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Cannabis Regulations (SOR/2018-144)

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Regulations are current to 2022-09-22 and last amended on 2022-07-21. Previous Versions

PART 11Retention of Documents and Information (continued)

Inventory and Distribution (continued)

Marginal note:Sale, distribution and export of cannabis

  •  (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

  •  (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

  •  (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.

Security

Marginal note:Organizational security plan

 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:Good production practices

  •  (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: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; and

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

  • 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

  •  (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

 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

 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

  •  (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

 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.

Research and Development

Marginal note:Research and development

  •  (1) A holder of a licence, if they undertake research and development activities, must retain a document that contains the following information:

    • (a) in respect of any cannabis that is used in the activities,

      • (i) its description, including, if applicable, its brand name,

      • (ii) the quantity used and, if applicable, the lot or batch number,

      • (iii) the date on which it is used, and

      • (iv) the purpose and a brief description of the activity;

    • (b) in respect of any cannabis that is produced in the course of the activities,

      • (i) its description,

      • (ii) the quantity produced,

      • (iii) the date on which it is produced,

      • (iv) if applicable, the date on which it is used for testing and the quantity used, and

      • (v) if applicable, the date on which it is placed in inventory intended for sale and the quantity placed in inventory; and

    • (c) any other information that can be used to reconcile the quantities of cannabis referred to in paragraphs (a) and (b).

  • Marginal note:Retention period

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

Limit for Micro-processing Licence

Marginal note:Limit — micro-processing licence

 A holder of a licence for micro-processing must maintain documentation that demonstrates that they comply with the limit set out in subsection 21(1) 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, for at least two years after the day on which the licence expires or is revoked.

Import and Export

Marginal note:Import of cannabis

 A holder or former holder of an import permit must retain a document that contains the information that they provided to the Minister under section 209 — together with a copy of the relevant export permit that was issued by a competent authority in the country of export — for at least two years after the day on which the information is provided.

Marginal note:Export of cannabis

 A holder or former holder of an export permit must retain a document that contains the information that they provided to the Minister under section 218 — together with a copy of the relevant import permit issued by a competent authority in the country of final destination — for at least two years after the day on which the information is provided.

Key Investors

Marginal note:Record of key investors

  •  (1) A holder of a licence for cultivation, processing or sale must maintain a record that contains the following information in respect of each key investor:

    • (a) the key investor’s name and mailing address;

    • (b) a detailed description of the means by which the key investor exercises, or is in a position to exercise, control over the holder;

    • (c) details regarding the transaction by virtue of which the key investor became such an investor, including

      • (i) if they provided money directly or indirectly to the holder, the amount provided, the date on which it was provided and the terms and conditions under which it was provided, and if the money was provided in the form of a loan, the interest rate and term, and

      • (ii) if they provided goods or services directly or indirectly to the holder, a description of the goods or services, their fair market value at the time they were provided, the date on which they were provided and the terms and conditions under which they were provided;

    • (d) details regarding each instance in which the key investor provides money, goods or services directly or indirectly to the holder, including

      • (i) in the case of money, the amount provided, the date on which it is provided and the terms and conditions under which it is provided, and if the money is provided in the form of a loan, the interest rate and term, and

      • (ii) in the case of goods or services, a description of the goods or services, their fair market value at the time at which they are provided, the date on which they are provided and the terms and conditions under which they are provided;

    • (e) details regarding any benefit that the key investor receives from the holder as a result of

      • (i) having provided money, goods or services to the holder, or

      • (ii) holding an ownership interest or other right or interest in, or in respect of, a business operated by the holder or, if the holder is an organization, in or in respect of the organization;

    • (f) details regarding each instance in which money is repaid or goods are returned to the key investor, including

      • (i) in the case of money, the amount repaid and the date on which it is repaid, and

      • (ii) in the case of goods, a description of the goods, their fair market value at the time they are returned and the date on which they are returned;

    • (g) if known, an indication of whether any ownership interest or other right or interest held by the key investor in, or in respect of, a business operated by the holder — or, if the holder is an organization, in or in respect of the organization — has been assigned, pledged, mortgaged, hypothecated or sold, in whole or in part, to any person;

    • (h) if known, an indication of whether an agreement has been entered into under which any right or interest referred to paragraph (g) will or could be assigned, pledged, mortgaged, hypothecated or sold, in whole or in part, to any person; and

    • (i) if known, the name and mailing address of any person referred to in paragraph (g) or (h).

  • Marginal note:Exception — published market

    (2) Subsection (1) does not apply to a holder that is an organization if their equity securities are, or a class of those securities is, listed on a published market.

  • Marginal note:Exception — key investors before issuance

    (3) The holder is not required to include the information referred to in paragraph (1)(c) in respect of a key investor that became such an investor before the day on which the licence was issued.

  • Marginal note:Exception — continued licences

    (4) If the licence has been continued in force by virtue of subsection 158(1) of the Act, the holder is not required to include the information referred to in paragraph (1)(c) in respect of a key investor that became such an investor before the day on which these Regulations come into force.

  • Marginal note:Requirements regarding content

    (5) The holder must not delete any information from the record and must indicate the effective date of the event in respect of which new information is added to the record.

  • Marginal note:Former key investors

    (6) For greater certainty, the information that has been included in the record in respect of a key investor must continue to be retained in the record even if the person ceases to be such an investor.

  • Marginal note:Annual reporting

    (7) The holder must, no later than January 31 in any given year, provide the Minister with

    • (a) a copy of the record; and

    • (b) if any person ceased to be a key investor during the previous calendar year, a document containing details regarding how and when they ceased to be such an investor.

  • Marginal note:Maintenance and retention of record

    (8) The holder must ensure that the record is

    • (a) maintained in a manner that will enable an audit of it to be made in a timely manner;

    • (b) available at the site specified in the licence; and

    • (c) retained for at least two years after the day on which the holder ceases to be required to maintain it.

  • Marginal note:Definitions

    (9) The following definitions apply in this section.

    key investor

    key investor means, in respect of the holder of a licence, a person that exercises, or is in a position to exercise, direct or indirect control over the holder by virtue of

    • (a) having provided money, goods or services directly or indirectly to the holder; or

    • (b) holding an ownership interest or other right or interest in, or in respect of, a business operated by the holder or, if the holder is an organization, in or in respect of the organization. (investisseur-clé)

    published market

    published market means a market inside or outside Canada on which equity securities are traded, if the prices at which the securities are traded are regularly published either electronically or in a newspaper or financial or business publication of general circulation. (marché publié)

 
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