Marihuana for Medical Purposes Regulations
SOR/2013-119
CONTROLLED DRUGS AND SUBSTANCES ACT
Registration 2013-06-07
Marihuana for Medical Purposes Regulations
P.C. 2013-645 2013-06-06
Whereas a provision of the annexed Regulations provides for the communication of information obtained under the Regulations to certain classes of persons referred to in paragraph 55(1)(s) of the Controlled Drugs and Substances ActFootnote a and, in the opinion of the Governor in Council, it is necessary to communicate that information to those classes of persons for the proper administration or enforcement of the Act and the Regulations;
Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 55(1) of the Controlled Drugs and Substances ActFootnote a, makes the annexed Marihuana for Medical Purposes Regulations.
Return to footnote aS.C. 1996, c. 19
Interpretation
Marginal note:Definitions
1 (1) The following definitions apply in these Regulations.
Act
Loi
Act means the Controlled Drugs and Substances Act. (Loi)
adult
adulte
adult means a person who is 18 years of age or older. (adulte)
advertisement
annonce
advertisement has the same meaning as in section 2 of the Narcotic Control Regulations. (annonce)
brand name
marque nominative
brand name means, with reference to cannabis, the name, in English or French,
(a) that is assigned to it;
(b) that is used to distinguish it; and
(c) under which it is sold, provided or advertised. (marque nominative)
cannabis
chanvre indien
cannabis means the substance set out in item 1 of Schedule II to the Act. (chanvre indien)
client
client
client means a person who is registered as a client with a licensed producer under section 111. (client)
competent authority
autorité compétente
competent authority has the same meaning as in section 2 of the Narcotic Control Regulations. (autorité compétente)
delta-9-tetrahydrocannabinol
delta-9-tétrahydrocannabinol
delta-9-tetrahydrocannabinol means Δ9-tetrahydrocannabinol ((6aR, 10aR)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo [b,d] pyran-1-ol). (delta-9-tétrahydrocannabinol)
dried marihuana
marihuana séchée
dried marihuana means harvested marihuana that has been subjected to any drying process. (marihuana séchée)
health care practitioner
praticien de la santé
health care practitioner means a medical practitioner or a nurse practitioner. (praticien de la santé)
hospital
hôpital
hospital has the same meaning as in section 2 of the Narcotic Control Regulations. (hôpital)
immediate container
contenant immédiat
immediate container means the container referred to in paragraph 64(a). (contenant immédiat)
international obligation
obligation internationale
international obligation means an obligation in respect of cannabis set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres. (obligation internationale)
licensed dealer
distributeur autorisé
licensed dealer has the same meaning as in section 2 of the Narcotic Control Regulations. (distributeur autorisé)
licensed producer
producteur autorisé
licensed producer means the holder of a licence issued under section 25. (producteur autorisé)
local government
administration locale
local government includes the government of
(a) an incorporated or unincorporated city, metropolitan area, town, village or municipality;
(b) a band, as defined in subsection 2(1) of the Indian Act; and
(c) a band that is a party to a comprehensive self-government agreement given effect by an Act of Parliament. (administration locale)
marihuana
marihuana
marihuana means the substance referred to as “Cannabis (marihuana)” in subitem 1(2) of Schedule II to the Act. (marihuana)
medical document
document médical
medical document means a medical document referred to in section 129. (document médical)
medical practitioner
médecin
medical practitioner means a person who
(a) is registered and entitled under the laws of a province to practise medicine in that province; and
(b) is not named in a notice issued under section 59 of the Narcotic Control Regulations that has not been retracted under section 60 of those Regulations. (médecin)
nurse practitioner
infirmier praticien
nurse practitioner means a nurse practitioner within the meaning of section 1 of the New Classes of Practitioners Regulations who
(a) is permitted to prescribe dried marihuana in the province in which they practise; and
(b) is not named in a notice issued under section 59 of the Narcotic Control Regulations that has not been retracted under section 60 of those Regulations. (infirmier praticien)
pest control product
produit antiparasitaire
pest control product has the same meaning as in subsection 2(1) of the Pest Control Products Act. (produit antiparasitaire)
pharmacist
pharmacien
pharmacist means a pharmacist within the meaning of section 2 of the Narcotic Control Regulations who is not named in a notice issued under section 48 of those Regulations that has not been retracted under section 49 of those Regulations. (pharmacien)
responsible person in charge
personne responsable
responsible person in charge means, for the purpose of Part 1, the person designated under paragraph 22(1)(b). (personne responsable)
security clearance
habilitation de sécurité
security clearance means a security clearance granted by the Minister under section 92. (habilitation de sécurité)
Security Directive
Directive en matière de sécurité
Security Directive means the Directive on Physical Security Requirements for Controlled Substances (Security Requirements for Licensed Dealers for the Storage of Controlled Substances) published by the Department of Health, as amended from time to time. (Directive en matière de sécurité)
senior person in charge
responsable principal
senior person in charge means the person designated under paragraph 22(1)(a). (responsable principal)
site
installation
site means
(a) a building or a place in a building used by a licensed producer; or
(b) an area occupied exclusively by buildings used by a licensed producer. (installation)
transfer
transférer
transfer means, except in sections 118, 122 and 132, to transfer, whether directly or indirectly, without consideration. (transférer)
Marginal note:Miscellaneous rules
(2) The rules set out in subsections (3) to (6) apply in these Regulations.
Marginal note:Producer’s site
(3) A reference to the site of a licensed producer is a reference to the site specified in the producer’s licence.
Marginal note:Destruction
(4) Cannabis is destroyed when it is altered or denatured to such an extent that its consumption is rendered impossible or improbable.
Marginal note:Drying
(5) The production of marihuana includes subjecting it to a drying process.
Marginal note:Transfer
(6) For greater certainty, a reference to “provide” includes “transfer”.
- SOR/2014-51, s. 5
Marginal note:Application of Narcotic Control Regulations
2 For greater certainty, except in the case of inconsistency with these Regulations, the Narcotic Control Regulations also apply to cannabis referred to in these Regulations.
Possession
Marginal note:Obtaining dried marihuana or cannabis
3 (1) A person listed in subsection (2) may possess dried marihuana and a person listed in subsection (3) may possess cannabis if the person has obtained it
(a) in accordance with these Regulations;
(b) in the course of activities performed in connection with the enforcement or administration of any Act or its regulations;
(c) from a person who is exempt under section 56 of the Act from the application of subsection 5(1) of the Act with respect to the dried marihuana or cannabis; or
(d) in the case referred to in subparagraph (2)(a)(iii), under subsection 65(2.1) of the Narcotic Control Regulations.
Marginal note:Possession — dried marihuana
(2) The following persons may possess dried marihuana:
(a) a person who has obtained the dried marihuana for their own medical purposes or for those of another person for whom they are responsible
(i) from a licensed producer, in accordance with a medical document,
(ii) from a health care practitioner in the course of treatment for a medical condition, or
(iii) from a hospital, under subsection 65(2.1) of the Narcotic Control Regulations;
(b) a person who requires dried marihuana for the practice of their profession as a health care practitioner in the province in which they have that possession; or
(c) a hospital employee, if they possess the dried marihuana for the purposes of and in connection with their employment.
Marginal note:Possession — cannabis
(3) The following persons may possess cannabis:
(a) a person who requires cannabis for their business as a licensed producer and who possesses it in accordance with section 12;
(b) a person who requires cannabis for their business as a licensed dealer;
(c) a person who is employed as an inspector, an analyst, a peace officer, a member of the Royal Canadian Mounted Police or a member of the technical or scientific staff of a department of the government of Canada or of a province and who possesses the cannabis for the purposes of and in connection with their employment; or
(d) a person who is acting as the agent or mandatary of a person whom they have reasonable grounds to believe is a person referred to in paragraph (c) and who possesses the cannabis for the purpose of assisting that person in the administration or enforcement of any Act or its regulations.
Marginal note:Employee, agent or mandatary — dried marihuana
(4) A person may possess dried marihuana if the person is an employee of or is acting as the agent or mandatary for a person referred to in paragraph (2)(b) or (c), while acting in the course of their employment or their role as agent or mandatary.
Marginal note:Employee, agent or mandatary — cannabis
(5) A person may possess cannabis if the person is an employee of or is acting as the agent or mandatary for a person referred to in paragraph (3)(a) or (b), while acting in the course of their employment or their role as agent or mandatary.
Marginal note:Providing assistance
(6) While in the presence of a person referred to in paragraph (2)(a) who has obtained dried marihuana for their own medical purposes, another person may, for the purpose of providing assistance in the administration of marihuana to the person who obtained it, possess a quantity of that dried marihuana not exceeding the daily quantity of dried marihuana that the person who obtained it is authorized to possess in accordance with section 5.
Marginal note:Obtaining cannabis — Narcotic Control Regulations
4 (1) A licensed producer may possess cannabis that they have obtained in accordance with the Narcotic Control Regulations if they require it for their business.
Marginal note:Employee, agent or mandatary
(2) A person may possess cannabis referred to in subsection (1) if the person is an employee of or is acting as the agent or mandatary of the licensed producer, while acting in the course of their employment or their role as agent or mandatary.
Marginal note:Possession limit
5 An individual who obtains dried marihuana for their own medical purposes or for those of another individual for whom they are responsible must not possess a quantity of dried marihuana that exceeds the least of the following amounts:
(a) in the case of dried marihuana obtained from a licensed producer, 30 times the daily quantity referred to in paragraph 129(1)(d);
(b) in the case of dried marihuana obtained from a hospital by or for an out-patient, 30 times the daily quantity referred to in subparagraph 65.2(c)(iii) of the Narcotic Control Regulations; and
(c) 150 g.
General Provisions
Marginal note:Dried marihuana
6 (1) Dried marihuana must not be sold or provided under these Regulations
(a) with any additive; or
(b) in any dosage form, such as in a roll or capsule.
Definition of additive
(2) For the purpose of paragraph (1)(a), additive means anything other than dried marihuana but does not include any residue of a pest control product or its components or derivatives unless the amount of the residue exceeds any maximum residue limit specified for the product, component or derivative under section 9 or 10 of the Pest Control Products Act.
- SOR/2014-51, s. 6
Marginal note:Notice of refusal or revocation
7 If the Minister proposes to refuse to issue, amend or renew a licence or permit or proposes to revoke a licence or permit under these Regulations, other than in the case of a revocation under section 35 or subsection 37(4), 81(1) or 88(1), the Minister must
(a) send a notice to the applicant or to the holder of the licence or permit together with a written report that sets out the reasons for the refusal or revocation; and
(b) give the applicant or holder an opportunity to be heard in respect of the refusal or revocation.
Marginal note:Further information
8 The Minister may, on receiving an application made under these Regulations, require the submission of any further information that pertains to the information contained in the application and that is necessary for the Minister to process the application.
Marginal note:Inspection of site
9 In order to confirm any information submitted in support of an application for a licence or an amendment or renewal of a licence made under these Regulations, an inspector may, at a time during normal business hours and with the reasonable assistance of the applicant, inspect the site in respect of which the application was made.
Marginal note:Police enforcement
10 If, under the Controlled Drugs and Substances Act (Police Enforcement) Regulations, a member of a police force or a person acting under the direction and control of the member is, in respect of the conduct of the member or person, exempt from the application of subsection 4(2) or section 5, 6 or 7 of the Act, the member or person is, in respect of that conduct, exempt from the application of these Regulations.
Marginal note:Alteration of documents
11 It is prohibited to mark, alter or deface in any manner a licence or permit issued under these Regulations or a medical document.
PART 1Licensed Producers
DIVISION 1Permitted Activities and General Obligations
Marginal note:Activities
12 (1) Subject to subsections (2) to (7) and to the other provisions of these Regulations, a licensed producer may
(a) possess, produce, sell, provide, ship, deliver, transport and destroy marihuana;
(b) possess and produce cannabis, other than marihuana, solely for the purpose of conducting in vitro testing that is necessary to determine the percentages of cannabinoids in dried marihuana; and
(c) sell, provide, ship, deliver, transport and destroy cannabis, other than marihuana, that was obtained or produced solely for the purpose of conducting the in vitro testing referred to in paragraph (b).
Marginal note:Restriction — cannabis
(2) A licensed producer may sell or provide a substance referred to in subsection (3) to
(a) another licensed producer;
(b) a licensed dealer;
(c) the Minister; or
(d) a person to whom an exemption relating to the substance has been granted under section 56 of the Act.
Marginal note:Substances
(3) The substances that may be sold or provided under subsection (2) are
(a) marihuana; and
(b) cannabis, other than marihuana, that was obtained or produced solely for the purpose of conducting in vitro testing that is necessary to determine the percentages of cannabinoids in dried marihuana.
Marginal note:Restriction — dried marihuana
(4) A licensed producer may
(a) sell or provide dried marihuana to
(i) a client of that producer or an individual who is responsible for the client,
(ii) a hospital employee, if the possession of the dried marihuana is for the purposes of and in connection with their employment, or
(iii) a person to whom an exemption relating to the dried marihuana has been granted under section 56 of the Act; and
(b) ship dried marihuana to a health care practitioner in the case referred to in subparagraph 108(1)(f)(iii).
Marginal note:Activities limited
(5) A licensed producer may conduct an activity referred to in subsection (1), (2) or (4) if the producer
(a) is licensed to conduct the activity; and
(b) conducts the activity in accordance with their licence.
Marginal note:Import
(6) A licensed producer may import marihuana if they do so in accordance with an import permit issued under section 75.
Marginal note:Export
(7) A licensed producer may
(a) possess marihuana for the purpose of export; and
(b) export marihuana if they do so in accordance with an export permit issued under section 83.
Marginal note:Dwelling place
13 A licensed producer must not conduct any activity referred to in section 12 at a dwelling place.
Marginal note:Indoor activities only
14 A licensed producer must produce, package or label marihuana only indoors and at the producer’s site.
Marginal note:Indoor storage only
15 (1) A licensed producer must store cannabis only indoors and at the producer’s site.
Marginal note:Storage of dried marihuana
(2) A licensed producer must store cannabis, other than marihuana plants, in accordance with the Security Directive.
Marginal note:Identification of licensed producer
16 A licensed producer must include their name, as set out in their licence, on all the means by which the producer identifies themself in relation to cannabis, including advertising, product labels, orders, shipping documents and invoices.
Marginal note:Responsible person in charge present
17 A licensed producer must not perform a transaction involving cannabis unless the responsible person in charge or, if applicable, the alternate responsible person in charge is physically present at the producer’s site.
Marginal note:Safekeeping during transportation
18 A licensed producer must, when transporting imported marihuana between the port of entry into Canada and the producer’s site, or when shipping, delivering or transporting any marihuana, including to a port of exit from Canada, take any steps that are necessary to ensure its safekeeping during transportation.
Marginal note:Report of loss or theft
19 If a licensed producer experiences a theft of cannabis or an unusual waste or disappearance of cannabis that cannot be explained on the basis of normally accepted business activities, the licensed producer must
(a) report the occurrence to a member of a police force within 24 hours after becoming aware of it; and
(b) provide a written report to the Minister within 10 days after becoming aware of the occurrence.
Marginal note:Destruction
20 (1) A licensed producer may destroy cannabis only if they do so
(a) in accordance with a method that
(i) conforms with all federal, provincial and municipal environmental legislation applicable to the location at which it is to be destroyed, and
(ii) does not result in any person being exposed to cannabis smoke; and
(b) in the presence of at least two persons who are qualified to witness the destruction, one of whom must be a person referred to in paragraph (2)(a).
Marginal note:Witness to destruction
(2) The following persons are qualified to witness the destruction of cannabis:
(a) the senior person in charge, the responsible person in charge and, if applicable, the alternate responsible person in charge; and
(b) a person who works for or provides services to the licensed producer and acts in a senior position.
Marginal note:Transportation of cannabis
(3) If the cannabis is to be destroyed at a location other than the licensed producer’s site, the senior person in charge, the responsible person in charge or, if applicable, the alternate responsible person in charge must accompany the cannabis to the location at which it is to be destroyed.
DIVISION 2Licensing
Marginal note:Eligible persons
21 The following persons are eligible to apply for a producer’s licence:
(a) an adult who ordinarily resides in Canada; and
(b) a corporation that has its head office in Canada or operates a branch office in Canada and whose officers and directors are all adults.
Marginal note:Senior person in charge and responsible person in charge
22 (1) A licensed producer must designate
(a) one senior person in charge to have overall responsibility for management of the activities carried out by the licensed producer under their licence at their site — who may, if appropriate, be the licensed producer; and
(b) one responsible person in charge to work at the licensed producer’s site and have responsibility for supervising the activities with respect to cannabis conducted at that site by the licensed producer under their licence and for ensuring that the activities comply with the Act and its regulations and the Food and Drugs Act — who may, if appropriate, be the senior person in charge.
Marginal note:Alternate responsible person in charge
(2) A licensed producer may designate one or more alternate responsible persons in charge to work at the licensed producer’s site and have authority to replace the responsible person in charge when that person is absent.
Marginal note:Eligibility
(3) The senior person in charge, the responsible person in charge and, if applicable, the alternate responsible person in charge
(a) must be adults; and
(b) must be familiar with the provisions of the Act and its regulations and the Food and Drugs Act that apply to the licence held by the licensed producer by whom they are designated.
Marginal note:Application for licence
23 (1) To apply for a producer’s licence, a person must submit to the Minister an application that contains the following information:
(a) if the applicant is
(i) an individual, the individual’s name, date of birth and gender and any other name registered with a province, under which the individual intends to identify themself or conduct the activities for which the licence is sought (referred to in this section as “the proposed activities”), or
(ii) a corporation, its corporate name and any other name registered with a province, under which it intends to identify itself or conduct the proposed activities, as well as the name, date of birth and gender of each of its officers and directors;
(b) the address, telephone number and, if applicable, the facsimile number and email address for
(i) the site for which the licence is sought (referred to in this section as “the proposed site”), and
(ii) if applicable, each building within the site at which the proposed activities are to be conducted;
(c) the mailing address for the proposed site and, if applicable, for each building referred to in subparagraph (b)(ii), if different from the address provided under paragraph (b);
(d) the name, date of birth and gender of each of the following persons:
(i) the proposed senior person in charge,
(ii) the proposed responsible person in charge, and
(iii) if applicable, the proposed alternate responsible person in charge;
(e) the name and gender of each of the persons authorized to place an order for cannabis on behalf of the applicant;
(f) the activities among those referred to in subsection 12(1) that are proposed to be conducted, the purposes for conducting those activities and the substances in respect of which each of the activities is to be conducted;
(g) the proposed activities that are to be conducted at each building referred to in subparagraph (b)(ii) and the substances in respect of which each of those activities is to be conducted at each building;
(h) a detailed description of the security measures at the proposed site, as determined in accordance with the Security Directive and Division 3;
(i) a detailed description of the method that the applicant proposes to use for keeping records, which must permit
(i) compliance with the requirements of Part 6,
(ii) the Minister to audit the activities of the licensed producer with respect to cannabis, and
(iii) the reconciliation of orders for cannabis and shipments and inventories of cannabis;
(j) if applicable, the maximum quantity (expressed as the net weight in kilograms) of dried marihuana to be produced by the applicant under the licence and the production period; and
(k) if applicable, the maximum quantity (expressed as the net weight in kilograms) of dried marihuana to be sold or provided by the applicant under the licence under subsection 12(4) and the period in which that quantity is to be sold or provided.
Marginal note:Multiple sites
(2) If the applicant intends to engage in an activity referred to in subsection 12(1) at more than one site, a separate application must be made for each proposed site.
Marginal note:Statement by signatory
(3) An application for a producer’s licence must
(a) be signed and dated by the proposed senior person in charge; and
(b) include a statement signed and dated by that person indicating that
(i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
(ii) they have the authority to bind the applicant.
Marginal note:Accompanying documents
(4) An application for a producer’s licence must be accompanied by
(a) a declaration, signed and dated by the proposed senior person in charge, stating that the proposed senior person in charge, the proposed responsible person in charge and, if applicable, the proposed alternate responsible person in charge are familiar with the provisions of the Act and its regulations and the Food and Drugs Act that will apply to the licence;
(b) if applicable, a copy of any document filed with the province in which the proposed site is located that states the applicant’s name and any other name registered with the province, under which the applicant intends to identify themself or conduct the proposed activities;
(c) if the applicant is a corporation, a copy of the certificate of incorporation or other constituting instrument;
(d) a declaration signed and dated by the proposed senior person in charge indicating whether or not the applicant is the owner of the entire proposed site;
(e) if the proposed site or any portion of it is not owned by the applicant, a declaration signed and dated by the owner of the site or each portion of the site consenting to the use of it by the applicant for the proposed activities;
(f) a declaration signed and dated by the proposed senior person in charge stating that the proposed site is not a dwelling place;
(g) a declaration signed and dated by the proposed senior person in charge stating that the notices to local authorities have been provided in accordance with section 38 and specifying the names, titles and addresses of the officials to whom they were addressed and the dates on which they were provided, together with a copy of each notice;
(h) a document signed and dated by the quality assurance person referred to in section 60 that includes
(i) a description of the person’s qualifications in respect of the matters referred to in subparagraph 60(1)(a)(ii), and
(ii) a report establishing that the buildings, equipment and sanitation program to be used in conducting the proposed activities referred to in Division 4 comply with the requirements of that Division; and
(i) floor plans for the proposed site.
Marginal note:Security clearance required
24 The following persons must hold a security clearance:
(a) the senior person in charge;
(b) the responsible person in charge;
(c) if applicable, the alternate responsible person in charge;
(d) if a producer’s licence is issued to an individual, that individual; and
(e) if a producer’s licence is issued to a corporation, each officer and director of the corporation.
Marginal note:Issuance of licence
25 Subject to section 26, the Minister must, after examining the information and documents required under section 23 and, if applicable, section 8, and after all of the security clearances required by section 24 have been granted under section 92, issue to the applicant a producer’s licence that indicates
(a) the licence number;
(b) the name of the licence holder;
(c) the list of permitted activities;
(d) the address of the site and, if applicable, of each building within the site at which the licensed producer may conduct the permitted activities;
(e) in respect of each building, the activities that may be conducted at that building and, in respect of each activity, the substances in respect of which the activity may be conducted;
(f) the security level, determined in accordance with the Security Directive, of each building referred to in paragraph (d) at which cannabis, other than marihuana plants, is stored;
(g) the effective date of the licence;
(h) the expiry date of the licence, which must not be later than three years after its effective date;
(i) if applicable, the maximum quantity of dried marihuana that may be produced under the licence in a specified period, expressed as the net weight in kilograms;
(j) if applicable, the maximum quantity of dried marihuana that may be sold or provided under the licence in a specified period in accordance with subsection 12(4), expressed as the net weight in kilograms; and
(k) if applicable, any conditions that the licence holder must meet in order to
(i) comply with an international obligation,
(ii) provide the security level referred to in paragraph (f ),
(iii) put in place the security measures referred to in Division 3, or
(iv) reduce any potential public health, safety or security risk, including the risk of cannabis being diverted to an illicit market or use.
Marginal note:Grounds for refusal
26 (1) The Minister must refuse to issue, renew or amend a producer’s licence in the following cases:
(a) the applicant is not eligible under section 21;
(b) the requirements of section 38 or 39 have not been met;
(c) an inspector, who has requested an inspection, has not been given the opportunity by the applicant to conduct an inspection under section 9;
(d) the Minister has reasonable grounds to believe that false or misleading information or false or falsified documents were submitted in or with the application;
(e) information received from a peace officer, a competent authority or the United Nations raises reasonable grounds to believe that the applicant has been involved in the diversion of a controlled substance or precursor to an illicit market or use;
(f) the applicant does not have in place the security measures set out in the Security Directive and Division 3 in respect of an activity for which the licence is sought;
(g) the applicant is in contravention of or has contravened in the past 10 years
(i) a provision of the Act or its regulations or the Food and Drugs Act, or
(ii) a term or condition of another licence or a permit issued to it under any of those regulations;
(h) the issuance, renewal or amendment of the licence would likely create a risk to public health, safety or security, including the risk of cannabis being diverted to an illicit market or use;
(i) any of the following persons does not hold a security clearance:
(i) the senior person in charge,
(ii) the responsible person in charge,
(iii) if applicable, the alternate responsible person in charge,
(iv) if the applicant is an individual, that individual, and
(v) if the applicant is a corporation, any of its officers or directors;
(j) the proposed method of record keeping does not meet the requirements of paragraph 23(1)(i); or
(k) if applicable, the information required under section 8 has not been provided or is insufficient to process the application.
Marginal note:Exception
(2) Unless it is necessary to do so to protect public health, safety or security, including preventing cannabis from being diverted to an illicit market or use, the Minister must not refuse to issue, renew or amend a licence under paragraph (1)(d) or (g) if the applicant has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and its regulations and the Food and Drugs Act.
Marginal note:Failure to comply with undertaking
(3) If an applicant fails to comply with an undertaking referred to in subsection (2), the Minister must refuse to issue, renew or amend the licence.
Marginal note:Period of validity
27 A producer’s licence is valid until the earlier of
(a) the expiry date of the licence, and
(b) the date on which the licence is revoked under any of sections 34 to 37.
Marginal note:Application for renewal
28 (1) To apply to renew their licence, a licensed producer must submit to the Minister an application that contains the following:
(a) the original of the licence; and
(b) a declaration signed and dated by the senior person in charge indicating that as of the date of the application
(i) that person has the authority to bind the applicant, and
(ii) to the best of that person’s knowledge,
(A) all of the information shown on the producer’s licence as specified in paragraphs 25(a) to (f ) and (i) to (k ) is correct and complete, and
(B) if applicable, the requirements of sections 30 and 31 have been met.
Marginal note:Renewal
(2) Subject to section 26, the Minister must, after examining the information and documents required under subsection (1) and, if applicable, section 8, issue a renewed licence that contains the information set out in paragraphs 25(a) to (k).
Marginal note:Simultaneous processing of applications
(3) If a licensed producer submits an application under section 29 or paragraph 30(1)(a) together with an application under subsection (1), the Minister may process them together.
Marginal note:Application for amendment
29 (1) A licensed producer proposing to amend the content of their licence must provide the Minister with the following documents:
(a) an application in writing describing the proposed amendment, as well as any information or documents mentioned in section 23 that are relevant to the proposed amendment;
(b) if applicable, a declaration signed and dated by the senior person in charge stating that the notices to local authorities have been provided in accordance with section 39 and specifying the names, titles and addresses of the officials to whom they were addressed and the dates on which they were provided, together with a copy of each notice; and
(c) the original of the licence.
Marginal note:Statement by signatory
(2) The application must
(a) be signed and dated by the senior person in charge; and
(b) include a statement signed and dated by that person indicating that
(i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
(ii) they have the authority to bind the applicant.
Marginal note:Issuance
(3) Subject to section 26, the Minister must, after examining the information and documents required under this section and, if applicable, section 8, amend the licence accordingly and may add any conditions that the licence holder must meet in order to
(a) comply with an international obligation;
(b) provide the security level referred to in paragraph 25(f) or the new level applicable as a result of the amendment of the licence;
(c) put in place the security measures referred to in Division 3; or
(d) reduce any potential public health, safety or security risk, including the risk of cannabis being diverted to an illicit market or use.
Marginal note:Notice to Minister — change of personnel
30 (1) A licensed producer must
(a) apply for and obtain the Minister’s approval before making a change involving the replacement or the addition of
(i) the senior person in charge,
(ii) the responsible person in charge and, if applicable, the alternate responsible person in charge,
(iii) if applicable, an officer or director referred to in subparagraph 23(1)(a)(ii), or
(iv) an individual authorized to place an order for cannabis on behalf of the licensed producer;
(b) except in the case referred to in subsection (3), notify the Minister, not later than five days after the event, when a person referred to in any of subparagraphs (a)(i), (ii) or (iv) ceases to carry out their duties; and
(c) notify the Minister, not later than five days after the event, when a person referred to in subparagraph (a)(iii) ceases to be an officer or director.
Marginal note:Accompanying information
(2) The licensed producer must, with the application for approval referred to in paragraph (1)(a), provide the Minister with the following information and documents with respect to the new person:
(a) in the case of the replacement of the senior person in charge or the responsible person in charge or the replacement or addition of an alternate responsible person in charge,
(i) the information specified in paragraph 23(1)(d), and
(ii) the declaration specified in paragraph 23(4)(a);
(b) in the case of the replacement or addition of an officer or director, the information specified in subparagraph 23(1)(a)(ii) concerning that person; and
(c) in the case of the replacement or addition of an individual who is authorized to place an order for cannabis on behalf of the licensed producer, the information specified in paragraph 23(1)(e).
Marginal note:Notice to Minister — responsible person in charge
(3) A licensed producer must notify the Minister not later than the next business day if the responsible person in charge ceases to carry out their duties and there is no person designated as an alternate responsible person in charge.
Marginal note:Notice to Minister — various changes
31 A licensed producer must, within five days after the change, notify the Minister of any change to
(a) the method used for keeping records;
(b) the telephone number and, if applicable, the facsimile number and email address for
(i) their site; and
(ii) if applicable, each building within the site at which the activities are conducted under the licence; or
(c) the security of their site, other than a changes that affects the security level of any building at which cannabis, other than marihuana plants, is stored.
Marginal note:Statement by signatory of notice
32 An application or notification made under section 30 or 31 must
(a) be signed and dated by the senior person in charge; and
(b) include a statement signed and dated by that person indicating that
(i) all information and, if applicable, documents submitted in support of the application or notification are correct and complete to the best of their knowledge, and
(ii) they have the authority to bind the licensed producer.
Marginal note:Suspension
33 (1) The Minister must suspend a producer’s licence without prior notice in respect of any or all activities or substances set out in the licence if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health, safety or security, including preventing cannabis from being diverted to an illicit market or use.
Marginal note:Notice of suspension
(2) The suspension takes effect as soon as the Minister notifies the licensed producer of the decision to suspend and provides a written report that sets out the reasons for the suspension.
Marginal note:Opportunity to be heard
(3) The licensed producer may, within 10 days after receipt of the notice, provide the Minister with reasons why the suspension is unfounded.
Marginal note:Ceasing of suspended activities
(4) If a licence is suspended in respect of any or all activities or substances set out in the licence, the licensed producer must cease conducting those activities with respect to those substances for the duration of the suspension.
Marginal note:Reinstatement of licence
(5) The Minister must, by notice to the licensed producer, reinstate a licence, in respect of any or all activities or substances affected by the suspension, if the licensed producer demonstrates to the Minister that
(a) the failure that gave rise to the suspension has been rectified; or
(b) the suspension was unfounded.
Marginal note:Revocation following suspension
34 The Minister must revoke a licence if the licensed producer fails to comply with the decision of the Minister to suspend the licence under section 33 or if the failure that gave rise to the suspension is not rectified.
Marginal note:Revocation — lost or stolen licence
35 The Minister must revoke a producer’s licence on being notified by the licensed producer that the licence has been lost or stolen.
Marginal note:Revocation — other grounds
36 (1) Subject to subsection (2), the Minister must revoke a producer’s licence in the following circumstances:
(a) the Minister has reasonable grounds to believe that the licence was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application;
(b) the licensed producer has, since the issuance of the licence, contravened a provision of the Act or its regulations or the Food and Drugs Act or a condition of their licence or of an import or export permit issued under these Regulations;
(c) the licensed producer is no longer eligible under section 21;
(d) information received from a peace officer, a competent authority or the United Nations raises reasonable grounds to believe that the licensed producer has been involved in the diversion of a controlled substance or precursor to an illicit market or use; or
(e) any of the persons referred to in section 24 does not hold a security clearance.
Marginal note:Exceptions
(2) Unless it is necessary to do so to protect public health, safety or security, including preventing cannabis from being diverted to an illicit market or use, the Minister must not revoke a producer’s licence in the circumstances described in paragraph (1)(a) or (b) if the licensed producer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and its regulations and the Food and Drugs Act.
Marginal note:Failure to comply with undertaking
(3) If the licensed producer fails to comply with an undertaking referred to in subsection (2), the Minister must revoke the licence.
Marginal note:Notice of cessation of activities
37 (1) A licensed producer who intends to cease conducting activities at their site — whether before or on the expiry of their licence — must submit to the Minister a written notice to that effect at least 30 days before ceasing those activities.
Marginal note:Content of notice
(2) The notice must be signed and dated by the senior person in charge and contain the following information:
(a) the expected date of the cessation of activities at the site;
(b) a description of the manner in which any cannabis remaining on the site as of the date referred to in paragraph (a) will be dealt with by the licensed producer, including
(i) if some or all of it will be sold or provided to another licensed producer who will be conducting activities at the same site, the name of that producer,
(ii) if some or all of it will be sold or provided to another licensed producer or a licensed dealer, the name of that producer and the address of their site or the name of that dealer and the address of their premises, and
(iii) if some or all of it will be destroyed, the date on which and the location at which the destruction is to take place;
(c) the address of the location at which the licensed producer’s records, books, electronic data and other documents will be kept after activities have ceased; and
(d) the name, address, telephone number and, if applicable, the facsimile number and email address of a person who the Minister may contact for further information after activities have ceased.
Marginal note:Update
(3) After having ceased the activities, the licensed producer must submit to the Minister a detailed update of the information referred to in paragraphs (2)(a) to (d), if it differs from what was set out in the notice submitted under subsection (1). The update must be signed and dated by the senior person in charge.
Marginal note:Return and revocation of licence
(4) If the activities are ceased before the expiry of the licence, the licensed producer must return to the Minister the original of the licence. The Minister must then revoke the licence.
Marginal note:Notice to local authorities – licence application
38 (1) Before submitting an application for a producer’s licence to the Minister under section 23, the applicant must provide a written notice to the following persons in the area in which the site referred to in paragraph 23(1)(b) is located:
(a) the local government;
(b) the local fire authority; and
(c) the local police force or the Royal Canadian Mounted Police detachment that is responsible for providing policing services to that area.
Marginal note:Content of notice
(2) The notice must contain the following information:
(a) the name of the applicant;
(b) the date on which the applicant will submit the application to the Minister;
(c) the activities referred to in subsection 12(1) for which the licence is to be sought, specifying that they are to be conducted in respect of cannabis; and
(d) the address of the site and, if applicable, of each building within the site at which the applicant proposes to conduct those activities.
Marginal note:Senior official
(3) The notice must be addressed to a senior official of the local authority to whom it is sent.
Marginal note:Notice to local authorities — amendment application
39 (1) Before submitting a licence amendment application to the Minister under section 29 concerning a change referred to in subsection (2), a licensed producer must provide a written notice to the persons referred to in paragraphs 38(1)(a) to (c) in the area in which the site to be specified in the amended licence is located.
Marginal note:Applicable changes
(2) Subsection (1) applies in respect of an application to amend a licence to change
(a) the name of the licensed producer;
(b) the activities to be conducted by the producer under the licence; or
(c) the address of the site and, if applicable, of each building within the site at which those activities are to be conducted.
Marginal note:Content of notice
(3) The notice must contain the following information:
(a) the name of the licensed producer and, if applicable, the proposed new name of the producer;
(b) the date on which the producer will submit the application to the Minister;
(c) the activities referred to in subsection 12(1) that are to be set out in the amended licence, specifying that they are to be conducted in respect of cannabis; and
(d) the address of the site and, if applicable, of each building within the site that is to be set out in the amended licence.
Marginal note:Senior official
(4) The notice must be addressed to a senior official of the local authority to whom it is sent.
Marginal note:Notice to local authorities — various matters
40 (1) Within 30 days after the issuance, renewal, amendment, suspension, reinstatement or revocation of its licence, a licensed producer must provide a written notice to the persons referred to in paragraphs 38(1)(a) to (c) in the area in which the site specified in the licence is located and provide a copy of the notice to the Minister.
Marginal note:Content of notice
(2) The notice must contain the following information:
(a) the name of the licensed producer and the address of their site; and
(b) a description of the applicable matter referred to in subsection (1) and its effective date and, in the case of an amendment to the licence, details of the amendment.
Marginal note:Senior official
(3) The notice must be addressed to a senior official of the local authority to whom it is sent.
DIVISION 3Security Measures
General
Marginal note:Compliance with security measures
41 A licensed producer must ensure that the security measures set out in this Division are carried out.
Marginal note:Unauthorized access
42 The licensed producer’s site must be designed in a manner that prevents unauthorized access.
Perimeter of Site
Marginal note:Visual monitoring
43 (1) The perimeter of the licensed producer’s site must be visually monitored at all times by visual recording devices to detect any attempted or actual unauthorized access.
Marginal note:Visual recording devices
(2) The devices must, in the conditions under which they are used, be capable of recording in a visible manner any attempted or actual unauthorized access.
Marginal note:Intrusion detection system
44 The perimeter of the licensed producer’s site must be secured by an intrusion detection system that operates at all times and that allows for the detection of any attempted or actual unauthorized access to or movement in the site or tampering with the system.
Marginal note:Monitoring by personnel
45 (1) The system must be monitored at all times by personnel who must determine the appropriate steps to be taken in response to the detection of any occurrence referred to in section 43 or 44.
Marginal note:Record of detected matters
(2) If any such occurrence is detected, the personnel must make a record of
(a) the date and time of the occurrence; and
(b) the measures taken in response to it and the date and time when they were taken.
Areas Within a Site where Cannabis is Present
Marginal note:Restricted access
46 (1) Access to areas within a site where cannabis is present (referred to in sections 46 to 50 as “those areas”) must be restricted to persons whose presence in those areas is required by their work responsibilities.
Marginal note:Responsible person in charge present
(2) The responsible person in charge or, if applicable, the alternate responsible person in charge must be physically present while other persons are in those areas.
Marginal note:Record
(3) A record must be made of the identity of every person entering or exiting those areas.
Marginal note:Physical barriers
47 Those areas must include physical barriers that prevent unauthorized access.
Marginal note:Visual monitoring
48 (1) Those areas must be visually monitored at all times by visual recording devices to detect illicit conduct.
Marginal note:Visual recording devices
(2) The devices must, in the conditions under which they are used, be capable of recording in a visible manner illicit conduct.
Marginal note:Intrusion detection system
49 Those areas must be secured by an intrusion detection system that operates at all times and that allows for the detection of any attempted or actual unauthorized access to or movement in those areas or tampering with the system.
Marginal note:Filtration of air
50 Those areas must be equipped with a system that filters air to prevent the escape of odours and, if present, pollen.
Marginal note:Monitoring by personnel
51 (1) The intrusion detection system must be monitored at all times by personnel who must determine the appropriate steps to be taken in response to the detection of any occurrence referred to in section 48 or 49.
Marginal note:Record of detected matters
(2) If any such occurrence is detected, the personnel must make a record of
(a) the date and time of the occurrence; and
(b) the measures taken in response to it and the date and time when they were taken.
DIVISION 4Good Production Practices
Marginal note:Prohibition — sale or provision
52 (1) A licensed producer must not sell or provide dried marihuana under subsection 12(4) unless the requirements of this Division have been met.
Marginal note:Prohibition — export
(2) A licensed producer must not export dried marihuana unless the requirements of this Division have been met.
Marginal note:Microbial and chemical contaminants
53 (1) The microbial and chemical contaminants of dried marihuana must be within generally accepted tolerance limits for herbal medicines for human consumption, as established in any publication referred to in Schedule B to the Food and Drugs Act.
Marginal note:Analytical testing
(2) Analytical testing for those contaminants and for the percentages of delta-9-tetrahydrocannabinol and cannabidiol referred to in these Regulations must be conducted using validated methods.
Marginal note:Pest control product
54 Marihuana must not be treated — before, during or after the drying process — with a pest control product unless the product is registered for use on marihuana under the Pest Control Products Act or is otherwise authorized for use under that Act.
- SOR/2014-51, s. 7
Marginal note:Premises
55 (1) Dried marihuana must be produced, packaged, labelled and stored in premises that are designed, constructed and maintained in a manner that permits those activities to be conducted under sanitary conditions, and in particular that
(a) permits the premises to be kept clean and orderly;
(b) permits the effective cleaning of all surfaces in the premises;
(c) permits the dried marihuana to be stored or processed appropriately;
(d) prevents the contamination of the dried marihuana; and
(e) prevents the addition of an extraneous substance to the dried marihuana.
Marginal note:Storage
(2) Dried marihuana must be stored under conditions that will maintain its quality.
Marginal note:Equipment
56 Dried marihuana must be produced, packaged, labelled and stored using equipment that is designed, constructed, maintained, operated and arranged in a manner that
(a) permits the effective cleaning of its surfaces;
(b) permits it to function in accordance with its intended use;
(c) prevents it from contaminating the dried marihuana; and
(d) prevents it from adding an extraneous substance to the dried marihuana.
Marginal note:Sanitation program
57 Dried marihuana must be produced, packaged, labelled and stored in accordance with a sanitation program that sets out
(a) procedures for effectively cleaning the premises in which those activities are conducted;
(b) procedures for effectively cleaning the equipment used in those activities;
(c) procedures for handling any substance used in those activities; and
(d) all requirements, in respect of the health, the hygienic behaviour and the clothing of the personnel who are involved in those activities, that are necessary to ensure that those activities are conducted in sanitary conditions.
Marginal note:Standard operating procedures
58 Dried marihuana must be produced, packaged, labelled and stored in accordance with standard operating procedures that are designed to ensure that those activities are conducted in accordance with the requirements of this Division.
Marginal note:Recall
59 A licensed producer must establish and maintain a system of control that permits the rapid and complete recall of every lot or batch of dried marihuana that has been made available for sale.
Marginal note:Quality assurance
60 (1) A licensed producer must
(a) have a quality assurance person who
(i) is responsible for assuring the quality of the dried marihuana before it is made available for sale, and
(ii) has the training, experience and technical knowledge relating to the activity conducted and the requirements of this Division; and
(b) investigate every complaint received in respect of the quality of the dried marihuana and, if necessary, take corrective and preventative measures.
Marginal note:Methods and procedures
(2) Dried marihuana must be produced, packaged, labelled and stored using methods and procedures that, prior to their implementation, have been approved by a quality assurance person.
Marginal note:Approval prior to sale
(3) Every lot or batch of dried marihuana must be approved by a quality assurance person before it is made available for sale.
Marginal note:Returns
(4) Dried marihuana that is sold or provided under subsection 12(4) and subsequently returned to the licensed producer must not be resold or provided again.
Marginal note:Sample of lot or batch
61 (1) Subject to subsection (3), if the Minister has reasonable grounds to believe that a lot or batch of dried marihuana made available for sale or provision by a licensed producer may — by reason of the manner in which it was produced, packaged, labelled or stored — pose a risk to the health of an individual who in accordance with these Regulations obtains the dried marihuana for their own medical purposes, the Minister may require the licensed producer to provide the Minister with a sample of that lot or batch.
Marginal note:Quantity
(2) The sample must be of sufficient quantity to enable a determination of whether the lot or batch of dried marihuana meets the requirements of sections 53 and 54.
Marginal note:Period
(3) The Minister must not require a sample to be provided if more than one year has elapsed after the date of the last sale or provision of any portion of the lot or batch of dried marihuana.
Marginal note:Recall reporting
62 A licensed producer who commences a recall of dried marihuana must provide the Minister with the following information in respect of the recalled dried marihuana within three days after the day on which the recall is commenced:
(a) its brand name;
(b) the number of each lot or batch recalled;
(c) if known by the licensed producer, the name and address of each licensed producer who imported or produced any of it;
(d) the reasons for commencing the recall;
(e) the quantity produced or imported into Canada by the licensed producer;
(f) the quantity that was sold or provided in Canada by the licensed producer;
(g) the quantity remaining in the possession of the licensed producer;
(h) the number of persons referred to in subsections 12(2) and (4) to whom it was sold or provided by the licensed producer; and
(i) a description of any other action that the licensed producer is taking in respect of the recall.
Marginal note:Adverse reactions
63 (1) A licensed producer who sells or provides dried marihuana must provide the Minister with a case report for each serious adverse reaction to the dried marihuana, within 15 days after the day on which the producer becomes aware of the reaction.
Marginal note:Summary report
(2) A licensed producer who sells or provides dried marihuana must annually prepare and maintain a summary report that contains a concise and critical analysis of all adverse reactions to the dried marihuana that have occurred during the previous 12 months.
Marginal note:Provide Minister with report on request
(3) If, after reviewing a case report provided under subsection (1) or after reviewing any other safety data relating to the dried marihuana, the Minister has reasonable grounds to believe that the dried marihuana may — by reason of the manner in which it was produced, packaged, labelled or stored — pose a risk to the health of an individual who in accordance with these Regulations obtains the dried marihuana for their own medical purposes, the Minister may request that, within 30 days after the day on which the request is received, the licensed producer
(a) provide the Minister with a copy of any summary report prepared under subsection (2); or
(b) prepare and provide the Minister with an interim summary report containing a concise and critical analysis of all adverse reactions to the dried marihuana that have occurred since the date of the most recent summary report prepared under subsection (2).
Marginal note:Definitions
(4) The following definitions apply in this section.
adverse reaction
réaction indésirable
adverse reaction means a noxious and unintended response to dried marihuana. (réaction indésirable)
case report
fiche d’observation
case report means a detailed record of all relevant data associated with the use of dried marihuana by a person. (fiche d’observation)
serious adverse reaction
réaction indésirable grave
serious adverse reaction means a noxious and unintended response to dried marihuana that requires in-patient hospitalization or a prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life threatening or that results in death. (réaction indésirable grave)
DIVISION 5Packaging, Labelling and Shipping
Marginal note:Packaging
64 A licensed producer who sells or provides dried marihuana under subsection 12(4) must ensure that
(a) the dried marihuana is packaged in an immediate container
(i) that is in direct contact with the dried marihuana,
(ii) that keeps the dried marihuana dry and free from contamination,
(iii) that has a security feature that provides reasonable assurance to consumers that the container has not been opened prior to receipt, and
(iv) that is a child resistant package that meets the requirements of subsections C.01.001(2) to (4) of the Food and Drug Regulations; and
(b) not more than 30 g of dried marihuana is in the immediate container.
Marginal note:Weight of dried marihuana
65 A licensed producer who sells or provides dried marihuana under subsection 12(4) must ensure that the net weight of the dried marihuana in the immediate container is not less than 95% and not more than 101% of the net weight specified on the label in accordance with subparagraph 66(c)(v).
Marginal note:Product label
66 A licensed producer who sells or provides dried marihuana under subsection 12(4) must ensure that the immediate container carries a label that contains the following information:
(a) the name of that licensed producer and a telephone number and email address that can be used to contact them;
(b) the words “Dried marihuana / Marihuana séchée”;
(c) in respect of the dried marihuana in the container:
(i) its brand name,
(ii) its lot number, preceded by one of the following designations:
(A) “Lot number”,
(B) “Lot no.”,
(C) “Lot”, or
(D) “(L)”,
(iii) the percentage of delta-9-tetrahydrocannabinol w/w, followed by the word “delta-9-tetrahydrocannabinol”,
(iv) the percentage of cannabidiol w/w, followed by the word “cannabidiol”,
(v) its net weight, in grams,
(vi) its recommended storage conditions,
(vii) its packaging date, and
(viii) either
(A) its expiry date, if a stability period for the dried marihuana has been established in accordance with section 71, or
(B) a statement to the effect that no expiry date based on stability data has been determined for the dried marihuana;
(d) the symbol “N” set out in the upper left quarter of the label in a colour contrasting with the rest of the label or in type not less than half the size of any other letters used on the label;
(e) the warning “KEEP OUT OF REACH OF CHILDREN / TENIR HORS DE LA PORTÉE DES ENFANTS”; and
(f) the statement “Important: Please read the Health Canada document provided with this package before using dried marihuana. / Important : Veuillez lire le document de Santé Canada qui accompagne ce colis avant d’utiliser la marihuana séchée.”.
- SOR/2014-51, s. 8
Marginal note:Client label
67 A licensed producer who sells or provides dried marihuana to a client or an individual who is responsible for the client must ensure that
(a) the immediate container carries a label that contains the following information:
(i) the given name and surname of the client,
(ii) the given name, surname and profession of the health care practitioner who provided the client’s medical document,
(iii) the name of the licensed producer,
(iv) the daily quantity of dried marihuana indicated on the client’s medical document, expressed in grams,
(v) the expiry date of the client’s registration referred to in section 112,
(vi) the shipping date, and
(vii) the date referred to in subsection 124(2); and
(b) a separate document containing the information referred to in paragraph (a) accompanies each shipment of the dried marihuana.
Marginal note:Combined label
68 In the case of dried marihuana to be sold or provided to a client or an individual who is responsible for the client, the information required under section 66 and paragraph 67(a) may be set out on one label.
Marginal note:Department of Health document
69 A licensed producer who sells or provides dried marihuana under subsection 12(4) must ensure that each shipment of the dried marihuana is accompanied by a copy of the current version of the document entitled Information on the Use of Marihuana for Medical Purposes, published by the Department of Health.
Marginal note:Presentation of information — label
70 (1) All information that is required under section 66 and paragraph 67(a) to appear on a label must be
(a) in English and in French;
(b) clearly and prominently displayed on the label; and
(c) readily discernible under the customary conditions of use.
Marginal note:Presentation of information — document
(2) All information in a document that is required under paragraph 67(b) or section 69 must be in English and in French and readily discernible under the customary conditions of use.
Marginal note:Expiry date
71 (1) A licensed producer must not include an expiry date on a label referred to in section 66 unless
(a) the licensed producer has submitted data to the Minister that establishes the stability period during which, after the dried marihuana is packaged in accordance with section 64 and when it is stored under its recommended storage conditions referred to in subparagraph 66(c)(vi),
(i) the dried marihuana maintains not less than 80% and not more than 120% of the percentages of delta-9-tetrahydrocannabinol w/w and cannabidiol w/w indicated on the label in accordance with subparagraphs 66(c)(iii) and (iv), and
(ii) the microbial and chemical contaminants of the dried marihuana remain within the limits referred to in subsection 53(1); and
(b) in the opinion of the Minister the data submitted by the licensed producer meets the requirements of paragraph (a) and has notified the producer to that effect.
Definition of expiry date
(2) For the purpose of subsection (1) and subparagraph 66(c)(viii), expiry date means the date, expressed at minimum as a year and month, that is the end of the stability period.
Marginal note:Reference to Acts or regulations
72 It is prohibited to include a reference, direct or indirect, to the Act, the Food and Drugs Act or any regulations made under those Acts on a label of or in an advertisement for dried marihuana unless the reference is a specific requirement of either of those Acts or those regulations.
Marginal note:Shipping
73 (1) A licensed producer who ships dried marihuana to a person referred to in subsection 12(2) or (4) must
(a) ship the marihuana in only one shipment per order;
(b) prepare the package in a manner that ensures the security of its contents, such that
(i) the package will not open or permit the escape of its contents during handling and transportation,
(ii) it is sealed so that it cannot be opened without the seal being broken,
(iii) it prevents the escape of marihuana odour, and
(iv) it prevents its contents from being identified without it being opened;
(c) use a shipping method that ensures the tracking and safekeeping of the package during transportation;
(d) ship it only to the following address:
(i) in the case of a client or an individual who is responsible for that client, the shipping address specified in the client’s registration document referred to in paragraph 111(2)(a), and
(ii) in the case of any other person referred to in subsection 12(2) or (4), the shipping address indicated in the order referred to in section 131; and
(e) in the case of a client or an individual who is responsible for that client, ship the marihuana in a quantity that does not exceed 150 g.
Marginal note:Shipping — cannabis other than dried marihuana
(2) A licensed producer who ships cannabis other than dried marihuana to a person referred to in subsection 12(2) must
(a) use a shipping method referred to in paragraph (1)(c); and
(b) ship it only to the shipping address indicated in the order referred to in section 131.
DIVISION 6Import and Export
Marginal note:Application for import permit
74 (1) To apply for a permit to import marihuana, a licensed producer must submit the following information to the Minister:
(a) their name, address and licence number;
(b) in respect of the marihuana to be imported,
(i) an indication of whether it is in the form of seeds, plants or dried marihuana,
(ii) its intended use,
(iii) if applicable, its brand name,
(iv) its quantity, and
(v) in the case of dried marihuana, its percentages of delta-9-tetrahydrocannabinol w/w and cannabidiol w/w;
(c) the name and address of the exporter in the country of export from whom the marihuana is being obtained;
(d) the port of entry into Canada;
(e) the address of the customs office, sufferance warehouse or bonded warehouse to which the marihuana is to be delivered; and
(f) each mode of transportation used, the country of export and, if applicable, any country of transit or transhipment.
Marginal note:Statement by signatory
(2) An application for an import permit must
(a) be signed and dated by the responsible person in charge or, if applicable, the alternate responsible person in charge at the licensed producer’s site; and
(b) include a statement, signed and dated by that person, indicating that all information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.
Marginal note:Issuance of import permit
75 (1) Subject to section 76, the Minister must, after examining the information and documents required under section 74 and, if applicable, section 8, issue to the licensed producer an import permit that indicates:
(a) the permit number;
(b) the information referred to in paragraphs 74(1)(a) to (f);
(c) the effective date of the permit;
(d) its expiry date, which is the earlier of
(i) the 180th day after the effective date, and
(ii) December 31 of the year of the effective date; and
(e) if applicable, any conditions that the permit holder must meet in order to
(i) comply with an international obligation, or
(ii) reduce any potential public health, safety or security risk, including the risk of the marihuana being diverted to an illicit market or use.
Marginal note:Duration of permit
(2) An import permit is valid until the earliest of
(a) its expiry date or the date on which it is suspended or revoked under section 80 or 81,
(b) the expiry date of the producer’s licence to which the permit pertains or the date on which the that licence is suspended or revoked, and
(c) the expiry date of the export permit that applies to the marihuana to be imported and that is issued by a competent authority in the country of export or the date on which that permit is suspended or revoked.
Marginal note:Validity
(3) A permit issued under this section is valid only for the importation in respect of which it is issued.
Marginal note:Refusal to issue import permit
76 The Minister must refuse to issue an import permit if
(a) in respect of the application for the permit, there exists a circumstance described in paragraph 26(1)(d), (e), (f) or (h), with any modifications that the circumstances require;
(b) the applicant does not hold a producer’s licence with respect to the marihuana that is to be imported;
(c) the applicant has been notified that one of the following applications submitted by the applicant in respect of the producer’s licence to which the requested permit pertains is to be refused under section 26:
(i) an application under section 23 for a producer’s licence,
(ii) an application under section 28 for the renewal of a producer’s licence, or
(iii) an application under section 29 for the amendment of a producer’s licence; or
(d) the Minister has reasonable grounds to believe that
(i) the shipment for which the permit is requested would contravene the laws of the country of export or any country of transit or transhipment, or
(ii) the importation is for the purpose of re-exporting the marihuana.
Marginal note:Provision of copy of import permit
77 On request of a customs officer, the holder of an import permit must provide a copy of the permit to the customs office, sufferance warehouse or bonded warehouse, as the case may be, at the port of entry into Canada at the time of importation.
Marginal note:Declaration after release from customs
78 The holder of an import permit must provide the Minister, within 15 days after the day of release, in accordance with the Customs Act, of a shipment that contains marihuana, with a declaration that contains the following information:
(a) the name of the licensed producer and the numbers of the producer’s licence and import permit in respect of the shipment;
(b) the date of release of the shipment; and
(c) in respect of the marihuana received,
(i) an indication of whether it is in the form of seeds, plants or dried marihuana,
(ii) its intended use,
(iii) if applicable, its brand name,
(iv) its quantity, and
(v) in the case of dried marihuana, its percentages of delta-9-tetrahydrocannabinol w/w and cannabidiol w/w.
Marginal note:Transportation of marihuana
79 The holder of an import permit must ensure that, after the imported marihuana clears customs, it is transported directly to the site specified in their producer’s licence.
Marginal note:Suspension of import permit
80 (1) The Minister must suspend an import permit without prior notice if
(a) the Minister has reasonable grounds to believe that it is necessary to do so to protect public health, safety or security, including preventing the marihuana from being diverted to an illicit market or use; or
(b) the importation would contravene the laws of any country of transit or transhipment.
Marginal note:Notice of suspension
(2) The suspension takes effect as soon as the Minister notifies the permit holder of the decision to suspend and provides a written report that sets out the reasons for the suspension.
Marginal note:Opportunity to be heard
(3) The permit holder may, within 10 days after receipt of the notice, provide the Minister with reasons why the suspension is unfounded.
Marginal note:Revocation of import permit
81 (1) The Minister must revoke an import permit
(a) at the request of the holder;
(b) if the holder informs the Minister that the permit has been lost or stolen; or
(c) if the permit is being replaced by a new permit.
Marginal note:Other revocation circumstances
(2) Subject to subsection (3), the Minister must revoke an import permit in the following circumstances:
(a) there exists a circumstance described in any of paragraphs 36(1)(a) to (e) in respect of the producer’s licence pertaining to the permit;
(b) the Minister has reasonable grounds to believe that the import permit was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application for the permit; or
(c) the importation is for the purpose of re-exporting the marihuana.
Marginal note:Exceptions
(3) Unless it is necessary to do so to protect public health, safety or security, including preventing the marihuana from being diverted to an illicit market or use, the Minister must not revoke an import permit in the circumstances described in paragraph (2)(b) or 36(1)(a) or (b) if the permit holder has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and its regulations and the Food and Drugs Act.
Marginal note:Failure to comply with undertaking
(4) If the licensed producer fails to comply with an undertaking mentioned in subsection (3), the Minister must revoke the permit.
Marginal note:Revocation following suspension
(5) The Minister must revoke a permit if the licensed producer fails to comply with the decision of the Minister to suspend the permit under section 80 or if the situation giving rise to the suspension is not rectified.
Marginal note:Application for export permit
82 (1) To apply for a permit to export marihuana, a licensed producer must submit the following information and statements to the Minister:
(a) their name, address and licence number;
(b) in respect of the marihuana to be exported,
(i) an indication of whether it is in the form of seeds, plants or dried marihuana,
(ii) its intended use,
(iii) if applicable, its brand name,
(iv) the quantity to be exported, and
(v) its percentages of delta-9-tetrahydrocannabinol w/w and cannabidiol w/w;
(c) the name and address of the importer in the country of final destination;
(d) the port of exit from Canada and, if applicable, any country of transit or transhipment;
(e) the address of the customs office, sufferance warehouse or bonded warehouse at which the shipment is to be presented for export;
(f) each mode of transportation used; and
(g) a statement that, to the best of their knowledge, the shipment does not contravene the laws of the country of final destination or any country of transit or transhipment.
Marginal note:Accompanying document
(2) An application for an export permit must be accompanied by a copy of the import permit issued by a competent authority in the country of final destination that sets out the name and address of the site of the importer in the country of final destination.
Marginal note:Statement by signatory
(3) An application for an export permit must
(a) be signed and dated by the responsible person in charge or, if applicable, the alternate responsible person in charge at the licensed producer’s site; and
(b) include a statement, signed and dated by that person, indicating that all information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.
Marginal note:Issuance of export permit
83 (1) Subject to section 84, the Minister must, after examining the information and documents required under section 82 and, if applicable, section 8, issue an export permit to the licensed producer that indicates:
(a) the permit number;
(b) the information referred to in paragraphs 82(1)(a) to (f);
(c) the effective date of the permit;
(d) its expiry date, which is the earliest of
(i) the 120th day after the effective date,
(ii) December 31 of the year of the effective date, and
(iii) the expiry date of the import permit issued by a competent authority in the country of final destination; and
(e) if applicable, any conditions that the permit holder must meet in order to
(i) comply with an international obligation, or
(ii) reduce any potential public health, safety or security risk, including the risk of the marihuana being diverted to an illicit market or use.
Marginal note:Duration of permit
(2) An export permit is valid until the earliest of
(a) its expiry date or the date on which it is suspended or revoked under section 87 or 88,
(b) the expiry date of the producer’s licence to which the permit pertains or the date on which the that licence is suspended or revoked, and
(c) the expiry date of the import permit that applies to the marihuana to be exported and that is issued by a competent authority in the country of final destination or the date on which that permit is suspended or revoked.
Marginal note:Validity
(3) A permit issued under this section is valid only for the exportation in respect of which it is issued.
Marginal note:Refusal to issue export permit
84 The Minister must refuse to issue an export permit if
(a) in respect of the application for the permit, there exists a circumstance described in paragraph 26(1)(d), (e) or (h), with any modifications that the circumstances require;
(b) the applicant does not hold a producer’s licence in respect of the marihuana to be exported;
(c) the applicant has been notified that one of the following applications submitted by the applicant in respect of the producer’s licence to which the requested permit pertains is to be refused under section 26:
(i) an application made under section 23 for a producer’s licence,
(ii) an application made under section 28 for the renewal of a producer’s licence, or
(iii) an application made under section 29 for the amendment of a producer’s licence;
(d) the Minister has reasonable grounds to believe that the shipment for which the permit is requested would contravene the laws of the country of final destination or any country of transit or transhipment; or
(e) the shipment would not be in conformity with the import permit issued by a competent authority of the country of final destination.
Marginal note:Provision of copy of export permit
85 On request of a customs officer, the holder of an export permit must provide a copy of the permit to the customs office, sufferance warehouse or bonded warehouse, as the case may be, at the port of exit from Canada at the time of exportation.
Marginal note:Declaration after export
86 The holder of an export permit must provide the Minister, within 15 days after the day on which a shipment that contains marihuana is exported, with a declaration that contains the following information:
(a) the name of the licensed producer and the numbers of the producer’s licence and export permit in respect of the shipment;
(b) the date of export;
(c) in respect of the exported marihuana,
(i) an indication as to whether it is in the form of seeds, plants or dried marihuana,
(ii) its intended use,
(iii) if applicable, its brand name, and
(iv) its quantity.
Marginal note:Suspension of export permit
87 (1) The Minister must suspend an export permit without prior notice if
(a) the Minister has reasonable grounds to believe that it is necessary to do so to protect public health, safety or security, including preventing the marihuana from being diverted to an illicit market or use;
(b) the exportation is not in conformity with an import permit issued by a competent authority of the country of final destination; or
(c) the exportation would contravene the laws of the country of final destination or any country of transit or transhipment.
Marginal note:Notice of suspension
(2) The suspension takes effect as soon as the Minister notifies the permit holder of the decision to suspend and provides a written report that sets out the reasons for the suspension.
Marginal note:Opportunity to be heard
(3) The permit holder may, within 10 days after receipt of the notice, provide the Minister with reasons why the suspension is unfounded.
Marginal note:Revocation of export permit
88 (1) The Minister must revoke an export permit
(a) at the request of the holder;
(b) if the holder informs the Minister that the permit has been lost or stolen; or
(c) if the permit is being replaced by a new permit.
Marginal note:Other revocation circumstances
(2) Subject to subsection (3), the Minister must revoke an export permit in the following circumstances:
(a) there exists a circumstance described in any of paragraphs 36(1)(a) to (e) in respect of the producer’s licence to which the permit pertains; or
(b) the Minister has reasonable grounds to believe that the export permit was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application.
Marginal note:Exceptions
(3) Unless it is necessary to do so to protect public health, safety or security, including preventing the marihuana from being diverted to an illicit market or use, the Minister must not revoke an export permit in the circumstances described in paragraph (2)(b) or 36(1)(a) or (b) if the permit holder has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and its regulations and the Food and Drugs Act.
Marginal note:Failure to comply with undertaking
(4) If the licensed producer fails to comply with an undertaking mentioned in subsection (3), the Minister must revoke the permit.
Marginal note:Revocation following suspension
(5) The Minister must revoke a permit if the licensed producer fails to comply with the decision of the Minister to suspend the permit under section 87 or if the situation giving rise to the suspension is not rectified.
DIVISION 7Security Clearances
Marginal note:Eligibility
89 Only the following persons may submit to the Minister an application for a security clearance:
(a) a person named in an application for a producer’s licence as
(i) the proposed senior person in charge,
(ii) the proposed responsible person in charge, or
(iii) if applicable, the proposed alternate responsible person in charge;
(b) if a producer’s licence is sought by an individual, that individual;
(c) if a producer’s licence is sought by a corporation, each officer and director of the corporation;
(d) a person referred to in any of subparagraphs 30(1)(a)(i) to (iii); and
(e) the holder of a security clearance who is seeking to obtain a new security clearance before the end of the validity period of their current clearance.
Marginal note:Application for security clearance
90 (1) An application for a security clearance must include the following information and documentation, to be used only for the purposes of sections 91 and 92:
(a) the applicant’s usual given name used, other given names, surname, all other names used and details of any name changes;
(b) the applicant’s date of birth, gender, height, weight, and eye and hair colour;
(c) if the applicant was born in Canada, the number and province of issue of their birth certificate;
(d) if the applicant was born outside Canada, their place of birth, the port and date of entry into Canada, and, in the case of a naturalized Canadian or permanent resident, the number of the applicable certificate issued under the Citizenship Act or the Immigration and Refugee Protection Act;
(e) either of the following documents:
(i) a copy of a valid piece of photo identification of the applicant issued by the government of Canada or of a province, or
(ii) a copy of the applicant’s passport that includes the passport number, country of issue, expiry date and the applicant’s photograph;
(f) the addresses of all locations at which the applicant resided during the five years preceding the application;
(g) an identification of the applicant’s activities during the five years preceding the application, including the names and addresses of the applicant’s employers and any post-secondary educational institutions attended;
(h) the dates, destination and purpose of any travel of more than 90 days outside Canada, excluding travel for government business, during the five years preceding the application;
(i) the information referred to in subsection (2) respecting
(i) the applicant’s spouse or common-law partner, and
(ii) any former spouses or common-law partners with whom the relationship ended within the preceding five years;
(j) the applicant’s fingerprints, taken by a Canadian police force or by a private company that is accredited by the Royal Canadian Mounted Police to submit fingerprints to it for the purpose of a criminal record check; and
(k) a statement signed and dated by the licensed producer or the applicant for a producer’s licence certifying that the applicant for the security clearance requires or will require a security clearance and specifying the reasons for that requirement.
Marginal note:Spouse or common-law partner
(2) The information required in respect of any of the persons referred to in paragraph (1)(i) is
(a) in the case of the applicant’s spouse or common-law partner, the following information:
(i) their gender, full given name, surname and, if applicable, maiden name,
(ii) their date and place of birth and, if applicable, date of death,
(iii) if born in Canada, the number and province of issue of their birth certificate,
(iv) if born outside Canada, their place of birth, their nationality and the port and date of entry into Canada, and
(v) their present address, if known; and
(b) in the case of former spouses and common-law partners with whom the relationship ended within the preceding five years, the information referred to in subparagraphs (a)(i), (ii) and (v).
Marginal note:Signed by applicant
(3) The application for a security clearance must be signed and dated by the applicant.
Definition of common-law partner
(4) In this section, common-law partner means any person who is cohabiting with the applicant in a relationship of a conjugal nature and has done so for a period of at least one year.
Marginal note:Checks
91 On receipt of a fully completed application for a security clearance, the Minister must conduct the following checks for the purpose of assessing whether an applicant poses a risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use:
(a) a criminal record check in respect of the applicant; and
(b) a check of the relevant files of law enforcement agencies, including intelligence gathered for law enforcement purposes.
Marginal note:Minister’s decisions
92 The Minister may grant a security clearance if, in the opinion of the Minister, the information provided by the applicant and that resulting from the checks is reliable and is sufficient for the Minister to determine, by taking into account the following factors, that the applicant does not pose an unacceptable risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use:
(a) whether the applicant has been found guilty as an adult, in the past 10 years, of
(i) a designated drug offence as defined in section 2 of the Narcotic Control Regulations,
(ii) a designated criminal offence as defined in that section, or
(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);
(b) whether it is known or there are reasonable grounds to suspect that the applicant
(i) is or has been involved in, or contributes or has contributed to, illicit activities directed toward or in support of the trafficking or diversion of controlled substances or precursors,
(ii) is or has been a member of a criminal organization as defined in subsection 467.1(1) of the Criminal Code, or participates or has participated in, or contributes or has contributed to, the activities of such an organization as referred to in subsection 467.11(1) of the Criminal Code,
(iii) is or has been a member of an organization that is known to be involved in or to contribute to — or in respect of which there are reasonable grounds to suspect involvement in or contribution to — activities directed toward or in support of the threat of or the use of acts of violence against persons or property, or is or has been involved in, or is contributing to or has contributed to, the activities of such an organization, or
(iv) is or has been associated with an individual who is known to be involved in or to contribute to — or in respect of whom there are reasonable grounds to suspect involvement in or contribution to — activities referred to in subparagraph (i), or is a member of an organization referred to in subparagraph (ii) or (iii);
(c) whether there are reasonable grounds to suspect that the applicant is in a position in which there is a risk that they be induced to commit an act or to aid or abet any person to commit an act that might constitute a risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use;
(d) whether the applicant has had a security clearance cancelled; and
(e) whether the applicant has submitted false or misleading information or false or falsified documents in or with their application for a security clearance.
- SOR/2014-51, s. 9(F)
Marginal note:Outstanding criminal charge
93 If there is an outstanding criminal charge against the applicant that could, if the applicant were found guilty, be taken into account by the Minister under paragraph 92(a), the Minister may decline to process the application until the charge has been disposed of by the courts, in which case the Minister must notify the applicant in writing.
Marginal note:Refusal to grant security clearance
94 (1) If the Minister intends to refuse to grant a security clearance, the Minister must notify the applicant in writing to that effect.
Marginal note:Content of notice
(2) The notice must set out the basis for the Minister’s intention and fix a period of time within which the applicant may make written representations to the Minister, which period of time must start on the day on which the notice is served or sent and must be not less than 20 days.
Marginal note:Opportunity to make written representations
(3) The Minister must not refuse to grant a security clearance until the written representations have been received and considered or before the period of time fixed in the notice has expired, whichever comes first. The Minister must notify the applicant in writing of any refusal.
Marginal note:Validity period
95 (1) The Minister must establish a period of validity for a security clearance in accordance with the level of risk posed by the applicant as determined under section 92, but the period must not exceed five years.
Marginal note:Extension of period
(2) If the validity period is less than five years, the Minister may extend the period to a total of five years if the Minister determines under section 92 that the holder does not pose an unacceptable risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use.
Marginal note:Security clearance no longer required
96 A licensed producer must notify the Minister in writing not later than five days after the holder of a security clearance is no longer required by these Regulations to hold a security clearance. The Minister must then cancel the clearance.
Marginal note:Suspension of security clearance
97 (1) The Minister may suspend a security clearance on receipt of information that could change the Minister’s determination made under section 92.
Marginal note:Written notice to holder
(2) Immediately after suspending a security clearance, the Minister must notify the holder in writing of the suspension.
Marginal note:Content of notice
(3) The notice must set out the basis for the suspension and must fix a period of time within which the holder may make written representations to the Minister, which period of time must start on the day on which the notice is served or sent and must be not less than 20 days.
Marginal note:Reinstatement of clearance
(4) The Minister may reinstate the security clearance if the Minister determines under section 92 that the holder does not pose an unacceptable risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use.
Marginal note:Cancellation of clearance
(5) The Minister may cancel the security clearance if the Minister determines under section 92 that the holder may pose an unacceptable risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use. The Minister must notify the holder in writing of any cancellation.
Marginal note:Opportunity to be heard
(6) The Minister must not cancel the security clearance until the written representations referred to in subsection (3) have been received and considered or before the time period fixed in the notice referred to in that subsection has expired, whichever comes first.
Marginal note:New applications
98 If the Minister refuses to grant or cancels a security clearance, an applicant may submit a new application only if
(a) a period of five years has elapsed after the day on which the refusal or cancellation occurs; or
(b) a change has occurred in the circumstances that led to the refusal or cancellation.
Marginal note:Sending of notices by Minister
99 The Minister must send any notice to be given under this Division to the person at their last known address by using a method of sending that involves
(a) a means of tracking it during transit;
(b) the safekeeping of it during transit; and
(c) the keeping of an accurate record of the signatures of any persons having charge of it until it is delivered.
Marginal note:False or misleading information
100 It is prohibited to knowingly submit to the Minister an application containing false or misleading information in order to obtain a security clearance.
DIVISION 8Communication of Information
Marginal note:Information concerning clients and responsible individuals
101 (1) Subject to subsections (2) and (3), if a licensed producer is provided with the given name, surname, date of birth and gender of an individual by a member of a Canadian police force who requests information in the course of an investigation under the Act or these Regulations, the producer must provide as soon as feasible, within 72 hours after receiving the request, the following information to that Canadian police force:
(a) an indication of whether or not the individual is
(i) a client of the producer, or
(ii) an individual who is responsible for a client of the producer; and
(b) the daily quantity of dried marihuana that is specified in the medical document supporting the client’s registration.
Marginal note:Verification
(2) Before providing the requested information, the licensed producer must verify in a reasonable manner that the person requesting the information is a member of a Canadian police force.
Marginal note:Use of information
(3) Information provided under this section must be used only for the purposes of the investigation referred to in subsection (1) and for the proper administration or enforcement of the Act or these Regulations.
Marginal note:Information concerning health care practitioners
102 A licensed producer must provide in writing, as soon as feasible, any factual information that has been obtained about a health care practitioner under the Act or these Regulations to the licensing authority responsible for the registration or authorization of the practise of the profession
(a) in the province in which the health care practitioner is authorized to practise if the authority submits to the licensed producer a written request that sets out the practitioner’s name and address, a description of the information being sought and a statement that the information is required for the purpose of assisting an official investigation by the authority; or
(b) in a province in which the health care practitioner is not authorized to practise, if the authority submits to the licensed producer
(i) a written request for information that sets out the name and address of the practitioner and a description of the information being sought, and
(ii) either
(A) documentation that shows that the practitioner has applied to that authority to practise in that province, or
(B) documentation that shows that the authority has reasonable grounds to believe that the practitioner is practising in that province without being authorized to do so.
Marginal note:Information concerning licensed producers
103 The Minister is authorized to provide any information set out in a notice referred to in section 38, 39 or 40 to a Canadian police force or a member of a Canadian police force who requests the information in the course of an investigation under the Act or these Regulations, subject to that information being used only for the purpose of that investigation and the proper administration or enforcement of the Act or these Regulations.
Marginal note:Information concerning import or export permit
104 The Minister is authorized, for the purpose of verifying whether an importation or exportation of marihuana complies with these Regulations, to provide to a customs officer in Canada any information referred to in sections 74, 75, 78, 82, 83 and 86 and to inform them whether a permit has been suspended or revoked.
Marginal note:Providing information to foreign organizations
105 The Minister is authorized, for the proper administration or enforcement of the Act or these Regulations and for the purpose of enabling Canada to fulfill its international obligations under section 12 of the United Nations’ Single Convention on Narcotic Drugs, 1961, to provide the following information or documents to the International Narcotics Control Board or a competent authority:
(a) any information or document that a licensed producer is required to provide to the Minister under Part 1;
(b) any information pertaining to an activity authorized by a licence or permit issued to a licensed producer under these Regulations, including the licensed producer’s name, the nature of the authorized activity and any conditions specified in the licence or permit;
(c) in respect of cannabis that a licensed producer receives from another licensed producer or a licensed dealer, the following information:
(i) in the case of dried marihuana, its quantity and the date on which it was received, or
(ii) in the case of cannabis other than dried marihuana, the name of the substance in question, its quantity and the date on which it was received;
(d) in respect of an order that a licensed producer fills under section 121, the quantity of dried marihuana and the date on which it was shipped;
(e) in respect of an order that a licensed producer fills under subsection 131(1) or (2), the following information:
(i) in the case of dried marihuana, its quantity and the date on which it was shipped, or
(ii) in the case of cannabis other than dried marihuana, the name of the substance in question, its quantity and the date on which it was shipped;
(f) any record that a licensed producer is required to keep under subsection 143(2) or section 144 or 146; and
(g) a copy of any permit issued under section 75 or 83.
Marginal note:Security clearance — Minister
106 The Minister is authorized to communicate to a law enforcement agency information concerning an application for a security clearance for the purpose of conducting the checks and verifications referred to in section 91, subject to that information being used by that agency only for that purpose.
PART 2Client Registration and Ordering
Registration
Marginal note:Eligibility
107 An individual is eligible to be a client of a licensed producer only if they ordinarily reside in Canada.
Marginal note:Registration application
108 (1) Before registering an individual as a client, a licensed producer must obtain from the individual or an individual who is responsible for the individual an application that contains the following information:
(a) the applicant’s given name, surname, date of birth and gender;
(b) either,
(i) the address of the place in Canada where the applicant ordinarily resides, as well as, if applicable, the applicant’s telephone number, facsimile number and email address, or
(ii) if the applicant ordinarily resides in Canada but has no dwelling place, the address, as well as, if applicable, the telephone number, facsimile number and email address of a shelter, hostel or similar institution, located in Canada, that provides food, lodging or other social services to the applicant;
(c) the mailing address of the place referred to in paragraph (b), if different from the address provided under that paragraph;
(d) if applicable, the given name, surname, date of birth and gender of one or more individuals who are responsible for the applicant ;
(e) if the place referred to in subparagraph (b)(i) is an establishment that is not a private residence, the type and name of the establishment; and
(f) an indication as to which of the following is to be their shipping address:
(i) the address referred to in subparagraph (b)(i),
(ii) the mailing address of the place referred to in subparagraph (b)(i), or
(iii) subject to section 109, the address of the health care practitioner who provided the medical document referred to in subsection (2).
Marginal note:Medical document
(2) The applicant must include with the application the original of their medical document.
Marginal note:Statement by applicant or responsible individual
(3) The application must be signed and dated by the applicant or an individual who is responsible for the applicant and include a statement that
(a) the applicant is ordinarily resident in Canada;
(b) the information in the application and the medical document is correct and complete;
(c) the medical document is not being used to seek or obtain dried marihuana from another source;
(d) the original of the medical document accompanies the application; and
(e) the applicant will use dried marihuana only for their own medical purposes.
Marginal note:Statement by responsible individual
(4) If the application is signed and dated by an individual who is responsible for the applicant, it must include a statement by that individual that they are responsible for the applicant.
Marginal note:Homeless applicant
(5) If an application includes the information referred to in subparagraph (1)(b)(ii), the applicant must include with the application an attestation of residence signed and dated by a manager of the specified shelter, hostel or similar institution confirming that the institution provides food, lodging or other social services to the applicant.
Marginal note:Health care practitioner’s consent to receive dried marihuana
109 (1) If the shipping address specified in a registration application is the one referred to in subparagraph 108(1)(f)(iii), the applicant must include with the application a statement signed and dated by the health care practitioner who provided the medical document to the applicant indicating that the practitioner consents to receive dried marihuana on behalf of the applicant.
Marginal note:Withdrawal of consent
(2) If the applicant becomes a client of a licensed producer in accordance with section 111 and the health care practitioner ceases to consent to receive dried marihuana on behalf of the client, the practitioner must send a written notice to that effect to the client and the licensed producer.
Marginal note:No further shipments
(3) A licensed producer who receives such a notice must not send any further shipments of dried marihuana to that health care practitioner for that client.
Marginal note:Amendment to registration
(4) A client who receives such a notice and wishes to specify a new shipping address must submit to the licensed producer a registration amendment application in accordance with section 115.
Marginal note:Verification of medical document
110 A licensed producer who receives an application under section 108 and intends to register the applicant must ensure that
(a) the medical document accompanying the application meets all of the requirements of section 129;
(b) the person who provided the applicant with the medical document
(i) is a health care practitioner,
(ii) is entitled to practise their profession in the province in which the applicant consulted with that person, and
(iii) is not named in a notice issued under section 59 of the Narcotic Control Regulations that has not been retracted under section 60 of those Regulations; and
(c) the applicant has consulted with the person referred to in paragraph (b) and that the information set out in the medical document is correct and complete, by confirming these matters with the office of that person.
Marginal note:Registration of client
111 (1) Subject to section 113, a licensed producer may register an applicant as a client.
Marginal note:Registration document and unique identifier
(2) If the licensed producer registers the applicant as a client, the producer must
(a) send the client a registration document that contains the following information:
(i) the name of the producer, and
(ii) in respect of the client,
(A) the client’s given name, surname, date of birth and gender,
(B) the address referred to in subparagraph 108(1)(b)(i) or (ii),
(C) the client’s shipping address in Canada, and
(D) the expiry date of the registration; and
(b) provide the client with information that will permit the client to use a unique identifier for the purpose of ordering dried marihuana.
Marginal note:Expiry of registration
112 A client’s registration expires at the end of the period of validity of the medical document supporting the registration, as determined in accordance with subsections 129(2) and (3).
Marginal note:Refusal to register
113 A licensed producer must refuse to register an applicant as a client if
(a) the application does not meet the requirements of section 108;
(b) the licensed producer has reasonable grounds to believe that false or misleading information or false or falsified documents were submitted in or with the application;
(c) the requirements of section 110 are not met;
(d) the medical document that is submitted with the application is no longer valid;
(e) the given name, surname or date of birth of the applicant is different from the given name, surname or date of birth that appears on the medical document;
(f) the health care practitioner who provided the medical document to the applicant notifies the licensed producer in writing that the use of dried marihuana by the applicant is no longer supported for clinical reasons; or
(g) the address specified in the application under subparagraph 108(1)(b)(i) or (ii) is not in Canada.
Marginal note:Notice — refusal to register
114 (1) A licensed producer who proposes to refuse to register an applicant for a ground set out in section 113 or for a business reason must without delay send the applicant a notice that indicates the reason for the refusal.
Marginal note:Opportunity to be heard
(2) The applicant may, within 10 days after receipt of the notice, provide the licensed producer with reasons why the refusal is unfounded.
Marginal note:Return of medical document
(3) A licensed producer who refuses to register an applicant must return the medical document to the applicant without delay.
Marginal note:Application to amend registration
115 (1) An application to amend a registration must be made to the licensed producer by the client or an individual responsible for the client when a change occurs in respect of any of the information provided under subsection 108(1).
Marginal note:Content of application
(2) The application must include
(a) the requested amendment;
(b) in the case of a change to any of the information provided under paragraph 108(1)(a), proof of the change; and
(c) in the case of a change to the information provided under subparagraph 108(1)(f)(iii), the statement referred to in subsection 109(1).
Marginal note:Statement
(3) The application must be signed and dated by the client or an individual who is responsible for the client and include a statement that
(a) the client is ordinarily resident in Canada; and
(b) the information contained in the application is correct and complete.
Marginal note:Statement by responsible individual
(4) If the application is signed and dated by an individual who is responsible for the client, it must include a statement by that individual that they are responsible for the client.
Marginal note:Amendment
116 (1) A licensed producer must amend a client’s registration if the client’s amendment application meets the requirements of subsections 115(2) and (3).
Marginal note:Amended registration document
(2) If the licensed producer amends the client’s registration, the producer must send the client an amended registration document that contains the information referred to in subparagraphs 111(2)(a)(i) and (ii).
Marginal note:Cancellation of registration
117 (1) A licensed producer must cancel the registration of a client if
(a) the client or an individual who is responsible for the client requests the licensed producer to cancel the registration;
(b) the client dies, ceases to be ordinarily resident in Canada or ceases to have a shipping address in Canada;
(c) the licensed producer has reasonable grounds to believe that
(i) the registration was made on the basis of false or misleading information or false or falsified documents submitted in or with the registration application, or
(ii) false or misleading information or false or falsified documents were submitted in or with the application to amend the registration;
(d) the health care practitioner who provided the medical document to the client notifies the licensed producer in writing that the use of dried marihuana by the client is no longer supported for clinical reasons; or
(e) the health care practitioner who provided the medical document to the client is named in a notice issued under section 59 of the Narcotic Control Regulations that has not been retracted under section 60 of those Regulations.
Marginal note:Time of cancellation
(2) The licensed producer must cancel the registration of the client without delay if the producer
(a) receives a request referred to in paragraph (1)(a) or a written notice under paragraph (1)(d);
(b) becomes aware of a ground referred to in paragraph (1)(b) or (e) and has verified in a reasonable manner the existence of the ground; or
(c) has reasonable grounds to believe that a ground referred to in subparagraph (1)(c)(i) or (ii) exists.
Marginal note:Cancellation of all registrations
(3) A licensed producer must cancel the registrations of all of its clients without delay if the producer’s licence is revoked.
Marginal note:Cancellation by producer for business reason
(4) A licensed producer may cancel the registration of a client for a business reason.
Marginal note:Notice
(5) Except in the case of the death of a client, a licensed producer who proposes to cancel a client’s registration must without delay send a notice that indicates the reason for the cancellation to the client.
Marginal note:Opportunity to be heard
(6) Within 10 days after receipt of the notice, the client or an individual responsible for the client may provide the licensed producer with reasons why the cancellation is unfounded.
Marginal note:Medical document
(7) A licensed producer who cancels a client’s registration must not return the medical document.
Marginal note:Prohibition — transfer of medical document
118 A licensed producer must not transfer to any person a medical document on the basis of which a client has been registered.
New Medical Document
Marginal note:New application
119 A licensed producer must not sell or provide dried marihuana to a client or an individual who is responsible for the client on the basis of a new medical document unless the client or the individual submits to the producer a new registration application that meets the requirements of section 108.
Marginal note:Applicable provisions
120 Sections 109 to 114 apply to an application under section 119 in the same way that they apply to an application under section 108.
Processing an Order
Marginal note:Order required
121 (1) A licensed producer must not sell or provide dried marihuana to a client or an individual responsible for the client unless the producer has first received, from the client or the individual, a written order in accordance with subsection (2) or a verbal order recorded in accordance with subsection (3).
Marginal note:Written orders
(2) A written order for dried marihuana must
(a) be dated as of the day on which it is made;
(b) set out
(i) the given name, surname and date of birth of the client for whom the order is made,
(ii) the given name and surname of the individual making the order,
(iii) the shipping address specified in the client’s registration document, and
(iv) the client’s unique identifier; and
(c) set out the quantity and the brand name of the dried marihuana being ordered.
Marginal note:Verbal orders
(3) A licensed producer who receives a verbal order must, before filling the order, make a record of the information referred to in section 137.
Marginal note:Shipping
122 In filling an order referred to in section 121, a licensed producer must not transfer physical possession of the dried marihuana to the client or to an individual responsible for that client other than by shipping it to that person.
Marginal note:Refusal
123 (1) A licensed producer must refuse to fill an order referred to in section 121 if
(a) the order does not meet the requirements of section 121;
(b) any of the information that is referred to in subparagraph 121(2)(b)(i) or (iii) does not correspond to the information set out in the client’s registration document in accordance with clause 111(2)(a)(ii)(A) or (C);
(c) the client’s unique identifier referred to in subparagraph 121(2)(b)(iv) is not correct;
(d) the client’s registration has expired or been cancelled;
(e) the order specifies a quantity of dried marihuana that exceeds 150 g;
(f) the order has been previously filled in whole or in part; or
(g) more than 30 days have elapsed since the date referred to in paragraph 121(2)(a) or 137(a).
Marginal note:Notice of refusal to fill order
(2) The licensed producer must send the client a written notice of the reason for the refusal.
Marginal note:Thirty-day limit
124 (1) A licensed producer must not sell or provide to a client or an individual responsible for the client in any 30-day period a total quantity of dried marihuana that exceeds 30 times the daily quantity referred to in paragraph 129(1)(d).
Marginal note:Date of sale
(2) A quantity of dried marihuana is deemed to be sold or provided, for the purpose of subsection (1), on the date that the licensed producer reasonably anticipates that it will be received by the client.
Marginal note:Return
(3) If the client or an individual responsible for the client returns to the licensed producer dried marihuana that the producer sold or provided to them, the producer may replace the returned marihuana with an equal quantity, to a maximum of 150 g.
Marginal note:Exclusion
(4) The quantity of any dried marihuana that the licensed producer provides to the client or an individual responsible for the client to replace the returned marihuana is to be excluded for the purpose of calculating the total quantity referred to in subsection (1).
PART 3Clients and other Authorized Users
Marginal note:Proof of authority to possess
125 On demand, an individual who, in accordance with these Regulations, obtains dried marihuana for their own medical purposes must show to a police officer proof that they are authorized to possess the dried marihuana.
Marginal note:Prohibition — obtaining from more than one source
126 It is prohibited to seek or obtain dried marihuana from more than one source at a time on the basis of the same medical document.
Marginal note:Return
127 (1) An individual who, in accordance with these Regulations or subsection 65(2.1) of the Narcotic Control Regulations, obtains dried marihuana for their own medical purposes or for those of another individual for whom they are responsible may return the dried marihuana to the person who sold or provided it to them if that person accepts the return of that dried marihuana.
Marginal note:Return by shipping
(2) If the individual returns the dried marihuana by means of shipping it to the person who sold or provided it to them, they must
(a) ship it in a package that meets the requirements of paragraph 73(1)(b); and
(b) use a shipping method that meets the requirements of paragraph 73(1)(c).
Marginal note:Return to licensed producer
(3) If the individual returns the dried marihuana to the licensed producer who sold or provided it to them, they must do so by shipping it to the producer’s site in accordance with paragraphs (2)(a) and (b).
PART 4Health Care Practitioners
Marginal note:Authorized activities
128 (1) In addition to being authorized to possess dried marihuana in accordance with section 3, a health care practitioner may perform the following activities in regard to a person who is under their professional treatment:
(a) transfer or administer dried marihuana; or
(b) provide a medical document.
Marginal note:Transfer
(2) The health care practitioner may also transfer dried marihuana to an individual who is responsible for the person under their professional treatment.
Marginal note:Medical document
129 (1) A medical document provided by a health care practitioner to a person who is under their professional treatment must indicate
(a) the practitioner’s given name, surname, profession, business address and telephone number, facsimile number and email address, if applicable, the province in which the practitioner is authorized to practise their profession and the number assigned by the province to that authorization;
(b) the person’s given name, surname and date of birth;
(c) the address of the location at which the person consulted with the practitioner;
(d) the daily quantity of dried marihuana to be used by the person, expressed in grams; and
(e) the period of use.
Marginal note:Period of use
(2) The period of use referred to in paragraph (1)(e)
(a) must be specified as a number of days, weeks or months, which must not exceed one year; and
(b) begins on the day on which the medical document is signed by the health care practitioner.
Marginal note:Validity of medical document
(3) A medical document is valid for the period of use specified in it.
Marginal note:Attestation
(4) The medical document must be signed and dated by the health care practitioner providing it and must attest that the information in the document is correct and complete.
Marginal note:Thirty-day limit
130 (1) A health care practitioner must not transfer to a person under their professional treatment or an individual who is responsible for that person (both of whom are referred to in this section as “the transferee”) in any 30-day period a total quantity of dried marihuana that exceeds 30 times the daily quantity to be used by the person under their professional treatment, as specified in the medical document on the basis of which the transfer is made.
Marginal note:Additional limit
(2) A health care practitioner must not, at any one time, transfer to the transferee a quantity of dried marihuana that exceeds 150 g.
Marginal note:Exclusion
(3) The quantity of any dried marihuana that the health care practitioner transfers to the transferee to replace any dried marihuana that the transferee has returned under section 127 is to be excluded for the purpose of calculating the total quantity referred to in subsection (1).
PART 5Sale or Provision by a Licensed Producer to a Person other than a Client
Marginal note:Order required — cannabis
131 (1) A licensed producer must not sell or provide cannabis under subsection 12(2) unless the producer has first received a written order in accordance with subsection (3) from
(a) in the case of a licensed dealer or another licensed producer, an individual who is authorized to place an order for cannabis on behalf of that dealer or producer; and
(b) in any other case, the person to whom the cannabis is to be sold or provided in accordance with the Act and these Regulations.
Marginal note:Order required — dried marihuana
(2) A licensed producer must not sell or provide dried marihuana under subparagraphs 12(4)(a)(ii) or (iii) unless the producer has first received a written order in accordance with subsection (3) from
(a) in the case referred to in subparagraph 12(4)(a)(ii), a pharmacist practising in the hospital or a health care practitioner authorized to place orders for dried marihuana on behalf of the hospital; and
(b) in the case referred to in subparagraph 12(4)(a)(iii), the person to whom the dried marihuana is to be sold or provided.
Marginal note:Requirements
(3) The written order must
(a) be signed and dated by a person described in subsection (1) or (2) and indicate their name;
(b) indicate the shipping address in Canada; and
(c) specify whether dried marihuana or cannabis other than dried marihuana is being ordered and include the following information:
(i) in the case of dried marihuana, its quantity and brand name, or
(ii) in the case of cannabis other than dried marihuana, the substance ordered, its quantity, description and, if applicable, brand name.
Marginal note:Signature
(4) A licensed producer must verify in a reasonable manner the identity of the person who placed the order if the signature on the order is not known to the producer.
Marginal note:Shipping
132 In filling an order referred to in subsection 131(2), a licensed producer must not transfer physical possession of the dried marihuana to the person to whom it is sold or provided other than by shipping it to them.
Marginal note:Refusal
133 (1) A licensed producer must refuse to fill an order referred to in subsection 131(1) or (2) if
(a) the order does not meet the requirements of subsection 131(3); or
(b) in the circumstances described in subsection 131(4), the identity of the person cannot be verified.
Marginal note:Notice of refusal to fill order
(2) The licensed producer must send the person who placed the order a written notice of the reason for the refusal.
PART 6Record Keeping by Licensed Producers
Transactions
Marginal note:Cannabis received
134 Except in the case referred to in section 139, 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 whether dried marihuana or cannabis other than dried marihuana was received, as well as the following information:
(i) in the case of dried marihuana, the quantity and, if applicable, brand name, or
(ii) in the case of cannabis other than dried marihuana, the substance ordered, its quantity, description, intended use and, if applicable, brand name.
Marginal note:Imported marihuana
135 A licensed producer who imports marihuana must retain a copy of the declaration required by section 78 and of the export permit issued by a competent authority in the country of export.
Marginal note:Exported marihuana
136 A licensed producer who exports marihuana must retain a copy of the declaration required by section 86 and of the import permit issued by a competent authority in the country of final destination.
Marginal note:Record of verbal order
137 A licensed producer who receives a verbal order referred to in subsection 121(3) must record the following information:
(a) the date on which the order was made and the order number;
(b) the information referred to in paragraphs 121(2)(b) and (c); and
(c) the name of the individual recording the order.
Marginal note:Filling of order from client
138 (1) A licensed producer who fills an order referred to in section 121 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 dried marihuana sold or provided;
(d) the date on which the order was received;
(e) the date on which the dried marihuana was shipped; and
(f) the address to which the dried marihuana was shipped.
Marginal note:Retention of documents
(2) A licensed producer must retain a written order referred to in subsection 121(2) or a written record of a verbal order referred to in subsection 121(3).
Marginal note:Refusal to fill an order
(3) A licensed producer who refuses to fill an order referred to in section 121 must retain a copy of the written notice referred to in subsection 123(2).
Marginal note:Dried marihuana returned by client
139 A licensed producer who receives dried marihuana that is returned under section 127 must record the following information:
(a) the given name and surname of the individual who returned it;
(b) the address of the site at which it was received;
(c) its quantity and brand name; and
(d) the date on which it was received.
Marginal note:Order from person other than client
140 (1) A licensed producer who fills an order referred to in subsection 131(1) or (2) must record the following information:
(a) the name of the person to whom the cannabis or dried marihuana was sold or provided;
(b) the shipping address;
(c) an indication of whether dried marihuana or cannabis other than dried marihuana was ordered, as well as the following information:
(i) in the case of dried marihuana, its quantity and, if applicable, brand name, or
(ii) in the case of cannabis other than dried marihuana, the substance ordered, its quantity, description and, if applicable, brand name; and
(d) the date on which the cannabis or dried marihuana was shipped.
Marginal note:Refusal to fill an order
(2) A licensed producer who refuses to fill an order referred to in subsection 131(1) or (2) must retain a copy of the written notice referred to in subsection 133(2).
Client Registrations
Marginal note:Information
141 (1) A licensed producer must record the following information:
(a) details of the verifications performed under subsection 101(2), section 110 and paragraph 117(2)(b); and
(b) what will serve as the unique identifier referred to in paragraph 111(2)(b) and the manner in which and the date on which it was communicated to the client.
Marginal note:Documents
(2) A licensed producer must retain the following documents:
(a) a registration application referred to in section 108;
(b) a medical document referred to in section 108, or, if the document has been returned in accordance with subsection 114(3), a copy of it;
(c) a copy of a registration document referred to in paragraph 111(2)(a);
(d) an application for the amendment of a registration referred to in section 115;
(e) a copy of an amended registration document referred to in subsection 116(2); and
(f) a copy of a notice referred to in section 114 or subsection 117(5).
Security, Production and Inventory
Marginal note:Security
142 A licensed producer must keep
(a) the visual recordings referred to in sections 43 and 48;
(b) the records referred to in subsections 45(2) and 51(2); and
(c) the record referred to in subsection 46(3).
Marginal note:Good production practices and packaging, labelling and shipping
143 (1) A licensed producer must keep
(a) records demonstrating that each lot or batch of dried marihuana that they sold or provided under subsection 12(4) was produced, packaged and labelled in accordance with Divisions 4 and 5 of Part 1;
(b) a list of all brand names of dried marihuana that they produced, packaged or labelled;
(c) a copy of the sanitation program referred to in section 57 in use at their site;
(d) a copy of the standard operating procedures referred to in section 58 in use at their site;
(e) documentation concerning the control system referred to in section 59 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 60(1)(a)(ii); and
(g) records of every complaint referred to in paragraph 60(1)(b) and of any corrective action taken.
Marginal note:Sale or provision
(2) A licensed producer who sells or provides dried marihuana
(a) must keep records of any testing conducted by or on behalf of the licensed producer in respect of any lot or batch of the dried marihuana;
(b) must keep records of information necessary for the system of control referred to in section 59; and
(c) must keep a record of the information that the licensed producer is required by section 62 to provide to the Minister in respect of the recall of dried marihuana.
Marginal note:Propagated, sown, harvested, dried, packaged and destroyed marihuana
144 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 total number of new plants propagated in this manner;
(b) the date on which marihuana seeds are sown and their total net weight on that date;
(c) the date on which marihuana is harvested and its net weight on that date;
(d) the date on which the drying process for marihuana is completed and its net weight on that date;
(e) the date on which marihuana is packaged and its net weight on that date; and
(f) the date on which marihuana is destroyed and its net weight on that date, before the destruction.
Marginal note:Destroyed cannabis
145 (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 20(1)(b) and the basis on which they are qualified to be witnesses under subsection 20(2); and
(e) if applicable, the name of the person who accompanied the cannabis in accordance with subsection 20(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 20(1)(b) stating that they have witnessed the destruction and that the cannabis was destroyed in accordance with section 20.
Marginal note:Inventory
146 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;
(b) harvested marihuana in respect of which the drying process has not been completed, other than marihuana referred in paragraph (d) or (e);
(c) harvested marihuana in respect of which the drying process has been completed, other than marihuana referred in paragraph (d) or (e);
(d) marihuana that is destined for destruction;
(e) packaged marihuana; and
(f) cannabis other than marihuana, specifying the name and net weight of each of the substances in question.
Notices to Local Authorities
Marginal note:Notices
147 A licensed producer must keep a copy of
(a) each notice sent to local authorities under sections 38 to 40; and
(b) each notice sent to the Minister under section 40.
General Obligations
Marginal note:Manner of keeping records
148 (1) A licensed producer must ensure that the records, documents and information referred to in this Part
(a) are kept in a manner that will enable an audit of them to be made in a timely manner; and
(b) 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 written notice that the producer is required to send under these Regulations, for a period of two years after the day on which the notice is sent;
(b) in the case of information that the producer is required to record under sections 134 and 137, subsection 138(1), section 139, subsections 140(1) and 141(1) and sections 144 and 146, 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 135 and 136, for a period of two years after the day on which the declaration referred to in section 78 or 86, as applicable, is sent to the Minister;
(d) in the case of the documents referred to in subsection 138(2) and paragraphs 141(2)(a) to (e), 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 142, 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 143(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 dried marihuana under subsection 12(4);
(g) in the case of a document referred to in paragraph 143(1)(b), (c), (d) or (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 143(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 143(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 143(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 143(2)(c), for a period of two years after the day on which the dried marihuana was recalled; and
(l) in the case of the records and documents referred to in section 145, for a period of two years after the day on which the cannabis was destroyed.
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 63(1) and (2) for a period of 25 years after the day on which they were made.
Marginal note:Information required by Minister
149 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 Part, in the form and at the times that the Minister specifies.
Marginal note:Former licensed producers
150 If a licence to produce expires without being renewed or is revoked, the former licensed producer must comply with the requirements of paragraph 148(1)(a), subsections 148(2) and (3) and section 149.
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PART 7Consequential Amendments, Transitional Provisions, Repeal and Coming into Force
Consequential Amendments
Narcotic Control Regulations
200 [Amendments]
201 [Amendment]
202 [Amendments]
203 [Amendments]
204 [Amendment]
205 [Amendment]
206 [Amendments]
207 [Amendment]
208 [Amendment]
209 [Amendments]
210 [Amendments]
211 [Amendment]
212 [Amendments]
213 [Amendment]
214 [Amendments]
215 [Amendments]
216 [Amendment]
217 [Amendments]
218 [Amendments]
219 [Amendment]
220 [Amendments]
221 [Amendments]
222 [Amendments]
223 [Amendment]
224 [Amendment]
225 [Amendments]
226 [Amendment]
227 [Amendment]
228 [Amendment]
Marihuana Medical Access Regulations
229 [Amendment]
230 [Amendment]
231 [Amendment]
232 [Amendment]
233 [Amendment]
234 [Amendment]
235 [Amendment]
236 [Amendment]
237 [Amendment]
238 [Amendment]
239 [Amendment]
240 [Amendment]
241 [Amendment]
242 [Amendments]
243 [Amendment]
244 [Amendment]
245 [Amendment]
246 [Amendment]
247 [Amendment]
248 [Amendment]
249 [Amendment]
250 [Amendment]
New Classes of Practitioners Regulations
251 [Amendment]
252 [Amendment]
Transitional Provisions
Interpretation
Marginal note:Definitions
253 (1) For the purpose of sections 254 to 266, authorization to possess, designated-person production licence, medical practitioner and personal-use production licence have the same meaning as in subsection 1(1) of the Marihuana Medical Access Regulations.
Marginal note:Medical declaration
(2) For the purpose of sections 254 to 266, medical declaration means a medical declaration that is made by a medical practitioner in accordance with sections 6 and 8 of the Marihuana Medical Access Regulations.
Registration Based on an Authorization to Possess
Marginal note:Applicable period
254 Sections 255 and 256 apply until March 31, 2015.
Marginal note:Registration based on authorization to possess
255 (1) For the purpose of subsection 108(2), an individual applying to become a client of a licensed producer may include an authorization to possess with their application, instead of a medical document.
Marginal note:Ongoing validity of authorization to possess
(2) An authorization to possess that was valid immediately before the repeal of the Marihuana Medical Access Regulations remains valid solely for the purpose of being used as specified in subsection (1).
Marginal note:Modified application of Regulations
256 If, in accordance with section 255, a registration application under section 108 is made on the basis of an authorization to possess, the provisions of these Regulations, other than section 129, apply with the following modifications:
(a) a reference in sections 1 to 150 to a medical document is to be read as a reference to an authorization to possess, except in the case of
(i) the definition medical document in subsection 1(1),
(ii) paragraph 128(1)(b), and
(iii) a provision referred to in paragraph (b); and
(b) a provision that is referred to in column 1 of the table to this section is to be read as set out in column 2.
TABLE
| Item | Column 1 | Column 2 |
|---|---|---|
| Provision | Modified text | |
| 1 | paragraph 5(a) |
|
| 2 | subparagraph 67(a)(ii) |
|
| 3 | subparagraph 67(a)(iv) |
|
| 4 | paragraph 101(1)(b) |
|
| 5 | subparagraph 108(1)(f)(iii) |
|
| 6 | subsection 109(1) |
|
| 7 | section 110 |
|
| 8 | section 112 | 112 A client’s registration expires at the earlier of
|
| 9 | paragraphs 113(d) to (f) |
|
| 10 | paragraphs 117(1)(d) and (e) |
|
| 11 | subsection 124(1) |
|
Registration Based on a Medical Declaration
Marginal note:Applicable period
257 Sections 258 and 259 apply until March 31, 2014.
Marginal note:Registration based on medical declaration
258 For the purpose of subsection 108(2), an individual applying to become a client of a licensed producer may include a medical declaration with the application instead of a medical document.
Marginal note:Modified application of Regulations
259 If, in accordance with section 258, a registration application under section 108 is made on the basis of a medical declaration, the provisions of these Regulations, other than paragraph 110(a) and section 129, apply with the following modifications:
(a) a reference in sections 1 to 150 to a medical document is to be read as a reference to a medical declaration, except in the case of
(i) the definition medical document in subsection 1(1),
(ii) paragraph 128(1)(b), and
(iii) a provision referred to in paragraph (b); and
(b) a provision that is referred to in column 1 of the table to this section is to be read as set out in column 2.
TABLE
| Item | Column 1 | Column 2 |
|---|---|---|
| Provision | Modified text | |
| 1 | paragraph 5(a) |
|
| 2 | subparagraph 67(a)(ii) |
|
| 3 | section 112 |
|
| 4 | paragraphs 113(d) to (f) |
|
| 5 | subsection 124(1) |
|
Destruction and Notice Obligations — Marihuana Obtained or Produced Under the Marihuana Medical Access Regulations
Marginal note:Applicable period
259.1 Sections 259.2 and 259.3 apply until September 30, 2014.
- SOR/2014-51, s. 10
Marginal note:Obligation to destroy
259.2 (1) When an authorization to possess expires without being renewed or is revoked, the person who held the authorization must immediately destroy any marihuana that they are no longer authorized to possess as a result of the expiry or revocation.
Marginal note:Production licences
(2) When a personal-use production licence or a designated-person production licence expires without being renewed or is revoked, the person who held the licence must immediately
(a) discontinue production of marihuana that was authorized under the licence; and
(b) subject to subsection (3), destroy any marihuana that they are no longer authorized to possess as a result of the expiry or revocation.
Marginal note:Exception — designated-person production licence
(3) If a designated-person production licence expires without being renewed but the authorization to possess on the basis of which the licence was issued remains valid, the person who held the licence may, before destroying marihuana, immediately transport, transfer, give or deliver, directly to the holder of the authorization, not more than a quantity of dried marihuana that results in the holder of the authorization being in possession of the maximum quantity permitted under the authorization.
Marginal note:Exception — March 31, 2014
(4) Despite subsections (1) to (3), when an authorization to possess, a personal-use production licence or a designated-person production licence expires on March 31, 2014, the holder of the authorization or licence must, by the end of that day,
(a) destroy any marihuana that they are not authorized to possess or produce, as the case may be, under these Regulations; and
(b) in the case of a licence, discontinue production of marihuana that was authorized under the licence.
Marginal note:Application of subsection (4)
(5) For greater certainty, for the purposes of subsection (4), every authorization or licence that is valid on March 31, 2014 expires on that day.
- SOR/2014-51, s. 10
Marginal note:Obligation to send notice
259.3 (1) When an authorization to possess, a personal-use production licence or a designated-person production licence expires without being renewed or is revoked, the person who held the authorization or licence must send the Minister a notice, in writing, no later than 30 days after the day the authorization or licence expired or was revoked.
Marginal note:Content of notice
(2) The notice must include the following information:
(a) the person’s given name, surname and date of birth;
(b) in the case of an authorization to possess,
(i) the amount of dried marihuana, if any, that has been destroyed in accordance with subsection 259.2(1) or (4), and
(ii) the authorization number;
(c) in the case of a personal-use production licence, the amount of dried marihuana and the number of marihuana plants, if any, that have been destroyed in accordance with subsection 259.2(2) or (4); and
(d) in the case of a designated-person production licence,
(i) the amount of dried marihuana and the number of marihuana plants, if any, that have been destroyed in accordance with subsection 259.2(2) or (4), and
(ii) the given name and surname of the person who holds or held the authorization to possess on the basis of which the licence was issued.
Marginal note:Statement
(3) The notice must include a statement that
(a) in the case of an authorization to possess, other than the case described in paragraph (b), the person no longer possesses any dried marihuana that was obtained under the Marihuana Medical Access Regulations;
(b) in the case of an authorization to possess when the person remains the holder of a valid designated-person production licence, the person no longer possesses any dried marihuana that was obtained under the Marihuana Medical Access Regulations except dried marihuana that they are authorized to produce or possess under the licence;
(c) in the case of a personal-use production licence when the person remains the holder of a valid authorization to possess, the person
(i) has discontinued production of marihuana that was authorized under the licence, and
(ii) no longer possesses any dried marihuana or marihuana plants produced under the licence except dried marihuana that they are authorized to possess under the authorization; and
(d) in the case of any other personal-use production licence or a designated-person production licence, the person
(i) has discontinued production of marihuana that was authorized under the licence, and
(ii) no longer possesses any dried marihuana or marihuana plants produced under the licence.
Marginal note:Attestation
(4) The notice must be signed and dated by the person and must attest that it is correct and complete.
Marginal note:Application of this section
(5) For greater certainty, for the purposes of this section,
(a) every authorization or licence that is valid on March 31, 2014 expires on that day;
(b) a notice must be sent even if the person who held the authorization or licence has no marihuana that must be destroyed under section 259.2; and
(c) when a person is required to send a notice in relation to an authorization and one or more licences, or in relation to more than one licence, they may send a single notice that includes all of the required information and statements.
Marginal note:Non-compliance with this section
(6) If there is significant evidence of non-compliance with the obligations imposed by this section,
(a) the Minister is, for greater certainty, authorized to use his or her full authority under the Act to achieve compliance; and
(b) the Governor in Council is prepared to consider, on an urgent basis, on the recommendation of the Minister, amendments to these Regulations to deter such non-compliance.
- SOR/2014-51, s. 10
Sale or Provision of Marihuana to Licensed Producer
Marginal note:Applicable period
260 Sections 261 to 266 apply until March 31, 2014.
Sale or Provision by Holder of a Personal-use Production Licence
Marginal note:Authorized sale
261 The holder of a personal-use production licence may sell or provide marihuana plants or seeds to a licensed producer if the holder does so in accordance with a notice of authorization issued by the Minister under subsection 263(2).
Marginal note:Application for authorization
262 (1) The holder of a personal-use production licence who proposes to sell or provide marihuana plants or seeds to a licensed producer must submit to the Minister an application for authorization of the proposed sale or provision that contains the following information:
(a) in respect of the holder of the personal-use production licence:
(i) their name and date of birth,
(ii) the number of their licence,
(iii) the address of the place where they ordinarily reside, and
(iv) the address of the site where the production of marihuana is authorized;
(b) in respect of the licensed producer:
(i) their name,
(ii) the number of their licence,
(iii) the address of their site, and
(iv) the name of their senior person in charge; and
(c) a description of the marihuana plants or seeds that are to be sold or provided and their quantity.
Marginal note:Signature
(2) The application must be signed and dated by the holder of the personal-use production licence and by the licensed producer’s senior person in charge and include a statement by each of them indicating that all of the information submitted in support of the application is correct and complete to the best of that person’s knowledge.
Marginal note:Verification by Minister
263 (1) The Minister must, after examining the application and information required under section 262, verify if the following conditions are met:
(a) the personal-use production licence and the licensed producer’s licence are valid; and
(b) the number of marihuana plants to be sold or provided, if any, does not exceed the maximum number of plants specified in the personal-use production licence.
Marginal note:Notice of authorization
(2) If the conditions are met, the Minister must send to both parties a notice of authorization of the proposed sale or provision that
(a) specifies the names of the parties, the type of licence held by each party and the licence numbers;
(b) describes the marihuana plants or seeds that are to be sold or provided and their quantity;
(c) specifies that the notice is valid only for the sale or provision in respect of which it is issued;
(d) specifies that the notice is valid only if the licences referred to in paragraph (1)(a) are valid at the time of the sale or provision; and
(e) specifies that the sale or provision must be completed not later than 30 days after the date of the notice.
Marginal note:Notice of refusal
(3) If the conditions are not met, the Minister must send to each of the parties a notice of refusal of the proposed sale or provision that sets out the reasons for the refusal.
Marginal note:Opportunity to be heard
(4) The parties may, within 10 days after the receipt of a notice of refusal, provide the Minister with reasons why the refusal is unfounded.
- SOR/2014-51, s. 11(E)
Sale or Provision by Holder of a Designated-person Production Licence
Marginal note:Authorized sale
264 The holder of a designated-person production licence may sell or provide marihuana plants or seeds to a licensed producer if the holder does so in accordance with a notice of authorization issued by the Minister under subsection 266(2).
Marginal note:Application for authorization
265 (1) The holder of a designated-person production licence who proposes to sell or provide marihuana plants or seeds to a licensed producer must submit to the Minister an application for authorization of the proposed sale or provision that contains the following information:
(a) in respect of the holder of the designated-person production licence:
(i) their name and date of birth,
(ii) the number of their licence,
(iii) the address of the place where they ordinarily reside, and
(iv) the address of the site where the production of marihuana is authorized;
(b) in respect of the holder of the authorization to possess on the basis of which the designated-person production licence was issued:
(i) their name and date of birth,
(ii) the number of their authorization,
(iii) the address of the place where they ordinarily reside, and
(iv) an indication that they consent to the proposed sale or provision;
(c) in regard to the licensed producer:
(i) their name,
(ii) the number of their licence,
(iii) the address of their site, and
(iv) the name of their senior person in charge; and
(d) a description of the marihuana plants or seeds that are to be sold or provided and their quantity.
Marginal note:Signature
(2) The application must be signed and dated by the holder of the designated-person production licence, the holder of the authorization to possess and the licensed producer’s senior person in charge and include a statement by each of them indicating that all of the information submitted in support of the application is correct and complete to the best of that person’s knowledge.
Marginal note:Separate applications
(3) If a person is the holder of more than one designated-person production licence and proposes to sell or provide marihuana plants or seeds produced under each of those licences, a separate application must be submitted in respect of each licence.
Marginal note:Verification by Minister
266 (1) The Minister must, after examining the application and information required under section 265, verify if the following conditions are met:
(a) the designated-person production licence, the authorization to possess and the licensed producer’s licence are valid;
(b) the designated-person production licence was issued on the basis of the authorization to possess;
(c) the holder of the authorization to possess has signed the application; and
(d) the number of marihuana plants to be sold or provided, if any, does not exceed the maximum number of plants specified in the designated-person production licence.
Marginal note:Notice of authorization
(2) If the conditions are met, the Minister must send to the holder of the designated-person production licence, the holder of the authorization to possess and the licensed producer a notice of authorization of the proposed sale or provision that
(a) specifies the names of those persons, the type of licence or authorization held by each person and the numbers of the licences and the authorization;
(b) describes the marihuana plants or seeds that are to be sold or provided and their quantity;
(c) specifies that the notice is valid only for the sale or provision in respect of which it is issued;
(d) specifies that the notice is valid only if the licences referred to in paragraph (1)(a) are valid at the time of the sale or provision; and
(e) specifies that the sale or provision must be completed not later than 30 days after the date of the notice.
Marginal note:Notice of refusal
(3) If the conditions are not met, the Minister must send to each of the persons referred to in subsection (2) a notice of refusal of the proposed sale or provision that sets out the reasons for the refusal.
Marginal note:Opportunity to be heard
(4) The recipients of a notice of refusal may, within 10 days after the receipt of the notice, provide the Minister with reasons why the refusal is unfounded.
- SOR/2014-51, s. 12(E)
Repeal
267 [Repeal]
Coming into Force
Marginal note:Registration
268 (1) Subject to subsections (2) to (4), these Regulations come into force on the day on which they are registered.
Marginal note:October 1, 2013
(2) Section 244 comes into force on October 1, 2013.
Marginal note:March 31, 2014
(3) Subsections 203(2), 217(2), 221(3) and 222(3) and section 267 come into force on March 31, 2014.
Marginal note:March 31, 2015
(4) Subsections 221(4) and 222(4) come into force on March 31, 2015.
- Date modified: