GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Benzodiazepines and Other Targeted Substances Regulations — (a)
hospital means a facility that (a) is licensed, approved or designated as a hospital by a province under the laws of the province to provide health care or treatment to persons or animals; or (b) is owned or operated by the government of Canada or of a province and that provides health services. ( hôpital )
Benzodiazepines and Other Targeted Substances Regulations — Benzodiazepines and Other Targeted Substances Regulations
import permit [Repealed, SOR/2019-170, s. 1]
Benzodiazepines and Other Targeted Substances Regulations — Benzodiazepines and Other Targeted Substances Regulations
international obligation means an obligation relative to a targeted substance set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres. ( obligation internationale )
Benzodiazepines and Other Targeted Substances Regulations — Benzodiazepines and Other Targeted Substances Regulations
licensed dealer means the holder of a licence issued under section 17.1. ( distributeur autorisé )
Benzodiazepines and Other Targeted Substances Regulations — Benzodiazepines and Other Targeted Substances Regulations
midwife has the same meaning as in section 1 of the New Classes of Practitioners Regulations . ( sage-femme )
Benzodiazepines and Other Targeted Substances Regulations — Benzodiazepines and Other Targeted Substances Regulations
nurse practitioner has the same meaning as in section 1 of the New Classes of Practitioners Regulations . ( infirmier praticien )
Benzodiazepines and Other Targeted Substances Regulations — Benzodiazepines and Other Targeted Substances Regulations
pharmacist means a person who is entitled under the laws of a province to practise pharmacy and is practising pharmacy in that province. ( pharmacien )
Benzodiazepines and Other Targeted Substances Regulations — Benzodiazepines and Other Targeted Substances Regulations
podiatrist has the same meaning as in section 1 of the New Classes of Practitioners Regulations . ( podiatre )
Benzodiazepines and Other Targeted Substances Regulations — Benzodiazepines and Other Targeted Substances Regulations
prescription means an authorization given by a practitioner that a stated amount of a targeted substance be dispensed for the person named in it or the animal identified in it. ( ordonnance )
Benzodiazepines and Other Targeted Substances Regulations — Benzodiazepines and Other Targeted Substances Regulations
qualified person in charge means the individual designated under subsection 15(1). ( responsable qualifié )
Benzodiazepines and Other Targeted Substances Regulations — Benzodiazepines and Other Targeted Substances Regulations
Security Directive means the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis , as amended from time to time and published by the Government of Canada on its website. ( Directive en matière de sécurité )
Benzodiazepines and Other Targeted Substances Regulations — Benzodiazepines and Other Targeted Substances Regulations
senior person in charge means the individual designated under section 14. ( responsable principal )
Benzodiazepines and Other Targeted Substances Regulations — (a)
specified name means, in respect of a controlled substance included in Schedule 1, (a) the name specified in column 1 of an item of Schedule 2, but, if only the chemical name is specified, means the chemical name specified in column 2 of that item; or (b) if the controlled substance is not specified in Schedule 2, its chemical name and, if available, its common name. ( nom spécifié )
Benzodiazepines and Other Targeted Substances Regulations — (a)
targeted substance means (a) a controlled substance set out in Schedule 1; or (b) in respect of a midwife, nurse practitioner or podiatrist, a controlled substance set out in Schedule 1 that the midwife, nurse practitioner or podiatrist may prescribe, possess or conduct an activity with, in accordance with section 3 of the New Classes of Practitioners Regulations . ( substance ciblée )
Benzodiazepines and Other Targeted Substances Regulations — (a)
test kit means a kit (a) that contains a targeted substance and a reagent system or buffering agent; (b) that is used during the course of a chemical or analytical procedure to test for the presence or quantity of a targeted substance for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and (c) the contents of which are not intended or likely to be consumed by, or administered to, a person or an animal. ( nécessaire d’essai )
Benzodiazepines and Other Targeted Substances Regulations — Benzodiazepines and Other Targeted Substances Regulations
transhipment [Repealed, SOR/2019-170, s. 1]
Benzodiazepines and Other Targeted Substances Regulations — 2
Member of police force 2 A member of a police force or a person acting under their direction and control who, in respect of the conduct of the member or person, is exempt from the application of subsection 4(2) or section 5, 6 or 7 of the Act by virtue of the Controlled Drugs and Substances Act (Police Enforcement) Regulations is, in respect of that conduct, exempt from the application of these Regulations. SOR/2010-223, s. 2(E) SOR/2019-170, s. 2
Benzodiazepines and Other Targeted Substances Regulations — 3
Authorized persons 3 (1) A person is authorized to possess a targeted substance set out in Part 2 of Schedule 1 if the person has obtained the targeted substance in accordance with these Regulations, in the course of activities conducted in connection with the administration or enforcement of an Act or regulation, or from a person who is exempt under section 56 of the Act from the application of subsection 5(1) of the Act with respect to that targeted substance, and the person (a) requires the targeted substance for their business or profession and is (i) a licensed dealer, (ii) a pharmacist, or (iii) a practitioner who is registered and entitled to practise in the province in which they possess the targeted substance; (b) is a practitioner who is registered and entitled to practise in a province other than the province in which they possess the targeted substance for emergency medical purposes only; (c) is a hospital employee or a practitioner in a hospital; (d) has obtained the targeted substance for their own use or the use of another person for whom, or an animal for which, they are responsible (i) from a practitioner, or (ii) in accordance with a prescription that was not issued or obtained in contravention of these Regulations; (e) is employed as an inspector, a member of the Royal Canadian Mounted Police, a police constable, a peace officer or a member of the technical or scientific staff of the Government of Canada, the government of a province or a university in Canada and their possession is in connection with that employment; (f) is exempt under section 56 of the Act with respect to the possession of that targeted substance and their possession is for a purpose set out in the exemption; (g) has imported the targeted substance in accordance with section 68 for their own use or the use of another person for whom, or an animal for which, they are responsible; (h) is a person who, in accordance with a permit for transit or transhipment, is responsible for the targeted substance while it is in transit or in transhipment in Canada; or (i) is the Minister. Agent or mandatary (2) A person is authorized to possess a targeted substance set out in Part 2 of Schedule 1 if the person is acting as the agent or mandatary of any person who is authorized to possess it in accordance with any of paragraphs (1)(a) to (d) and (f) to (h). Agent or mandatary — person referred to in paragraph (1)(e) (3) A person is authorized to possess a targeted substance set out in Part 2 of Schedule 1 if they (a) are acting as the agent or mandatary of a person who they have reasonable grounds to believe is a person referred to in paragraph (1)(e); and (b) possess the targeted substance for the purpose of assisting that person in the administration or enforcement of an Act or regulation. Export by individual (4) An individual may possess a targeted substance set out in Part 2 of Schedule 1 for the purpose of exporting that substance in accordance with section 69. SOR/2019-170, s. 2
Benzodiazepines and Other Targeted Substances Regulations — 4
Authorized activities 4 A person may sell, possess or otherwise deal in a test kit if the following conditions are met: (a) a registration number has been issued for the test kit under section 6 or subsection 10(2) and has not been cancelled under subsection 9(1); (b) the test kit is labelled with (i) the registration number, and (ii) in the case of a test kit that is not subject to the labelling requirements of the Medical Devices Regulations , (A) the name and address of the manufacturer or assembler or, if the test kit is manufactured or assembled in accordance with a custom order, the name and address of the person for whom the test kit was manufactured or assembled, and (B) its brand name; and (c) the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose. SOR/2010-223, s. 3(F); SOR/2018-69, s. 78(E) SOR/2019-170, s. 2
Benzodiazepines and Other Targeted Substances Regulations — 5
Application for registration number 5 (1) The manufacturer or assembler of a test kit or, if the test kit is manufactured or assembled in accordance with a custom order, the person for whom the test kit was manufactured or assembled, may obtain a registration number for the test kit by submitting to the Minister an application containing (a) the brand name of the test kit; (b) a detailed description of the design and construction of the test kit; (c) a detailed description of the targeted substance and other substances, if any, contained in the test kit, including (i) the specified name of the targeted substance and the name of any other substance, (ii) if the substance is a salt, the name of the salt, and (iii) the quantity of the substance; (d) a description of the proposed use of the test kit; and (e) the directions for use of the test kit. Signature and attestation (2) The application must (a) be signed and dated by the person authorized by the applicant for that purpose; and (b) include an attestation by that person that all of the information submitted in support of the application is correct and complete to the best of their knowledge. Additional information and documents (3) The applicant must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. SOR/2019-170, s. 2
Benzodiazepines and Other Targeted Substances Regulations — 6
Issuance of registration number 6 Subject to section 7, on completion of the review of the application for a registration number, the Minister must issue a registration number for the test kit, preceded by the letters “TK”, if the Minister determines that the test kit will only be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose. SOR/2019-170, s. 2
Benzodiazepines and Other Targeted Substances Regulations — 7
Refusal of registration number 7 (1) The Minister must refuse to issue a registration number for a test kit if the Minister has reasonable grounds to believe that (a) the test kit poses a risk to public health or safety, including the risk of the targeted substance in the test kit being diverted to an illicit market or use, because (i) the total amount of the targeted substance in the test kit is too high, or (ii) the adulterating or denaturing agent in the test kit is not likely to prevent or deter the consumption of the targeted substance in the test kit by a person or animal or the administration of that substance to a person or animal; or (b) the test kit is likely to be used for a purpose other than one referred to in section 6. Notice (2) Before refusing to issue a registration number, the Minister must send the applicant a notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard. SOR/2019-170, s. 2
Benzodiazepines and Other Targeted Substances Regulations — 8
Labelling — non-application 8 The symbol required by subparagraph C.01.004(1)(b)(iv) of the Food and Drug Regulations does not need to appear on the label of a test kit if the label displays the registration number that has been issued for the test kit under section 6 or subsection 10(2). SOR/2019-170, s. 2
Benzodiazepines and Other Targeted Substances Regulations — 9
Cancellation of registration number 9 (1) The Minister must cancel the registration number of a test kit if (a) the Minister receives a notice from the holder of the registration number stating that they have ceased to conduct all activities with respect to the test kit; (b) the test kit is a medical device and is no longer approved for sale in Canada under the Medical Devices Regulations ; (c) one of the circumstances referred to in subparagraph 7(1)(a)(i) or (ii) exists; or (d) the Minister has reasonable grounds to believe that the test kit is being used for a purpose other than a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose and that the test kit poses a risk to public health or safety, including the risk of the targeted substance in the test kit being diverted to an illicit market or use. Effect of cancellation (2) When the registration number of a test kit is cancelled, the number (a) must not be displayed on the label of any test kit manufactured or assembled after the cancellation; and (b) in the case of a cancellation under paragraph (1)(a), must remain on the label of any existing test kit until all of the test kits with that registration number are disposed of. SOR/2019-170, s. 2
Benzodiazepines and Other Targeted Substances Regulations — 10
Application for new number 10 (1) The following persons may, after a period of 90 days following the cancellation of the registration number of a test kit, obtain a new registration number by submitting to the Minister an application that is supported by proof that the circumstances that gave rise to the cancellation have been corrected: (a) the manufacturer or assembler of the test kit; or (b) if the test kit is manufactured or assembled in accordance with a custom order, the person for whom the test kit was manufactured or assembled. New number (2) On completion of the review of the application, the Minister must issue a new registration number for the test kit unless a condition referred to in any of paragraphs 9(1)(b) to (d) applies. SOR/2010-223, s. 4 SOR/2019-170, s. 2
Benzodiazepines and Other Targeted Substances Regulations — 11
Notice to Minister 11 The holder of a registration number for a test kit must inform the Minister in writing, within 30 days after the occurrence, if they have (a) ceased to conduct all activities authorized by section 4 with respect to the test kit; (b) transferred the manufacturing or assembly of the test kit to another person; (c) increased the quantity of targeted substance in the test kit; (d) changed the brand name of the test kit; (e) altered in any manner the adulterating or denaturing agent in the test kit or changed the quantity of either agent in it; or (f) substituted the adulterating or denaturing agent with another one. SOR/2019-170, s. 2
Benzodiazepines and Other Targeted Substances Regulations — 12
General 12 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a targeted substance if they comply with these Regulations and the terms and conditions of their dealer’s licence and any permit issued under these Regulations. Qualified person in charge present (2) A licensed dealer may conduct an activity in relation to a targeted substance at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site. Permit — import and export (3) A licensed dealer must obtain a permit in order to import or export a targeted substance. Possession for export (4) A licensed dealer may possess a targeted substance for the purpose of exporting it if they have obtained it in accordance with these Regulations. SOR/2019-170, s. 2
Benzodiazepines and Other Targeted Substances Regulations — 13
Eligible persons 13 The following persons may apply for a dealer’s licence: (a) an individual who ordinarily resides in Canada; (b) a corporation that has its head office in Canada or operates a branch office in Canada; or (c) the holder of a position that includes responsibility for targeted substances on behalf of the Government of Canada or of a government of a province, a police force, a hospital or a university in Canada. SOR/2019-170, s. 2
Benzodiazepines and Other Targeted Substances Regulations — 14
Senior person in charge 14 An applicant for a dealer’s licence must designate only one individual as the senior person in charge, who has overall responsibility for management of the activities with respect to targeted substances that are specified in the licence application. The applicant may designate themself if the applicant is an individual. SOR/2019-170, s. 2
Benzodiazepines and Other Targeted Substances Regulations — 15
Qualified person in charge 15 (1) An applicant for a dealer’s licence must designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to targeted substances that are specified in the licence application and for ensuring that those activities comply with these Regulations. The applicant may designate themself if the applicant is an individual. Alternate qualified person in charge (2) An applicant for a dealer’s licence may designate an individual as an alternate qualified person in charge, who is authorized to replace the qualified person in charge when that person is absent. The applicant may designate themself if the applicant is an individual. Qualifications (3) Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge: (a) they work at the site specified in the dealer’s licence; (b) they (i) are entitled or, if applicable, registered and entitled by a provincial professional licensing authority or a professional association in Canada and entitled to practise a profession that is relevant to their duties, such as pharmacist, practitioner, pharmacy technician or laboratory technician, (ii) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or (iii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and hold (A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations , or (B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province; (c) they have sufficient knowledge of and experience with the use and handling of the targeted substances specified in the dealer’s licence to properly carry out their duties; and (d) they have sufficient knowledge of the provisions of the Act and these Regulations that are applicable to the activities specified in the dealer’s licence to properly carry out their duties. Exception (4) An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements of paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if (a) no other individual working at the site meets those requirements; (b) those requirements are not necessary for the activities specified in the licence; and (c) the individual has sufficient knowledge — acquired from a combination of education, training or work experience — to properly carry out their duties. SOR/2019-170, s. 2
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Ineligibility 16 An individual is not eligible to be a senior person in charge, a qualified person in charge or an alternate qualified person in charge if, during the 10 years before the day on which the dealer’s licence application is submitted, (a) in respect of a designated substance offence or a designated criminal offence or a designated offence as defined in subsection 2(1) of the Cannabis Act , the individual (i) was convicted as an adult, or (ii) was a young person who received an adult sentence , as those terms are defined in subsection 2(1) of the Youth Criminal Justice Act ; or (b) in respect of an offence committed outside Canada that, if committed in Canada, would have constituted a designated substance offence or a designated criminal offence or a designated offence as defined in subsection 2(1) of the Cannabis Act , (i) the individual was convicted as an adult, or (ii) if they committed the offence when they were at least 14 years old but less than 18 years old, the individual received a sentence that was longer than the maximum youth sentence , as that term is defined in subsection 2(1) of the Youth Criminal Justice Act , that could have been imposed under that Act for such an offence. SOR/2014-260, s. 29(E) SOR/2019-170, s. 2