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Canada

TRELLIS ACMPR REGULATIONS SUPPORT DOCUMENT

The purpose of this document is to demonstrate how Trellis software meets regulatory compliance with the Access to Cannabis for Medical Purposes Regulations (ACMPR) developed by Health Canada. Trellis has compiled this document to assist customers and regulators ensure compliance with regulatory track-and-trace requirements.

DIVISION 5 | Record Keeping by Licensed Producers

Cannabis received

152 Except in the case referred to in section 157, a licensed producer who receives cannabis must record the following information:

  • (a) the name of the person from whom it was received;
  • (b) the address of the site at which it was received;
  • (c) the date on which it was received; and
  • (d) an indication of which substance was received, as well as the following information:
    •  (i) in the case of fresh or dried marihuana or cannabis oil, the quantity and, if applicable, brand name, or
    •  (ii) in the case of cannabis other than cannabis referred to in subparagraph (i), its quantity, description, intended use and, if applicable, brand name.

Trellis tracks and reports the inbound transfer of cannabis in the ‘Purchasing’ module. Once a marihuana product is received or rejected, the user will update the status of the ‘Purchase Order’ in Trellis. Purchase Orders can be downloaded to report required compliance data.

Exported substances

154 A licensed producer who exports marihuana or a substance referred to in paragraph 22(3)(c) must retain a copy of the declaration required by section 106 and of the import permit issued by a competent authority in the country of final destination.

Record of verbal order
155 A licensed producer who receives a verbal order referred to in subsection 143(3) must record the following information:

  • (a) the date on which the order was placed and the order number;
  • (b) the information referred to in paragraphs 143(2)(b) and (c); and
  • (c) the name of the individual recording the order.

Filling of order from client

  • 156 (1) A licensed producer who fills an order referred to in section 143 must record the following information:
    • (a) the given name, surname and date of birth of the client for whom the order is placed;
    • (b) the given name and surname of the individual placing the order;
    • (c) the quantity, brand name and lot number of the fresh or dried marihuana, cannabis oil or marihuana plants or seeds sold or provided;
    • (d) the date on which the order was received;
    • (e) the date on which the substance was shipped; and
    • (f) the address to which the substance was shipped.

Retention of documents

(2) A licensed producer must retain a written order referred to in subsection 143(2) or a written record of a verbal order referred to in subsection 143(3).

Orders to licensed producers are tracked via the ‘Orders’ module. An order can only be initiated with a registered client. Users record each lot number, quantity and weight of marihuana or marihuana products for transfer. The fulfillment method, including shipping and pick up, is recorded and once completed, a record of the order and chain of custody is stored in ‘Order History’. An ‘Order Manifest’ is available for reporting purposes. Users can use the Trellis Order Manifest to report the required compliance data.

Refusal to fill an order

(3) A licensed producer who refuses to fill an order referred to in section 143 must retain a copy of the written notice referred to in subsection 145(3).

Returned substance

157 A licensed producer who receives fresh or dried marihuana, cannabis oil or marihuana plants or seeds that are returned under section 148 must record the following information:

  • (a) the given name and surname of the client who returned the substance or on behalf of whom the substance was returned;
  • (b) the address of the site at which it was received;
  • (c) the name of the substance, its quantity and brand name; and
  • (d) the date on which it was received.

Users record returns in the Orders module. Trellis documents the client information, date and marihuana substance information and generates a downloadable Return Manifest. All historical returns are stored in the ‘Orders’ module.

Order from person other than client

  • 158 (1) A licensed producer who fills an order referred to in subsection 149(1) or (2) must record the following information:
    • (a) the name of the person to whom the substance was sold or provided;
    • (b) the shipping address;
    • (c) an indication of which substance was ordered, as well as the following information:
      • (i) in the case of fresh or dried marihuana or cannabis oil, its quantity and, if applicable, brand name, or
      • (ii) in the case of cannabis other than cannabis referred to in subparagraph (i), its quantity, description and, if applicable, brand name; and
    • (d) the date on which the substance was shipped.

Refusal to fill an order

(2) A licensed producer who refuses to fill an order referred to in subsection 149(1) or (2) must retain a copy of the written notice referred to in subsection 151(2).

Client Registrations Information

  •  159 (1) A licensed producer must record the following information:
    • (a) details of the verifications performed under subsection 121(2), section 132, subsection 135(2) and paragraph 139(2)(b); and
    • (b) what will serve as the unique identifier referred to in paragraph 133(2)(b) and the manner in which and the date on which it was communicated to the client.

Documents
(2) A licensed producer must retain the following documents:

  • (a) the registration application referred to in section 130;
  • (b) the medical document referred to in section 130, or, if the document has been returned in accordance with subsection 136(3), a copy of it;
  • (c) the copy of a registration certificate referred to in section 130;
  • (d) a copy of a registration document referred to in paragraph 133(2)(a);
  • (e) the application for the amendment of a registration referred to in section 137;
  • (f) a copy of an amended registration document referred to in subsection 138(2); and
  • (g) a copy of a notice referred to in section 136 or subsection 139(4) or (6).

All clients and persons to whom marihuana is sold are registered in the ‘Patients’ and ‘Wholesale’ modules. As part of the patient or wholesale profile, users may attach registration, medical and other documentation in the ‘Additional Documents’ tab.

Good production practices and packaging, labelling and shipping

  • 161 (1) A licensed producer must keep
    • (a) records demonstrating that each lot or batch of fresh or dried marihuana, cannabis oil or marihuana plants or seeds that they sold or provided under subsection 22(4) or (5) was produced, packaged and labelled in accordance with Subdivisions D and F of Division 1;
    • (b) a list of all brand names of fresh or dried marihuana, cannabis oil or marihuana plants or seeds that they produced, packaged or labelled;
    • (c) a copy of the sanitation program referred to in section 72 in use at their site; o (d) a copy of the standard operating procedures referred to in section 73 in use at their site;
    • (e) documentation concerning the system of control referred to in section 74 in use at their site;
    • (f) a description of the qualifications of the quality assurance person in respect of the matters referred to in subparagraph 75(1)(a)(ii); and
    • (g) records of every complaint referred to in paragraph 75(1)(b) and of any corrective action taken.

Current and historical packaging activity is recorded in the ‘Packaging’ module. A report of packaged marihuana, cannabis oil or marihuana plants/seeds are accessed via user-generated reports in the ‘Reports’ module. Reports can be exported and saved locally on licensed premises or at a different location designated by the user.

Sale or provision

  • (2) A licensed producer who sells or provides fresh or dried marihuana, cannabis oil or marihuana plants or seeds must keep
    • (a) records of any testing conducted by or on behalf of the licensed producer in respect of any lot or batch of the substance;Lab test results for test samples are stored in the ‘Quality Control’ module and tied to a marihuana, cannabis oil or marihuana plant/seeds.
    • (b) records of information necessary for the system of control referred to in section 74; andUsers can initiate a recall using Trellis. The ‘Recall’ module identifies all lots that are tied to the recalled inventory. Once recalled inventory is collected, users receive unique disposal IDs used to track the cannabis waste throughout the disposal process from collection to permanent removal. The software tracks the weight of the recalled cannabis product and the disposal process used.
    • o (c) a record of the information that the licensed producer is required by section 77 to provide to the Minister in respect of the recall of the substance.Users can generate an exportable recall report in the ‘Recall’ module. The recall report lists the weight of the product, reason for destruction, and the date the quarantine period began.

Lot or batch — marihuana

  • 163 (1) A licensed producer must keep a record of the following information concerning each lot or batch of marihuana that they propagate, sow, harvest, dry, package or destroy:
    • (a) the date on which marihuana plants are propagated by means other than sowing seeds and the number of new plants propagated in this manner;
    • (b) the date on which marihuana seeds are sown and their net weight on that date;Plants are assigned to lots in Trellis and assigned a batch number used to track the lot during the cultivation process. Plants also receive an internal plant number from Trellis to track each plant until flowering. A batch report can be generated in the ‘Reports’ module. Trellis logs net weight of seeds when entered into the system as inventory.
    • (c) the date on which marihuana is harvested and its net weight on that date;Trellis logs harvest date and net weight for each harvest batch. This information can be accessed in the ‘Harvest Batch’, ‘Wet Weight’ or ‘Reports’ modules.
    • (d) the date on which the drying process for marihuana is completed, if any, and its net weight on that date;Once a harvest batch has completed the drying and trimming processes the harvest batch will be closed and Trellis logs the dates and net weight. Once a harvest is closed, a harvest manifest is generated with total net weights and calculations for moisture loss and yield loss.
    • (e) the date on which marihuana is packaged and its net weight on that date; andThe date on which marihuana is packaged and its net weight on that date is recorded in the ‘Packaging’ module. This information can be quickly accessed in the lot’s ‘Activity Log’, which includes a time stamped record of each activity (e.g. packaging, transfer, etc.) and the authorizer’s user ID.
    • (f) the date on which marihuana is destroyed and its net weight on that date, before the destruction.Upon destruction of marihuana, Trellis collects and records the date, reason for destruction, net weight and method of disposal. Users can generate disposal reports in the ‘Reports’ module and track active disposal data in the ‘Disposal’ dashboard. To process waste, Trellis requires users to input a supervisory authorization pin and a witness authorization pin.

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Research and development

164 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).

Inventory is categorized as intended for research and development when entered into Trellis. The ‘Reports’ module generates reports that can be filtered by intended use. The Activity Log for each lot includes a time stamped record of each activity (e.g. extraction, transfer, waste creation, etc.).

Destroyed cannabis

  • 165 (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).

Upon destruction of cannabis, Trellis collects and records the date, reason for destruction, location, net weight and method of disposal. Users can generate disposal reports in the ‘Reports’ module and track active disposal data in the ‘Disposal’ dashboard. To process waste, Trellis requires users to input a supervisory authorization pin and a witness authorization pin.

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.

To process waste, Trellis requires users to input a supervisory authorization code and a witness authorization code. Historical disposal information, including witness authorization records, can be accessed in the ‘Disposal’ or ‘Reports’ modules.

Inventory — marihuana

  • 166 (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.

Trellis records the weight of all marihuana inventory once it is created and throughout the production process. User generated, inventory reports can be generated in the ‘Reports’ module. Reports can be exported and saved locally on licensed premises or at a different location designated by the user.

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.

A report that includes all plant and batch numbers can be generated in the ‘Reports’ module. These reports can be filtered by cultivation stage, batch number, etc. Reports can be exported and saved locally on licensed premises or at a different location designated by the user.

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.

An inventory report for cannabis oil that includes net weight can be generated in the ‘Reports’ module. Active and historical reports are accessible. Cannabis oil destined for destruction can be accessed in the disposal section of the ‘Reports’ module.

General Obligations
Manner of keeping records

  • 169 (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.

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.

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.

Information required by Minister

170 A licensed producer must provide the Minister with any information that the Minister may require in respect of the records, documents and information referred to in this Division, in the form and at the times that the Minister specifies.

Trellis stores client track-and-trace data on servers hosted by Amazon Web Services (AWS). All records are accessible via a web portal and administrators can configure user permissions to prevent unauthorized access. Records can be accessed via user-generated reports in the ‘Reports’ module. Reports can be exported and saved locally for authorized use. Trellis conducts routine daily database backups and clients have the option to subscribe to an additional local backup service.

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