Access to Cannabis for Medical Purposes Regulations (SOR/2016-230)

Regulations are current to 2017-06-19 and last amended on 2017-02-13. Previous Versions

Marginal note:Research and development

 Every licensed producer must keep a record of the following information concerning cannabis that they use in a research and development activity:

  • (a) its description, the quantity used, its lot or batch number and, if applicable, its brand name;

  • (b) the date on which it was used in that activity;

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

  • (d) in respect of any product or compound containing that cannabis that they have made or assembled in the course of that activity,

    • (i) its description,

    • (ii) the date on which it was made or assembled and the quantity made or assembled,

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

    • (iv) if applicable, the date on which it was placed in inventory and the quantity placed in inventory; and

  • (e) any other details permitting the reconciliation of the quantity of cannabis referred to in paragraph (a) and the quantities of products or compounds referred to in paragraph (d).

Marginal note:Destroyed cannabis
  •  (1) A licensed producer must keep, for each instance in which they destroy cannabis, a record of the following information:

    • (a) the date on which the cannabis was destroyed, the name of the substance destroyed and its net weight on that date, before the destruction;

    • (b) the location at which it was destroyed;

    • (c) a brief description of the method of destruction;

    • (d) the names of the witnesses to the destruction that are referred to in paragraph 30(1)(b) and the basis on which they are qualified to be witnesses under subsection 30(2); and

    • (e) if applicable, the name of the person who accompanied the cannabis in accordance with subsection 30(3).

  • Marginal note:Statement by witnesses

    (2) A licensed producer must keep, for each instance in which they destroy cannabis, a statement signed and dated by each of the witnesses referred to in paragraph 30(1)(b) stating that they have witnessed the destruction and that the cannabis was destroyed in accordance with section 30.

Marginal note:Inventory — marihuana
  •  (1) A licensed producer must keep a record of the net weight of each of the following that are in inventory at their site at the end of each quarter of the calendar year:

    • (a) marihuana seeds, other than marihuana seeds referred to in paragraph (h);

    • (b) harvested marihuana, other than marihuana referred to in paragraphs (e) and (f), that is not to be subjected to a drying process;

    • (c) harvested marihuana, other than marihuana referred to in paragraphs (e) and (g), in respect of which the drying process has not been completed;

    • (d) harvested marihuana, other than marihuana referred to in paragraphs (e) and (g), in respect of which the drying process has been completed;

    • (e) marihuana that is destined for destruction;

    • (f) packaged fresh marihuana;

    • (g) packaged dried marihuana;

    • (h) packaged marihuana seeds; and

    • (i) cannabis other than marihuana or cannabis oil, with an indication of the name and net weight of each of the substances in question.

  • Marginal note:Inventory — marihuana plants

    (2) A licensed producer must keep a record of the number of marihuana plants destined to be sold or provided that are in inventory at their site at the end of each quarter of the calendar year.

  • Marginal note:Inventory — cannabis oil

    (3) A licensed producer must keep a record of the net weight of each of the following that are in inventory at their site at the end of each quarter of the calendar year:

    • (a) cannabis oil that has not been packaged, other than cannabis oil referred to in paragraph (c);

    • (b) packaged cannabis oil, other than cannabis oil referred to in paragraph (c); and

    • (c) cannabis oil that is destined for destruction.

Notices to Local Authorities

Marginal note:Notices

 A licensed producer must keep a copy of

  • (a) each notice provided to local authorities under sections 48 to 50; and

  • (b) each copy of a notice provided to the Minister under section 50.

Communications with Licensing Authorities

Marginal note:Documents

 A licensed producer must keep

  • (a) a copy of each notice provided to a licensing authority under section 51, as well a copy of the copy of the notice provided to the Minister under that section;

  • (b) for each request received from a licensing authority under subsection 123(1),

    • (i) a copy of the request, together with any supporting documentation received,

    • (ii) a record of the date on which the request and documentation were received,

    • (iii) a copy of the information that was provided in response to the request,

    • (iv) a record of the date on which the information was provided, and

    • (v) a record of the steps that were taken to ensure that the information was securely transmitted to the authority;

  • (c) a copy of any request or notice received from a licensing authority under section 124 and a record of the date on which it was received;

  • (d) for each instance in which they provide information to a licensing authority under section 124,

    • (i) a copy of the information,

    • (ii) a record of the date on which the information was provided, and

    • (iii) a record of the steps that were taken to ensure that the information was securely transmitted to the authority; and

  • (e) a copy of the notice sent under subsection 124(5).

General Obligations

Marginal note:Manner of keeping records
  •  (1) A licensed producer must ensure that the records, documents and information referred to in this Division are kept in a manner that will enable an audit of them to be made in a timely manner and are available at their site.

  • Marginal note:Retention period

    (2) A licensed producer must retain the records, documents and information for the following periods:

    • (a) in the case of a notice that the producer is required to provide or send under this Part, for a period of two years after the day on which the notice is provided or sent;

    • (b) in the case of information that the producer is required to record under sections 152 and 155, subsection 156(1), section 157, subsections 158(1) and 159(1) and sections 163, 164 and 166, for a period of two years after the day on which the information is recorded;

    • (c) in the case of the documents referred to in sections 153 and 154, for a period of two years after the day on which the declaration referred to in section 98 or 106, as applicable, is sent to the Minister;

    • (d) in the case of the documents referred to in subsection 156(2) and paragraphs 159(2)(a) to (f), for a period of two years after the day on which the producer obtained them or, in the case of documents made by the producer, the day on which they were made;

    • (e) in the case of the visual recordings or the records referred to in section 160, for a period of two years after the day on which they were made;

    • (f) in the case of the records referred to in paragraphs 161(1)(a) and (2)(b), for a period of two years after the date of the last sale or provision of any portion of the lot or batch of fresh or dried marihuana, cannabis oil or marihuana plants or seeds under subsection 22(4) or (5);

    • (g) in the case of a document referred to in any of paragraphs 161(1)(b) to (e), for the period during which it is current and for an additional period of two years after the day on which it is replaced by a new version;

    • (h) in the case of a document referred to in paragraph 161(1)(f), for the period during which the quality assurance person acts in that capacity and for an additional period of two years after the day on which the person ceases to do so;

    • (i) in the case of the records referred to in paragraph 161(1)(g), for a period of two years after the day on which the complaint was recorded;

    • (j) in the case of the records referred to in paragraph 161(2)(a), for a period of two years after the date of the last sale or provision of any portion of the lot or batch, other than a sale or provision for destruction;

    • (k) in the case of the records referred to in paragraph 161(2)(c), for a period of two years after the day on which the substance was recalled;

    • (l) in the case of the information concerning the method referred to in section 162, for a period of two years after the day on which the information is recorded;

    • (m) in the case of the records and documents referred to in section 165, for a period of two years after the day on which the cannabis was destroyed;

    • (n) in the case of a document or record referred to in paragraph 168(b), for a period of two years after the day on which the information was provided to the licensing authority;

    • (o) in the case of a request or notice referred to in paragraph 168(c), for a period of two years after the day on which it was received;

    • (p) in the case of a document or record referred to in paragraph 168(d), for a period of two years after the day by which the producer was required to provide the information; and

    • (q) in the case of a notice referred to in paragraph 168(e), for a period of two years after the end of the quarter to which the notice relates.

  • Marginal note:Case reports and summary reports

    (3) A licensed producer must retain the serious adverse reaction case reports and the summary reports referred to in subsections 78(1) and (2), respectively, for a period of 25 years after the day on which they were made.

 
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