Cannabis Regulations (SOR/2018-144)

Marginal note:Things to be used as ingredients

• 226.1 (1) A holder of a licence for processing must, if they obtain or produce anything that will be used as an ingredient to produce a cannabis extract, a cannabis topical or edible cannabis, retain a document that contains the following information:

  • (a) the name and business address of the person, if any, that supplies the thing;

  • (b) the date on which the holder takes possession of the thing or, if the thing is produced by the holder, the date on which production is completed;

  • (c) a description of the thing, including the name by which it is generally known and, if applicable,

    • (i) its chemical name,

    • (ii) its common name, if that name is not the name by which it is generally known,

    • (iii) its INCI name, and

    • (iv) its CAS registry number; and

  • (d) any lot code or other unique identifier that enables the thing to be traced.

• Marginal note:Retention period

  (2) The document must be retained for at least two years after the day on which it is prepared.

• Marginal note:Definitions

  (3) The following definitions apply in paragraph (1)(c).

  CAS registry number

  CAS registry number means the identification number assigned to a chemical by the Chemical Abstracts Service, a division of the American Chemical Society. (numéro d’enregistrement CAS)

  common name

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

  INCI name

  INCI name has the same meaning as in subsection 2(1) of the Cosmetic Regulations. (appellation INCI)

Marginal note:Sale, distribution and export of cannabis

• 227 (1) A holder of a licence, if they sell, distribute or export cannabis, must retain a document that contains the following information:

  • (a) the name of the person to which it is sold, distributed or exported;

  • (b) the address of the location from which it is sold, distributed or exported and the place to which it is sent or delivered;

  • (c) the date on which it is sold, distributed or exported;

  • (d) the quantity that is sold, distributed or exported;

  • (e) a description of the cannabis, including, if applicable, the brand name;

  • (f) its lot or batch number;

  • (f.1) in the case of a cannabis extract, a cannabis topical or edible cannabis that is a cannabis product or that is contained in a cannabis accessory that is a cannabis product, the list of ingredients that appears on the label of the cannabis product;

  • (g) in the case of a drug containing cannabis, the form of the drug and its strength per unit;

  • (h) in the case of cannabis plants, cannabis plant seeds or cannabis that is not of a class of cannabis set out in Schedule 4 to the Act, the intended use, if known; and

  • (i) in the case of a cannabis accessory that is a cannabis product, a description of the cannabis accessory.

• Marginal note:Exceptions

  (2) The obligation set out in subsection (1) does not apply if the cannabis is sold or distributed to

  • (a) an individual who has placed a purchase order for it under subsection 289(1); or

  • (b) an individual, other than an individual referred to in paragraph (a), who does not hold a licence and who is obtaining the cannabis for their personal use.

• Marginal note:Retention period

  (3) The document must be retained for at least two years after the day on which it is prepared.

Marginal note:Antimicrobial treatment

• 228 (1) A holder of a licence, if they conduct antimicrobial treatment of cannabis at a location other than the site specified in the licence, must retain a document that contains the following information:

  • (a) a description of the cannabis, including, if applicable, the brand name;

  • (b) the date on which the cannabis leaves the site specified in the licence and the quantity that leaves the site;

  • (c) the name of the person that receives the cannabis at the location where the treatment is to be conducted;

  • (d) the address of the location referred to in paragraph (c);

  • (e) the name of the person from which the cannabis is received after the treatment;

  • (f) the address of the site to which the cannabis is returned, or of the location to which it is distributed, after the treatment; and

  • (g) the date on which the cannabis is received at the site or location referred to in paragraph (f) and the quantity that is received.

• Marginal note:Retention period

  (2) The document must be retained for at least two years after the day on which it is prepared.

Destruction

Marginal note:Destruction of cannabis

• 229 (1) A holder of a licence other than a cannabis drug licence, if they destroy cannabis or cause it to be destroyed, must retain a document that contains the following information:

  • (a) a description of the cannabis, including, if applicable, the brand name;

  • (b) the date on which the cannabis is destroyed and its pre-destruction net weight or volume on that date;

  • (c) the address of the location at which the cannabis is destroyed;

  • (d) a brief description of the method of destruction; and

  • (e) the names of the individuals who witness the destruction and are qualified to do so under paragraph 43(1)(b), together with the basis on which they are qualified under subsection 43(2).

• Marginal note:Statement by witnesses

  (2) The holder must obtain, for each instance in which cannabis is destroyed, a statement signed and dated by two of the witnesses referred to in paragraph (1)(e) stating that they witnessed the destruction and that the cannabis was destroyed in accordance with a method referred to in paragraph 43(1)(a).

• Marginal note:Retention period

  (3) The document referred to in subsection (1) and the statement referred to in subsection (2) must be retained for at least two years after the day on which the cannabis is destroyed, except if they relate to cannabis destroyed under section 28.5, in which case they must be retained for at least two years after the day on which the non-therapeutic research on cannabis ends.

Security

Marginal note:Organizational security plan

230 A holder of a licence must retain a copy of any organizational security plan that they submit to the Minister — including any updated plan referred to in section 45 — for at least two years after the day on which the plan is replaced by an updated plan or, if the plan has not been replaced, at least two years after the day on which the licence expires or is revoked.

Production

Marginal note:Production

• 231 (1) A holder of a licence other than a cannabis drug licence must

  • (a) for each lot or batch of cannabis any portion of which has been sold or exported, retain a document demonstrating that the cannabis and anything that was used as an ingredient was produced, packaged, labelled, distributed, stored, sampled and tested in accordance with the applicable provisions of Parts 5 and 6;

  • (b) if applicable, maintain a list of the brand names of cannabis — of any class of cannabis set out in Schedule 4 to the Act — that the holder has produced, packaged, labelled, distributed, stored, sampled or tested;

  • (c) in respect of each instance in which a substance — including a pest control product and a fertilizer but excluding water — is applied directly or indirectly to cannabis, retain a document that contains the following information:

    • (i) the name of the substance and the quantity used,

    • (ii) the method and date of application, and

    • (iii) the rationale for the use of the substance;

  • (d) in respect of the testing conducted under Part 5 or to meet the requirements set out in Part 6,

    • (i) maintain a document that describes the validated methods used, and

    • (ii) for each lot or batch of cannabis that is tested, retain a document that contains the test results;

  • (e) in the case of a licence for processing, retain

    • (i) a document that describes the qualifications of the quality assurance person — and of any alternate quality assurance person — in respect of the matters referred to in subsection 19(1), and

    • (ii) a document that describes every investigation conducted under paragraph 19(2)(b) or (c) and any measures taken under that paragraph; and

  • (f) in the case of a licence for analytical testing, retain a document that describes the qualifications of the head of laboratory in respect of the matters referred to in subsection 23(2).

• Marginal note:Non-therapeutic research on cannabis

  (1.1) The holder of a licence for research must also retain a document demonstrating that each lot or batch of cannabis that the holder produced or received from another holder of a licence for research and that has been distributed to human participants in the conduct of non-therapeutic research on cannabis, and anything that was used as an ingredient, was produced, packaged, labelled, distributed, stored, sampled or tested in accordance with sections 28.1 and 28.2 and the provisions of Parts 5 and 6, if applicable.

• Marginal note:Retention periods

  (2) The following documents must be retained for the following periods:

  • (a) a document referred to in paragraph (1)(a), for at least two years after the day on which the last sale or export of any portion of the lot or batch takes place;

  • (b) a document referred to in paragraph (1)(c), for at least two years after the day on which it is prepared;

  • (c) a document referred to in subparagraph (1)(d)(ii), for at least two years after the day on which the last sale or export of any portion of the lot or batch takes place;

  • (d) a document referred to in subparagraph (1)(e)(i) or paragraph (f), for the period during which the quality assurance person, the alternate quality assurance person or the head of laboratory acts in that capacity and at least two years after the day on which they cease to do so;

  • (e) a document referred to in subparagraph (1)(e)(ii), for at least two years after the day on which it is prepared; and

  • (f) a document referred to in subsection (1.1), for at least two years after the day on which the non-therapeutic research on cannabis ends.

• Marginal note:Retention periods — previous versions

  (3) The holder must retain

  • (a) each version of the list referred to in paragraph (1)(b), for at least two years after the day on which it is replaced by a new version or, if it has not been replaced, at least two years after the day on which the licence expires or is revoked; and

  • (b) each version of the document referred to in subparagraph (1)(d)(i), for at least two years after the day on which the validated methods are replaced or, if the methods have not been replaced, two years after the day on which the licence expires or is revoked.

Marginal note:Standard operating procedures and sanitation program

• 232 (1) A holder of a licence other than a cannabis drug licence must maintain documentation describing

  • (a) the standard operating procedures referred to in section 80 that are in use at the site set out in the licence; and

  • (b) the sanitation program referred to in section 87 that is in use at the site set out in the licence.

• Marginal note:Retention period

  (2) The holder must retain each version of the documentation for at least two years after the day on which it is replaced by a new version or, if it has not been replaced, at least two years after the day on which the licence expires or is revoked.

Packaging and Labelling

Marginal note:Packages and labels

233 A holder of a licence other than a cannabis drug licence must retain the following samples and copies for at least two years after the day on which they are made:

• (a) a sample or copy of each distinct package for a cannabis product that the holder makes available for sale; and

• (b) a copy of each distinct label that relates to a cannabis product that the holder makes available for sale.

Cannabis Accessories

Marginal note:Cannabis accessories

234 A holder of a licence must maintain a list of the names and types of the cannabis accessories that they sell and must retain each version of the list for at least two years after the day on which it is replaced by a new version or, if it has not been replaced, at least two years after the day on which the licence expires or is revoked.

System of Control for Recalls

Marginal note:System of control

• 235 (1) A holder of a licence, other than a licence for analytical testing or a cannabis drug licence must retain, for each lot or batch of cannabis that they sell or distribute, a document that contains the information that is necessary for the system of control referred to in subsection 46(1).

• Marginal note:Retention period

  (2) The document must be retained for at least two years after the day on which the last sale or distribution of any portion of the lot or batch takes place, other than for destruction.

• Marginal note:Documentation

  (3) The holder must maintain documentation concerning the system of control and retain each version of the documentation for at least two years after the day on which it is replaced by a new version or, if it has not been replaced, at least two years after the day on which the licence expires or is revoked.

Promotion

Marginal note:Promotion

236 A holder of a licence must retain

• (a) a document that contains the information referred to in subparagraphs 245(1)(a)(i) and (ii) and (2)(a)(i) and (ii) for at least two years after the date by which the information must be provided to the Minister;

• (b) if applicable, a document that contains any information that is provided to the Minister under subsection 43(4) of the Act for at least two years after the day on which the information is provided; and

• (c) a sample or copy of any promotional materials for at least two years after the last day on which the promotion in question takes place.