Registration

SOR/2013-119 June 7, 2013

CONTROLLED DRUGS AND SUBSTANCES ACT

Marihuana for Medical Purposes Regulations

P.C. 2013-645 June 6, 2013

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 Act 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 Act , makes the annexed Marihuana for Medical Purposes Regulations.

TABLE OF CONTENTS

(This table is not part of the Regulations.)

MARIHUANA FOR MEDICAL PURPOSES REGULATIONS

INTERPRETATION

1. Definitions

2. Application of Narcotic Control Regulations

POSSESSION

3. Obtaining dried marihuana or cannabis

4. Obtaining cannabis — Narcotic Control Regulations

5. Possession limit

GENERAL PROVISIONS

6. Dried marihuana

7. Notice of refusal or revocation

8. Further information

9. Inspection of site

10. Police enforcement

11. Alteration of documents

PART 1



LICENSED PRODUCERS

DIVISION 1



PERMITTED ACTIVITIES AND GENERAL OBLIGATIONS

12. Activities

13. Dwelling-place

14. Indoor activities only

15. Indoor storage only

16. Identification of licensed producer

17. Responsible person in charge present

18. Safekeeping during transportation

19. Report of loss or theft

20. Destruction

DIVISION 2



LICENSING

21. Eligible persons

22. Senior person in charge and responsible person in charge

23. Application for licence

24. Security clearance required

25. Issuance of licence

26. Grounds for refusal

27. Period of validity

28. Application for renewal

29. Application for amendment

30. Notice to Minister — change of personnel

31. Notice to Minister — various changes

32. Statement by signatory of notice

33. Suspension

34. Revocation following suspension

35. Revocation — lost or stolen licence

36. Revocation — other grounds

37. Notice of cessation of activities

38. Notice to local authorities – licence application

39. Notice to local authorities — amendment application

40. Notice to local authorities — various matters

DIVISION 3



SECURITY MEASURES

General

41. Compliance with security measures

42. Unauthorized access

Perimeter of Site

43. Visual monitoring

44. Intrusion detection system

45. Monitoring by personnel

Areas Within a Site where Cannabis is Present

46. Restricted access

47. Physical barriers

48. Visual monitoring

49. Intrusion detection system

50. Filtration of air

51. Monitoring by personnel

DIVISION 4



GOOD PRODUCTION PRACTICES

52. Prohibition — sale or provision

53. Microbial and chemical contaminants

54. Pest control product

55. Premises

56. Equipment

57. Sanitation program

58. Standard operating procedures

59. Recall

60. Quality assurance

61. Sample of lot or batch

62. Recall reporting

63. Adverse reactions

DIVISION 5



PACKAGING, LABELLING AND SHIPPING

64. Packaging

65. Weight of dried marihuana

66. Product label

67. Client label

68. Combined label

69. Department of Health document

70. Presentation of information — label

71. Expiry date

72. Reference to Acts or regulations

73. Shipping

DIVISION 6



IMPORT AND EXPORT

74. Application for import permit

75. Issuance of import permit

76. Refusal to issue import permit

77. Provision of copy of import permit

78. Declaration after release from customs

79. Transportation of marihuana

80. Suspension of import permit

81. Revocation of import permit

82. Application for export permit

83. Issuance of export permit

84. Refusal to issue export permit

85. Provision of copy of export permit

86. Declaration after export

87. Suspension of export permit

88. Revocation of export permit

DIVISION 7



SECURITY CLEARANCES

89. Eligibility

90. Application for security clearance

91. Checks

92. Minister’s decisions

93. Outstanding criminal charge

94. Refusal to grant security clearance

95. Validity period

96. Security clearance no longer required

97. Suspension of security clearance

98. New applications

99. Sending of notices by Minister

100. False or misleading information

DIVISION 8



COMMUNICATION OF INFORMATION

101. Information concerning clients and responsible individuals

102. Information concerning health care practitioners

103. Information concerning licensed producers

104. Information concerning import or export permit

105. Providing information to foreign organizations

106. Security clearance — Minister

PART 2



CLIENT REGISTRATION AND ORDERING

REGISTRATION

107. Eligibility

108. Registration application

109. Health care practitioner’s consent to receive dried marihuana

110. Verification of medical document

111. Registration of client

112. Expiry of registration

113. Refusal to register

114. Notice — refusal to register

115. Application to amend registration

116. Amendment

117. Cancellation of registration

118. Prohibition — transfer of medical document

NEW MEDICAL DOCUMENT

119. New application

120. Applicable provisions

PROCESSING AN ORDER

121. Order required

122. Shipping

123. Refusal

124. Thirty-day limit

PART 3

CLIENTS AND OTHER AUTHORIZED USERS

125. Proof of authority to possess

126. Prohibition — obtaining from more than one source

127. Return

PART 4

HEALTH CARE PRACTITIONERS

128. Authorized activities

129. Medical document

130. Thirty-day limit

PART 5

SALE OR PROVISION BY A LICENSED PRODUCER TO A PERSON OTHER THAN A CLIENT

131. Order required — cannabis

132. Shipping

133. Refusal

PART 6



RECORD KEEPING BY LICENSED PRODUCERS

TRANSACTIONS

134. Cannabis received

135. Imported marihuana

136. Exported marihuana

137. Record of verbal order

138. Filling of order from client

139. Dried marihuana returned by client

140. Order from person other than client

CLIENT REGISTRATIONS

141. Information

SECURITY, PRODUCTION AND INVENTORY

142. Security

143. Good production practices and packaging, labelling and shipping

144. Propagated, sown, harvested, dried, packaged and destroyed marihuana

145. Destroyed cannabis

146. Inventory

NOTICES TO LOCAL AUTHORITIES

147. Notices

GENERAL OBLIGATIONS

148. Manner of keeping records

149. Information required by Minister

150. Former licensed producers

PART 7



CONSEQUENTIAL AMENDMENTS, TRANSITIONAL PROVISIONS, REPEAL AND COMING INTO FORCE

CONSEQUENTIAL AMENDMENTS

200–228. Narcotic Control Regulations

229–250. Marihuana Medical Access Regulations

251–252. New Classes of Practitioners Regulations

TRANSITIONAL PROVISIONS

Interpretation

253. Definitions

Registration Based on an Authorization to Possess

254. Applicable period

255. Registration based on authorization to possess

256. Modified application of Regulations

Registration Based on a Medical Declaration

257. Applicable period

258. Registration based on medical declaration

259. Modified application of Regulations

Sale or Provision of Marihuana to Licensed Producer

260. Applicable period

Sale or Provision by Holder of a Personal-use Production Licence

261. Authorized sale

262. Application for authorization

263. Verification by Minister

Sale or Provision by Holder of a Designated-person Production Licence

264. Authorized sale

265. Application for authorization

266. Verification by Minister

REPEAL

267. Repeal

COMING INTO FORCE

268. Registration

MARIHUANA FOR MEDICAL PURPOSES REGULATIONS

INTERPRETATION

Definitions

1. (1) The following definitions apply in these Regulations.

“Act”

« Loi »

“Act” means the Controlled Drugs and Substances Act.

“adult”

« adulte »

“adult” means a person who is 18 years of age or older.

“advertisement”

« annonce »

“advertisement” has the same meaning as in section 2 of the Narcotic Control Regulations.

“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.

“cannabis”

« chanvre indien »

“cannabis” means the substance set out in item 1 of Schedule II to the Act.

“client”

« client »

“client” means a person who is registered as a client with a licensed producer under section 111.

“competent authority”

« autorité compétente »

“competent authority” has the same meaning as in section 2 of the Narcotic Control Regulations.

“delta-9-tetrahydrocannabinol”

« delta-9-tétrahydrocannabinol »

“delta-9-tetrahydrocannabinol” means Δ 9 -tetrahydrocannabinol ((6aR, 10aR)-6a,7,8,10atetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo [b,d] pyran-1-ol).

-tetrahydrocannabinol ((6aR, 10aR)-6a,7,8,10atetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo [b,d] pyran-1-ol). “dried marihuana”

« marihuana séchée »

“dried marihuana” means harvested marihuana that has been subjected to any drying process.

“health care practitioner”

« praticien de la santé »

“health care practitioner” means a medical practitioner or a nurse practitioner.

“hospital”

« hôpital »

“hospital” has the same meaning as in section 2 of the Narcotic Control Regulations.

“immediate container”

« contenant immédiat »

“immediate container” means the container referred to in paragraph 64(a).

“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.

“licensed dealer”

« distributeur autorisé »

“licensed dealer” has the same meaning as in section 2 of the Narcotic Control Regulations.

“licensed producer”

« producteur autorisé »

“licensed producer” means the holder of a licence issued under section 25.

“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.

“marihuana”

« marihuana »

“marihuana” means the substance referred to as “Cannabis (marihuana)” in subitem 1(2) of Schedule II to the Act.

“medical document”

« document médical »

“medical document” means a medical document referred to in section 129.

“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.

“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.

“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.

“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).

“security clearance”

« habilitation de sécurité »

“security clearance” means a security clearance granted by the Minister under section 92.

“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.

“senior person in charge”

« responsable principal »

“senior person in charge” means the person designated under paragraph 22(1)(a).

“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.

“transfer”

« transférer »

“transfer” means, except in sections 118, 122 and 132, to transfer, whether directly or indirectly, without consideration.

Miscellaneous rules

(2) The rules set out in subsections (3) to (6) apply in these Regulations.

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.

Destruction

(4) Cannabis is destroyed when it is altered or denatured to such an extent that its consumption is rendered impossible or improbable.

Drying

(5) The production of marihuana includes subjecting it to a drying process.

Transfer

(6) For greater certainty, a reference to “provide” includes “transfer”.

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

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.

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.

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.

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.

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.

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.

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.

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.

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

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, except for any residue of a pest control product that is not in excess of the limit referred to in subsection 54(2).

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.

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.

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.

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.

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 1



LICENSED PRODUCERS

DIVISION 1



PERMITTED ACTIVITIES AND GENERAL OBLIGATIONS

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).

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.

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.

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).

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.

Import

(6) A licensed producer may import marihuana if they do so in accordance with an import permit issued under section 75.

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.

Dwelling place

13. A licensed producer must not conduct any activity referred to in section 12 at a dwelling place.

Indoor activities only

14. A licensed producer must produce, package or label marihuana only indoors and at the producer’s site.

Indoor storage only

15. (1) A licensed producer must store cannabis only indoors and at the producer’s site.

Storage of dried marihuana

(2) A licensed producer must store cannabis, other than marihuana plants, in accordance with the Security Directive.

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.

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.

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.

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.

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).

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.

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 2



LICENSING

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.

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.

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.

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.

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.

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.

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.



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.

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.

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.



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.

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.

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.

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.

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.



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).

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.

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.

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.



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.

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.

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).

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.

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.

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.



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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Senior official

(3) The notice must be addressed to a senior official of the local authority to whom it is sent.

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.

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.

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.

Senior official

(4) The notice must be addressed to a senior official of the local authority to whom it is sent.

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.

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.

Senior official

(3) The notice must be addressed to a senior official of the local authority to whom it is sent.

DIVISION 3



SECURITY MEASURES

General

Compliance with security measures

41. A licensed producer must ensure that the security measures set out in this Division are carried out.

Unauthorized access

42. The licensed producer’s site must be designed in a manner that prevents unauthorized access.

Perimeter of Site

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.

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.

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.

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.

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

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.

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.

Record

(3) A record must be made of the identity of every person entering or exiting those areas.

Physical barriers-

47. Those areas must include physical barriers that prevent unauthorized access.

Visual monitoring

48. (1) Those areas must be visually monitored at all times by visual recording devices to detect illicit conduct.

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.

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.

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.

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.

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 4



GOOD PRODUCTION PRACTICES

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.

Prohibition — export

(2) A licensed producer must not export dried marihuana unless the requirements of this Division have been met.

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.

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.

Pest control product

54. (1) Marihuana must not be treated — before, during or after the drying process — with a pest control product that has not been registered under the Pest Control Products Act for use on marihuana for medical purposes.

Residue

(2) Dried marihuana must not contain any residue of a pest control product in excess of any maximum residue limit specified for the product under section 9 of the Pest Control Products Act.

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.

Storage

(2) Dried marihuana must be stored under conditions that will maintain its quality.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

Definitions

(4) The following definitions apply in this section.

“adverse reaction”

« réaction indésirable »

“adverse reaction” means a noxious and unintended response to dried marihuana.

“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.

“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.

DIVISION 5



PACKAGING, LABELLING AND SHIPPING

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.

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).

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 the address of their site;

(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 corner 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.”.

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.

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.

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.

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.

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.

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.

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.

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.

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 6



IMPORT AND EXPORT

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.



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.

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.



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.

Validity

(3) A permit issued under this section is valid only for the importation in respect of which it is issued.

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.



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.

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.



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.

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.

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.

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.

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.

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 reexporting the marihuana.

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.

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.

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.

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.

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.

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.

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.



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.

Validity

(3) A permit issued under this section is valid only for the exportation in respect of which it is issued.

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.

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.

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.



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.

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.

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.

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.

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.

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.

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.

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 7



SECURITY CLEARANCES

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Written notice to holder

(2) Immediately after suspending a security clearance, the Minister must notify the holder in writing of the suspension.

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.

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.

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.

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.

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 da