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Cannabis Regulations (SOR/2018-144)

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Regulations are current to 2019-11-19 and last amended on 2019-10-17. Previous Versions

PART 11Retention of Documents and Information (continued)

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.

  • SOR/2019-206, s. 65

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.

  • SOR/2019-206, s. 66

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.

 
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