Cannabis Regulations: SOR/2018-144

Canada Gazette, Part II, Volume 152, Number 14

Registration

June 27, 2018

FOOD AND DRUGS ACT

CONTROLLED DRUGS AND SUBSTANCES ACT

CANNABIS ACT

P.C. 2018-948 June 26, 2018

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) footnote a of the Food and Drugs Act footnote b, subsection 55(1) footnote c of the Controlled Drugs and Substances Act footnote d and subsection 139(1) and section 161 of the Cannabis Act footnote e, makes the annexed Cannabis Regulations.

Cannabis Regulations

Interpretation

Definitions — Act and Regulations

1 (1) The following definitions apply in the Act and in these Regulations.

cannabis non-solid concentrates means substances that are in non-solid form at a temperature of 22 ± 2°C and that have a maximum yield percentage of greater than 3% w/w of THC, taking into account the potential to convert THCA into THC. (cannabis sous forme d’un concentré qui n’est pas solide)

cannabis oil means an oil that contains anything referred to in item 1 or 3 of Schedule 1 to the Act and that is in liquid form at a temperature of 22 ± 2°C. (huile de cannabis)

cannabis solid concentrates means substances that are in solid form at a temperature of 22 ± 2°C and that have a maximum yield percentage of greater than 3% w/w of THC, taking into account the potential to convert THCA into THC. (cannabis sous forme d’un concentré solide)

fresh cannabis means freshly harvested cannabis buds and leaves, but does not include plant material that can be used to propagate cannabis. (cannabis frais)

non-solids containing cannabis means substances that are in non-solid form at a temperature of 22 ± 2°C and that have a maximum yield percentage of 3% w/w or less of THC, taking into account the potential to convert THCA into THC. (substances qui ne sont pas solides et qui contiennent du cannabis)

solids containing cannabis means substances that are in solid form at a temperature of 22 ± 2°C and that have a maximum yield percentage of 3% w/w or less of THC, taking into account the potential to convert THCA into THC. (solides qui contiennent du cannabis)

Definitions — Regulations

(2) The following definitions apply in these Regulations.

Act means the Cannabis Act. (Loi)

cannabis drug licence means a licence for a drug containing cannabis. (Version anglaise seulement)

cannabis product means cannabis of only one of the classes that are set out in Schedule 4 to the Act — or a cannabis accessory if that accessory contains such cannabis — after it has been packaged and labelled for sale to a consumer at the retail level, but does not include a drug containing cannabis. (produit du cannabis)

CBD means cannabidiol. (CBD)

CBDA means cannabidiolic acid. (ACBD)

client means, in respect of a holder of a licence for sale for medical purposes, an individual who is registered with that holder of the licence under subsection 282(1). (client)

common-law partner means an individual who is cohabiting with an individual in a conjugal relationship, having done so for a period of at least one year. (conjoint de fait)

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

controlled substance offence means

(a) an offence under Part I of the Controlled Drugs and Substances Act, except subsection 4(1) of that Act; or

an offence under Part I of the Controlled Drugs and Substances Act, except subsection 4(1) of that Act; or (b) 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 paragraph (a). ( infraction relative à une substance désignée )

device has the same meaning as in section 2 of the Food and Drugs Act. (instrument)

drug has the same meaning as in section 2 of the Food and Drugs Act, but excludes cannabis that is

(a) a natural health product to which the Natural Health Products Regulations apply; or

a natural health product to which the Natural Health Products Regulations apply; or (b) manufactured or sold — within the meaning of section 2 of the Food and Drugs Act — and is not represented, for use in (i) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings, or (ii) restoring, correcting or modifying organic functions in human beings.

manufactured or sold — within the meaning of section 2 of the Food and Drugs Act — and is not represented, for use in

It includes cannabis that is an active pharmaceutical ingredient as defined in subsection C.01A.001(1) of the Food and Drug Regulations or that is manufactured or sold for use in a clinical trial as defined in section C.05.001 of those Regulations. (drogue)

export permit means a permit issued under subsection 62(1) of the Act that authorizes the exportation of cannabis for medical or scientific purposes. (permis d’exportation)

former Access to Cannabis for Medical Purposes Regulations means the regulations made by Order in Council P.C. 2016-743 of August 5, 2016 and registered as SOR/2016-230. (ancien Règlement sur l’accès au cannabis à des fins médicales)

grow area means, in respect of a site set out in a licence, an area of the site where cannabis plants are cultivated, harvested or propagated. (zone de culture)

hospital means, except in Part 8, a facility

(a) that is licensed, approved or designated by a province under the laws of the province to provide care or treatment to individuals suffering from any form of disease or illness; or

that is licensed, approved or designated by a province under the laws of the province to provide care or treatment to individuals suffering from any form of disease or illness; or (b) that is owned or operated by the Government of Canada or the government of a province and that provides health services. ( hôpital )

import permit means a permit issued under subsection 62(1) of the Act that authorizes the importation of cannabis for medical or scientific purposes. (permis d’importation)

licence means a licence issued under subsection 62(1) of the Act in relation to cannabis. (licence)

operations area means, in respect of a site set out in a licence, an area of the site — other than a storage area — where cannabis is present as a result of any activities conducted under a licence. It includes a grow area. (zone d’exploitation)

pharmacist means an individual who is entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province. (pharmacien)

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

point means the unit of measurement for type size that is known as a PostScript point and is equal to 0.3527777778 mm. (point)

prescription has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (ordonnance)

prescription drug means a drug

(a) that contains cannabis;

that contains cannabis; (b) that is a prescription drug, as defined in section A.01.010 of the Food and Drug Regulations; and

that is a prescription drug, as defined in section A.01.010 of the Food and Drug Regulations; and (c) for which a drug identification number has been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations. ( drogue sur ordonnance )

security clearance means, except in paragraph 53(2)(g), a security clearance granted by the Minister under section 67 of the Act and includes, for the purpose of paragraph 53(2)(e), a security clearance granted under section 112 of the former Access to Cannabis for Medical Purposes Regulations. (habilitation de sécurité)

site means, in respect of a holder of a licence, an area that is used exclusively by the holder and that consists of at least one building or one part of a building. (lieu)

storage area means, in respect of a site set out in a licence, an area of the site where cannabis is stored. (zone d’entreposage)

test kit means a kit

(a) that contains (i) cannabis, and (ii) a reagent system or buffering agent, or both;

that contains (b) that is designed to be used during the course of a chemical or analytical procedure to test for the presence or quantity of cannabis for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and

that is designed to be used during the course of a chemical or analytical procedure to test for the presence or quantity of cannabis for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and (c) the contents of which are not intended or likely to be consumed or administered. ( nécessaire d’essai )

THC means delta-9-tetrahydrocannabinol. (THC)

THCA means delta-9-tetrahydrocannabinolic acid. (ATHC)

Incorporation by reference

(3) For the purpose of the incorporation by reference into these Regulations of any documents published by the Government of Canada, terms that are used but not defined in those documents have the same meaning as in these Regulations.

Non-application

Non-application — Industrial Hemp Regulations

2 These Regulations do not apply to a holder of a licence that is subject to the Industrial Hemp Regulations, or to an applicant for such a licence.

Non-application — holder of cannabis drug licence



3 Subsection 10(1), sections 29 to 48 and Parts 5 and 7 do not apply to a holder of a cannabis drug licence referred to in Part 8, or to an applicant for such a licence.

PART 1

General Authorizations

Authorized activities — federal or provincial laboratory

4 (1) Individuals who are involved in the testing of cannabis as a requirement of their duties at a laboratory that is operated by the Government of Canada or the government of a province are authorized to conduct the following activities to the extent necessary to conduct the testing:

(a) to possess cannabis;

to possess cannabis; (b) to obtain cannabis by altering its chemical or physical properties by any means;

to obtain cannabis by altering its chemical or physical properties by any means; (c) in the case of seed viability testing, to obtain cannabis by cultivating it; and

in the case of seed viability testing, to obtain cannabis by cultivating it; and (d) to distribute cannabis to another laboratory that is operated by the Government of Canada or the government of a province.



Offer

(2) An individual who conducts an activity referred to in paragraph (1)(b) or (c) is also authorized to offer to conduct that activity.

Use of organic solvent

(3) An individual who conducts an activity referred to in paragraph (1)(b) is also authorized to alter or offer to alter the chemical or physical properties of cannabis by the use of an organic solvent when conducting that activity.

Authorized activities — accredited laboratory

(4) Individuals who are involved in the testing of cannabis as a requirement of their duties at a laboratory that is designated as an accredited laboratory under section 14 of the Canada Agricultural Products Act are authorized to conduct the activities referred to in paragraphs (1)(a) and (c), and to offer to conduct the activity referred to in paragraph (1)(c), to the extent necessary to conduct the testing.

Distribution — analytical testing

5 An individual is authorized to distribute cannabis to a holder of a licence for analytical testing if the quantity of cannabis does not exceed the equivalent of 30 g of dried cannabis, as determined in accordance with subsection 2(4) of the Act.

PART 2

Licensing

Definition of distribute

6 In this Part, distribute does not include administering.

Pre-licensing Requirements

Notice to local authorities

7 (1) Before submitting an application to the Minister for a licence for cultivation, a licence for processing or a licence for sale that authorizes the possession of cannabis, the person that intends to submit the application must provide a written notice to the following authorities in the area in which the site referred to in the application is located:

(a) the local government;

the local government; (b) the local fire authority; and

the local fire authority; and (c) the local police force or the Royal Canadian Mounted Police detachment that is responsible for providing policing services to that area.

Content of notice

(2) The notice must contain the following information:

(a) the person’s name;

the person’s name; (b) the date on which the person expects to submit the application;

the date on which the person expects to submit the application; (c) the class and the subclass of licence that will be sought, the activity that the person expects to conduct under the licence and an indication that the activity will be conducted in relation to cannabis; and

the class and the subclass of licence that will be sought, the activity that the person expects to conduct under the licence and an indication that the activity will be conducted in relation to cannabis; and (d) the address of the site where the person proposes to conduct the activities and, if applicable, of each building within the site.

Senior official

(3) The notice must be addressed to a senior official of the local authority to which it is provided.

Definition of local government

(4) In this section, local government includes

(a) an incorporated city, metropolitan area, town, village or other municipality;

an incorporated city, metropolitan area, town, village or other municipality; (b) an authority responsible for delivering municipal services that are related to the activities to be conducted under the licence to an unincorporated city, metropolitan area, town, village or other municipality;

an authority responsible for delivering municipal services that are related to the activities to be conducted under the licence to an unincorporated city, metropolitan area, town, village or other municipality; (c) a band, as defined in subsection 2(1) of the Indian Act; and

a band, as defined in subsection 2(1) of the Indian Act; and (d) a First Nation, Métis or Inuit government that is party to a self-government or land claims agreement that is given effect by an Act of Parliament, or a First Nation, Métis or Inuit government established under a provincial Act.



Classes of Licences

Classes of licences

8 (1) The following, among others, are established as classes of licences that authorize activities in relation to cannabis:

(a) a licence for cultivation;

a licence for cultivation; (b) a licence for processing;

a licence for processing; (c) a licence for analytical testing;

a licence for analytical testing; (d) a licence for sale;

a licence for sale; (e) a licence for research; and

a licence for research; and (f) a cannabis drug licence.

Drug containing cannabis

(2) Despite subsection (1), the licences referred to in paragraphs (1)(a), (b) and (d) authorize activities in relation to cannabis, other than a drug containing cannabis.

Subclasses — cultivation

(3) The following, among others, are established as subclasses of a licence for cultivation:

(a) a licence for micro-cultivation;

a licence for micro-cultivation; (b) a licence for standard cultivation; and

a licence for standard cultivation; and (c) a licence for a nursery.

Subclasses — processing

(4) The following, among others, are established as subclasses of a licence for processing:

(a) a licence for micro-processing; and

a licence for micro-processing; and (b) a licence for standard processing.

Subclasses — sale

(5) A licence for sale for medical purposes is established as a subclass, among others, of a licence for sale.

Licence Content

Licence — content

9 A licence, other than a licence referred to in paragraph 8(1)(f), must set out the following information:

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

the name of the holder of the licence; (b) the licence number;

the licence number; (c) the class of the licence and, if applicable, the subclass of the licence;

the class of the licence and, if applicable, the subclass of the licence; (d) the address of the site where the activity is authorized and, if applicable, of each building within the site;

the address of the site where the activity is authorized and, if applicable, of each building within the site; (e) the authorized activity at the site and, if applicable, the authorized activity that may be conducted at each building within the site;

the authorized activity at the site and, if applicable, the authorized activity that may be conducted at each building within the site; (f) any conditions that the Minister considers appropriate;

any conditions that the Minister considers appropriate; (g) the effective date of the licence; and

the effective date of the licence; and (h) the date of expiry of the licence.

Possession

Obtaining cannabis

10 (1) Subject to the other provisions of these Regulations, a holder of a licence that authorizes the possession of cannabis must only possess cannabis that was obtained in accordance with the former Access to Cannabis for Medical Purposes Regulations, or that is obtained in accordance with these Regulations or from a person authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act.

Exception — licence for cultivation

(2) A holder of a licence for cultivation is authorized to possess cannabis plants and cannabis plant seeds that were not obtained in accordance with subsection (1) if the holder had submitted to the Minister, with the licence application, a declaration, signed and dated by the individual who signed and dated the application, indicating the quantity of such cannabis plants and cannabis plant seeds that they will have in their possession on the effective date of the licence.

Authorized quantity

(3) The quantity of cannabis plants and cannabis plant seeds that the holder is authorized to possess under subsection (2) must be equal to the amount indicated in the declaration.

Cultivation Licences

Licences for Micro-cultivation and Standard Cultivation

Authorized activities

11 (1) Subject to the other provisions of these Regulations, a holder of a licence for micro-cultivation or standard cultivation is authorized to conduct those of the following activities that are authorized by the licence:

(a) to possess cannabis;

to possess cannabis; (b) to obtain dried cannabis, fresh cannabis, cannabis plants or cannabis plant seeds by cultivating, propagating and harvesting cannabis;

to obtain dried cannabis, fresh cannabis, cannabis plants or cannabis plant seeds by cultivating, propagating and harvesting cannabis; (c) for the purpose of testing, to obtain cannabis by altering its chemical or physical properties by any means; and

for the purpose of testing, to obtain cannabis by altering its chemical or physical properties by any means; and (d) to sell cannabis.



Offer

(2) A holder of a licence for micro-cultivation or standard cultivation that is authorized to conduct the activity referred to in paragraph (1)(b) is also authorized to offer to conduct that activity.

Ancillary activities

(3) A holder of a licence for micro-cultivation or standard cultivation that is authorized to conduct the activity referred to in paragraph (1)(b) is also authorized, to the extent necessary to conduct that activity, to conduct ancillary activities such as drying, trimming and milling cannabis.

Use of organic solvent

(4) A holder of a licence for micro-cultivation or standard cultivation that is authorized to conduct the activity referred to in paragraph (1)(c) is also authorized to alter the chemical or physical properties of cannabis by the use of an organic solvent when conducting that activity.

Sale

(5) A holder of a licence for micro-cultivation or standard cultivation whose licence authorizes the sale of cannabis is authorized to conduct the following activities:

(a) to sell and distribute dried cannabis, fresh cannabis, cannabis plants and cannabis plant seeds to any of the following: (i) a holder of a licence for micro-cultivation or standard cultivation, (ii) a holder of a licence for processing, (iii) a holder of a licence for analytical testing, (iv) a holder of a licence for research, (v) a holder of a cannabis drug licence, (vi) the Minister, (vii) a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or class of cannabis that is sold or distributed; or (viii) the individuals referred to in section 4;

to sell and distribute dried cannabis, fresh cannabis, cannabis plants and cannabis plant seeds to any of the following: (b) to sell and distribute cannabis plants and cannabis plant seeds to a holder of a licence for a nursery;

to sell and distribute cannabis plants and cannabis plant seeds to a holder of a licence for a nursery; (c) to sell and distribute cannabis plants and cannabis plant seeds, that are cannabis products, to (i) a holder of a licence for sale, or (ii) a person authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act; and

to sell and distribute cannabis plants and cannabis plant seeds, that are cannabis products, to (d) to send and deliver cannabis plants and cannabis plant seeds, that are cannabis products, to the purchaser of the products at the request of (i) a person authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act, or (ii) a holder of a licence for sale.



to send and deliver cannabis plants and cannabis plant seeds, that are cannabis products, to the purchaser of the products at the request of

Client’s shipping address

(6) If a holder of a licence for micro-cultivation or standard cultivation sends or delivers cannabis plants and cannabis plant seeds under subparagraph (5)(d)(ii) the sale of such products under section 289, the holder must send or deliver the products to the client’s shipping address as indicated by the holder of a licence for sale for medical purposes.

Master grower

12 (1) A holder of a licence for micro-cultivation or standard cultivation must retain the services of one individual as a master grower.

Responsibilities and knowledge

(2) The master grower is responsible for the cultivation, propagation and harvesting of cannabis and must have sufficient knowledge of the provisions of the Act and these Regulations in relation to those activities.

Alternate

(3) A holder of a licence for micro-cultivation or standard cultivation may designate one individual as the alternate master grower who is qualified to replace the master grower.

Micro-cultivation — threshold

13 (1) A holder of a licence for micro-cultivation

(a) must clearly delineate a surface area that does not exceed 200 m 2 in which all the cannabis plants, including all the parts of the plants, must be contained; and

must clearly delineate a surface area that does not exceed 200 m in which all the cannabis plants, including all the parts of the plants, must be contained; and (b) must cultivate, propagate or harvest cannabis plants only from that surface area.



Surface area — calculation

(2) If the surface area referred to in paragraph (1)(a) consists of multiple surfaces, such as surfaces arranged above one another, the area of each surface must be included in the calculation of the total surface area.

Licence for Nursery

Authorized activities

14 (1) Subject to the other provisions of these Regulations, a holder of a licence for a nursery is authorized to conduct those of the following activities that are authorized by the licence:

(a) to possess cannabis;

to possess cannabis; (b) to obtain cannabis plants or cannabis plant seeds by cultivating, propagating and harvesting cannabis;

to obtain cannabis plants or cannabis plant seeds by cultivating, propagating and harvesting cannabis; (c) for the purpose of testing, to obtain cannabis by altering its chemical or physical properties by any means; and

for the purpose of testing, to obtain cannabis by altering its chemical or physical properties by any means; and (d) to sell cannabis.



Offer

(2) A holder of a licence for a nursery that is authorized to conduct the activity referred to in paragraph (1)(b) is also authorized to offer to conduct that activity.

Ancillary activity

(3) A holder of a licence for a nursery that is authorized to conduct the activity referred to in paragraph (1)(b) is also authorized, to the extent necessary to conduct that activity, to conduct ancillary activities such as drying cannabis.

Use of organic solvent

(4) A holder of a licence for a nursery that is authorized to conduct the activity referred to in paragraph (1)(c) is also authorized to alter the chemical or physical properties of cannabis by the use of an organic solvent when conducting that activity.

Sale

(5) A holder of a licence for a nursery whose licence authorizes the sale of cannabis is authorized to conduct the following activities:

(a) to sell and distribute cannabis plants and cannabis plant seeds to any of the following: (i) a holder of a licence for cultivation, (ii) a holder of a licence for processing, (iii) a holder of a licence for analytical testing, (iv) a holder of a licence for research, (v) a holder of a cannabis drug licence, (vi) the Minister, (vii) a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or class of cannabis that is sold or distributed, or (viii) the individuals referred to in section 4;

to sell and distribute cannabis plants and cannabis plant seeds to any of the following: (b) to sell and distribute cannabis plants and cannabis plant seeds, that are cannabis products, to the following: (i) a holder of a licence for sale, or (ii) a person authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act; and

to sell and distribute cannabis plants and cannabis plant seeds, that are cannabis products, to the following: (c) to send and deliver cannabis plants and cannabis plant seeds, that are cannabis products, to the purchaser of the products at the request of (i) a person authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act, or (ii) a holder of a licence for sale.



to send and deliver cannabis plants and cannabis plant seeds, that are cannabis products, to the purchaser of the products at the request of

Client’s shipping address

(6) If a holder of a licence for a nursery sends or delivers cannabis plants and cannabis plant seeds under subparagraph (5)(c)(ii) further to the sale of such products under section 289, the holder must send or deliver the products to the client’s shipping address as indicated by the holder of a licence for sale for medical purposes.

Master grower

15 (1) A holder of a licence for a nursery must retain the services of one individual as a master grower.

Responsibilities and knowledge

(2) The master grower is responsible for the cultivation, propagation and harvesting of cannabis and must have sufficient knowledge of the provisions of the Act and these Regulations in relation to those activities.

Alternate

(3) A holder of a licence for a nursery may designate one individual as the alternate master grower who is qualified to replace the master grower.

Obtaining cannabis plant seeds

16 (1) A holder of a licence for a nursery that cultivates cannabis for the purpose of obtaining cannabis plant seeds must

(a) clearly delineate a total surface area that does not exceed 50 m 2 in which all the budding or flowering cannabis plants, including all the parts of those plants, must be contained;

clearly delineate a total surface area that does not exceed 50 m in which all the budding or flowering cannabis plants, including all the parts of those plants, must be contained; (b) not possess more than 5 kg of flowering heads harvested from the plants referred to in paragraph (a), with the exception of the cannabis plant seeds; and

not possess more than 5 kg of flowering heads harvested from the plants referred to in paragraph (a), with the exception of the cannabis plant seeds; and (c) destroy the flowering heads — with the exception of the cannabis plant seeds — leaves and branches of the plants referred to in paragraph (a) within 30 days of harvesting them.



Surface area — calculation

(2) If the surface area referred to in paragraph (1)(a) consists of multiple surfaces, such as surfaces arranged above one another, the area of each surface must be included in the calculation of the total surface area.

Processing Licences

Authorized activities — licence for standard processing

17 (1) Subject to the other provisions of these Regulations, a holder of a licence for standard processing is authorized to conduct those of the following activities that are authorized by the licence:

(a) to possess cannabis;

to possess cannabis; (b) to produce cannabis, other than obtain it by cultivating, propagating or harvesting it; and

to produce cannabis, other than obtain it by cultivating, propagating or harvesting it; and (c) to sell cannabis.

Authorized activities — licence for micro-processing



(2) Subject to the other provisions of these Regulations, a holder of a licence for micro-processing is authorized to conduct those of the following activities that are authorized by the licence:

(a) to possess cannabis;

to possess cannabis; (b) to produce cannabis, other than obtain it by (i) synthesis, or (ii) cultivating, propagating or harvesting it; and

to produce cannabis, other than obtain it by (c) to sell cannabis.



Offer

(3) A holder of a licence for micro-processing or standard processing that is authorized to conduct the activity referred to in paragraph (1)(b) or (2)(b) is also authorized to offer to obtain cannabis by any method authorized by the licence.

Use of organic solvent

(4) A holder of a licence for micro-processing or standard processing that is authorized to conduct the activity referred to in paragraph 1(b) or (2)(b) is also authorized to alter or offer to alter the chemical or physical properties of cannabis by the use of an organic solvent when conducting that activity.

Sale

(5) A holder of a licence for micro-processing or standard processing whose licence authorizes the sale of cannabis is authorized to conduct the following activities:

(a) to sell and distribute cannabis to any of the following: (i) a holder of a licence for processing, (ii) a holder of a licence for analytical testing, (iii) a holder of a licence for research, (iv) a holder of a cannabis drug licence, (v) the Minister, (vi) a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or a class of cannabis that is sold or distributed, or (vii) the individuals referred to in section 4;

to sell and distribute cannabis to any of the following: (b) to sell and distribute the following cannabis to a holder of a licence for micro-cultivation or standard cultivation: (i) dried cannabis, fresh cannabis, cannabis plants and cannabis plant seeds, or (ii) any cannabis that was obtained or produced for the purpose of conducting testing that is necessary to determine the chemical characterization of cannabis;

to sell and distribute the following cannabis to a holder of a licence for micro-cultivation or standard cultivation: (c) to sell and distribute the following cannabis to a holder of a licence for a nursery: (i) cannabis plants and cannabis plant seeds, or (ii) cannabis that was obtained or produced for the purpose of conducting testing that is necessary to determine the chemical characterization of cannabis;

to sell and distribute the following cannabis to a holder of a licence for a nursery: (d) to sell and distribute cannabis products to the following: (i) a holder of a licence for sale, or (ii) a person authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act; and

to sell and distribute cannabis products to the following: (e) to send and deliver cannabis products to the purchaser of the products at the request of (i) a person authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act, or (ii) a holder of a licence for sale.



to send and deliver cannabis products to the purchaser of the products at the request of

Client’s shipping address

(6) If a holder of a licence for micro-processing or standard processing sends or delivers cannabis products under subparagraph (5)(e)(ii) the sale of such products under section 289, the holder must send or deliver the products to the client’s shipping address as indicated by the holder of a licence for sale for medical purposes.

Consumer information document

18 (1) A holder of a licence for processing must ensure that each shipment of a cannabis product, other than cannabis plants and cannabis plant seeds, is accompanied by copies of the current version of the document entitled Consumer Information — Cannabis, published by the Government of Canada on its website, in a number that is equal to or greater than the number of cannabis products in the shipment in the following cases:

(a) the sale and distribution of cannabis products to a person authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act; and

the sale and distribution of cannabis products to a person authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act; and (b) the sending or delivering of cannabis products under paragraph 17(5)(e).



Exception

(2) Subsection (1) does not apply if the holder sells or distributes the product to a person referred to in paragraph (1)(a) and that person has notified the holder in writing, that they will obtain the copies through other means and provide it to consumers with their purchase of the product.

No modification

(3) The copies must be identical to the document referred to in subsection (1).

Quality assurance person

19 (1) A holder of a licence for processing must retain the services of one individual as a quality assurance person who has the training, experience and technical knowledge related to the requirements of Part 5.

Responsibilities

(2) The quality assurance person is responsible for

(a) assuring the quality of the cannabis before it is made available for sale; and

assuring the quality of the cannabis before it is made available for sale; and (b) investigating every complaint received in respect of the quality of the cannabis and, if necessary, taking corrective and preventative measures.



Alternate

(3) A holder of a licence for processing may designate up to two individuals as alternate quality assurance persons who are qualified to replace the quality assurance person.

Non-application

(4) Subsections (1) to (3) do not apply to a holder of a licence for processing that only manufactures or assembles test kits.

Minister’s approval

20 (1) A holder of a licence for processing must obtain the Minister’s approval before

(a) designating or replacing an alternate quality assurance person; and

designating or replacing an alternate quality assurance person; and (b) replacing the quality assurance person by an individual, other than by the alternate quality assurance person.

Application — content

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

(a) the name and date of birth of the proposed alternate quality assurance person or the proposed quality assurance person;

the name and date of birth of the proposed alternate quality assurance person or the proposed quality assurance person; (b) a description of the proposed quality assurance person’s or the proposed alternate quality assurance person’s qualifications in respect of the matters referred to in subsection 19(1); and

a description of the proposed quality assurance person’s or the proposed alternate quality assurance person’s qualifications in respect of the matters referred to in subsection 19(1); and (c) a declaration, signed and dated by the responsible person referred to in section 37, indicating that all information provided in support of the application is correct and complete to the best of their knowledge.

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.

Micro-processing — threshold

21 (1) A holder of a licence for micro-processing must not possess, in a calendar year, cannabis of one or more classes of cannabis — other than cannabis plants and cannabis plant seeds — that has been sold or distributed to them the total amount of which, as determined in accordance with the table to this section, is equivalent to more than 600 kg of dried cannabis.

Equivalency

(2) The cannabis referred to in subsection (1) is exempt from the application of subsection 2(4) of the Act and a quantity referred to in column 2 of the table to this section in respect of any class of cannabis referred to in column 1 is deemed to be equivalent to 1 kg of dried cannabis.

Non-application

(3) Subsection (1) does not apply if the holder also holds a licence for micro-cultivation in relation to the same site and the cannabis that is sold or distributed to them is exclusively from that site.

TABLE

Item Column 1



Class of cannabis Column 2



Amount that is equivalent to 1 kg of dried cannabis 1 dried cannabis 1 kg 2 fresh cannabis 5 kg 3 solids containing

cannabis 10 kg 4 non-solids containing cannabis

10 kg 5 cannabis solid

concentrates 0.25 kg 6 cannabis non-solid concentrates

0.25 kg

Licence for Analytical Testing

Authorized activities

22 (1) Subject to the other provisions of these Regulations, a holder of a licence for analytical testing is authorized, for the purpose of testing, to conduct those of the following activities that are authorized by the licence:

(a) to possess cannabis; and

to possess cannabis; and (b) to obtain cannabis by altering its chemical or physical properties by any means.



Offer

(2) A holder of a licence for analytical testing that is authorized to conduct the activity referred to in paragraph (1)(b) is also authorized to offer to conduct that activity.

Use of organic solvent

(3) A holder of a licence for analytical testing that is authorized to conduct the activity referred to in paragraph (1)(b) is also authorized to alter or offer to alter the chemical or physical properties of cannabis by the use of an organic solvent when conducting that activity.

Head of laboratory

23 (1) A holder of a licence for analytical testing must retain the services of one individual as the head of laboratory who must work at the site set out in the licence and who is responsible for the testing referred to in section 91.

Qualifications

(2) The head of laboratory must have sufficient knowledge of the provisions of the Act and these Regulations that apply to the holder of the licence for analytical testing, have knowledge and experience related to the duties of the position and possess a degree in a science related to the work to be carried out that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association.

Alternate

(3) A holder of a licence for analytical testing may designate one or more individuals as the alternate heads of laboratory who are qualified to replace the head of laboratory.

Minister’s approval

24 (1) A holder of a licence for analytical testing must obtain the Minister’s approval before

(a) designating or replacing an alternate head of laboratory; and

designating or replacing an alternate head of laboratory; and (b) replacing the head of laboratory by an individual, other than by an alternate head of laboratory.

Application — content

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

(a) the name and date of birth of the proposed alternate head of laboratory or the proposed head of laboratory;

the name and date of birth of the proposed alternate head of laboratory or the proposed head of laboratory; (b) a description of the proposed head of laboratory’s or the proposed alternate head of laboratory’s qualifications in respect of the matters referred to in subsection 23(2); and

a description of the proposed head of laboratory’s or the proposed alternate head of laboratory’s qualifications in respect of the matters referred to in subsection 23(2); and (c) a declaration, signed and dated by the responsible person referred to in section 37, indicating that all information provided in support of the application is correct and complete to the best of their knowledge.

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.

Destruction

25 (1) A holder of a licence for analytical testing must destroy all samples of cannabis of a lot or batch that have been distributed to them, and all cannabis obtained from those samples, within 90 days after completing the testing of the samples of the lot or batch.

Samples not tested

(2) If testing of the samples of cannabis distributed to the holder of the licence for analytical testing is not initiated within 120 days of their receipt, the holder must destroy the samples within that period.

Licence for Sale for Medical Purposes

Authorized activities

26 Subject to the other provisions of these Regulations, a holder of a licence for sale for medical purposes is authorized to conduct those of the following activities that are authorized by the licence:

(a) to possess cannabis products; and

to possess cannabis products; and (b) to sell cannabis products.

Sale — other than clients

27 (1) Subject to subsection (2), a holder of a licence for sale for medical purposes that authorizes the sale of cannabis products is authorized to sell or distribute

(a) cannabis products to any of the following: (i) a holder of a licence, other than a licence for cultivation, (ii) the Minister, or (iii) a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or class of cannabis that is, or is contained in, a cannabis product that is sold or distributed;

cannabis products to any of the following: (b) dried cannabis, fresh cannabis, cannabis plants and cannabis plant seeds, that are cannabis products, to a holder of a licence for micro-cultivation or standard cultivation;

dried cannabis, fresh cannabis, cannabis plants and cannabis plant seeds, that are cannabis products, to a holder of a licence for micro-cultivation or standard cultivation; (c) cannabis plants and cannabis plant seeds, that are cannabis products, to a holder of a licence for a nursery; and

cannabis plants and cannabis plant seeds, that are cannabis products, to a holder of a licence for a nursery; and (d) cannabis products, other than cannabis plants and cannabis plant seeds, to a hospital employee if the employee’s possession of the cannabis product is for the purpose of, and in connection with, their duties.



Packaging

(2) A holder of a licence for sale for medical purposes must sell the cannabis products referred to in subsection (1) in the packaging in which they were sold or distributed to the holder.

Licence for Research

Authorized activities

28 (1) Subject to the other provisions of these Regulations, a holder of a licence for research is authorized to conduct those of the following activities, that are authorized by the licence:

(a) for the purpose of research, (i) to possess cannabis, (ii) to produce cannabis, and (iii) to transport, send or deliver cannabis between the sites that are set out by the licence; and

for the purpose of research, (b) to sell cannabis plants and cannabis plant seeds to any of the following: (i) a holder of a licence for cultivation, (ii) another holder of a licence for research, (iii) a holder of a cannabis drug licence, (iv) the Minister, or (v) a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or class of cannabis that is sold or distributed.



to sell cannabis plants and cannabis plant seeds to any of the following:

Offer

(2) A holder of a licence for research that is authorized to conduct the activity referred to in subparagraph (1)(a)(ii) is also authorized to offer to obtain cannabis by any method authorized by the licence.

Use of organic solvent

(3) A holder of a licence for research that is authorized to obtain cannabis by altering its chemical or physical properties by any means is also authorized to alter or offer to alter its chemical or physical properties by the use of an organic solvent when conducting that activity.

Administer and distribute — research subject

(4) A holder of a licence for research is also authorized, for the purpose of research, to administer and distribute cannabis to a research subject.

Distribution

(5) A holder of a licence for research is also authorized to distribute

(a) cannabis to any of the following: (i) another holder of a licence for research, (ii) a holder of a licence for analytical testing, (iii) a holder of a cannabis drug licence, or (iv) the Minister; and

cannabis to any of the following: (b) cannabis plants and cannabis plant seeds to the following: (i) a holder of a licence for cultivation, or (ii) a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or class of cannabis that is sold or distributed.

cannabis plants and cannabis plant seeds to the following:

Refusal, Suspension and Revocation

Refusal to issue, renew or amend — other grounds



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

(a) an individual who is required to hold a security clearance under section 50 in respect of an application does not hold such a security clearance;

an individual who is required to hold a security clearance under section 50 in respect of an application does not hold such a security clearance; (b) in respect of the renewal or amendment of a licence, the holder of the licence does not hold a cannabis licence issued under subsection 14(1.1) of the Excise Act, 2001, if it is required;

in respect of the renewal or amendment of a licence, the holder of the licence does not hold a cannabis licence issued under subsection 14(1.1) of the Excise Act, 2001, if it is required; (c) in respect of the issuance or amendment of a licence for cultivation, the site proposed in the application would be authorized by another licence for cultivation;

in respect of the issuance or amendment of a licence for cultivation, the site proposed in the application would be authorized by another licence for cultivation; (d) in respect of the issuance or amendment of a licence for micro-cultivation, the site proposed in the application would be authorized by a licence for standard processing and a licence for micro-cultivation;

in respect of the issuance or amendment of a licence for micro-cultivation, the site proposed in the application would be authorized by a licence for standard processing and a licence for micro-cultivation; (e) in respect of the issuance or amendment of a licence for standard cultivation, the site proposed in the application would be authorized by a licence for micro-processing and a licence for standard cultivation;

in respect of the issuance or amendment of a licence for standard cultivation, the site proposed in the application would be authorized by a licence for micro-processing and a licence for standard cultivation; (f) in respect of the issuance or amendment of a licence for a nursery, the site proposed in the application would be authorized by a licence for processing and a licence for a nursery;

in respect of the issuance or amendment of a licence for a nursery, the site proposed in the application would be authorized by a licence for processing and a licence for a nursery; (g) in respect of the issuance or amendment of a licence for processing, the site proposed in the application would be authorized by another licence for processing;

in respect of the issuance or amendment of a licence for processing, the site proposed in the application would be authorized by another licence for processing; (h) in respect of the issuance or amendment of a licence for processing, the site proposed in the application would be authorized by a licence for processing and a licence for a nursery;

in respect of the issuance or amendment of a licence for processing, the site proposed in the application would be authorized by a licence for processing and a licence for a nursery; (i) in respect of the issuance or amendment of a licence for micro-processing, the site proposed in the application would be authorized by a licence for standard cultivation and a licence for micro-processing; and

in respect of the issuance or amendment of a licence for micro-processing, the site proposed in the application would be authorized by a licence for standard cultivation and a licence for micro-processing; and (j) in respect of the issuance or amendment of a licence for standard processing, the site proposed in the application would be authorized by a licence for micro-cultivation and a licence for standard processing.



Suspension — other circumstance

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

(a) an individual who is required to hold a security clearance under section 50 in respect of the licence does not hold such a security clearance;

an individual who is required to hold a security clearance under section 50 in respect of the licence does not hold such a security clearance; (b) the holder of a licence has failed to pay a fee in relation to the licence that is fixed under subsection 142(1) of the Act; and

the holder of a licence has failed to pay a fee in relation to the licence that is fixed under subsection 142(1) of the Act; and (c) the cannabis licence issued to the holder under subsection 14(1.1) of the Excise Act, 2001 is suspended under subsection 23(2) of that Act.

Revocation — other circumstances

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

(a) the holder of the licence has requested, in writing, the revocation;

the holder of the licence has requested, in writing, the revocation; (b) the licence has been suspended and 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;

the licence has been suspended and 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; (c) since the issuance of the licence, a security clearance in respect of the licence has been refused; and

since the issuance of the licence, a security clearance in respect of the licence has been refused; and (d) the holder of the licence no longer holds the cannabis licence issued under subsection 14(1.1) of the Excise Act, 2001, if it is required.

Changes Relating to Licence

Amendment

32 A holder of a licence must submit an application for an amendment to the licence if they propose to make any of the following changes:

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

a change to the name of the holder of the licence; (b) a change to the address of the site or building within the site where the activity is authorized; or

a change to the address of the site or building within the site where the activity is authorized; or (c) a change to the authorized activity at the site or the authorized activity that may be conducted at each building within the site.

Minister’s approval

33 (1) A holder of a licence that proposes to make a change to the site plan that would require physical security measures to be carried out in order to comply with Part 4 must obtain the Minister’s approval before making the change.

Application — content

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

(a) a description of the change;

a description of the change; (b) the proposed site plan; and

the proposed site plan; and (c) a declaration, signed and dated by the responsible person referred to in section 37, indicating that all information provided in support of the application is correct and complete to the best of their knowledge.

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.

Notification — various changes

34 (1) A holder of a 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 or facsimile number of the holder;

a change to the mailing address, telephone number, email address or facsimile number of the holder; (b) a change to the site plan, other than a change referred to in subsection 33(1);

a change to the site plan, other than a change referred to in subsection 33(1); (c) the replacement of an individual who must hold a security clearance referred to in any of paragraphs 50(b) to (g), (i) and (j) or the addition of another such individual, other than an individual who is designated as an alternate for the position of quality assurance person referred to in section 19; and

the replacement of an individual who must hold a security clearance referred to in any of paragraphs 50(b) to (g), (i) and (j) or the addition of another such individual, other than an individual who is designated as an alternate for the position of quality assurance person referred to in section 19; and (d) in the case of a holder of a licence for cultivation, a licence for processing or a licence for sale, a change to the organizational security plan.

Notification — content

(2) The notification must include the following:

(a) a description of the change; and

a description of the change; and (b) a declaration, signed and dated by the responsible person referred to in section 37, indicating that all information provided in support of the notification is correct and complete to the best of their knowledge.

Additional information

(3) In the case of a change referred to in paragraph (1)(c), the notification must also include the following:

(a) the name and date of birth of the individual who replaced an individual referred to in any of paragraphs 50(b) to (g), (i) and (j) or who was added as another such individual; and

the name and date of birth of the individual who replaced an individual referred to in any of paragraphs 50(b) to (g), (i) and (j) or who was added as another such individual; and (b) if the individual replaced a director or officer referred to in subparagraph 50(b)(i) or (c)(i) or was added as such a director or officer, the certificate of incorporation or other amended incorporating instrument of the corporation or cooperative.

Notification to local authorities

35 (1) A holder of a licence for cultivation, a licence for processing or a licence for sale that authorizes the possession of cannabis must, within 30 days after the issuance, amendment, suspension, reinstatement or revocation of the licence, provide a written notice to the local authorities referred to in paragraphs 7(1)(a) to (c) in the area in which the site set out in the licence is located and provide a copy of the notice to the Minister.

Content of notice

(2) The notice must contain the following information:

(a) the name of the holder of the licence and the address of the site set out in the licence; and

the name of the holder of the licence and the address of the site set out in the licence; and (b) a description of the applicable event referred to in subsection (1) and its effective date and, in the case of an amendment to the licence, details of the amendment.



Senior official

(3) The notice must be addressed to a senior official of the local authority to which it is provided.

Cessation of activities

36 (1) A holder of a 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 the Minister with a written notice to that effect at least 30 days before the day on which those activities cease.

Content of notice

(2) The notice must be signed and dated by the responsible person referred to in section 37 and contain the following information:

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

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 of the licence, 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;

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 of the licence, including (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

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.

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 the information submitted in the notice under subsection (1). The update must be signed and dated by the responsible person referred to in section 37.

General Requirements Relating to Authorized Activities

Responsible person

37 (1) A holder of a licence must retain the services of one individual as the responsible person who has the authority to bind the holder.

Responsibilities and knowledge

(2) The responsible person is responsible for the activities conducted under the licence and must have sufficient knowledge of the provisions of the Act and these Regulations that apply to the holder of the licence.

Alternate

(3) A holder of a licence may designate one individual as the alternate responsible person who is qualified to replace the responsible person.

Head of security

38 (1) A holder of a licence, other than a licence for analytical testing or a licence for research, must retain the services of one individual as the head of security who is responsible for

(a) ensuring that the applicable physical security measures set out in Part 4 are complied with; and

ensuring that the applicable physical security measures set out in Part 4 are complied with; and (b) the organizational security plan of the holder.

Alternate

(2) A holder of a licence, other than a licence for analytical testing or a licence for research, may designate one individual as the alternate head of security who is qualified to replace the head of security.

Approved site

39 (1) A holder of a licence must only conduct activities that are authorized by the licence at the site and, if applicable, the building within the site, set out in the licence.

Non-application

(2) Subsection (1) does not apply to the possession of cannabis for the purpose of antimicrobial treatment or destruction or the distribution of cannabis.

Dwelling-house

40 A holder of a licence must not conduct any activity that is authorized by the licence at a dwelling-house.

Outdoor activities

41 A holder of a licence must not produce cannabis — other than obtain cannabis by cultivating, propagating or harvesting it — or test, store, package or label cannabis outdoors.

Antimicrobial treatment

42 A holder of a licence, other than a licence for analytical testing, may conduct antimicrobial treatment of cannabis at a location other than the site set out in the licence only if

(a) the holder ensures that the cannabis that is at the location is, at all times, in the presence of at least one individual referred to in paragraph 43(2)(a), or in the case of a holder of a licence for research, an individual referred to in paragraph 43(2)(b); and

the holder ensures that the cannabis that is at the location is, at all times, in the presence of at least one individual referred to in paragraph 43(2)(a), or in the case of a holder of a licence for research, an individual referred to in paragraph 43(2)(b); and (b) the cannabis is subsequently returned to the site set out in the licence or distributed in accordance with these Regulations.

Destruction

43 (1) A holder of a licence is authorized to destroy cannabis only

(a) in accordance with a method that (i) complies with all federal, provincial and municipal environmental protection legislation applicable to the location where it is to be destroyed, and (ii) does not result in any individual being exposed to cannabis smoke or cannabis vapour;

in accordance with a method that (b) in the presence of at least two individuals who are qualified to witness the destruction and, except in the case of a holder of a licence for analytical testing or a licence for research, one of whom is an individual referred to in paragraph (2)(a); and

in the presence of at least two individuals who are qualified to witness the destruction and, except in the case of a holder of a licence for analytical testing or a licence for research, one of whom is an individual referred to in paragraph (2)(a); and (c) in the case where the cannabis is destroyed at a location other than the site set out in the licence, the holder of the licence ensures that the cannabis that is at the location is, at all times, in the presence of at least one individual referred to in paragraph (2)(a) or, in the case of a holder of a licence for analytical testing or a licence for research, an individual referred to in paragraph (2)(b).

Witness to destruction

(2) The following individuals are qualified to witness the destruction of cannabis:

(a) an individual who holds a security clearance; and

an individual who holds a security clearance; and (b) an employee of the holder of the licence.

Security clearance holder

44 A holder of a licence, other than a holder of a licence for analytical testing, a licence for research, or a licence for sale that does not authorize the possession of cannabis, must ensure that an individual who holds a security clearance is present at the site when activities are conducted by other individuals in an operations area or a storage area.

Organizational security plan — update

45 A holder of a licence, other than a holder of a licence for analytical testing or a licence for research, must on request of the Minister, update and submit the organizational security plan.

Recall

46 A holder of a licence must establish and maintain a system of control that permits the rapid and complete recall of every lot or batch of cannabis that has been sold or distributed.

Safekeeping during distribution

47 A holder of a licence must take any steps that are necessary to ensure the safekeeping of cannabis when distributing it.

Identification of holder of a licence

48 A holder of a licence must include their name, as set out in the licence, in all the means by which they identify themself in relation to cannabis, including advertising, purchase orders, shipping documents and invoices.

PART 3

Security Clearances

Definitions

49 The following definitions apply in this Part.

corporation does not include a federal or provincial Crown corporation. (personne morale)

partnership does not include an incorporated entity. (société de personnes)

Requirement for security clearance

50 The following individuals must hold a security clearance:

(a) an individual who holds a licence for cultivation, processing or sale;

an individual who holds a licence for cultivation, processing or sale; (b) in the case of a corporation that holds a licence for cultivation, processing or sale, (i) the directors and officers of the corporation, (ii) any individual who exercises, or is in a position to exercise, direct control over the corporation, (iii) the directors and officers of any corporation or cooperative that exercises, or is in a position to exercise, direct control over the corporation, (iv) any individual who is a partner in a partnership that exercises, or is in a position to exercise, direct control over the corporation, and (v) the directors and officers of any corporation that is a partner in a partnership that exercises, or is in a position to exercise, direct control over the corporation;

in the case of a corporation that holds a licence for cultivation, processing or sale, (c) in the case of a cooperative that holds a licence for cultivation, processing or sale, (i) the directors and officers of the cooperative, (ii) any individual who exercises, or is in a position to exercise, direct control over the cooperative, (iii) the directors and officers of any corporation or cooperative that exercises, or is in a position to exercise, direct control over the cooperative, (iv) any individual who is a partner in a partnership that exercises, or is in a position to exercise, direct control over the cooperative, and (v) the directors and officers of any corporation that is a partner in a partnership that exercises, or is in a position to exercise, direct control over the cooperative;

in the case of a cooperative that holds a licence for cultivation, processing or sale, (d) in the case of a partnership that holds a licence for cultivation, processing or sale, (i) any individual who is a partner, (ii) the directors and officers of any corporation or cooperative that is a partner, (iii) any individual who is a partner in a partnership that exercises, or is in a position to exercise, direct control over the partnership that holds the licence, and (iv) the directors and officers of any corporation that is a partner in a partnership that exercises, or is in a position to exercise, direct control over the partnership that holds the licence;

in the case of a partnership that holds a licence for cultivation, processing or sale, (e) in the case of a licence for cultivation, processing or sale, the responsible person referred to in section 37;

in the case of a licence for cultivation, processing or sale, the responsible person referred to in section 37; (f) in the case of a licence for cultivation, processing or sale, the head of security referred to in section 38;

in the case of a licence for cultivation, processing or sale, the head of security referred to in section 38; (g) in the case of a licence for cultivation, the master grower referred to in section 12 or 15;

in the case of a licence for cultivation, the master grower referred to in section 12 or 15; (h) in the case of a licence for processing, the quality assurance person referred to in section 19;

in the case of a licence for processing, the quality assurance person referred to in section 19; (i) an individual who has been designated as an alternate for a position referred to in any of paragraphs (e) to (h); and

an individual who has been designated as an alternate for a position referred to in any of paragraphs (e) to (h); and (j) an individual who has been specified by name by the Minister under subsection 67(2) of the Act or who occupies a position that has been specified by the Minister under that subsection.



Eligibility

51 Only the following individuals may submit an application for a security clearance:

(a) an individual who is required to hold a security clearance;

an individual who is required to hold a security clearance; (b) an individual who will be required to hold a security clearance if an application for a licence, or for its renewal or amendment, that has been filed with the Minister results in the issuance, renewal or amendment of the licence;

an individual who will be required to hold a security clearance if an application for a licence, or for its renewal or amendment, that has been filed with the Minister results in the issuance, renewal or amendment of the licence; (c) an individual who will be required to hold a security clearance if a pending business transaction is completed;

an individual who will be required to hold a security clearance if a pending business transaction is completed; (d) an individual who has been selected for a position referred to in any of paragraphs 50(e) to (h) or as an alternate for such a position; and

an individual who has been selected for a position referred to in any of paragraphs 50(e) to (h) or as an alternate for such a position; and (e) an individual who has been selected for a position that has been specified by the Minister under subsection 67(2) of the Act or who has been notified that the Minister intends to specify them, by name or position, under that subsection.

Checks

52 The Minister may, at any time, conduct checks that are necessary to determine whether an applicant for, or the holder of, a security clearance poses a risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity. Such checks include

(a) a check of the applicant’s or holder’s criminal record; and

a check of the applicant’s or holder’s criminal record; and (b) a check of the relevant files of law enforcement agencies that relate to the applicant or holder, including intelligence gathered for law enforcement purposes.



Grant of security clearance

53 (1) Before granting a security clearance, the Minister must, taking into account any licence conditions that he or she imposes under subsection 62(10) of the Act, determine that the applicant does not pose an unacceptable risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity.

Factors

(2) Factors that the Minister may consider to determine the level of risk posed by the applicant include

(a) the circumstances of any events or convictions that are relevant to the determination, the seriousness of those events or convictions, their number and frequency, the date of the most recent event or conviction and any sentence or other disposition;

the circumstances of any events or convictions that are relevant to the determination, the seriousness of those events or convictions, their number and frequency, the date of the most recent event or conviction and any sentence or other disposition; (b) whether it is known, or there are reasonable grounds to suspect, that the applicant (i) is or has been involved in, or contributes or has contributed to, an activity that is prohibited by, or conducted in contravention of, any of the provisions of Division 1 of Part 1 of the Act — other than paragraphs 8(1)(a) to (e) — or Subdivision E of Division 2 of Part 1 of the Act, (ii) is or has been involved in, or contributes or has contributed to, an activity that is prohibited by, or conducted in contravention of, any of the provisions of Part I of the Controlled Drugs and Substances Act — other than subsection 4(1) — or subsection 32(1) or (2) of that Act, (iii) is or has been involved in, or contributes or has contributed to, an activity that is prohibited by, or conducted in contravention of, any provision of the Criminal Code relating to fraud, corruption of public officials, terrorism financing, counterfeiting or laundering the proceeds of crime, (iv) is or has been involved in, or contributes or has contributed to, an offence involving an act of violence or the threat of violence, (v) is or has been a member of a criminal organization as defined in subsection 467.1(1) of the Criminal Code, or is or has been involved in, or contributes or has contributed to, the activities of such an organization, (vi) is or has been a member of an organization that is known to be involved in or to contribute to — or in respect of which there are reasonable grounds to suspect its involvement in or contribution to — activities directed toward, or in support of, acts of violence or the threat of violence, or is or has been involved in, or contributes or has contributed to, the activities of such an organization, (vii) is or has been associated with an individual who (A) is known to be involved in or to contribute to — or in respect of whom there are reasonable grounds to suspect their involvement in or contribution to — activities referred to in subparagraphs (i) to (iii), or (B) is a member of an organization referred to in subparagraph (v) or (vi), or (viii) has conspired to commit (A) an offence under any of the provisions of the Criminal Code referred to in subparagraph (iii), (B) an offence referred to in subparagraph (iv), or (C) an offence under any of sections 467.11 to 467.13 of the Criminal Code;

whether it is known, or there are reasonable grounds to suspect, that the applicant (c) whether there are reasonable grounds to suspect that the applicant could be induced to commit an act — or to aid or abet any person to commit an act — that might constitute a risk to public health or public safety;

whether there are reasonable grounds to suspect that the applicant could be induced to commit an act — or to aid or abet any person to commit an act — that might constitute a risk to public health or public safety; (d) whether there are reasonable grounds to believe that the applicant’s activities, including their financial activities, pose a risk to the integrity of the control of the production and distribution of cannabis under the Act;

whether there are reasonable grounds to believe that the applicant’s activities, including their financial activities, pose a risk to the integrity of the control of the production and distribution of cannabis under the Act; (e) whether the applicant has had a security clearance suspended or cancelled;

whether the applicant has had a security clearance suspended or cancelled; (f) whether there are reasonable grounds to believe the applicant has, now or in the past, submitted false or misleading information, or false or falsified documents, to the Minister; and

whether there are reasonable grounds to believe the applicant has, now or in the past, submitted false or misleading information, or false or falsified documents, to the Minister; and (g) whether an entity has refused to issue a security clearance to the applicant — or has suspended or cancelled one — and the reason for the refusal, suspension or cancellation.



Outstanding criminal charge

54 If the Minister refuses to consider an application for a security clearance because there is an outstanding criminal charge against the applicant that may be relevant to the determination of the risk under subsection 53(1), the Minister must provide the applicant, and any affected holder of or applicant for a licence, with notice of the refusal in writing.

Refusal to grant security clearance

55 (1) If the Minister intends to refuse to grant a security clearance, the Minister must provide the applicant with a notice that sets out the reason for the proposed refusal and that specifies the period of time within which they may make written representations to the Minister. The period must start on the day on which the notice is provided and must be not less than 20 days.

Notice of refusal

(2) If the Minister refuses to grant the security clearance, the Minister must provide the applicant, and any affected holder of or applicant for a licence, with notice of the refusal in writing.

Validity period

56 (1) The Minister must establish a validity period for a security clearance in accordance with the level of risk to public health or public safety — including the risk of cannabis being diverted to an illicit market or activity — posed by the applicant, but the period must not exceed five years.

Extension of validity period

(2) If the validity period of a security clearance is less than five years, the Minister may subsequently extend the period to a total of five years if the Minister, taking into account any licence conditions that he or she imposes under subsection 62(10) of the Act, determines that the holder does not pose an unacceptable risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity.

Factors

(3) The factors that the Minister may consider to determine the level of risk posed by the holder include those set out in subsection 53(2).

Obligation to notify — offences

57 A holder of a security clearance must, without delay, provide the Minister with notice in writing if they are charged with, or found guilty of, an offence under the Act, the Controlled Drugs and Substances Act or the Criminal Code.

Suspension of security clearance

58 (1) Before suspending a security clearance, the Minister must have reasonable grounds to believe that the risk to public health or public safety posed by the holder, including the risk of cannabis being diverted to an illicit market or activity, has become unacceptable.

Notice of suspension

(2) A suspension takes effect as soon as the Minister provides the holder with a notice in writing that sets out the reasons for the suspension and that specifies the period of time within which they may make written representations to the Minister. The period starts on the day on which the notice is provided and must be not less than 20 days.

Notice to holder of licence

(3) The Minister must, without delay after suspending a security clearance, also provide any affected holder of or applicant for a licence with notice of the suspension in writing.

Reinstatement of security clearance

59 (1) The Minister must reinstate a suspended security clearance if

(a) the reasons for the suspension no longer exist or the holder of the security clearance demonstrates to the Minister that the suspension was unfounded; or

the reasons for the suspension no longer exist or the holder of the security clearance demonstrates to the Minister that the suspension was unfounded; or (b) the Minister determines, taking into account any licence conditions that he or she imposes under subsection 62(10) of the Act, that the holder of the security clearance does not pose an unacceptable risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity.

Factors

(2) The factors that the Minister may consider to determine the level of risk posed by the holder of the security clearance include those set out in subsection 53(2).

Notice of reinstatement

(3) The Minister must, without delay after reinstating a security clearance, provide the holder of the security clearance, and any affected holder of or applicant for a licence, with notice of the reinstatement in writing.

Cancellation of security clearance

60 (1) A security clearance may not be cancelled unless

(a) it is suspended and the period within which the holder may make representations in respect of the suspension has expired; and

it is suspended and the period within which the holder may make representations in respect of the suspension has expired; and (b) the Minister has determined that the holder poses an unacceptable risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity.



Factors

(2) The factors that the Minister may consider to determine the level of risk posed by the holder include those set out in subsection 53(2).

Notice of cancellation

(3) The Minister must, without delay after cancelling a security clearance, provide the holder, and any affected holder of or applicant for a licence, with notice of the cancellation in writing.

Ineligibility — new application

61 If the Minister refuses to grant or cancels a security clearance, the individual who has been refused a security clearance or the former holder may submit a new application for a security clearance only if

(a) a period of five years has elapsed since the day on which the refusal or cancellation occurred; or

a period of five years has elapsed since the day on which the refusal or cancellation occurred; or (b) a change has occurred in the circumstances that led to the refusal or cancellation.

PART 4

Physical Security Measures

DIVISION 1

Licences Requiring Increased Security Measures

General Provisions

Security measures

62 (1) The security measures set out in sections 63 to 72 apply in respect of the sites set out in the following licences:

(a) a licence for standard cultivation;

a licence for standard cultivation; (b) a licence for standard processing;

a licence for standard processing; (c) a licence for sale that authorizes the possession of cannabis; and

a licence for sale that authorizes the possession of cannabis; and (d) a cannabis drug licence if the amount of cannabis that is sold or distributed to the holder of the licence is, as determined in accordance with the table to section 21, equivalent to more than 600 kg of dried cannabis per calendar year.

Compliance with security measures

(2) A holder of a licence referred to in subsection (1) must ensure that the security measures are complied with.

Equivalency

(3) The cannabis referred to in paragraph (1)(d) is exempt from the application of subsection 2(4) of the Act and a quantity referred to in column 2 of the table to section 21 in respect of any class of cannabis referred to in column 1 is deemed to be equivalent to 1 kg of dried cannabis.

Site Design

Site design

63 The site must be designed in a manner that prevents unauthorized access.

Perimeter of Site

Visual monitoring

64 (1) The perimeter of the site must be monitored at all times by visual recording devices to detect any attempted or actual unauthorized access to the site.

Visual recording devices

(2) The devices must, in the conditions under which they are used, be capable of making a visible recording of any attempted or actual unauthorized access.

Intrusion detection system

65 The perimeter of the site must be secured by means of an intrusion detection system that operates at all times and that allows for the detection of any attempted or actual unauthorized access to the site and any attempted or actual tampering with the system.

Monitoring and response

66 (1) The intrusion detection system referred to in section 65 must be monitored at all times.

Appropriate measures

(2) The holder of the licence must determine the appropriate measures to be taken if any occurrence referred to in section 65 is detected.

Record of detected occurrences

(3) If any such occurrence is detected, the holder of the licence must ensure that a document is retained that contains the following information:

(a) the date and time of the occurrence; and

the date and time of the occurrence; and (b) the measures taken in response to it and the date and time when they were taken.



Operations Areas and Storage Areas

Location of storage area

67 Each storage area must be located within an area that satisfies the security measures set out in subsection 68(1), section 69, subsections 70(1) and (3), subsection 71(1) and section 72.

Restricted access

68 (1) Access to each operations area and storage area must be restricted to individuals whose presence in the area is required by their duties.

Record — storage area

(2) A record must be maintained of the identity of every individual entering or exiting a storage area.

Physical barrier

69 Each operations area and storage area must be surrounded by a physical barrier that prevents unauthorized access.

Visual monitoring

70 (1) Each operations area and storage area must be monitored at all times by visual recording devices to detect illicit conduct.

Exception — grow area

(2) For a grow area, only the entry and exit points of the area must be monitored by the devices.

Visual recording devices

(3) The devices must, in the conditions under which they are used, be capable of making a visible recording of any illicit conduct.

Intrusion detection system

71 (1) Each operations area and storage area must be secured by means of an intrusion detection system that operates at all times and that allows for the detection of any attempted or actual unauthorized access to the area, any unauthorized movement in the area and any attempted or actual tampering with the system.

Exception — grow area

(2) The intrusion detection system is not required to detect unauthorized movement in a grow area.

Monitoring and response

72 (1) The intrusion detection system referred to in section 71 must be monitored at all times.

Appropriate measures

(2) The holder of the licence must determine the appropriate measures to be taken if any occurrence referred to in section 70 or 71 is detected.

Record of detected occurrences

(3) If any such occurrence is detected, the holder of the licence must ensure that a document is retained that contains the following information:

(a) the date and time of the occurrence; and

the date and time of the occurrence; and (b) the measures taken in response to it and the date and time when they were taken.



Retention

73 A holder of a licence referred to in subsection 62(1) must retain

(a) a visual recording made under section 64 or 70 for at least one year after the day on which it is made;

a visual recording made under section 64 or 70 for at least one year after the day on which it is made; (b) a document referred to in subsection 66(3) or 72(3) for at least two years after the day on which it is prepared; and

a document referred to in subsection 66(3) or 72(3) for at least two years after the day on which it is prepared; and (c) the information in the record referred to in subsection 68(2) for at least two years after the day on which the information is recorded.



DIVISION 2

Other Licences

Micro-cultivation, micro-processing and nurseries

74 A holder of a licence for micro-cultivation, micro-processing or a nursery must ensure that the following security measures are complied with in respect of the site set out in the licence:

(a) the site is designed in a manner that prevents unauthorized access;

the site is designed in a manner that prevents unauthorized access; (b) the site is surrounded by a physical barrier that prevents unauthorized access;

the site is surrounded by a physical barrier that prevents unauthorized access; (c) storage areas are surrounded by a physical barrier that prevents unauthorized access; and

storage areas are surrounded by a physical barrier that prevents unauthorized access; and (d) access to each storage area is restricted to individuals whose presence in the area is required by their duties.



Analytical testing

75 A holder of a licence for analytical testing must ensure that the following security measures are complied with in respect of the site set out in the licence:

(a) storage areas are surrounded by a physical barrier that prevents unauthorized access; and

storage areas are surrounded by a physical barrier that prevents unauthorized access; and (b) access to each storage area is restricted to individuals whose presence in the area is required by their duties.



Cannabis drug licences

76 (1) If the amount of cannabis that is sold or distributed to the holder of a cannabis drug licence is not equivalent, as determined in accordance with the table to section 21, to more than 600 kg of dried cannabis per calendar year, the holder must ensure that

(a) if they only conduct analytical testing, the security measures set out in paragraphs 75(a) and (b) are complied with in respect of the site set out in the licence; and

if they only conduct analytical testing, the security measures set out in paragraphs 75(a) and (b) are complied with in respect of the site set out in the licence; and (b) in any other case, the security measures set out in paragraphs 74(a) to (d) are complied with in respect of the site set out in the licence.

Equivalency

(2) The cannabis referred to in subsection (1) is exempt from the application of subsection 2(4) of the Act and a quantity referred to in column 2 of the table to section 21 in respect of any class of cannabis referred to in column 1 is deemed to be equivalent to 1 kg of dried cannabis.

Research

77 A holder of a licence for research must ensure that operations areas at the site set out in the licence are designed in a manner that prevents unauthorized access.

DIVISION 3

Exemptions

Exemption — storage area

78 (1) A holder of a licence referred to in paragraph 62(1)(a), (b) or (c) is exempt from the application of section 67 in respect of the site set out in the licence if

(a) immediately before the day on which these Regulations come into force, the holder was, in respect of the site, (i) licensed under Part 1 of the former Access to Cannabis for Medical Purposes Regulations, (ii) in compliance with their obligations under sections 57 to 60 and 62 of those Regulations, and (iii) securely storing cannabis, other than cannabis plants and cannabis plant seeds, in accordance with the Directive on Physical Security Requirements for Controlled Substances (Security Requirements for Licensed Dealers for the Storage of Controlled Substances), as amended in December 1999 and published by the Government of Canada on its website; and

immediately before the day on which these Regulations come into force, the holder was, in respect of the site, (b) the holder has, since the day on which these Regulations come into force, been securely storing cannabis, other than cannabis plants and cannabis plant seeds, in accordance with the Directive referred to in subparagraph (a)(iii).

Exemption — application under former Regulations

(2) A holder of a licence referred to in paragraph 62(1)(a), (b) or (c) is exempt from the application of section 67 in respect of the site set out in the licence if

(a) the holder had, before the day on which these Regulations come into force, submitted an application under section 33 of the former Access to Cannabis for Medical Purposes Regulations in respect of the same site;

the holder had, before the day on which these Regulations come into force, submitted an application under section 33 of the former Access to Cannabis for Medical Purposes Regulations in respect of the same site; (b) the application referred to in paragraph (a) was, by virtue of subsection 158(9) of the Act, deemed to be an application for a licence made under section 62 of the Act;

the application referred to in paragraph (a) was, by virtue of subsection 158(9) of the Act, deemed to be an application for a licence made under section 62 of the Act; (c) the Minister issued a licence under section 62 of the Act on the basis of the deemed application; and

the Minister issued a licence under section 62 of the Act on the basis of the deemed application; and (d) the holder has, since the licence referred to in paragraph (c) was issued, been securely storing cannabis, other than cannabis plants and cannabis plant seeds, in accordance with the Directive referred to in subparagraph (1)(a)(iii).

Interpretation

(3) For the purposes of paragraphs (1)(b) and (2)(d), a reference in the Directive to a term set out in column 1 of the table to this subsection is deemed to be a reference to the corresponding term set out in column 2.

TABLE

Item Column 1



Term used in the Directive Column 2



Corresponding term 1 Controlled substance Cannabis 2 Licensed dealer / licenced dealer Holder of a licence 3 Cannabis Sativa, its preparations, derivatives and similar synthetic preparations except Nabilone Cannabis 4 Office of Controlled Substances, Therapeutic Products Programme Health Canada 5 Office Health Canada

Exemption — cannabis drug licence

(4) The holder of a cannabis drug licence is exempt from the application of this Part in respect of the site set out in the licence if they are securely storing cannabis in accordance with the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis, as amended from time to time and published by the Government of Canada on its website.

PART 5

Good Production Practices

General Provisions

Sale, distribution and exportation

79 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.

Standard operating procedures

80 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.

Pest control product

81 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.

Storage

82 Cannabis must be stored under conditions that maintain its quality.

Distribution

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

Building or part of building

84 (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;

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;

permits the effective cleaning of all surfaces in the building or part of the building; (c) prevents the contamination of cannabis; and

prevents the contamination of cannabis; and (d) prevents the addition of an extraneous substance to the cannabis.

Non-application

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

Filtration of air

85 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.

Equipment

86 (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;

permits the effective cleaning of its surfaces; (b) permits it to function in accordance with its intended use;

permits it to function in accordance with its intended use; (c) prevents the contamination of the cannabis; and

prevents the contamination of the cannabis; and (d) prevents the addition of an extraneous substance to the cannabis.

Non-application

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

Sanitation program

87 (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;

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;

procedures for effectively cleaning the equipment used in those activities; (c) procedures for handling any substance used in those activities; and

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.

Non-application

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

Quality assurance

88 (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.

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.

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

Sale and exportation — cannabis product

89 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.

Validated methods

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

Composition

91 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;

the residues of solvents used in the production of cannabis oil; (b) the contaminants referred to in section 94;

the contaminants referred to in section 94; (c) the dissolution or disintegration referred to in section 95; and

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.



Representative sample

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

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

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