GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 33
Labelling 33 (1) A person must not import or sell a COVID-19 drug for which a COVID-19 drug authorization has been issued or conduct a clinical trial in respect of such a drug unless the drug has a label that sets out the following information: (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 contact information of the holder of the authorization; and (g) the protocol code or identification. Presentation of information (2) The information required by subsection (1) to be set out on the label must be in English and in French.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 34
Serious unexpected adverse drug reaction 34 A holder of a COVID-19 drug authorization must inform the Minister of any serious unexpected adverse drug reaction that has occurred inside or outside Canada, in respect of the COVID-19 drug that is tested in the clinical trial, as follows: (a) within 15 days after becoming aware of the reaction, if it is neither fatal nor life‑threatening; and (b) within seven days after becoming aware of the reaction, if it is fatal or life‑threatening.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 35
Records 35 (1) A holder of a COVID-19 drug 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 following, in respect of a COVID-19 drug for which the authorization has been issued in order to establish that the clinical trial is conducted in accordance with good clinical practices and these Regulations: (a) the information and material referred to in paragraphs 20 (2)(e) to (k); (b) records respecting each change made to the information and material referred to in paragraph (a), 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 the indication for use and the dosage form of the drug at the time of the adverse event; (d) in respect of a drug that meets the requirements of paragraphs 27 (a) to (c), records respecting any serious unexpected adverse drug reaction that has occurred inside or outside Canada; (e) records respecting the enrolment of clinical trial subjects, including information that allows all subjects to be identified and contacted in the event that the sale of the drug may endanger the health of the subjects or other persons; (f) records respecting the shipment, receipt, disposition, return and destruction of the drug; (g) for each clinical trial site, an undertaking, signed and dated by the qualified investigator prior to the commencement of their responsibilities in respect of the clinical trial stating 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, in whole or in part, by the holder, 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 subjects or other persons; (h) 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 a research ethics board for that site; and (i) for each clinical trial site, an attestation, signed and dated by a research ethics board, 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. 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 all records referred to in subsection (2) for a period of 15 years.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 36
Remote written informed consent 36 (1) If a qualified investigator is not able to obtain, in person, the written informed consent of a person to participate in a clinical trial in respect of a COVID-19 medical device for which a COVID-19 medical device authorization has been issued or a COVID-19 drug for which a COVID-19 drug authorization has been issued, the qualified investigator may obtain the written informed consent remotely. Non-written informed consent (2) In the case where the person is not able to provide their written informed consent, the qualified investigator may obtain their non-written informed consent if the following conditions are met: (a) the qualified investigator reads the contents of the informed consent form to the person; (b) the person provides their informed consent before a witness; and (c) an attestation by the witness that the person has provided their informed consent is provided to the qualified investigator as soon as feasible.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 37
Exemption — certain drugs 37 (1) A person that is authorized under Division 5 of Part C of the Food and Drug Regulations to sell or import a drug for the purposes of a clinical trial — and any other person that conducts the clinical trial — is, in respect of the clinical trial, exempt from section 3.1 of the Act. Clarification — suspension and cancellation (2) For greater certainty, the exemption does not apply (a) if the authorization to sell or import the drug is suspended in its entirety; or (b) in respect of the conduct of the clinical trial at a clinical trial site, if the authorization to sell or import the drug is suspended or cancelled in respect of that site. Definition of clinical trial (3) In this section, clinical trial has the same meaning as in section C.05.001 of the Food and Drug Regulations .
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 38
Exemption — positron-emitting radiopharmaceuticals 38 (1) A person that is authorized under Division 3 of Part C of the Food and Drug Regulations to sell or import a positron-emitting radiopharmaceutical for the purposes of a study — and any other person that conducts the study — is, in respect of the study, exempt from section 3.1 of the Act. Clarification — suspension and cancellation (2) For greater certainty, the exemption does not apply (a) if the authorization to sell or import the radiopharmaceutical is suspended in its entirety; or (b) in respect of the conduct of the study at a study site, if the authorization to sell or import the radiopharmaceutical is suspended or cancelled in respect of that site.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 39
Exemption — natural health products 39 (1) A person that is authorized under Part 4 of the Natural Health Products Regulations to sell or import a natural health product for the purposes of a clinical trial — and any other person that conducts the clinical trial — is, in respect of the clinical trial, exempt from section 3.1 of the Act. Clarification — suspension and cancellation (2) For greater certainty, the exemption does not apply (a) if the authorization to sell or import the natural health product is suspended in its entirety; or (b) in respect of the conduct of the clinical trial at a clinical trial site, if the authorization to sell or import the natural health product is suspended or cancelled in respect of that site. Definitions (3) The following definitions apply in this section. clinical trial has the same meaning as in section 63 of the Natural Health Products Regulations . ( essai clinique ) natural health product has the same meaning as in subsection 1(1) of the Natural Health Products Regulations . ( produit de santé naturel )
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
clinical trial has the same meaning as in section 63 of the Natural Health Products Regulations . ( essai clinique )
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
natural health product has the same meaning as in subsection 1(1) of the Natural Health Products Regulations . ( produit de santé naturel )
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 40
Exemption — medical devices 40 (1) A person that is authorized under Part 3 of the Medical Devices Regulations to sell a medical device for investigational testing — and any person that conducts the testing of the device — is, in respect of the testing, exempt from section 3.1 of the Act. Exception (2) The exemption does not apply in respect of any person to whom the medical device can no longer be sold as a result of a measure taken by the Minister under subsection 85(2) of the Medical Devices Regulations .
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 41
Suspension — deemed holder 41 (1) An authorization to conduct a clinical trial in respect of a drug is suspended if (a) the holder is deemed to hold the authorization under any of sections 180 to 182 of the Budget Implementation Act, 2019, No. 1 ; and (b) the holder’s authorization to sell or import the drug for the purposes of the clinical trial is suspended under (i) section C.03.317, C.05.016 or C.05.017 of the Food and Drug Regulations , or (ii) section 80 or 81 of the Natural Health Products Regulations . Reinstatement (2) An authorization that is suspended under subsection (1) is reinstated if the authorization referred to in paragraph (1)(b) is reinstated. Revocation — deemed holder (3) An authorization to conduct a clinical trial in respect of a drug or medical device is revoked if (a) the holder is deemed to hold the authorization under any of sections 180 to 183 of the Budget Implementation Act, 2019, No. 1 ; and (b) the holder’s authorization to sell or import the drug or device for the purposes of the clinical trial is cancelled (i) in the case of a drug, under (A) section C.03.319 or paragraph C.05.016(4)(b) or C.05.017(3)(b) of the Food and Drug Regulations , or (B) paragraph 82(b) of the Natural Health Products Regulations , and (ii) in the case of a device, under paragraph 85(2)(b) of the Medical Devices Regulations . Partial suspensions or revocations (4) If the authorization referred to in paragraph (1)(b) or (3)(b) is only partially suspended or cancelled, the authorization to conduct the clinical trial is suspended or revoked to the same extent.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 42
Definition of Interim Order No. 2 42 In sections 43 to 52, Interim Order No. 2 means the Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 , made by the Minister on May 3, 2021, and published in Part I of the Canada Gazette on May 22, 2021.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 43
Applications 43 An application for a COVID-19 medical device authorization or a COVID-19 drug authorization that was submitted to the Minister under Interim Order No. 2 before the day on which this section comes into force and in respect of which no decision has been made before that day is deemed to be an application for a COVID-19 medical device authorization or a COVID-19 drug authorization submitted under these Regulations.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 44
Authorizations 44 A COVID-19 medical device authorization or a COVID-19 drug authorization that was issued or reinstated by the Minister under Interim Order No. 2 before the day on which this section comes into force and that has not been revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization issued or reinstated under these Regulations.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 45
Approval — research ethics board 45 Any approval of a research ethics board that was obtained by a holder of a COVID-19 medical device authorization or a holder of a COVID-19 drug authorization under Interim Order No. 2 before the day on which this section comes into force is deemed to be an approval of the research ethics board obtained by the holder of a COVID-19 medical device authorization or the holder of a COVID-19 drug authorization under these Regulations.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 46
Terms and conditions 46 Any terms and conditions that were imposed on a COVID-19 medical device authorization or a COVID-19 drug authorization by the Minister under Interim Order No. 2 before the day on which this section comes into force are deemed to be terms and conditions imposed on the COVID-19 medical device authorization or the COVID-19 drug authorization under these Regulations.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 47
Amendment applications 47 An application to amend a COVID-19 medical device authorization or a COVID-19 drug authorization that was submitted to the Minister under Interim Order No. 2 before the day on which this section comes into force and in respect of which no decision has been made before that day is deemed to be an application to amend a COVID-19 medical device authorization or a COVID-19 drug authorization submitted under these Regulations.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 48
Amended authorization 48 A COVID-19 medical device authorization or a COVID-19 drug authorization that was amended by the Minister under Interim Order No. 2 before the day on which this section comes into force and that has not been revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization amended to the same extent under these Regulations.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 49
Suspension 49 A COVID-19 medical device authorization or a COVID-19 drug authorization that was suspended in whole or in part by the Minister under Interim Order No. 2 before the day on which this section comes into force and that has not been revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization suspended in whole or in part to the same extent under these Regulations.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 50
Request — additional information and material 50 A request for additional information or material, including samples, that was made by the Minister under Interim Order No. 2 before the day on which this section comes into force is deemed to be a request for additional information or material under these Regulations.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 51
Discontinuance 51 A notice of discontinuance provided to the Minister, or information in respect of discontinuance provided in writing to a qualified investigator, by the holder of a COVID-19 medical device authorization or a COVID-19 drug authorization under Interim Order No. 2 before the day on which this section comes into force is deemed to be a notice of discontinuance or information provided under these Regulations.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 52
Revocation in part 52 A COVID-19 medical device authorization or a COVID-19 drug authorization that was revoked in part by the Minister under Interim Order No. 2 before the day on which this section comes into force and that has not been revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization revoked in part to the same extent under these Regulations.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — Registration
Registration * 57 (1) Subject to subsection (2), these Regulations come into force on the day on which they are registered. Cessation of effect of interim order (2) Sections 1 to 53 come into force on the day following the day on which the Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 , made by the Minister on May 3, 2021, and published in the Part I of the Canada Gazette on May 22, 2021, ceases to have effect. * [Note: Sections 1 to 53 in force February 27, 2022.]
Underused Housing Tax Regulations — 1
Definition of Act 1 In these Regulations, Act means the Underused Housing Tax Act .
Underused Housing Tax Regulations — 1.1
Prescribed property — excluded property 1.1 For the purposes of the portion of the definition residential property in section 2 of the Act before paragraph (a), a particular residential condominium unit that is part of a building containing four or more residential condominium units is prescribed property if (a) a person that is the owner of all or substantially all of the residential condominium units in the building is the owner of the particular residential condominium unit; and (b) all or substantially all of those residential condominium units of which the person is the owner are held by the person for the purpose of providing individuals with continuous occupancy of a residential condominium unit as a place of residence or lodging for a period of at least one month. 2024, c. 17, s. 145
Underused Housing Tax Regulations — Underused Housing Tax Regulations
census metropolitan area means a census metropolitan area within the meaning of the Statistics Canada document entitled Standard Geographical Classification (SGC) 2021 . ( région métropolitaine de recensement )
Underused Housing Tax Regulations — Underused Housing Tax Regulations
population centre means a population centre within the meaning of the Statistics Canada document entitled Standard Geographical Classification (SGC) 2021 . ( centre de population )
Underused Housing Tax Regulations — Underused Housing Tax Regulations
specified census agglomeration means a census agglomeration within the meaning of the Statistics Canada document entitled Standard Geographical Classification (SGC) 2021 that has a total population of at least 30,000. ( agglomération de recensement désignée )
Underused Housing Tax Regulations — 3
Social Insurance Number 3 The Minister may require an individual to provide their Social Insurance Number in a return filed under the Act.
Underused Housing Tax Regulations — 117
117 2022 and subsequent calendar years (2) Subsections 2(2) and (3) of the Underused Housing Tax Regulations , as made by section 116 , apply to the 2022 and subsequent calendar years. Authority and Statutory Instruments Act (3) The Underused Housing Tax Regulations , as made by section 116 , are deemed (a) to have been made under section 84 of the Underused Housing Tax Act ; (b) for the purposes of subsection 5(1) of the Statutory Instruments Act , to have been transmitted to the Clerk of the Privy Council for registration; and (c) to have met the publication requirements of subsection 11(1) of the Statutory Instruments Act .
Underused Housing Tax Regulations — 146
146 (5) Subsection (1) applies to the 2022 calendar year. (6) Subsections (2) and (3) apply to the 2023 and subsequent calendar years. (7) Subsection (4) applies to the 2024 and subsequent calendar years.
Underused Housing Tax Regulations — 170
Repeal 170 (1) The Underused Housing Tax Regulations , section 116 of chapter 19 of the Statutes of Canada, 2022, are repealed.
Critical Habitat of the Striped Bass (Morone saxatilis) St. Lawrence River Population Order — a
Whereas the Striped Bass ( Morone saxatilis ) St. Lawrence River population is a wildlife species that is listed as an endangered species in Part 2 of Schedule 1 to the Species at Risk Act a ; a S.C. 2002, c. 29
Critical Habitat of the Striped Bass (Morone saxatilis) St. Lawrence River Population Order — Critical Habitat of the Striped Bass (Morone saxatilis) St. Lawrence River Population Order
Whereas the recovery strategy that identified the critical habitat of that species has been included in the Species at Risk Public Registry;
Critical Habitat of the Striped Bass (Morone saxatilis) St. Lawrence River Population Order — b
And whereas a portion of the critical habitat of that species is in a place referred to in subsection 58(2) b of that Act and, under subsection 58(5) of that Act, that portion must be excluded from the annexed Order; b S.C. 2015, c. 10, s. 60
Critical Habitat of the Striped Bass (Morone saxatilis) St. Lawrence River Population Order — Critical Habitat of the Striped Bass (Morone saxatilis) St. Lawrence River Population Order
Therefore, the Minister of Fisheries and Oceans, pursuant to subsections 58(4) and (5) of the Species at Risk Act a , makes the annexed Critical Habitat of the Striped Bass (Morone saxatilis) St. Lawrence River Population Order .
Critical Habitat of the Striped Bass (Morone saxatilis) St. Lawrence River Population Order — Critical Habitat of the Striped Bass (Morone saxatilis) St. Lawrence River Population Order
Ottawa, January 6, 2021 La ministre des Pêches et des Océans, Joyce Catherine Murray Minister of Fisheries and Oceans
Critical Habitat of the Striped Bass (Morone saxatilis) St. Lawrence River Population Order — 1
Application 1 Subsection 58(1) of the Species at Risk Act applies to the critical habitat of the Striped Bass ( Morone saxatilis ) St. Lawrence River population – which is identified in the recovery strategy for that species that is included in the Species at Risk Public Registry – other than the portion of that critical habitat that is in a place referred to in subsection 58(2) of that Act, more specifically, in Cap Tourmente National Wildlife Area as described in Part III of Schedule I to the Wildlife Area Regulations , and in Cap-Saint-Ignace Bird Sanctuary, L’Islet Bird Sanctuary, Montmagny Bird Sanctuary, Saint-Vallier Bird Sanctuary and Trois-Saumons Bird Sanctuary as described in Part V of the schedule to the Migratory Bird Sanctuary Regulations .
Critical Habitat of the Striped Bass (Morone saxatilis) St. Lawrence River Population Order — 2
Coming into force 2 This Order comes into force on the day on which it is registered.
Proclamation Declaring a Public Order Emergency — Proclamation Declaring a Public Order Emergency
ELIZABETH THE SECOND, by the Grace of God of the United Kingdom, Canada and Her other Realms and Territories QUEEN, Head of the Commonwealth, Defender of the Faith.
Proclamation Declaring a Public Order Emergency — Proclamation Declaring a Public Order Emergency
TO ALL WHOM these presents shall come or whom the same may in any way concern,
Proclamation Declaring a Public Order Emergency — Proclamation Declaring a Public Order Emergency
Whereas the Governor in Council believes, on reasonable grounds, that a public order emergency exists and necessitates the taking of special temporary measures for dealing with the emergency;
Proclamation Declaring a Public Order Emergency — Proclamation Declaring a Public Order Emergency
Whereas the Governor in Council has, before declaring a public order emergency and in accordance with subsection 25(1) of the Emergencies Act , consulted the Lieutenant Governor in Council of each province, the Commissioners of Yukon and the Northwest Territories, acting with consent of their respective Executive Councils, and the Commissioner of Nunavut;