GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 7
Terms and conditions 7 The Minister may, at any time, impose terms and conditions on a COVID-19 medical device authorization or amend those terms and conditions.
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Prohibition 8 (1) Subject to subsection (2), if the substance of any of the information or material referred to in paragraphs 4 (2)(a) to (d), (f), (h), (j), (k) and (p) and, if applicable, submitted under subsection 10 (1) is significantly different from the substance of the information or material contained in the application for a COVID-19 medical device authorization, (a) the conduct of the clinical trial referred to in the authorization that is issued as a result of that application is no longer authorized for the purposes of section 3.1 of the Act; and (b) the holder of the authorization must not import or sell the COVID-19 medical device for which the authorization was issued. Amendment (2) Subsection (1) does not apply if (a) the holder of the COVID-19 medical device authorization has submitted to the Minister an application to amend the authorization; (b) the Minister determines that the requirements set out in subparagraphs 5 (c)(i) to (iii) are met; (c) the holder has submitted to the Minister any additional information or material requested under subsection 10 (1) in the time, form and manner specified under subsection 10 (2); and (d) the Minister amends the authorization.
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Suspension 9 (1) The Minister may suspend, in whole or in part, a COVID-19 medical device authorization by notice, giving reasons, if (a) the Minister determines that any of the requirements set out in subparagraphs 5 (c)(i) to (iii) is no longer met; (b) the holder of the authorization has not submitted to the Minister any additional information or material requested under subsection 10 (1) in the time, form and manner specified under subsection 10 (2); or (c) the holder of the authorization has contravened these Regulations or any provisions of the Act relating to the device. Reinstatement (2) The Minister must reinstate a COVID-19 medical device authorization if the holder of the authorization submits to the Minister, in the time, form and manner specified by the Minister, information or material that demonstrates that the situation giving rise to the suspension did not exist or has been corrected.
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Additional information and material 10 (1) The Minister may request that an applicant for a COVID-19 medical device authorization or a holder of such an authorization submit any additional information or material, including samples, that is necessary to enable the Minister to determine whether to issue, amend or suspend the authorization. Time, form and manner (2) The applicant or holder must submit the information or material in the time, form and manner specified by the Minister.
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Discontinuance 11 If a holder of a COVID-19 medical device authorization discontinues, in whole or in part, the clinical trial for which the authorization has been issued, the holder must, without delay, (a) notify the Minister, in writing, of the discontinuance and the reasons for it; (b) inform all qualified investigators, in writing, of the discontinuance and the reasons for it and advise them, in writing, of any potential risks to the health of clinical trial subjects, users or other persons; and (c) in respect of each clinical trial site at which the trial is discontinued, stop the importation or sale of the device as of the date of the discontinuance and take all reasonable measures to ensure the recovery of all unused quantities of the device that have been sold.
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Discretionary revocation 12 (1) The Minister may revoke, in whole or in part, a COVID-19 medical device authorization by notice, giving reasons, if the holder of the authorization has not submitted to the Minister, in the time, form and manner specified by the Minister, the information or material referred to in subsection 9 (2). Mandatory revocation (2) The Minister must revoke, in whole or in part, the authorization if the Minister has received a notice of discontinuance referred to in paragraph 11 (a).
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Labelling 13 (1) A person must not import or sell a medical device for which a COVID-19 medical device authorization has been issued or conduct a clinical trial in respect of such a device unless the device has a label that sets out the following information: (a) the name of the device; (b) the name and contact information of the manufacturer; (c) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or device group family; (d) in the case of a Class III or IV device, the control number; (e) if the contents are not readily apparent, an indication of what the package contains, expressed in terms appropriate to the device, such as the size, net weight, length, volume or number of units; (f) a statement indicating that the device is sterile, if the device is to be sold in a sterile condition; (g) the expiry date of the device, if applicable; (h) the medical conditions, purposes and uses for which the device is manufactured, sold or represented, including its performance specifications if those specifications are necessary for proper use; (i) the directions for use, unless directions are not required for the device to be used safely and effectively; (j) any special storage conditions applicable to the device; (k) a statement indicating that the device is an investigational device; (l) a statement indicating that the device is to be used by qualified investigators only; and (m) in the case of an in vitro diagnostic device, a statement indicating that the performance specifications of the device have not been established. Presentation of information (2) The information required by subsection (1) to be set out on the label must be in English and in French.
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Incident reporting 14 A holder of a COVID-19 medical device authorization must, within 10 days after becoming aware of an incident inside or outside Canada involving a COVID-19 medical device for which the authorization has been issued, report the incident to the Minister and specify the nature of the incident and the circumstances surrounding it.
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Records 15 (1) A holder of a COVID-19 medical device authorization must record, handle and store all information in respect of the clinical trial for which the authorization has been issued in a manner that allows for the complete and accurate reporting as well as the interpretation and verification of the information. Content (2) The holder of the authorization must maintain complete and accurate records, which include the information and material referred to in subsection 4 (2), in respect of a COVID-19 medical device for which the authorization has been issued in order to establish that the clinical trial is conducted in accordance with these Regulations. Retention period (3) The holder of the authorization must retain all records for the period during which the authorization has not been revoked in whole.
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Distribution records 16 (1) A holder of a COVID-19 medical device authorization must maintain a distribution record in respect of each device that is imported or sold under the authorization or tested in a clinical trial under the authorization. Withdrawal (2) The distribution record must contain sufficient information to permit complete and rapid withdrawal of the COVID-19 medical device for which the authorization has been issued. Retention period (3) The holder — or former holder, in the case of an authorization that has been revoked in whole — of the authorization must retain the distribution record for the longer of (a) the projected useful life of the device, and (b) two years after the date on which the holder took possession, care or control of the device in Canada. Timely retrieval (4) Distribution records must be maintained in a manner that will allow their timely retrieval.
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Complaint handling 17 A holder of a COVID-19 medical device authorization must, in respect of a COVID-19 medical device for which the authorization has been issued, maintain records of the following: (a) any reported problems relating to the performance characteristics or safety of the device that are received by the holder after the device was first sold in Canada; and (b) all actions taken by the holder in response to those problems.
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Documented procedures 18 A holder of a COVID-19 medical device authorization must, in respect of a COVID-19 medical device for which the authorization has been issued, establish and implement documented procedures that will enable the holder to carry out (a) an effective and timely investigation of the problems referred to in paragraph 17 (a); and (b) an effective and timely recall of the device.
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Information — recall 19 (1) A holder of a COVID-19 medical device authorization must, on or before recalling a COVID-19 medical device for which the authorization has been issued, provide the Minister with the following: (a) the name of the device and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family; (b) the name and contact information of the manufacturer and, if applicable, the importer, as well as the name and contact information of the establishment where the device was manufactured, if different from that of the manufacturer; (c) the reason for the recall, the nature of the defectiveness or possible defectiveness and the date on and circumstances under which it was discovered; (d) an evaluation of the risk associated with the defectiveness or possible defectiveness; (e) the number of affected units of the device that were manufactured or sold in Canada or imported into Canada; (f) the period during which the affected units of the device were sold in Canada; (g) the name of each person to whom the affected device was sold and the number of units sold to each person; (h) a copy of any communication issued with respect to the recall; (i) the proposed strategy for conducting the recall, including the date for beginning the recall, information as to how and when the Minister will be informed of the progress of the recall and the proposed date for its completion; (j) the proposed action to prevent a recurrence of the problem; and (k) the name, title and telephone number of the representative of the holder of the authorization to contact for any information concerning the recall. Information — after completion of recall (2) The holder of the authorization must, as soon as feasible after the completion of the recall, prepare and submit to the Minister a report on (a) the results of the recall; and (b) the action taken to prevent a recurrence of the problem. Submission on holder’s behalf (3) Despite subsections (1) and (2), the holder of the authorization may permit the importer of the COVID-19 medical device to prepare and submit, on the holder’s behalf, the information and material required under those subsections if the importer has the same information and material. Notice to Minister (4) The holder of the authorization must notify the Minister, in writing, if the holder has permitted the importer to prepare and submit the information and material with respect to the recall on the holder’s behalf.
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ce of compliance has not been issued under section C.08.004 or C.08.004.01 of those Regulations, the chemistry and manufacturing information in respect of the drug, including its site of manufacture; and (n) the proposed date for the commencement of the clinical trial at each clinical trial site, if known at the time of submitting the application. Marketed drug (3) If the application for the authorization is in respect of a COVID-19 drug that meets the requirements of paragraphs 27 (a) to (c), the application must also contain (a) a copy of the label of the drug; and (b) information demonstrating that the proposed use of the drug is consistent with the standard of medical practice.
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Issuance 21 The Minister must issue a COVID-19 drug authorization if the following requirements are met: (a) the applicant has submitted to the Minister an application that meets the requirements set out in section 20 ; (b) the applicant has submitted to the Minister any additional information or material requested under subsection 30 (1) in the time, form and manner specified under subsection 30 (2); and (c) the Minister determines that (i) the use of the drug that is to be tested in the clinical trial will not unduly affect the health or safety of clinical trial subjects or other persons, (ii) the clinical trial is not contrary to the best interests of clinical trial subjects, and (iii) the objectives of the clinical trial are achievable.
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Additional information prior to clinical trial 22 A holder of a COVID-19 drug authorization must not import or sell a COVID-19 drug for which the authorization has been issued or conduct a clinical trial in respect of such a drug unless the holder has (a) for each clinical trial site, obtained the approval of a research ethics board in respect of the protocol referred to in paragraph 20 (2)(a) and the informed consent form that contains the statement referred to in paragraph 20 (2)(b); and (b) submitted to the Minister the information and material referred to in subparagraphs 20 (2)(c)(ix) and (x) and paragraphs 20 (2)(d) and (n), if it was not submitted at the time of submitting the application.
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Terms and conditions 23 The Minister may, at any time, impose terms and conditions on a COVID-19 drug authorization or amend those terms and conditions.
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Prohibition 24 (1) Subject to subsection (2), if the substance of any of the information or material referred to in paragraph 20 (2)(a) or (m) is significantly different from the substance of the information or material contained in the application for a COVID-19 drug authorization, (a) the conduct of the clinical trial referred to in the authorization that is issued as a result of that application is no longer authorized for the purposes of section 3.1 of the Act; and (b) the holder of the authorization must not import or sell the COVID-19 drug for which the authorization was issued. Amendment (2) Subsection (1) does not apply if (a) the holder of the COVID-19 drug authorization has submitted to the Minister an application to amend the authorization; (b) for each clinical trial site, the holder has obtained the approval of a research ethics board in respect of the protocol referred to in paragraph 20 (2)(a) and the informed consent form that contains the statement referred to in paragraph 20 (2)(b); (c) the holder has submitted to the Minister the information and material referred to in subparagraphs 20 (2)(c)(ix) and (x) and paragraphs 20 (2)(d) and (n), if it was not submitted at the time of submitting the application; (d) the Minister determines that the requirements set out in subparagraphs 21 (c)(i) to (iii) are met; (e) the holder has submitted to the Minister any additional information or material requested under subsection 30 (1) in the time, form and manner specified under subsection 30 (2); and (f) the Minister amends the authorization. Immediate change (3) Despite subsections (1) and (2), if an immediate change is required to be made to the substance of any of the information or material referred to in paragraph 20 (2)(a) or (m) because the clinical trial or the use of the COVID-19 drug that is tested in the clinical trial endangers the health of a clinical trial subject or other person, the holder of the authorization may immediately make the change. Immediate change — application to amend (4) The holder of the authorization must, within 15 days after making the change referred to in subsection (3), submit the application referred to in subsection (2) to amend the authorization.
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Prohibition — import 25 A holder of a COVID-19 drug authorization must not import a COVID-19 drug for which the authorization has been issued if the sale of the drug would constitute a violation of the Act.
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Prohibition — import and sale 26 A holder of a COVID-19 drug authorization must not import or sell a COVID-19 drug for which the authorization has been issued unless the holder has a representative in Canada who is responsible for the sale of the drug.
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Marketed drugs 27 Paragraphs 20 (2)(e) to (l), section 33 and paragraphs 35 (2)(a) to (c) do not apply to a COVID-19 drug for which a COVID-19 drug authorization has been issued if (a) the use of the drug is consistent with the standard of medical practice; (b) the drug has been issued a notice of compliance under subsection C.08.004(1) of the Food and Drug Regulations or has been assigned a drug identification number under subsection C.01.014.2(1) of those Regulations; and (c) the clinical trial for which the authorization has been issued is in respect of a purpose or condition of use other than that for which the notice of compliance was issued or drug identification number was assigned.
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Good clinical practices 28 A holder of a COVID-19 drug authorization must ensure that the clinical trial for which the authorization has been issued is conducted in accordance with good clinical practices and, without limiting the generality of the foregoing, must ensure that (a) the clinical trial is scientifically sound and clearly described in the protocol; (b) the clinical trial is conducted, and the drug is used, in accordance with the protocol and these Regulations; (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; (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 a health care professional who is authorized to provide medical care and make medical decisions; (g) each person who is involved in the conduct of the clinical trial is qualified by education, training and experience to perform their respective tasks; (h) informed consent, given in accordance with the applicable laws governing consent, is obtained from every person before they participate in the clinical trial, but only after that person has been informed of (i) the risks and anticipated benefits to their 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; and (i) the drug is manufactured, handled and stored in accordance with the applicable good manufacturing practices referred to in Divisions 2 and 4 of Part C of the Food and Drug Regulations , with the exception of sections C.02.019, C.02.025 and C.02.026 of those Regulations.
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Suspension 29 (1) The Minister may suspend, in whole or in part, a COVID-19 drug authorization by notice, giving reasons, if (a) the Minister determines that any of the requirements set out in subparagraphs 21 (c)(i) to (iii) is no longer met; (b) the holder of the authorization has not submitted to the Minister any additional information or material requested under subsection 30 (1) in the time, form and manner specified under subsection 30 (2); or (c) the holder of the authorization has contravened these Regulations or any provisions of the Act relating to the drug. Reinstatement (2) The Minister must reinstate a COVID-19 drug authorization if the holder of the authorization submits to the Minister, in the time, form and manner specified by the Minister, information or material that demonstrates that the situation giving rise to the suspension did not exist or has been corrected.
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Additional information and material 30 (1) The Minister may request that an applicant for a COVID-19 drug authorization or a holder of such an authorization submit any additional information or material, including samples, that is necessary to enable the Minister to determine whether to issue, amend or suspend the authorization. Time, form and manner (2) The applicant or holder must submit the information or material in the time, form and manner specified by the Minister.
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Discontinuance 31 If a holder of a COVID-19 drug authorization discontinues, in whole or in part, the clinical trial for which the authorization has been issued, the holder must, without delay, (a) notify the Minister, in writing, of the discontinuance and the reasons for it; (b) inform all qualified investigators, in writing, of the discontinuance and the reasons for it and advise them, in writing, of any potential risks to the health of clinical trial subjects or other persons; and (c) in respect of each clinical trial site at which the trial is discontinued, stop the importation or sale 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.
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Discretionary revocation 32 (1) The Minister may revoke, in whole or in part, a COVID-19 drug authorization by notice, giving reasons, if the holder of the authorization has not submitted to the Minister, in the time, form and manner specified by the Minister, the information or material referred to in subsection 29 (2). Mandatory revocation (2) The Minister must revoke, in whole or in part, the authorization if the Minister has received a notice of discontinuance referred to in paragraph 31 (a).