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Cannabis Regulations (SOR/2018-144)

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Regulations are current to 2021-12-23 and last amended on 2020-10-17. Previous Versions

PART 8Drugs Containing Cannabis (continued)

DIVISION 1Licence (continued)

Licence Issuance

Marginal note:Licence — content

 A cannabis drug licence must set out the following information:

  • (a) the name of the holder of the licence;

  • (b) the licence number;

  • (c) the address of the site where the activity is authorized and, if applicable, of each building within the site;

  • (d) the authorized activity at the site and, if applicable, the authorized activity that may be conducted at each building within the site;

  • (e) the security measures to be implemented to comply with the requirements of either the Security Directive or Part 4;

  • (f) any conditions that the Minister considers appropriate;

  • (g) the effective date of the licence; and

  • (h) the date of expiry of the licence.

Marginal note:Amendment

 A holder of a cannabis drug licence must submit an application to amend the licence if they propose to make any of the following changes:

  • (a) a change to the name of the holder;

  • (b) a change to the authorized activity at the site or the authorized activity at each building within the site; and

  • (c) a change to the security measures implemented to comply with the requirements of either the Security Directive or Part 4.

Individuals in Charge

Marginal note:Senior person in charge

 The holder of a cannabis drug licence must retain the services of one individual as a senior person in charge who has overall responsibility for the management of the activities, with respect to cannabis, that are authorized under the licence.

Marginal note:Qualified person in charge

  •  (1) A holder of a cannabis drug licence must retain the services of one individual as a qualified person in charge who is responsible for supervising the activities with respect to cannabis that are authorized under the licence and for ensuring, on behalf of the holder, that those activities comply with these Regulations.

  • Marginal note:Alternate qualified person in charge

    (2) A holder of a cannabis drug licence may designate an individual as an alternate qualified person in charge who is authorized to replace the qualified person in charge.

  • Marginal note:Qualifications

    (3) Only an individual who meets the following requirements may be a qualified person in charge or an alternate qualified person in charge:

    • (a) they work at the site specified in the licence;

    • (b) they

      • (i) are entitled to practise a profession that is relevant to their duties, such as that of pharmacist, practitioner, pharmacy technician or laboratory technician,

      • (ii) hold a diploma, certificate or credential that is 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

        • (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 drugs to properly carry out their duties; and

    • (d) they are familiar with the provisions of the Act and these Regulations that apply to the holder of the licence.

  • Marginal note:Exception

    (4) A holder of a cannabis drug licence may retain the services of an individual as a qualified person in charge or designate an alternate qualified person in charge who does not meet any of the requirements of paragraph (3)(b) if

    • (a) no other individual working at the site specified in the licence meets those requirements;

    • (b) those requirements are not necessary for the activities that are authorized under the licence; and

    • (c) the individual possesses knowledge — acquired from a combination of education, training and work experience — that is sufficient to enable them to properly carry out their duties.

Marginal note:Ineligibility

  •  (1) 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, in the past 10 years,

    • (a) in respect of a designated offence, a controlled substance offence, or any other offence referred to in subsection (2), 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 offence, a controlled substance offence or any other offence referred to in subsection (2),

      • (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 that could have been imposed under the Youth Criminal Justice Act for such an offence.

  • Marginal note:Other offences

    (2) The other offences for the purpose of subsection (1) are the following:

    • (a) an offence involving the financing of terrorism referred to in any of sections 83.02 to 83.04 of the Criminal Code;

    • (b) an offence involving fraud referred to in any of sections 380 to 382 of the Criminal Code;

    • (c) the offence of laundering proceeds of crime referred to in section 462.31 of the Criminal Code;

    • (d) an offence involving a criminal organization referred to in any of sections 467.11 to 467.13 of the Criminal Code; and

    • (e) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in any of paragraphs (a) to (d). 

Changes

Marginal note:Minister’s approval

  •  (1) A holder of a cannabis drug licence must obtain the Minister’s approval before making the following changes:

    • (a) replacing the senior person in charge;

    • (b) replacing the qualified person in charge; or

    • (c) designating or replacing an alternate qualified person in charge.

  • Marginal note:Application — content

    (2) The holder must, for the purpose of obtaining the Minister’s approval, submit an application that includes the following:

    • (a) a description of the change;

    • (b) in the case of the replacement of the senior person in charge,

      • (i) a declaration signed and dated by the proposed individual attesting that they are not ineligible for a reason specified in section 151,

      • (ii) a document issued by a Canadian police force indicating whether, during the 10 years before the day on which the application is submitted, the individual was convicted as specified in subparagraph 151(1)(a)(i) or received a sentence as specified in subparagraph 151(1)(a)(ii), and

      • (iii) if the individual 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 they were convicted as specified in subparagraph 151(1)(b)(i) or received a sentence as specified in subparagraph 151(1)(b)(ii); and

    • (c) in the case of the designation of an alternate qualified person in charge or in the case of the replacement of the qualified person in charge or an alternate qualified person in charge

      • (i) the declaration and the documents referred to in subparagraphs (b)(i) to (iii),

      • (ii) a declaration, signed and dated by the senior person in charge, attesting that the proposed individual has the knowledge and experience required under paragraphs 150(3)(c) and (d), and

      • (iii) if the proposed individual does not meet the requirement of subparagraph 150(3)(b)(i), either

        • (A) a copy of the individual’s diploma, certificate or credential referred to in subparagraph 150(3)(b)(ii) or (iii) and a copy of the course transcript for it, or

        • (B) a detailed description of the individual’s education, training or work experience required under paragraph 150(4)(c), together with supporting evidence, such as a copy of a course transcript or an attestation by the person who provided the training.

  • Marginal note:Additional information

    (3) The Minister may, on receiving an application for approval, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to consider the application.

  • Marginal note:Approval issued

    (4) The Minister must approve the change on completion of the review of the application if the applicable requirements referred to in subsections 150(3) and (4) and section 151 are met.

Marginal note:Notification — various changes

  •  (1) A holder of a cannabis drug licence must notify the Minister of any of the following changes within five days after the change occurs:

    • (a) a change to the mailing address, telephone number, email address and facsimile number of the holder; and

    • (b) a change to the plan of the licensed site that does not require different security measures to be implemented in order to comply with Part 4.

  • Marginal note:Notification — content

    (2) The notification must include

    • (a) a description of the change; and

    • (b) a declaration, signed and dated by the senior person in charge, indicating that all information provided in support of the notification is correct and complete to the best of their knowledge.

Marginal note:Cessation of activities

  •  (1) A holder of a cannabis drug licence that intends to cease conducting all the activities authorized by the licence — whether before or on the date of expiry of the licence — must provide to the Minister a written notice to that effect at least 30 days before the day on which those activities cease.

  • Marginal note:Content of notice

    (2) The notice must be signed and dated by the senior person in charge and contain the following information:

    • (a) the date on which activities are expected to cease;

    • (b) a description of the manner in which any cannabis remaining at the site as of the date referred to in paragraph (a) will be disposed of by the holder, including

      • (i) if the cannabis will be sold or distributed, in whole or in part, the name and address of the person to which it will be sold or distributed, and

      • (ii) if it will be destroyed, in whole or in part, the day on which and the location at which the destruction is to take place;

    • (c) the address of the location at which the holder’s records, reports, electronic data and other documents that are required to be retained under the Act by the holder, will be retained after activities have ceased; and

    • (d) the name, address, telephone number and, if applicable, facsimile number and email address of a person from which the Minister may obtain further information after activities have ceased.

  • Marginal note:Update

    (3) After having ceased the activities, the holder must submit to the Minister an update of the information referred to in paragraphs (2)(a) to (d), if it differs from what was set out in the notice submitted under subsection (1). The update must be signed and dated by the senior person in charge.

Refusal, suspension and revocation

Marginal note:Other grounds for refusal

 For the purpose of paragraph 62(7)(h) of the Act, the other grounds for refusing to issue, renew or amend a cannabis drug licence are as follows:

  • (a) the applicant does not hold an establishment licence that is necessary to authorize them to conduct, at the site proposed in the application or at a building within the site, the activities in relation to drugs containing cannabis that they intend to conduct there;

  • (a.1) the Minister of Health suspends, in respect of an activity that the applicant intends to conduct in relation to drugs containing cannabis, an establishment licence that is necessary to authorize the applicant to conduct that activity at the site proposed in the application or at a building within the site;

  • (b) the holder of the cannabis drug licence applies for an amendment to change the location of the site where an activity that is authorized by the licence may be conducted; and

  • (c) in respect of the renewal or amendment of the licence, the holder of the licence does not hold the cannabis licence issued under subsection 14(1.1) of the Excise Act, 2001, if it is required;

Marginal note:Suspension — other circumstance

 For the purpose of paragraph 64(1)(b) of the Act, other circumstances for the suspension of a cannabis drug licence are the following:

  • (a) the Minister of Health suspends, in respect of an activity that the holder of the cannabis drug licence is authorized to conduct under the licence, an establishment licence that is necessary to authorize the holder to conduct that activity at the site or at a building within the site;

  • (b) the cannabis licence issued to the holder of the cannabis drug licence under subsection 14(1.1) of the Excise Act, 2001 is suspended under subsection 23(2) of that Act.

Marginal note:Revocation — other circumstances

 For the purpose of paragraph 65(h) of the Act, other circumstances for the revocation of a cannabis drug licence are the following:

  • (a) the licence that has been suspended is not reinstated because the reasons for the suspension still exist or the holder of the licence has not demonstrated to the Minister that the suspension is unfounded;

  • (b) the holder of the licence has requested its revocation in writing;

  • (c) the holder of the licence no longer holds an establishment licence that is necessary to authorize them to conduct, at the site or at a building within the site, an activity that is authorized under the cannabis drug licence; and

  • (d) the holder of the licence no longer holds the cannabis licence referred to in subsection 14(1.1) of the Excise Act, 2001, if it is required.

 
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