Cannabis Regulations (SOR/2018-144)

Marginal note:Additional information

259 The Minister may, on receiving an application referred to in section 258, 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:Issuance of a registration number

• 260 (1) Subject to subsection (2), the Minister must, after examining the information and documents required under sections 258 and 259, issue a registration number for the test kit to the applicant if the applicant demonstrates that the test kit is designed to be used solely for a medical, laboratory, industrial, educational, law administration or enforcement or research purpose.

• Marginal note:Refusal

  (2) The Minister must refuse to issue a registration number if he or she has reasonable grounds to believe that

  • (a) the test kit is likely to create a risk to public health or safety, including the risk of cannabis being diverted to an illicit market or activity, because

    • (i) the quantity of cannabis 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 consumption or administration of the cannabis; or

  • (b) the test kit is likely to be used for a purpose other than any of those set out in subsection (1).

Marginal note:Cancellation

• 261 (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 it has ceased all authorized activities referred to in section 255, 256 or 257 with respect to the test kit;

  • (b) the Minister has reasonable grounds to believe that

    • (i) the test kit is likely to create a risk to public health or safety, including the risk of cannabis being diverted to an illicit market or activity, because

      • (A) the quantity of cannabis in the test kit is too high, or

      • (B) the adulterating or denaturing agent in the test kit is not likely to prevent or deter consumption or administration of the cannabis, or

    • (ii) the test kit is likely to be used for a purpose other than any of those set out in subsection 260(1); or

  • (c) the test kit is a medical device and is no longer authorized for sale in Canada under the Medical Devices Regulations.

• Marginal note:Effect of cancellation

  (2) When a registration number issued for a test kit is cancelled, the cancelled registration number

  • (a) must not be displayed on the label of any test kit manufactured or assembled further to a custom order 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.

Marginal note:Refusal or cancellation

262 If the Minister proposes to refuse to issue or to cancel a registration number, the Minister must

• (a) send a notice to the applicant or to the holder of the registration number that sets out the reasons for the refusal or cancellation; and

• (b) give the applicant or holder an opportunity to be heard in respect of the refusal or cancellation.

Marginal note:Application for new number

• 263 (1) If a registration number issued for a test kit has been cancelled under section 261, the manufacturer or assembler of the test kit or, if the test kit is manufactured or assembled further to a custom order, the person for which the test kit was manufactured or assembled,

  • (a) may apply to the Minister for the issuance of a new registration number in accordance with section 258; and

  • (b) must, in support of the application, provide the Minister with proof that the circumstance that gave rise to the cancellation has been corrected.

• Marginal note:New registration number

  (2) The Minister, after examining the application and supporting proof referred to in subsection (1), must issue a new registration number for the test kit unless there exists a circumstance set out in paragraph 261(1)(b) or (c).

PART 14Access to Cannabis for Medical Purposes

Interpretation

Marginal note:Definitions

• 264 (1) The following definitions apply in this Part.

  adult

  adult means an individual who is 18 years of age or older. (adulte)

  designated person

  designated person means an individual who is designated by a registered person, in accordance with Division 2 of this Part, to produce cannabis for the medical purposes of the registered person. (personne désignée)

  former Marihuana for Medical Purposes Regulations

  former Marihuana for Medical Purposes Regulations means the regulations made by Order in Council P.C. 2013-645 of June 6, 2013 and registered as SOR/2013-119. (ancien Règlement sur la marihuana à des fins médicales)

  health care practitioner

  health care practitioner means, except as otherwise provided, a medical practitioner or a nurse practitioner. (praticien de la santé)

  licence for sale

  licence for sale means a licence for sale for medical purposes. (licence de vente)

  medical document

  medical document means a document provided by a health care practitioner to support the use of cannabis for medical purposes. (document médical)

  medical practitioner

  medical practitioner means an individual who

  • (a) is entitled under the laws of a province to practise medicine in that province;

  • (b) is not restricted, under the laws of the province in which they practise, from authorizing the use of cannabis; and

  • (c) is not named in a notice issued under section 335 that has not been retracted. (médecin)

  named responsible adult

  named responsible adult means, in respect of a client, an adult who is named in the client’s registration document under subparagraph 282(2)(a)(iv) or subsection 285(5). (responsable nommé)

  nurse practitioner

  nurse practitioner means an individual who

  • (a) is entitled under the laws of a province to practise as a nurse practitioner or an equivalent designation and is practising as a nurse practitioner or an equivalent designation in that province;

  • (b) is not restricted, under the laws of the province in which they practise, from authorizing the use of cannabis; and

  • (c) is not named in a notice issued under section 335 that has not been retracted. (infirmier praticien)

  provincial professional licensing authority

  provincial professional licensing authority means

  • (a) except in sections 343 to 345, an authority that is responsible for

    • (i) authorizing the practise of medicine in a province, or

    • (ii) authorizing individuals to practise as nurse practitioners in a province; and

  • (b) in sections 343 to 345, an authority that is responsible for authorizing individuals to practise pharmacy in a province. (autorité provinciale attributive de licences en matière d’activités professionelles)

  registered person

  registered person means an individual who is registered with the Minister under subsection 313(1). (personne inscrite)

  registration certificate

  registration certificate means a certificate issued by the Minister under subsection 313(1). (certificat d’inscription)

  registration document

  registration document means a document provided under paragraph 282(2)(a) to a client by a holder of a licence for sale. (document d’inscription)

  written order

  written order means a written authorization given by a health care practitioner that a stated amount of cannabis be dispensed for the individual named in the authorization. (commande écrite)

• Marginal note:Equivalent designation — nurse practitioner

  (2) For the purpose of paragraph (a) of the definition of nurse practitioner, a designation is equivalent when it designates an individual who

  • (a) is a registered nurse;

  • (b) possesses additional educational preparation and experience related to health care;

  • (c) can autonomously make diagnoses, order and interpret diagnostic tests, prescribe drugs and perform other specific procedures under the laws of a province; and

  • (d) is practising their profession in accordance with one of the following provincial laws, as amended from time to time, or a similar law in another province:

    • (i) the Extended Practice Regulation, Man. Reg. 43/2005, made under The Registered Nurses Act, C.C.S.M., c. R40,

    • (ii) Ontario Regulation 275/94, made under the Nursing Act, 1991, S.O. 1991, c. 32, or

    • (iii) the Regulation respecting the classes of specialization of the Ordre des infirmières et infirmiers du Québec for the activities referred to in section 36.1 of the Nurses Act to be engaged in, CQLR, c. I-8, r. 8, made under the Nurses Act of Quebec, CQLR, c. I-8.

• Marginal note:Equivalent quantity — cannabis

  (3) In the following provisions, the equivalency of a quantity of cannabis is to be determined in accordance with subsection 2(4) of the Act:

  • (a) subsections 266(2), (3), (4), (6) and (7);

  • (b) subsections 267(2) to (5);

  • (c) paragraph 290(1)(e);

  • (d) subsection 292(4);

  • (e) subsection 293(1);

  • (f) subparagraph 297(1)(e)(iii);

  • (g) paragraph 322(1)(c);

  • (h) paragraph 348(3)(a); and

  • (i) subsection 350(2).