Cannabis Regulations (SOR/2018-144)

Hospitals

Marginal note:Record keeping

191 An individual who is in charge of a hospital must retain a record of the following information:

• (a) with respect to any prescription drug received by the hospital,

  • (i) the name and quantity of the drug,

  • (ii) the name and address of the person from whom the drug was received, and

  • (iii) the date the drug was received; and

• (b) with respect to a prescription drug that is dispensed by the hospital,

  • (i) the name of the patient for whom or animal for which the drug was dispensed,

  • (ii) the name of the practitioner who ordered or prescribed the drug, and

  • (iii) the date on which the drug was ordered or prescribed and the form and quantity of the drug.

Marginal note:Security obligations

192 An individual in charge of a hospital must, with respect to a drug containing cannabis for which the hospital is responsible,

• (a) take reasonable steps to protect it against theft or loss; and

• (b) notify the Minister, in writing, within 10 days after becoming aware of its theft or loss.

Marginal note:Sale, distribution and administration

• 193 (1) Subject to the other provisions of these Regulations, it is prohibited for a person to sell, distribute or administer a prescription drug that a hospital possesses without the authorization of the individual in charge of the hospital.

• Marginal note:In–patients and out-patients

  (2) The individual in charge of a hospital may authorize the sale, distribution or administration of a prescription drug only in accordance with a prescription or a written order, signed and dated by a practitioner and only

  • (a) in the case of administration, to an individual or an animal under treatment as an in-patient or out-patient of the hospital; or

  • (b) in the case of sale or distribution, for the individual referred to in paragraph (a) or to the person in charge of the animal referred to in paragraph (a).

• Marginal note:Distribution or sale in an emergency

  (3) Despite subsection (2), for emergency purposes, the individual in charge of a hospital may authorize the sale or distribution of a prescription drug without a prescription to

  • (a) an employee of or a practitioner in another hospital, if

    • (i) the drug is sold or distributed in accordance with a written order signed and dated by a pharmacist in charge of the pharmacy in the other hospital or by a practitioner who is authorized by the individual in charge of the other hospital to sign the order, and

    • (ii) if the signature of the pharmacist or the practitioner is known to the person who sells or distributes the drug or has been verified by that person;

  • (b) a pharmacist of another hospital, if

    • (i) the drug is sold or distributed in accordance with a written order signed and dated by the pharmacist, and

    • (ii) the signature of the pharmacist or the practitioner who is authorized by the individual in charge of the other hospital to sign the order is known to the person who sells or distributes the drug or has been verified by that person; and

  • (c) an individual who is exempted under section 140 of the Act with respect to the drug and who is employed in a research laboratory in the hospital for the purpose of research.

Marginal note:Return and destruction

• 194 (1) Despite subsection 193(2), the individual in charge of a hospital may authorize the sale or distribution of a prescription drug in accordance with a written order to

  • (a) the holder of a cannabis drug licence from which the drug was received, if the drug is sold or distributed for the purpose of its return; and

  • (b) a holder of a cannabis drug licence or a licensed dealer, if the drug is sold or distributed for the purpose of its destruction.

• Marginal note:Written Order

  (2) The written order must contain

  • (a) the name, the quantity and the strength per unit of the drug; and

  • (b) if the sale or distribution is for the purpose of its destruction, a written statement that affirms that the sole purpose of the order is the destruction of the drug and that is signed and dated by, or on behalf of, the holder of the cannabis drug licence or the licensed dealer, as the case may be.

• Marginal note:Record keeping

  (3) The individual in charge of the hospital must prepare a record, with respect to the drug for the purpose of its return or destruction, that sets out

  • (a) its brand name, form, quantity and strength per unit;

  • (b) the name and the address of the person to whom it was sold or distributed; and

  • (c) the date on which it was sold or distributed.

Marginal note:Retention period

195 An individual in charge of a hospital must retain the records that the individual is required to retain under these Regulations for at least two years after the day on which they are prepared.

PART 9Combination Products and Devices

Marginal note:Definitions

196 The following definitions apply in this Part.

brand name

brand name has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (nom commercial)

combination product

combination product[Repealed, SOR/2019-206, s. 54]

common name

common name has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (nom usuel)

Marginal note:Authorization

197 Subject to the other provisions of these Regulations, a person may promote a combination product by communicating the brand name, proper name, common name, price or quantity of the product.

Marginal note:Exemption — section 21 of Act

198 A person is exempt from the application of section 21 of the Act if they display, refer to or otherwise use the brand name of a combination product, or the name of the holder of the drug identification number assigned in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations for the product, directly or indirectly in a promotion that is used in the sponsorship of a person, entity, event, activity or facility.

Marginal note:Exemption — section 22 of Act

199 A person is exempt from the application of section 22 of the Act if they display on a facility, as part of the name of the facility or otherwise, if the facility is used for a sports or cultural event or activity, the brand name of a combination product or the name of the holder of the drug identification number assigned in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations for the product.

Marginal note:Exemption — subsection 23(1) of Act

200 A person is exempt from the application of subsection 23(1) of the Act if they publish, broadcast or otherwise disseminate, on behalf of another person, with or without consideration, any promotion that is authorized under sections 197 to 199.

Marginal note:Authorization — combination product for veterinary use

201 Subject to the other provisions of these Regulations, a person that is authorized to sell a combination product for veterinary use may sell it in a package or with a label that sets out a depiction of a real or fictional animal that corresponds to the species of the animal for which the product is intended.

Marginal note:Authorization — combination product

• 202 (1) Subject to the other provisions of these Regulations, a person is authorized to sell a combination product to a young person.

• Marginal note:Authorization — device

  (2) Subject to the other provisions of these Regulations, a person is authorized to sell a device licensed for use with a prescription drug to a young person if the person

  • (a) has ascertained that there is a written prescription for the young person with respect to the drug; and

  • (b) is entitled under the laws of a province to dispense a prescription drug.

PART 10Importation and Exportation for Medical or Scientific Purposes

Definitions

Marginal note:Definitions

203 The following definitions apply in this Part.

customs office

customs office has the same meaning as in subsection 2(1) of the Customs Act. (bureau de douane)

customs officer

customs officer has the meaning assigned by the definition officer in subsection 2(1) of the Customs Act. (agent des douanes)

Importation

Marginal note:Import permit

• 204 (1) A holder of a licence is authorized to import cannabis for medical or scientific purposes if they also hold an import permit for each shipment of cannabis that is imported.

• Marginal note:Ancillary activities

  (2) A holder of an import permit is also authorized to possess, transfer, transport, send or deliver the shipment of cannabis to the extent necessary to import the cannabis.

Marginal note:Import permit — content

205 The import permit must set out the following information:

• (a) the name and mailing address of the holder;

• (b) the permit number and the licence number;

• (c) in respect of the shipment of cannabis to be imported,

  • (i) a description of the cannabis,

  • (ii) the intended use of the cannabis,

  • (iii) if applicable, the brand name of the cannabis,

  • (iv) quantity of the cannabis, and

  • (v) the percentage of THC w/w and CBD w/w of the cannabis, except in the case of cannabis plants and cannabis plant seeds;

• (d) the name and address of the exporter in the country of export;

• (e) the port of entry into Canada;

• (f) the address of the customs office to which the shipment is to be delivered;

• (g) each mode of transportation used, the country of export and, if applicable, any country of transit or transhipment;

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

• (i) the effective date of the permit; and

• (j) the date of expiry of the permit.

Marginal note:Refusal to issue — other grounds

206 For the purpose of paragraph 62(7)(h) of the Act, other grounds for refusing to issue an import permit are the following:

• (a) the applicant does not hold a licence; and

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

  • (i) the shipment to which the permit application pertains would contravene these Regulations or the laws of the country of export or any country of transit or transhipment, or

  • (ii) the importation of the cannabis is for the purpose of exporting it.

Marginal note:Period of validity

207 An import permit is valid until the earliest of the following dates:

• (a) the date on which the shipment is imported,

• (b) the date of expiry of the permit or the date of its revocation,

• (c) the date of expiry of the licence referred to in paragraph 205(b) or the date of its revocation, or

• (d) the date of revocation of the permit for exportation issued by the competent authority of the country of export that pertains to the shipment.

Marginal note:Provision of copy of import permit

208 A holder of an import permit must provide a copy of the import permit to the customs office at the time of importation.

Marginal note:Information

209 The holder of an import permit must, within 15 days after the date of release of a shipment of cannabis in Canada, provide the Minister with the following information:

• (a) their name, the number of the licence referred to in paragraph 205(b) and the import permit number issued in respect of the shipment;

• (b) the date of release of the shipment; and

• (c) in respect of the shipment of cannabis that is imported,

  • (i) a description of the cannabis,

  • (ii) the intended use of the cannabis,

  • (iii) if applicable, the brand name of the cannabis,

  • (iv) the quantity of the cannabis, and

  • (v) the percentage of THC w/w and CBD w/w of the cannabis, except in the case of cannabis plants and cannabis plant seeds.

Marginal note:Transportation of imported cannabis

210 The holder of an import permit must ensure that, after the imported cannabis is released, it is transported directly to the site set out in the licence referred to in paragraph 205(b).

Marginal note:Revocation — other circumstances

211 For the purpose of paragraph 65(h) of the Act, other circumstances for the revocation of an import permit are the following:

• (a) the permit holder has requested, in writing, the revocation;

• (b) the licence referred to in paragraph 205(b) has been revoked;

• (c) the importation of the cannabis is for the purpose of exporting it; and

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

Marginal note:Disclosure of information

212 The Minister may, for the purpose of verifying whether an importation of cannabis complies with these Regulations, provide to a customs officer any information provided in the import permit application or referred to in sections 205 and 209 and inform that customs officer whether the import permit has been suspended or revoked.