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Cannabis Regulations (SOR/2018-144)

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Regulations are current to 2019-06-20 and last amended on 2019-01-15. Previous Versions

PART 5Good Production Practices

General Provisions

Marginal note:Sale, distribution and exportation

 A holder of a licence must not sell, distribute or export cannabis unless the applicable requirements set out in sections 80 to 88 have been met.

Marginal note:Standard operating procedures

 Cannabis must be produced, packaged, labelled, distributed, stored, sampled and tested in accordance with standard operating procedures that are designed to ensure that those activities are conducted in accordance with the requirements of this Part.

Marginal note:Pest control product

 Cannabis must not be treated with a pest control product unless the product is registered for use on cannabis under the Pest Control Products Act or is otherwise authorized for use under that Act.

Marginal note:Storage

 Cannabis must be stored under conditions that maintain its quality.

Marginal note:Distribution

 Cannabis must be distributed in a manner that maintains its quality.

Marginal note:Building or part of building

  •  (1) Cannabis must be produced, packaged, labelled, stored, sampled and tested in a building or part of a building that is designed, constructed and maintained in a manner that permits those activities to be conducted appropriately and under sanitary conditions, and in particular that

    • (a) permits the building or part of the building to be kept clean and orderly;

    • (b) permits the effective cleaning of all surfaces in the building or part of the building;

    • (c) prevents the contamination of cannabis; and

    • (d) prevents the addition of an extraneous substance to the cannabis.

  • Marginal note:Non-application

    (2) Despite subsection (1), cannabis may be obtained by cultivating, propagating or harvesting it outdoors.

Marginal note:Filtration of air

 The building or part of the building where cannabis is produced, packaged, labelled and stored must be equipped with a system that filters air to prevent the escape of odours.

Marginal note:Equipment

  •  (1) Cannabis must be produced, packaged, labelled, stored, sampled and tested using equipment that is designed, constructed, maintained, operated and arranged in a manner that

    • (a) permits the effective cleaning of its surfaces;

    • (b) permits it to function in accordance with its intended use;

    • (c) prevents the contamination of the cannabis; and

    • (d) prevents the addition of an extraneous substance to the cannabis.

  • Marginal note:Non-application

    (2) Paragraph 1(d) does not apply to the outdoor cultivation, propagation or harvesting of cannabis.

Marginal note:Sanitation program

  •  (1) Cannabis must be produced, packaged, labelled, stored, sampled and tested in accordance with a sanitation program that sets out

    • (a) procedures for effectively cleaning the building or part of the building in which those activities are conducted;

    • (b) procedures for effectively cleaning the equipment used in those activities;

    • (c) procedures for handling any substance used in those activities; and

    • (d) all requirements, in respect of the health and hygienic behaviour of the personnel who are involved in those activities, that are necessary to ensure that those activities are conducted in sanitary conditions.

  • Marginal note:Non-application

    (2) Paragraph (1)(a) does not apply to the outdoor cultivation, propagation or harvesting of cannabis.

Marginal note:Quality assurance

  •  (1) In the case of a holder of a licence for processing, every complaint received in respect of the quality of the cannabis must be investigated by the quality assurance person referred to in section 19 who must, if necessary, take corrective and preventative measures.

  • Marginal note:Methods and procedures

    (2) In the case of a holder of a licence for processing, the cannabis must be produced, packaged, labelled, distributed, stored, sampled and tested using methods and procedures that, prior to their implementation, have been approved by a quality assurance person.

  • Marginal note:Approval prior to sale

    (3) In the case of a holder of a licence for processing, every lot or batch of cannabis must be approved by a quality assurance person before it is made available for sale.

Testing

Marginal note:Sale and exportation — cannabis product

 A holder of a licence must not sell or export a cannabis product unless the applicable requirements set out in sections 90 to 92 have been met.

Marginal note:Validated methods

 The testing conducted under section 91 and further to the requirements in Part 6 must be conducted using validated methods.

Marginal note:Composition

 Testing for the following must be conducted on each lot or batch of cannabis, other than cannabis plants or cannabis plant seeds, that will become a cannabis product or that will be contained in a cannabis accessory that is a cannabis product:

  • (a) the residues of solvents used in the production of cannabis oil;

  • (b) the contaminants referred to in section 94;

  • (c) the dissolution or disintegration referred to in section 95; and

  • (d) the quantity or percentage of THC, THCA, CBD and CBDA, as the case may be.

Marginal note:Representative sample

  •  (1) For the purposes of the testing referred to in section 90, a representative sample of the lot or batch must be taken.

  • Marginal note:Quantity

    (2) A portion of the sample referred to in subsection (1) must be retained for at least one year after the date of the last sale of any portion of the lot or batch and must be of sufficient quantity to enable a determination of

    • (a) whether the lot or batch meets the requirements of section 81, subsection 93(2) and section 94 and, if applicable, subsection 93(3) and sections 95, 97, 101 and 102; and

    • (b) the quantity or percentage of THC, THCA, CBD and CBDA, as the case may be.

PART 6Cannabis Products

General Provisions

Marginal note:Substances

  •  (1) Cannabis that is a cannabis product or that is contained in a cannabis accessory that is a cannabis product must not contain any substance other than the cannabis.

  • Marginal note:Maximum residue limit

    (2) Despite subsection (1), the cannabis may contain residues of a pest control product, its components or derivatives, if they do not exceed any maximum residue limit, in relation to cannabis, specified for the pest control product, its components or derivatives under section 9 or 10 of the Pest Control Products Act.

  • Marginal note:Cannabis oil

    (3) Despite subsection (1), cannabis oil may contain the carrier oil, residues of the solvents listed in the document entitled Limits for Residual Solvents in Cannabis Products, as amended from time to time and published by the Government of Canada on its website that do not exceed the limits established in that document and other substances that are necessary to maintain the oil’s quality and stability.

Marginal note:Microbial and chemical contaminants

  •  (1) Despite subsection 93(1), cannabis that is a cannabis product or that is contained in a cannabis accessory that is a cannabis product may contain microbial or chemical contaminants provided that they are within generally accepted tolerance limits for herbal medicines for human consumption, as established in any publication referred to in Schedule B to the Food and Drugs Act.

  • Marginal note:Non-application — cannabis plant or cannabis plant seeds

    (2) The tolerance limits referred to in subsection (1) do not apply to a cannabis product that is a cannabis plant or cannabis plant seeds.

Marginal note:Dissolution and disintegration

 Each discrete unit of a cannabis product that is intended to be administered orally, rectally or vaginally must meet the requirements of a dissolution or disintegration test that is applicable to its formulation and that is set out in any publication referred to in Schedule B to the Food and Drugs Act.

 
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