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TRELLIS CANNABIS ACT REGULATIONS SUPPORT DOCUMENT

PART 11 Retention of Documents and Information

General Provisions

Manner of retention

221 A person that is required to retain a document or information — or that must ensure that a document or information is retained — under these Regulations must ensure that

  • (a) the document or information is retained in a manner that will enable an audit of it to be made in a timely manner;
  • (b) if the person holds a licence, the document or information is available at the site specified in the licence; and
  • (c) if the person does not hold a licence, the document or information is available at their place of business in Canada or, if they do not have such a place of business, at a place of business in Canada.

Requirement to continue to retain

222 If a person ceases to hold a licence, they must, in respect of any document or information that they were required to retain under these Regulations and for which the retention period has not yet ended,

  • (a) ensure that the document or information continues to be retained until the end of the retention period; and
  • (b) provide the Minister with notice in writing of the address of the location at which the document or information is retained and of any subsequent change to the address.

Notices

Retention of notices

223 A holder of a licence, if they send or provide a notice under these Regulations and are not otherwise required to retain a copy, must retain a copy for at least two years after the day on which the notice is sent or provided.

Inventory and Distribution

Inventory — cannabis other than oil

224 (1) A holder of a licence must retain, for each lot or batch of cannabis — other than cannabis oil — that they produce, a document that contains the following information, as applicable:

  • (a) the date on which cannabis plants are propagated by means other than sowing seeds and the number of new plants propagated in this manner;
  • (b) the date on which cannabis plant seeds are sown and their net weight on that date;
  • (c) the date on which cannabis is harvested and its net weight on that date;
  • (d) the date on which drying processes are completed for the cannabis and its net weight on that date;
  • (e) the date on which dried or fresh cannabis is put into a discrete unit form, the net weight of cannabis in each unit and the number of units; and
  • (f) the date on which cannabis that is not of a class of cannabis set out in Schedule 4 to the Act is produced and its net weight or volume on that date.

Packaging

(2) A holder of a licence must retain, for each lot or batch of cannabis — other than cannabis oil — that they package, 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 packaged and its net weight on that date; and
  • (c) in the case of a drug containing cannabis, the strength per unit of the drug.

Retention period

(3) The documents must be retained for at least two years after the day on which they are prepared.

Inventory — cannabis oil

225 (1) A holder of a licence must retain, for each lot or batch of cannabis oil that they produce, a document that contains the following information:

  • (a) the date on which the cannabis oil is produced and its net weight or volume on that date;
  • (b) if applicable, the date on which the cannabis oil is put into a discrete unit form, the net weight or volume of the oil in each unit and the number of units; and
  • (c) in respect of the cannabis that was used to produce the cannabis oil, its description, its net weight or volume, its lot or batch number and the date on which it was produced.

Packaging

(2) A holder of a licence must retain, for each lot or batch of cannabis oil that they package, a document that contains the following information:

  • (a) a description of the cannabis oil, including the brand name, if applicable;
  • (b) the date on which the cannabis oil is packaged and its net weight or volume on that date; and
  • (c) in the case of a drug containing cannabis, the strength per unit of the drug.

Retention period

(3) The documents must be retained for at least two years after the day on which they are prepared.

Receipt of cannabis

226 (1) A holder of a licence must, if they receive cannabis, retain a document that contains the following information:

  • (a) the name of the person from which it is received;
  • (b) the address of the location at which it is received and, if known, from which it is received;
  • (c) the date on which it is received;
  • (d) the quantity that is received;
  • (e) a description of the cannabis, including, if applicable, the brand name;
  • (f) if known, the lot or batch number of the cannabis;
  • (g) in the case of a drug containing cannabis, the form of the drug and its strength per unit; and
  • (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.

Retention period

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

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;
  • (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.

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.

Retention period

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

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.

Retention period

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

Destruction

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 in the case of cannabis oil, 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).

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).

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

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

Good production practices

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 was produced, packaged, labelled, distributed, stored, sampled and tested in accordance with the provisions of Part 5;
  • (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 any 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 concerning every complaint received in respect of the quality of the cannabis and of any corrective or preventative measures taken; 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).

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.

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 licence expires or is revoked.

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.

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

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

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

System of control

235 (1) A holder of a licence other than 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 section 46.

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.

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

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.

Research and Development

Research and development

237 (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).

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

Limit — micro-processing licence

238 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.

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Import and Export

Import of cannabis

239 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.

Export of cannabis

240 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

Record of key investors

241 (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).

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.

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.

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.

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.

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.

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.

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.

Definitions

(9) The following definitions apply in this section.

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 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)

PART 12 Reporting and Disclosure

Documents and Information Provided to Minister

Form and manner

242 Except as otherwise provided in these Regulations, documents that are required to be provided to the Minister under this Part, Part 8, subsection 241(7) or section 297 must be provided in the form and manner specified in the document entitled Form and Manner Requirements – Documents Provided to the Minister of Health under the Cannabis Act, as amended from time to time and published by the Government of Canada on its website.

Request by Minister

243 (1) A person that is required to ensure the retention of documents or information under these Regulations and that is not authorized under the Act to conduct activities in relation to cannabis may be required by the Minister to provide the documents or information to the Minister if the Minister has reasonable grounds to believe that the documents are, or the information is, necessary to address an issue of public health or public safety or to verify compliance or prevent non-compliance with the provisions of the Act or of these Regulations. If the person is required to provide the documents or information to the Minister, they must do so as soon as feasible.

Import and export permits

(2) A person that has ceased to hold a licence and that is required to retain documents — including copies of permits — under section 239 or 240 may be required by the Minister to provide the documents to the Minister if the Minister has reasonable grounds to believe that they are necessary for a purpose specified in subsection (1). If the person is required to provide the documents to the Minister, they must do so as soon as feasible.

Exception — urgent issues

(3) A document or information that must be provided under subsection (1) or (2) to address an issue of public health or public safety must be provided without delay if the Minister has reasonable grounds to believe that the issue must be addressed urgently and so indicates in the request.

Notice — new cannabis product

244 (1) A holder of a licence for processing, at least 60 days before making available for sale a cannabis product — except cannabis plants or cannabis plant seeds — that they have not previously sold in Canada, must provide the Minister with a written notice that contains the following information:

  • (a) the class of cannabis set out in Schedule 4 to the Act to which the cannabis product belongs;
  • (b) a description of the cannabis product, including the brand name; and
  • (c) the date on which the cannabis product is expected to be made available for sale.

Retention period

(2) The holder must retain a copy of the notice for at least two years after the date referred to in paragraph (1)(c).

Information related to promotion

245 (1) For the purpose of subsection 43(1) of the Act,

  • (a) the information that a person referred to in that subsection must provide to the Minister in respect of the promotion of cannabis is
    • (i) the total amount of money that the person spent in a given calendar year on promotion that is directed at consumers who purchase cannabis at the retail level in Canada, together with a description of the types of promotion on which the money was spent, and
    • (ii) the total amount of money that the person spent in a given calendar year on promotion conducted in Canada that is not directed at consumers referred to in subparagraph (i), together with a description of the types of promotion on which the money was spent; and
  • (b) the information must be provided, in writing, no later than March 31 of the year after the year to which the information relates.

Cannabis accessories and services

(2) For the purpose of subsection 43(2) of the Act,

  • (a) the information that a person referred to in that subsection must provide to the Minister, in respect of the promotion of cannabis accessories that they sell or distribute or a service related to cannabis that they provide, is
    • (i) the total amount of money that the person spent in a given calendar year on promotion that is directed at consumers who purchase cannabis at the retail level in Canada, together with a description of the types of promotion on which the money was spent, and
    • (ii) the total amount of money that the person spent in a given calendar year on promotion conducted in Canada that is not directed at consumers referred to in subparagraph (i), together with a description of the types of promotion on which the money was spent; and
  • (b) the information must be provided, in writing, no later than March 31 of the year after the year to which the information relates.

Exemption

(3) A person referred to in subsection 43(1) or (2) of the Act is exempt from the requirement to provide the information referred to in subsection (1) or (2) if they do not hold a licence.

Prior promotions

(4) The information referred to in subsections (1) and (2) is not required to be provided in respect of any promotion that is conducted before the day on which these Regulations come into force.

Theft or loss of cannabis

246 (1) A holder of a licence other than a cannabis drug licence must, if they experience a theft of cannabis or a loss of cannabis that cannot be explained on the basis of normally accepted business activities,

  • (a) notify a police force within 24 hours after becoming aware of its theft or loss; and
  • (b) provide the Minister with a written notice within 10 days after becoming aware of its theft or loss.

Retention period

(2) The holder must retain a copy of the notice provided to the Minister for at least two years after the day by which the Minister must be notified.

Voluntary recall

247 (1) A holder of a licence must, before commencing a voluntary recall of a cannabis product that has been sold or distributed in Canada, provide the Minister with a document that contains the following information:

  • (a) a description of the cannabis product, including the brand name;
  • (b) the number of each lot or batch of the cannabis product to be recalled, together with, if known, the number of any lot or batch of cannabis that was used to make the cannabis product;
  • (c) if known, the name and address of each person that
    • (i) produced or imported into Canada the cannabis that is, or is contained in, the cannabis product,
    • (ii) packaged or labelled the cannabis referred to in subparagraph (i) before it became, or became part of, the cannabis product,
    • (iii) in the case of a cannabis accessory that is a cannabis product, produced or imported into Canada the cannabis accessory or any component of it, or
    • (iv) packaged or labelled the cannabis product;
  • (d) the reasons for commencing the recall;
  • (e) if the cannabis that is, or is contained in, the cannabis product was produced or imported into Canada by the holder, the quantity of cannabis that was produced or imported;
  • (f) the quantity of the cannabis product that was sold or distributed by the holder in Canada;
  • (g) if applicable, the quantity of the cannabis product that is affected by the problem or potential problem underlying the recall and that remains in the possession of the holder;
  • (h) the number of persons to which the holder sold or distributed the cannabis product in Canada;
  • (i) the period during which the holder sold or distributed the cannabis product in Canada;
  • (j) the time and manner in which the recall is to be carried out, including
    • (i) the expected date for the commencement of the recall,
    • (ii) how and when the Minister will be informed of the progress of the recall, and
    • (iii) the date by which the recall is expected to be completed;
  • (k) a description of any other measure that the holder is taking, or intends to take, in respect of the recall; and
  • (l) contact information for a representative who will be responsible for the recall.

Recall — exported cannabis

(2) A holder of a licence must, before commencing a voluntary recall of cannabis that has been exported from Canada, provide the Minister with a document that contains the following information:

  • (a) a description of the cannabis, including, if applicable, the brand name;
  • (b) the number of each lot or batch of the cannabis;
  • (c) if known, the name and address of each person that
    • (i) produced or imported into Canada the cannabis, and, if applicable, packaged or labelled it, and
    • (ii) in the case where the cannabis is contained in a cannabis accessory, produced or imported into Canada the cannabis accessory or any component of it;
  • (d) the reasons for commencing the recall;
  • (e) if applicable, the quantity of the cannabis that was produced or imported into Canada by the holder;
  • (f) the quantity of the cannabis that was sold or distributed by the holder in foreign countries;
  • (g) if applicable, the quantity of the cannabis that is affected by the problem or potential problem underlying the recall and that remains in the possession of the holder;
  • (h) the number of persons to which the holder sold or distributed the cannabis in foreign countries;
    • (i) the period during which the holder sold or distributed the cannabis in foreign countries;
  • (j) the time and manner in which the recall is to be carried out, including
    • (i) the expected date for the commencement of the recall,
    • (ii) how and when the Minister will be informed of the progress of the recall, and
    • (iii) the date by which the recall is expected to be completed;
  • (k) a description of any other measure that the holder is taking, or intends to take, in respect of the recall; and
  • (l) contact information for a representative who will be responsible for the recall.

Risk evaluation

(3) The holder must, within 72 hours after providing the Minister with the document referred to in subsection (1) or (2), provide the Minister with a document that contains an evaluation of the risk associated with the problem or potential problem that underlies the recall.

Report

(4) The holder must, within 30 days after the day on which the recall is completed, provide the Minister with a written report that sets out the results of the recall and the measures taken to prevent a recurrence of the problem.

Extension

(5) Despite subsection (4), the Minister may extend the period for providing the report — to a maximum of 90 days after the day on which the recall is completed — if, for reasons beyond the holder’s control, it is not feasible to provide it within the 30-day period.

Retention periods

(6) The holder must retain

  • (a) a copy of the documents that they provide to the Minister under subsections (1) and (3) for at least two years after the day on which their last sale or distribution of any cannabis product that is the subject of the recall takes place;
  • (b) a copy of the documents that they provide to the Minister under subsections (2) and (3) for at least two years after the day on which their last export of any of the cannabis that is the subject of the recall takes place; and
  • (c) a copy of the report that they provide to the Minister under subsection (4) for at least two years after the day on which the recall is completed.

Adverse reactions

248 (1) A holder of a licence that sells or distributes a cannabis product must

  • (a) within 15 days after becoming aware of a serious adverse reaction to the cannabis product, provide the Minister with a detailed report containing all information in their possession that is associated with the use of the cannabis product by the individual who experienced the reaction; and
  • (b) prepare an annual summary report that contains a concise and critical analysis of all adverse reactions to the cannabis product that the holder became aware of during the previous 12 months.

Retention period

(2) The holder must retain the reports for at least 25 years after the day on which they are prepared.

Definitions

(3) The following definitions apply in this section.

adverse reaction means a noxious and unintended response to a cannabis product. (réaction indésirable)

serious adverse reaction means a noxious and unintended response to a cannabis product that requires inpatient hospitalization or a prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. (réaction indésirable grave)

Disclosure of Information to Third Parties

Notices to local authorities

249 (1) The Minister may, at the request of the government of a province or any police force or other law enforcement agency in a province, disclose to the government, police force or agency any information set out in a notice that is referred to in section 7 or 35 and that relates to a site located in that province if the disclosure is for a purpose related to verifying compliance or preventing non-compliance with the provisions of

  • (a) the Act;
  • (b) these Regulations;
  • (c) a provincial Act; or
  • (d) regulations made under a provincial Act.

Police investigation

(2) The Minister may disclose any information that is set out in a notice referred to in section 7 or 35 to a Canadian police force, or a member of a Canadian police force, that requests the information in the course of an investigation under the Act.

Use of information

(3) Information that is disclosed under subsection (2) must be used only for the purposes of the investigation or the administration or enforcement of the Act or these Regulations.

Disclosure to province

250 (1) For the purpose of paragraph 83(f) of the Act, information contained in the national cannabis tracking system may be disclosed to the government of a province, at its request, if the disclosure is for a purpose related to the implementation of public health programs or activities that are related to cannabis.

Public health programs and activities

(2) The Minister may, at the request of the government of a province, disclose to the government any information obtained under section 297 if the disclosure is for a purpose related to the implementation of public health programs or activities that are related to cannabis.

International Narcotics Control Board

251 (1) In addition to the information that may be disclosed under sections 83, 128 and 129 of the Act, the Minister may disclose to the International Narcotics Control Board other information that is obtained under the Act if the disclosure is necessary to enable Canada to fulfill its international obligations in relation to cannabis.

Former statute

(2) The Minister may also disclose to the International Narcotics Control Board any information relating to cannabis that was obtained under the Controlled Drugs and Substances Act before the day on which these Regulations come into force if the disclosure is necessary to enable Canada to fulfill its international obligations in relation to cannabis.

Competent authorities

252 The Minister may, for the purposes of the administration or enforcement of the Act or these Regulations or if it is necessary to enable Canada to fulfill its international obligations in relation to cannabis, disclose to a competent authority

  • (a) information obtained from a person that has applied for or that holds an import or export permit;
  • (b) information relating to an activity authorized by
    • (i) an import or export permit, or
    • (ii) a licence held by a person that has applied for or that holds an import or export permit;
    • (c) any document that the holder or former holder of an import or export permit is required to retain, including any document that relates to a licence that they hold or held; and
    • (d) a copy of any import or export permit.

To make compliance and reporting simpler, 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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