GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — G.01.002
Agricultural implants G.01.002 (1) The Act and this Part do not apply in respect of a controlled drug that is contained in an agricultural implant and set out in Part III of the schedule to this Part, but nothing in this section exempts such a drug from the requirements of Part C. Definition of agricultural implant (2) In this section, agricultural implant means a product that is presented in a form suitable to allow sustained release of an active ingredient over a certain period of time and that is intended for insertion under the skin of a food-producing animal for the purpose of increasing weight gain and improving feed efficiency. SOR/97-515, s. 3; SOR/99-125, s. 1; SOR/2003-34, s. 1; SOR/2003-413, s. 1; SOR/2018-69, ss. 67, 68 SOR/2019-171, s. 1
Food and Drug Regulations — G.01.002.1
G.01.002.1 [Repealed, SOR/2019-171, s. 1]
Food and Drug Regulations — G.01.003
Member of police force G.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/80-543, s. 11; SOR/2004-238, s. 2(F) SOR/2019-171, s. 1
Food and Drug Regulations — G.01.004
Application of Parts C and D G.01.004 Except as otherwise provided in this Part, it is prohibited to sell or provide a controlled drug or a preparation that does not comply with all provisions of Parts C and D that are applicable to it. SOR/92-386, s. 2; SOR/97-228, s. 8 SOR/2019-171, s. 1
Food and Drug Regulations — G.01.005
Authorized persons G.01.005 (1) A person is authorized to possess a controlled drug set out in any of items 1 to 3, 8 to 10, 12 to 14, 16 and 17 of Part I of the schedule to this Part if the person has obtained the controlled drug 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 controlled drug, and the person (a) requires the controlled drug 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 that drug; (b) is a practitioner who is registered and entitled to practise in a province other than the province in which they have that possession for emergency medical purposes only; (c) is a hospital employee or a practitioner in a hospital; (d) has obtained the controlled drug for their own use (i) from a practitioner, or (ii) in accordance with a prescription that was not issued or obtained in contravention of these Regulations; (e) is a practitioner of medicine who received the controlled drug under subsection G.06.003(1) or (2) and their possession is for the purpose of providing or delivering it to a person referred to in subsection G.06.003(3); (f) is an agent or mandatary of a practitioner of medicine who received the controlled drug under subsection G.06.003(1) and their possession is for the purpose of providing or delivering it to a person referred to in subsection G.06.003(2); (g) 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; (h) is not a practitioner of medicine referred to in paragraph (e) or an agent or mandatary referred to in paragraph (f), is exempted under section 56 of the Act with respect to possession of that controlled drug and their possession is for a purpose set out in the exemption; or (i) is the Minister. Agent or mandatary (2) A person is authorized to possess a controlled drug referred to in subsection (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 (e), (h) and (i). Agent or mandatary — person referred to in paragraph (1)(g) (3) A person is authorized to possess a controlled drug referred to in subsection (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)(g); and (b) possess the controlled drug for the purpose of assisting that person in the administration or enforcement of an Act or a regulation. SOR/2019-171, s. 1
Food and Drug Regulations — G.01.006
Authorized activities G.01.006 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 G.01.008 and has not been cancelled under section G.01.009; (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. 1
Food and Drug Regulations — G.01.007
Application for registration number G.01.007 (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 controlled 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. 1
Food and Drug Regulations — G.01.008
Issuance of registration number G.01.008 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 controlled 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 controlled drug as to have no significant drug abuse potential. SOR/2019-171, s. 1
Food and Drug Regulations — G.01.009
Cancellation of registration number G.01.009 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 controlled drug from being diverted to an illicit market or use. SOR/2019-171, s. 1
Food and Drug Regulations — G.02.001
General G.02.001 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a controlled 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 controlled 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 controlled drug. Possession for export (4) A licensed dealer may possess a controlled drug for the purpose of exporting it if they have obtained it in accordance with this Part. SOR/2004-238, s. 3 SOR/2019-171, s. 1
Food and Drug Regulations — G.02.001.1
G.02.001.1 [Repealed, SOR/2019-171, s. 1]
Food and Drug Regulations — G.02.001.2
G.02.001.2 [Repealed, SOR/2019-171, s. 1]
Food and Drug Regulations — G.02.002
Eligible persons G.02.002 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 controlled drugs on behalf of the Government of Canada, the government of a province, a police force, a hospital or a university in Canada. SOR/2019-171, s. 1
Food and Drug Regulations — G.02.002.1
G.02.002.1 [Repealed, SOR/2019-171, s. 1]
Food and Drug Regulations — G.02.003
Senior person in charge G.02.003 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 controlled drugs that are specified in the licence application. The applicant may designate themself if the applicant is an individual. SOR/2004-238, s. 4; SOR/2010-222, s. 2; SOR/2012-230, s. 8; SOR/2014-260, ss. 1, 16(F) SOR/2019-171, s. 1
Food and Drug Regulations — G.02.003.1
G.02.003.1 [Repealed, SOR/2019-171, s. 1]
Food and Drug Regulations — G.02.003.2
G.02.003.2 [Repealed, SOR/2019-171, s. 1]
Food and Drug Regulations — G.02.003.3
G.02.003.3 [Repealed, SOR/2019-171, s. 1]
Food and Drug Regulations — G.02.003.4
G.02.003.4 [Repealed, SOR/2019-171, s. 1]
Food and Drug Regulations — G.02.003.5
G.02.003.5 [Repealed, SOR/2019-171, s. 1]
Food and Drug Regulations — G.02.003.6
G.02.003.6 [Repealed, SOR/2019-171, s. 1]
Food and Drug Regulations — G.02.003.7
G.02.003.7 [Repealed, SOR/2019-171, s. 1]
Food and Drug Regulations — G.02.003.8
G.02.003.8 [Repealed, SOR/2019-171, s. 1]
Food and Drug Regulations — G.02.003.9
G.02.003.9 [Repealed, SOR/2019-171, s. 1]
Food and Drug Regulations — G.02.003.91
G.02.003.91 [Repealed, SOR/2019-171, s. 1]
Food and Drug Regulations — G.02.004
Qualified person in charge G.02.004 (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 controlled 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 controlled 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. 4 SOR/2019-171, s. 1
Food and Drug Regulations — G.02.005
Ineligibility G.02.005 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 person 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/2019-171, s. 1
Food and Drug Regulations — G.02.006
me registered with the province under which the applicant intends to conduct the activities specified in 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 G.02.005; (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 G.02.005(a)(i) or received a sentence as specified in subparagraph G.02.005(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 G.02.005(b)(i) or received a sentence as specified in subparagraph G.02.005(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 G.02.004(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 G.02.004(3)(b)(i), either (i) a copy of the person’s diploma, certificate or credential referred to in subparagraph G.02.004(3)(b)(ii) or (iii), or (ii) a detailed description of the education, training and work experience that is required under paragraph G.02.004(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. 1
Food and Drug Regulations — G.02.007
Issuance G.02.007 Subject to section G.02.009, 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 controlled 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 controlled drug being diverted to an illicit market or use; and (i) if the licensed dealer produces a controlled drug, the quantity that they may produce and the authorized production period. SOR/2019-171, s. 1
Food and Drug Regulations — G.02.008
Validity G.02.008 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 G.02.027 or G.02.028. SOR/2019-171, s. 1
Food and Drug Regulations — G.02.009
Refusal G.02.009 (1) The Minister must refuse to issue a dealer’s licence if (a) the applicant may not apply for a licence under section G.02.002; (b) during the 10 years before the day on which the licence application is submitted, the applicant has contravened (i) a provision of the Act, the Cannabis Act or their regulations, or (ii) a term or condition of a licence or permit issued to the applicant under any regulations made under the Act or issued to the applicant under the Cannabis Act or its regulations; (c) during the 10 years before the day on which the application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph G.02.005(a)(i) or (b)(i) or received a sentence as specified in subparagraph G.02.005(a)(ii) or (b)(ii); (d) an activity for which the licence is requested would contravene an international obligation; (e) the applicant does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence is requested; (f) the method referred to in paragraph G.02.006(1)(j) does not permit the recording of information as required under section G.02.071; (g) the applicant has not complied with the requirements of subsection G.02.006(4) or the information and documents that they have provided are not sufficient to complete the review of the licence application; (h) the Minister has reasonable grounds to believe that the applicant has submitted false or misleading information or false or falsified documents in or in support of the licence application; (i) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the applicant has been involved in the diversion of a controlled drug to an illicit market or use or has been involved in an activity that contravened an international obligation; or (j) the Minister has reasonable grounds to believe that the issuance of the licence would likely create a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use. Exceptions (2) The Minister must not refuse to issue a licence under paragraph (1)(b) or (h) if the applicant meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled drug from being diverted to an illicit market or use: (a) the applicant does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and (b) the applicant has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations. Notice (3) Before refusing to issue a licence, 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/2019-171, s. 1
Food and Drug Regulations — G.02.010
Application G.02.010 (1) To apply to renew a dealer’s licence, a licensed dealer must submit to the Minister an application that contains the information and documents referred to in subsections G.02.006(1) and (2). Signature and attestation (2) The application must (a) be signed and dated by the senior person in charge of the site specified in the application; and (b) include an attestation by that person that (i) all of the 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 licensed dealer. Additional information and documents (3) The licensed dealer 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. 1