/2001-203, s. 4 SOR/2022-18, s. 55
Food and Drug Regulations — C.05.013
C.05.013 (1) The Minister shall require a sponsor to submit, within two days after receipt of the request, information concerning the drug or the clinical trial, or samples of the drug, if the Minister has reasonable grounds to believe that (a) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person; (b) the clinical trial is contrary to the best interests of a clinical trial subject; (c) the objectives of the clinical trial will not be achieved; (d) a qualified investigator is not respecting the undertaking referred to in paragraph C.05.012(3)(f); or (e) information submitted in respect of the drug or the clinical trial is false or misleading. (2) The Minister may require the sponsor to submit, within seven days after receipt of the request, any information or records kept under section C.05.012, or samples of the drug, in order to assess the safety of the drug or the health of clinical trial subjects or other persons. SOR/2001-203, s. 4; SOR/2012-16, s. 9(F)
Food and Drug Regulations — C.05.014
C.05.014 (1) During the course of a clinical trial, the sponsor shall inform the Minister of any serious unexpected adverse drug reaction in respect of the drug that has occurred inside or outside Canada as follows: (a) if it is neither fatal nor life threatening, within 15 days after becoming aware of the information; and (b) if it is fatal or life threatening, within seven days after becoming aware of the information. (2) The sponsor shall, within eight days after having informed the Minister under paragraph (1)(b), submit to the Minister a complete report in respect of that information that includes an assessment of the importance and implication of any findings made. (3) Sections C.01.016 to C.01.020 do not apply to drugs used for the purposes of a clinical trial. SOR/2001-203, s. 4; SOR/2017-18, s. 16
Food and Drug Regulations — C.05.015
C.05.015 (1) If a clinical trial is discontinued by the sponsor in its entirety or at a clinical trial site, the sponsor shall (a) inform the Minister no later than 15 days after the date of the discontinuance; (b) provide the Minister with the reason for the discontinuance and its impact on the proposed or ongoing clinical trials in respect of the drug conducted in Canada by the sponsor; (c) as soon as possible, inform all qualified investigators of the discontinuance and of the reasons for the discontinuance, and advise them in writing of any potential risks to the health of clinical trial subjects or other persons; and (d) in respect of each discontinued clinical trial site, stop the sale or importation of the drug as of the date of the discontinuance and take all reasonable measures to ensure the recovery of all unused quantities of the drug that have been sold. (2) If the sponsor has discontinued the clinical trial in its entirety or at a clinical trial site, the sponsor may resume selling or importing the drug for the purposes of a clinical trial in its entirety or at a clinical trial site if, in respect of each clinical trial site where the sale or importation is to be resumed, the sponsor submits to the Minister the information referred to in subparagraphs C.05.005(c)(ix) and (x) and paragraphs C.05.005(d) and (h). SOR/2001-203, s. 4
Food and Drug Regulations — C.05.016
C.05.016 (1) Subject to subsection (2), the Minister shall suspend the authorization to sell or import a drug for the purposes of a clinical trial, in its entirety or at a clinical trial site, if the Minister has reasonable grounds to believe that (a) the sponsor has contravened these Regulations or any provisions of the Act relating to the drug; (b) any information submitted in respect of the drug or clinical trial is false or misleading; (c) the sponsor has failed to comply with good clinical practices; or (d) the sponsor has failed to provide (i) information or samples of the drug as required under section C.05.009 or C.05.013, or (ii) information or a report under section C.05.014. (2) Subject to section C.05.017, the Minister shall not suspend an authorization referred to in subsection (1) unless (a) the Minister has sent to the sponsor a written notice of the intention to suspend the authorization that indicates whether the authorization is to be suspended in its entirety or at a clinical trial site and the reason for the intended suspension; (b) the sponsor has not, within 30 days after receipt of the notice referred to in paragraph (a), provided the Minister with information or documents that demonstrate that the authorization should not be suspended on the grounds that (i) the situation giving rise to the intended suspension did not exist, or (ii) the situation giving rise to the intended suspension has been corrected; and (c) the Minister has provided the sponsor with the opportunity to be heard in paragraph (b). (3) The Minister shall suspend the authorization by sending to the sponsor a written notice of suspension of the authorization that indicates the effective date of the suspension, whether the authorization is suspended in its entirety or at a clinical trial site and the reason for the suspension. (4) If the Minister has suspended an authorization under subsection (1), the Minister shall (a) reinstate the authorization in its entirety or at a clinical trial site, as the case may be, if within 30 days after the effective date of the suspension the sponsor provides the Minister with information or documents that demonstrate that the situation giving rise to the suspension has been corrected; or (b) cancel the authorization in its entirety or at a clinical trial site, as the case may be, if within 30 days after the effective date of the suspension the sponsor has not provided the Minister with the information or documents referred to in paragraph (a). SOR/2001-203, s. 4; SOR/2012-16, s. 10
Food and Drug Regulations — C.05.017
C.05.017 (1) The Minister shall suspend an authorization to sell or import a drug for the purposes of a clinical trial, in its entirety or at a clinical trial site, before giving the sponsor an opportunity to be heard if the Minister has reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a clinical trial subject or other person. (2) The Minister shall suspend the authorization by sending to the sponsor a written notice of suspension of the authorization that indicates the effective date of the suspension, whether the authorization is suspended in its entirety or at a clinical trial site and the reason for the suspension. (3) If the Minister has suspended an authorization under subsection (1), the Minister shall (a) reinstate the authorization in its entirety or at a clinical trial site, as the case may be, if within 60 days after the effective date of the suspension the sponsor provides the Minister with information or documents that demonstrate that the situation giving rise to the suspension did not exist or that it has been corrected; or (b) cancel the authorization in its entirety or at a clinical trial site, as the case may be, if within 60 days after the effective date of the suspension the sponsor has not provided the Minister with the information or documents referred to in paragraph (a). SOR/2001-203, s. 4; SOR/2012-16, s. 11
Food and Drug Regulations — C.06.001
C.06.001 In this Division, (a) solubility and specific gravity shall be determined at 25°C; (b) tests for identity, quantitative tests for arsenic, lead, copper, zinc, fluorine, and sulphur dioxide, and limit tests shall be made by the official methods; and (c) determination of physical and chemical constants shall be carried out by acceptable methods.
Food and Drug Regulations — C.06.002
C.06.002 [S]. Conjugated estrogens shall be the drug conjugated estrogens described in The Pharmacopeia of the United States of America, XVIII (1970), except that (a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and (b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981. SOR/82-429, s. 5
Food and Drug Regulations — C.06.003
C.06.003 [S]. Conjugated estrogens for injection shall be the drug conjugated estrogens for injection described in The Pharmacopeia of the United States of America, XVIII (1970), except that (a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and (b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981. SOR/82-429, s. 6
Food and Drug Regulations — C.06.004
C.06.004 [S]. Conjugated estrogens tablets shall be the drug conjugated estrogens tablets described in The Pharmacopeia of the United States of America, XVIII (1970), except that (a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and (b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981. SOR/82-429, s. 7
Food and Drug Regulations — C.06.100 and C.06.101
C.06.100 and C.06.101 [Repealed, SOR/80-544, s. 12]
Food and Drug Regulations — C.06.120
C.06.120 [S]. Digitoxin shall be the drug digitoxin described in the Pharmacopeia of the United States of America.
Food and Drug Regulations — C.06.121
C.06.121 [S]. Digitoxin tablets shall be the drug digitoxin tablets described in the Pharmacopeia of the United States of America.
Food and Drug Regulations — C.06.130
C.06.130 [S]. Digoxin shall be the drug digoxin described in the Pharmacopeia of the United States of America.
Food and Drug Regulations — C.06.131
C.06.131 [S]. Digoxin Elixir shall be the drug digoxin elixir described in the Pharmacopeia of the United States of America.
Food and Drug Regulations — C.06.132
C.06.132 [S]. Digoxin injection shall be the drug digoxin injection described in the Pharmacopeia of the United States of America.
Food and Drug Regulations — C.06.133
C.06.133 [S]. Digoxin tablets shall be the drug digoxin tablets described in the Pharmacopeia of the United States of America.
Food and Drug Regulations — C.06.140 to C.06.142
C.06.140 to C.06.142 [Repealed, SOR/80-544, s. 12]
Food and Drug Regulations — C.06.150 to C.06.153
C.06.150 to C.06.153 [Repealed, SOR/80-544, s. 12]
Food and Drug Regulations — C.06.154 to C.06.156
C.06.154 to C.06.156 [Repealed, SOR/80-544, s. 12]
Food and Drug Regulations — C.06.157 to C.06.160
C.06.157 to C.06.160 [Repealed, SOR/80-544, s. 12]
Food and Drug Regulations — C.06.161
C.06.161 [S]. Esterified estrogens shall be the drug esterified estrogens described in the Pharmacopeia of the United States of America.
Food and Drug Regulations — C.06.162
C.06.162 [S]. Esterified estrogens tablets shall be the drug esterified estrogens tablets described in the Pharmacopeia of the United States of America.
Food and Drug Regulations — C.06.170
C.06.170 Gelatin shall be the drug gelatin described in the Pharmacopeia of the United States or the British Pharmacopeia.
Food and Drug Regulations — C.06.180 to C.06.183
C.06.180 to C.06.183 [Repealed, SOR/80-544, s. 12]
Food and Drug Regulations — C.06.230 to C.06.233
C.06.230 to C.06.233 [Repealed, SOR/80-544, s. 12]
Food and Drug Regulations — C.06.240 to C.06.242
C.06.240 to C.06.242 [Repealed, SOR/80-544, s. 12]