Cannabis Regulations (SOR/2018-144)

Site Design

Marginal note:Site design

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

Perimeter of Site

Marginal note: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.

• Marginal note: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.

Marginal note: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.

Marginal note:Monitoring and response

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

• Marginal note: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.

• Marginal note: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

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

Operations Areas and Storage Areas

Marginal note: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.

Marginal note: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.

• Marginal note:Record — storage area

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

Marginal note:Physical barrier

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

Marginal note:Visual monitoring

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

• Marginal note:Exception — grow area

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

• Marginal note: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.

Marginal note: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.

• Marginal note:Exception — grow area

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

Marginal note:Monitoring and response

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

• Marginal note: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.

• Marginal note: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

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

Marginal note: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;

• (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

• (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 2Other Licences

Marginal note: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;

• (b) 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

• (d) access to each storage area is restricted to individuals whose presence in the area is required by their duties.

Marginal note: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

• (b) access to each storage area is restricted to individuals whose presence in the area is required by their duties.

Marginal note: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

  • (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.

• Marginal note: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.

Marginal note: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 3Exemptions

Marginal note: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

  • (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) .

• Marginal note: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;

  • (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;

  • (c) 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).

• Marginal note: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.

  	Column 1	Column 2
  Item	Term used in the Directive	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

• Marginal note: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 5Good Production Practices

Definitions

Marginal note:Definitions

78.1 The following definitions apply in this Part.

acceptable level

acceptable level means a level of a biological, chemical or physical hazard that does not present a risk of contamination of cannabis or anything that will be used as an ingredient. (niveau acceptable)

control measure

control measure means a measure that can be applied to prevent or eliminate any biological, chemical or physical hazard that presents a risk of contamination of cannabis or anything that will be used as an ingredient, or to reduce the hazard to an acceptable level. (mesure de contrôle)

critical control point

critical control point means a step at which the application of a control measure is essential to prevent or eliminate any biological, chemical or physical hazard that presents a risk of contamination of cannabis or anything that will be used as an ingredient, or to reduce the hazard to an acceptable level. (point de contrôle critique)

sanitary condition

sanitary condition means a condition that does not present a risk of contamination, allergen cross-contamination or introduction of an extraneous substance to cannabis or anything that will be used as an ingredient. (conditions hygiéniques)

General Requirements

Marginal note:Sale, distribution and exportation — cannabis

79 A holder of a licence must not sell, distribute or export cannabis unless the applicable requirements set out in sections 80 to 88.94 have been met.

Marginal note:Non-application — person not holding a licence

79.1 The requirements of this Part do not apply to any activity that a person conducts in respect of anything that will be used as an ingredient unless the activity is conducted by a holder of a licence.

Marginal note:Non-application — holder of licence for analytical testing or research

79.2 Sections 80 to 87.1 do not apply to

• (a) a holder of a licence for analytical testing; or

• (b) a holder of a licence for research, except in respect of non-therapeutic research on cannabis.

Marginal note:Non-application — reference standard

79.3 The requirements of this Part do not apply in respect of a reference standard and anything that will be used as an ingredient in the production of a reference standard.

Marginal note:Standard operating procedures

80 Cannabis and anything that will be used as an ingredient 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 applicable requirements of this Part and Part 6.

Marginal note:Pest control product

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

• Marginal note:Exception — edible cannabis

  (2) Despite subsection (1), edible cannabis may be treated during the course of production with a pest control product referred to in subparagraph 3(1)(b)(ii) of the Pest Control Products Regulations.