GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — Food and Drug Regulations
nursing statutory body means any provincial professional licensing authority that, in accordance with the laws of that province, authorizes a person to practise nursing. ( organisme régissant la profession d’infirmier )
Food and Drug Regulations — G.06.007
Notification of application for order of restoration G.06.007 (1) For the purpose of subsection 24(1) of the Act, notification of an application for an order of restoration must be given in writing to the Attorney General by registered mail and be mailed not less than 15 days before the date on which the application is to be made to a justice. Content of notification (2) The notification must specify (a) the name of the justice to whom the application is to be made; (b) the time and place at which the application is to be heard; (c) details concerning the controlled drug or other thing in respect of which the application is to be made; and (d) the evidence on which the applicant intends to rely to establish that they are entitled to possession of the controlled drug or other thing referred to in paragraph (c). SOR/2019-171, s. 20
Food and Drug Regulations — G.07.001
G.07.001 [Repealed, SOR/2019-171, s. 20]
Food and Drug Regulations — G.07.002
G.07.002 [Repealed, SOR/2019-171, s. 20]
Food and Drug Regulations — J.01.001
erson in charge means the individual designated under section J.01.011. ( responsable principal ) test kit means a kit (a) that contains a restricted drug 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 restricted drug 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 ) SOR/97-228, s. 22; SOR/2004-238, s. 31; SOR/2013-172, s. 1 SOR/2019-171, s. 22 SOR/2021-271, s. 1
Food and Drug Regulations — Food and Drug Regulations
competent authority means a public authority of a foreign country that is authorized under the laws of the country to approve the importation or exportation of restricted drugs into or from the country. ( autorité compétente )
Food and Drug Regulations — Food and Drug Regulations
destroy , in respect of a restricted drug, means to alter or denature it to such an extent that its consumption is rendered impossible or improbable. ( destruction )
Food and Drug Regulations — Food and Drug Regulations
institution means any institution engaged in research on drugs and includes a hospital, a university in Canada or a department or agency of the Government of Canada or of a government of a province or any part of them. ( établissement )
Food and Drug Regulations — Food and Drug Regulations
international obligation means an obligation in respect of a restricted drug set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres. ( obligation internationale )
Food and Drug Regulations — Food and Drug Regulations
licensed dealer means the holder of a licence issued under section J.01.015. ( distributeur autorisé )
Food and Drug Regulations — Food and Drug Regulations
package includes anything in which a restricted drug is wholly or partly contained, placed or packed. ( emballage )
Food and Drug Regulations — Food and Drug Regulations
pharmacist [Repealed, SOR/2021-271, s. 1]
Food and Drug Regulations — Food and Drug Regulations
prescription [Repealed, SOR/2021-271, s. 1]
Food and Drug Regulations — (a)
proper name , in respect of a restricted drug, means the name in English or French that (a) is assigned to the drug in section C.01.002; (b) appears in bold face type for the drug in these Regulations and, if the drug is dispensed in a form other than that described in Part C, the name of the dispensing form; or (c) is assigned in any of the publications mentioned in Schedule B to the Food and Drugs Act in the case of a drug not included in paragraph (a) or (b). ( nom propre )
Food and Drug Regulations — (a)
qualified investigator means, in respect of a restricted drug, a person whose use and possession of that drug are authorized by the Minister under subsection J.01.059(4) and who is (a) employed by or connected with an institution; or (b) engaged in clinical testing or laboratory research in an institution in respect of that drug. ( chercheur compétent )
Food and Drug Regulations — Food and Drug Regulations
qualified person in charge means the individual designated under subsection J.01.012(1). ( responsable qualifié )
Food and Drug Regulations — Food and Drug Regulations
restricted drug means a controlled substance that is set out in the schedule to this Part. ( drogue d’usage restreint )
Food and Drug Regulations — Food and Drug Regulations
senior person in charge means the individual designated under section J.01.011. ( responsable principal )
Food and Drug Regulations — (a)
test kit means a kit (a) that contains a restricted drug 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 restricted drug 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 )
Food and Drug Regulations — J.01.002
Temporary accelerated scheduling J.01.002 (1) The Minister may, by order, add to column 1 of Part III of the schedule to this Part any item or portion of an item listed in Schedule V to the Act for a period referred to in column 2 that is the same as that listed in Schedule V for that item. Deletion (2) The Minister may, by order, delete any item or portion of an item from column 1 of Part III of the schedule to this Part. Deletion — Schedule V to Act (3) An item or portion of an item listed in Part III of the schedule to this Part is deemed to be deleted on the day on which it is no longer listed in Schedule V to the Act. SOR/97-228, s. 23; SOR/99-125, s. 7; SOR/2010-222, s. 23; SOR/2015-210, s. 2; SOR/2018-85, s. 1 SOR/2019-171, s. 22
Food and Drug Regulations — J.01.003
Non-application — member of police force J.01.003 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 this Part. SOR/2004-238, s. 32 SOR/2019-171, s. 22
Food and Drug Regulations — J.01.003.1
J.01.003.1 [Repealed, SOR/2019-171, s. 22]
Food and Drug Regulations — J.01.003.2
J.01.003.2 [Repealed, SOR/2019-171, s. 22]
Food and Drug Regulations — J.01.004
Authorized persons J.01.004 (1) The following persons are authorized to possess a restricted drug listed in Part I of the schedule to this Part: (a) a licensed dealer; (b) a qualified investigator who possesses the drug for the purpose of conducting clinical testing or laboratory research in an institution; (c) an inspector, member of the Royal Canadian Mounted Police, police constable, peace officer, member of the technical or scientific staff of the Government of Canada, the government of a province or a university in Canada who possesses the drug in connection with their employment; (d) a person exempted under section 56 of the Act with respect to the possession of that drug; and (e) the Minister. Agent or mandatary (2) A person is authorized to possess a restricted drug listed in Part I of the schedule to this Part if they are acting as the agent or mandatary of a person referred to in paragraph (1)(a), (b), (d) or (e). Agent or mandatary — person referred to in paragraph (1)(c) (3) A person is authorized to possess a restricted drug listed in Part I of the schedule to this Part 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)(c); and (b) possess the restricted drug for the purpose of assisting that person in the administration or enforcement of an Act or regulation. SOR/2019-171, s. 22 SOR/2021-271, s. 2
Food and Drug Regulations — J.01.004.1
J.01.004.1 [Repealed, SOR/2019-171, s. 22]
Food and Drug Regulations — J.01.005
Authorized activities J.01.005 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 J.01.007 and has not been cancelled under section J.01.008; (b) the test kit bears, on its external surface, (i) the name of the manufacturer, (ii) the trade name or trademark, and (iii) the registration number; and (c) the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.006
Application for registration number J.01.006 (1) The manufacturer of a test kit may obtain a registration number for it by submitting to the Minister an application containing (a) a detailed description of the design and construction of the test kit; (b) a detailed description of the restricted drug and other substances, if any, contained in the test kit, including the qualitative and quantitative composition of each component; and (c) a description of the proposed 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 or document (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/2019-171, s. 22
Food and Drug Regulations — J.01.007
Issuance of registration number J.01.007 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 and that it contains (a) a restricted drug and an adulterating or denaturing agent that are combined in such a manner and in such a quantity, proportion or concentration that the preparation or mixture has no significant drug abuse potential; or (b) such small quantities or concentrations of any restricted drug as to have no significant drug abuse potential. SOR/2004-238, s. 33; SOR/2010-222, s. 25; SOR/2014-260, ss. 9, 16(F) SOR/2019-171, s. 22
Food and Drug Regulations — J.01.007.1
J.01.007.1 [Repealed, SOR/2019-171, s. 22]
Food and Drug Regulations — J.01.007.2
J.01.007.2 [Repealed, SOR/2019-171, s. 22]
Food and Drug Regulations — J.01.007.3
J.01.007.3 [Repealed, SOR/2019-171, s. 22]
Food and Drug Regulations — J.01.007.4
J.01.007.4 [Repealed, SOR/2019-171, s. 22]
Food and Drug Regulations — J.01.007.5
J.01.007.5 [Repealed, SOR/2019-171, s. 22]
Food and Drug Regulations — J.01.007.6
J.01.007.6 [Repealed, SOR/2019-171, s. 22]
Food and Drug Regulations — J.01.007.7
J.01.007.7 [Repealed, SOR/2019-171, s. 22]
Food and Drug Regulations — J.01.007.8
J.01.007.8 [Repealed, SOR/2019-171, s. 22]
Food and Drug Regulations — J.01.007.9
J.01.007.9 [Repealed, SOR/2019-171, s. 22]
Food and Drug Regulations — J.01.007.91
J.01.007.91 [Repealed, SOR/2019-171, s. 22]
Food and Drug Regulations — J.01.008
Cancellation of registration number J.01.008 The Minister must cancel the registration number for a test kit if (a) the test kit is removed from the market by the manufacturer; (b) the Minister has reasonable grounds to believe that the test kit is used or is likely to be used for any purpose other than a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; or (c) the Minister has reasonable grounds to believe that the cancellation is necessary to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.009
General J.01.009 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a restricted drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part. Qualified person in charge present (2) A licensed dealer may conduct an activity in relation to a restricted drug 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 to import or export a restricted drug. Possession for export (4) A licensed dealer may possess a restricted drug for the purpose of exporting it if they have obtained it in accordance with this Part. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.010
Eligible persons J.01.010 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 restricted drugs 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/2019-171, s. 22
Food and Drug Regulations — J.01.011
Senior person in charge J.01.011 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 restricted drugs that are specified in the licence application. The applicant may designate themself if the applicant is an individual. SOR/2004-238, s. 34 SOR/2019-171, s. 22
Food and Drug Regulations — J.01.012
Qualified person in charge J.01.012 (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 restricted drugs that are specified in the licence application and for ensuring that those activities comply with this Part. 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 a person 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 restricted drugs 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 this Part 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/2004-238, s. 34; SOR/2010-222, s. 30 SOR/2019-171, s. 22
Food and Drug Regulations — J.01.012.1
J.01.012.1 [Repealed, SOR/2019-171, s. 22]
Food and Drug Regulations — J.01.012.2
J.01.012.2 [Repealed, SOR/2019-171, s. 22]
Food and Drug Regulations — J.01.013
Ineligibility J.01.013 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/2004-238, s. 34 SOR/2019-171, s. 22
Food and Drug Regulations — J.01.014
its dealer’s licence or by which it intends to identify itself; (b) individual declarations signed and dated by each of the proposed senior person in charge, and qualified person in charge and any proposed alternate qualified person in charge, attesting that the person is not ineligible for a reason specified in section J.01.013; (c) a document issued by a Canadian police force in relation to each person referred to in paragraph (b), indicating whether, during the 10 years before the day on which the application is submitted, the person was convicted as specified in subparagraph J.01.013(a)(i) or received a sentence as specified in subparagraph J.01.013(a)(ii); (d) if any of the persons referred to in paragraph (b) has ordinarily resided in a country other than Canada during the 10 years before the day on which the application is submitted, a document issued by a police force of that country indicating whether in that period that person was convicted as specified in subparagraph J.01.013(b)(i) or received a sentence as specified in subparagraph J.01.013(b)(ii); (e) declaration, signed and dated by the proposed senior person in charge, attesting that the proposed qualified person in charge and any proposed alternate qualified person in charge have the knowledge and experience required under paragraphs J.01.012(3)(c) and (d); and (f) if the proposed qualified person in charge or any proposed alternate qualified person in charge does not meet the requirement of subparagraph J.01.012(3)(b)(i), either (i) a copy of the person’s diploma, certificate or credential referred to in subparagraph J.01.012(3)(b)(ii) or (iii), or (ii) a detailed description of the education, training and work experience that is required under paragraph J.01.012(4)(c), together with supporting evidence, such as a copy of a course transcript or an attestation by the person who provided the training. Signature and attestation (3) The application must (a) be signed and dated by the proposed senior person in charge; and (b) include an attestation by that person that (i) all information and documents submitted in support of the application are correct and complete to the best of their knowledge, and (ii) they have the authority to bind the applicant. Additional information and documents (4) 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/2019-171, s. 22
Food and Drug Regulations — J.01.015
Issuance J.01.015 Subject to section J.01.017, on completion of the review of the licence application, the Minister must issue a dealer’s licence, with or without terms and conditions, that contains (a) the licence number; (b) the name of the licensed dealer, their corporate name or the title of the position they hold; (c) the activities that are authorized and the names of the restricted drugs in respect of which each activity may be conducted; (d) the municipal address of the site at which the dealer may conduct the authorized activities; (e) the security level at the site, determined in accordance with the Security Directive; (f) the effective date of the licence; (g) the expiry date of the licence, which must be not later than three years after its effective date; (h) any terms and conditions that the Minister has reasonable grounds to believe are necessary to (i) ensure that an international obligation is respected, (ii) ensure conformity with the requirements associated with the security level that is referred to in paragraph (e), or (iii) reduce a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use; and (i) if the licensed dealer produces a restricted drug, the quantity that they may produce and the authorized production period. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.016
Validity J.01.016 A dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section J.01.035 or J.01.036. SOR/2019-171, s. 22