Registration

SOR/2016-230 August 5, 2016

CONTROLLED DRUGS AND SUBSTANCES ACT

Access to Cannabis for Medical Purposes Regulations

P.C. 2016-743 August 5, 2016

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 Access to Cannabis for Medical Purposes Regulations.

TABLE OF PROVISIONS

Access to Cannabis for Medical Purposes Regulations

Interpretation

1 Definitions

2 Equivalency in dried marihuana

Possession

3 Obtaining substance

4 Altering substance

5 Obtaining cannabis — Narcotic Control Regulations



6 Possession limit

Health Care Practitioners

7 Authorized activities

8 Medical document

9 Thirty-day limit

General Provisions

10 Application of Narcotic Control Regulations

11 Further information

12 Police enforcement

13 Alteration of documents

14 Providing assistance in administration of substance

15 Demonstrate authority to possess or produce

16 Prohibition — obtaining from more than one source

PART 1

Commercial Production

Interpretation

17 Definitions

General Provisions

18 Marihuana

19 Cannabis oil

20 Notice of refusal or revocation

21 Inspection of site

DIVISION 1

Licensed Producers

SUBDIVISION A

Authorized Activities and General Obligations

22 Activities

23 Dwelling place

24 Activities — indoors and at site

25 Indoor storage only

26 Identification of licensed producer

27 Responsible person in charge present

28 Safekeeping during transportation

29 Report of loss or theft

30 Destruction

SUBDIVISION B

Licensing

31 Eligible persons

32 Senior person in charge and responsible person in charge

33 Application for licence

34 Security clearance required

35 Issuance of licence

36 Grounds for refusal

37 Period of validity

38 Renewal application

39 Amendment application

40 Notice to Minister — change of personnel

41 Notice to Minister — various changes

42 Statement by signatory of notice

43 Suspension

44 Revocation following suspension

45 Revocation — lost or stolen licence

46 Revocation — other grounds

47 Notice of cessation of activities

48 Notice to local authorities – licence application

49 Notice to local authorities — amendment application

50 Notice to local authorities — various matters

51 Notice to licensing authorities

SUBDIVISION C

Security Measures

General

52 Compliance with security measures

53 Unauthorized access

Perimeter of Site

54 Visual monitoring

55 Intrusion detection system

56 Monitoring by personnel

Areas Within a Site Where Cannabis is Present

57 Restricted access

58 Physical barriers

59 Visual monitoring

60 Intrusion detection system

61 Filtration of air

62 Monitoring by personnel

SUBDIVISION D

Good Production Practices

63 Prohibition — sale, provision or export

64 Microbial and chemical contaminants

65 Disintegration of capsule

66 Pest control product

67 Maximum yield quantity — cannabis oil

68 Solvents

69 Analytical testing

70 Premises

71 Equipment

72 Sanitation program

73 Standard operating procedures

74 Recall

75 Quality assurance

76 Sample of lot or batch

77 Recall reporting

78 Adverse reactions

SUBDIVISION E

Dried Marihuana Equivalency Factor

79 Equivalency factor

SUBDIVISION F

Packaging, Labelling and Shipping

80 Packaging

81 Accuracy of weight

82 Accuracy — number of seeds

83 Accuracy — number of plants

84 Product label — marihuana or cannabis oil

85 Product label – marihuana seeds

86 Product label – marihuana plants

87 Client label

88 Combined label

89 Department of Health document

90 Presentation of information — label

91 Expiry date

92 Reference to Acts or regulations

93 Shipping

SUBDIVISION G

Import and Export

94 Application for import permit

95 Issuance of import permit

96 Refusal to issue import permit

97 Provision of copy of import permit

98 Declaration after release from customs

99 Transportation of imported substance

100 Suspension of import permit

101 Revocation of import permit

102 Application for export permit

103 Issuance of export permit

104 Refusal to issue export permit

105 Provision of copy of export permit

106 Declaration after export

107 Suspension of export permit

108 Revocation of export permit

SUBDIVISION H

Security Clearances

109 Eligibility

110 Application for security clearance

111 Checks

112 Minister’s decision

113 Outstanding criminal charge

114 Refusal to grant security clearance

115 Validity period

116 Security clearance no longer required

117 Suspension of security clearance

118 New applications

119 Sending of notices by Minister

120 False or misleading information

SUBDIVISION I

Communication of Information

121 Information concerning clients

122 Definition of health care practitioner

123 Information concerning health care practitioners

124 Quarterly reports to licensing authorities

125 Information concerning licensed producers

126 Information concerning import or export permit

127 Providing information to foreign organizations

128 Security clearance — Minister

DIVISION 2

Client Registration and Ordering

Registration

129 Eligibility

130 Registration application

131 Health care practitioner’s consent to receive substance

132 Verification of medical document

133 Registration of client

134 Expiry of registration

135 Refusal to register

136 Notice — refusal to register

137 Application to amend registration

138 Amendment

139 Cancellation of registration

140 Prohibition — transfer of document

New Medical Document or Registration Certificate

141 New application – new medical document

142 Applicable provisions

Processing an Order

143 Order required

144 Shipping

145 Refusal

146 Thirty-day limit

147 Return of marihuana plants or seeds

DIVISION 3

Clients and Other Authorized Users

148 Return

DIVISION 4

Sale or Provision by a Licensed Producer to a Person Other than a Client

149 Order required — cannabis

150 Shipping

151 Refusal

DIVISION 5

Record Keeping by Licensed Producers

Transactions

152 Cannabis received

153 Imported substances

154 Exported substances

155 Record of verbal order

156 Filling of order from client

157 Returned substance

158 Order from person other than client

Client Registrations

159 Information

Security, Production and Inventory

160 Security

161 Good production practices and packaging, labelling and shipping

162 Dried marihuana equivalency factor

163 Lot or batch — marihuana

164 Research and development

165 Destroyed cannabis

166 Inventory — marihuana

Notices to Local Authorities

167 Notices

Communications with Licensing Authorities

168 Documents

General Obligations

169 Manner of keeping records

170 Information required by Minister

171 Former licensed producers

PART 2

Production for Own Medical Purposes and Production by a Designated Person

Interpretation

172 Definition

General Provision

173 Signature and attestation

DIVISION 1

Registration with Minister

174 Eligibility – registered person

175 Eligibility — one registration only

176 Eligibility — designated person

177 Registration application

178 Registration

179 Renewal application

180 Renewal

181 Amendment application

182 Amendment

183 Grounds for refusal — registration

184 Grounds for refusal — production for own medical purposes

185 Grounds for refusal — designated person

186 Notice of refusal

DIVISION 2

Production

Authorized Activities

187 Registered person — production for own medical purposes

188 Registered person who has a designated person

189 Designated person

General Provisions

190 Maximum number of plants under production

191 Maximum quantity of dried marihuana in storage

192 Maximum quantity of cannabis in storage

193 Location and type of production

194 Storage at specified site

195 Inspection

DIVISION 3

General Obligations

196 Security

197 Cancellation of registration

198 Notice of cancellation

199 Destruction of cannabis — registered person

200 Destruction of cannabis — designated person

201 Destruction of cannabis — change in production area

202 Communication of information – police

203 Communication of information — licensing authorities

PART 3

Transitional Provisions

254 Definition of Licensed Producers Exemption

255 Licences and permits continued

256 Decisions by Minister

257 Packaging and labelling — dried marihuana

258 Packaging and labelling — fresh marihuana or cannabis oil

259 Sale or provision of marihuana plants or seeds

260 Licence and permit applications

PART 4

Consequential Amendments, Repeal, Application and Coming into Force

Consequential Amendments

261 Narcotic Control Regulations

280 New Classes of Practitioners Regulations

Repeal

281

Application Before Publication

282 Application

Coming into Force

283 August 24, 2016

Access to Cannabis for Medical Purposes Regulations

Interpretation

Definitions

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

Act means the Controlled Drugs and Substances Act. (Loi)

adult means a person who is 18 years of age or older. (adulte)

cannabis means the substance set out in item 1 of Schedule II to the Act. (cannabis ou chanvre indien)

cannabis oil means an oil, in liquid form at room temperature of 22 ± 2°C, that contains cannabis in its natural form. (huile de chanvre indien)

designated person means the individual who is authorized by a registration referred to in section 178 to produce cannabis for the medical purposes of the registered person. (personne désignée)

dried marihuana means harvested marihuana that has been subjected to any drying process, but does not include seeds. (marihuana séchée)

former Marihuana for Medical Purposes Regulations means the regulations made by Order in Council P.C. 2013-645 of June 6, 2013 and registered as SOR/2013-119. (ancien Règlement sur la marihuana à des fins médicales)

former Marihuana Medical Access Regulations means the regulations made by Order in Council P.C. 2001-1146 of June 14, 2001 and registered as SOR/2001-227. (ancien Règlement sur l’accès à la marihuana à des fins médicales)

fresh marihuana means freshly harvested marihuana buds and leaves, but does not include plant material that can be used to propagate marihuana. (marihuana fraîche)

health care practitioner means, except in sections 123, 124 and 203, a medical practitioner or a nurse practitioner. (praticien de la santé)

licensed dealer has the same meaning as in section 2 of the Narcotic Control Regulations. (distributeur autorisé)

licensed producer means the holder of a licence issued under section 35. (producteur autorisé)

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

medical document means a medical document referred to in section 8. (document médical)

medical practitioner means a person who

(a) is registered and entitled under the laws of a province to practise medicine in that province; and

is registered and entitled under the laws of a province to practise medicine in that province; and (b) is not named in a notice issued under section 59 of the Narcotic Control Regulations that has not been retracted under section 60 of those Regulations. ( médecin )

nurse practitioner means a nurse practitioner as defined in 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

is permitted to prescribe dried marihuana in the province in which they practise; and (b) is not named in a notice issued under section 59 of the Narcotic Control Regulations that has not been retracted under section 60 of those Regulations. ( infirmier praticien )

registered person means an individual who is registered with the Minister under Part 2. (personne inscrite)

security clearance means a security clearance granted by the Minister under section 112. (habilitation de sécurité)

transfer means, except in sections 140, 144 and 150, to transfer, whether directly or indirectly, without consideration. (transférer)

Destruction

(2) Cannabis is considered to be destroyed when it is altered or denatured to such an extent that its consumption and propagation is rendered impossible or improbable.

Drying

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

Equivalency in dried marihuana

2 (1) The provisions of this section apply for determining, for the purposes of these Regulations, the quantity of cannabis other than dried marihuana that is equivalent to a given quantity of dried marihuana.

Substances obtained from a licensed producer and products

(2) The quantity of any fresh marihuana or cannabis oil that is obtained from a licensed producer — and the quantity of any products referred to in paragraphs 4(1)(b) and (c) originating from those substances — that is equivalent to a given quantity of dried marihuana must be calculated by

(a) taking into account the dried marihuana equivalency factor determined under section 79 that the licensed producer has indicated on the label of the fresh marihuana or cannabis oil; and

taking into account the dried marihuana equivalency factor determined under section 79 that the licensed producer has indicated on the label of the fresh marihuana or cannabis oil; and (b) in the case of products referred to in paragraphs 4(1)(b) and (c), taking into account the weight of the fresh or dried marihuana — or the volume of the cannabis oil — that was used to make them.

Marihuana produced under Part 2 and products

(3) The quantity of any marihuana that is produced under Part 2 — and the quantity of any products referred to in paragraphs 4(1)(b) and (c) originating from that marihuana — that is equivalent to a given quantity of dried marihuana must be calculated by:

(a) considering 5 g of fresh marihuana as equivalent to 1 g of dried marihuana; and

considering 5 g of fresh marihuana as equivalent to 1 g of dried marihuana; and (b) in the case of products referred to in paragraphs 4(1)(b) and (c), taking into account the weight of the fresh or dried marihuana that was used to make them.

Possession

Obtaining substance

3 (1) Subject to the other provisions of these Regulations, a person listed in subsection (2) may possess fresh or dried marihuana or cannabis oil and a person listed in subsection (3) may possess cannabis if the person has obtained it

(a) in accordance with these Regulations;

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;

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 that substance; or

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 that substance; or (d) in the case referred to in subparagraph (2)(a)(iii), under subsection 65(2.1) of the Narcotic Control Regulations.

Fresh or dried marihuana or cannabis oil

(2) The following persons may possess fresh or dried marihuana or cannabis oil:

(a) a person who has obtained the substance for their own medical purposes or for those of another individual for whom they are responsible (i) from a licensed producer, (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;

a person who has obtained the substance for their own medical purposes or for those of another individual for whom they are responsible (b) a person who requires the substance for the practice of their profession as a health care practitioner in the province in which they have that possession; or

a person who requires the substance 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 substance for the purposes of and in connection with their employment.

Cannabis

(3) The following persons may possess cannabis:

(a) a person who has obtained cannabis for their own medical purposes by producing it as a registered person;

a person who has obtained cannabis for their own medical purposes by producing it as a registered person; (b) a person who has obtained cannabis — for their own medical purposes or for those of another individual for whom they are responsible — from a designated person;

a person who has obtained cannabis — for their own medical purposes or for those of another individual for whom they are responsible — from a designated person; (c) a person who requires cannabis for their business as a licensed producer and who possesses it in accordance with section 22;

a person who requires cannabis for their business as a licensed producer and who possesses it in accordance with section 22; (d) a person who requires cannabis for their business as a licensed dealer;

a person who requires cannabis for their business as a licensed dealer; (e) 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 the government of a province and who possesses the cannabis for the purposes of and in connection with their employment; or

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 the government of a province and who possesses the cannabis for the purposes of and in connection with their employment; or (f) 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 (e) and who possesses the cannabis for the purpose of assisting that person in the administration or enforcement of any Act or its regulations.

Employee or agent or mandatary

(4) A person may possess fresh or dried marihuana or cannabis oil 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 or agent or mandatary

(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)(c) or (d), while acting in the course of their employment or their role as agent or mandatary.

Altering substance

4 (1) An individual who, in accordance with these Regulations or subsection 65(2.1) of the Narcotic Control Regulations, obtains fresh or dried marihuana or cannabis oil for their own medical purposes or for those of another individual for whom they are responsible, and an individual who, in accordance with these Regulations, produces marihuana for their own medical purposes or those of another person for whom they are the designated person, may alter the chemical or physical properties of

(a) the fresh or dried marihuana or cannabis oil;

the fresh or dried marihuana or cannabis oil; (b) a product resulting from an alteration of a substance referred to in paragraph (a); or

a product resulting from an alteration of a substance referred to in paragraph (a); or (c) a product that is derived from a product referred to in paragraph (b).

No organic solvents

(2) The individual must not use organic solvents when doing those alterations. For the purposes of this subsection, organic solvent means any organic compound that is highly flammable, explosive or toxic, including petroleum naphtha and compressed liquid hydrocarbons such as butane, isobutane, propane and propylene.

Providing substance

(3) An individual who is responsible for another individual may provide a product referred to in subsection (1) only to that individual.

Possession

(4) An individual may possess a product referred to in subsection (1) if they produced it in accordance with this section or obtained it in accordance with these Regulations.

Obtaining cannabis — Narcotic Control Regulations

5 (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 or 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

6 (1) An individual who possesses products referred to in paragraphs 4(1)(b) and (c), fresh or dried marihuana or cannabis oil — for their own medical purposes or for those of another individual for whom they are responsible — must not possess a total quantity of those products and substances that exceeds the equivalent of the least of the following amounts:

(a) in the case of substances obtained from a licensed producer or products originating from those substances, 30 times the daily quantity of dried marihuana referred to in paragraph 8(1)(d),

in the case of substances obtained from a licensed producer or products originating from those substances, 30 times the daily quantity of dried marihuana referred to in paragraph 8(1)(d), (b) in the case of marihuana produced in accordance with Part 2 or products originating from it, 30 times the daily quantity of dried marihuana referred to in paragraph 8(1)(d),

in the case of marihuana produced in accordance with Part 2 or products originating from it, 30 times the daily quantity of dried marihuana referred to in paragraph 8(1)(d), (c) in the case of substances obtained from a hospital by or for an out-patient or products originating from those substances, 30 times the daily quantity of dried marihuana referred to in subparagraph 65.2(c)(iii) of the Narcotic Control Regulations, and

in the case of substances obtained from a hospital by or for an out-patient or products originating from those substances, 30 times the daily quantity of dried marihuana referred to in subparagraph 65.2(c)(iii) of the Narcotic Control Regulations, and (d) 150 g of dried marihuana.

Dried marihuana equivalency factor

(2) For the purposes of paragraph (1)(c), the quantity of any products referred to in paragraphs 4(1)(b) and (c), fresh marihuana and cannabis oil must be calculated taking into account the dried marihuana equivalency factor determined under section 79 that the licensed producer has indicated on the label of the fresh marihuana or cannabis oil and, in the case of products described in those paragraphs, also taking into account the weight of the fresh or dried marihuana – or the volume of the cannabis oil – that was used to make them.

Health Care Practitioners

Authorized activities

7 (1) In addition to being authorized to possess fresh or dried marihuana or cannabis oil in accordance with section 3, a health care practitioner may conduct the following activities in regard to a person who is under their professional treatment:

(a) transfer or administer the substance; or

transfer or administer the substance; or (b) provide a medical document.

Transfer

(2) The health care practitioner may also transfer the substance to an individual who is responsible for the person under their professional treatment.

Medical document

8 (1) A medical document provided by a health care practitioner to a person who is under their professional treatment must indicate

(a) the practitioner’s given name, surname, profession, business address and telephone number, the province in which they are authorized to practise their profession and the number assigned by the province to that authorization and, if applicable, their facsimile number and email address;

the practitioner’s given name, surname, profession, business address and telephone number, the province in which they are authorized to practise their profession and the number assigned by the province to that authorization and, if applicable, their facsimile number and email address; (b) the person’s given name, surname and date of birth;

the person’s given name, surname and date of birth; (c) the address of the location at which the person consulted with the practitioner;

the address of the location at which the person consulted with the practitioner; (d) the daily quantity of dried marihuana, expressed in grams, that the practitioner authorizes for the person; and

the daily quantity of dried marihuana, expressed in grams, that the practitioner authorizes for the person; and (e) the period of use.

Period of use

(2) The period of use referred to in paragraph (1)(e)

(a) must be specified as a number of days, weeks or months, which must not exceed one year; and

must be specified as a number of days, weeks or months, which must not exceed one year; and (b) begins on the day on which the medical document is signed by the practitioner.

Validity of medical document

(3) A medical document is valid for the period of use specified in it.

Attestation

(4) The medical document must be signed and dated by the practitioner providing it and must attest that the information in the document is correct and complete.

Thirty-day limit

9 (1) A health care practitioner must not transfer to a person under their professional treatment or an individual who is responsible for that person (both of whom are referred to in this section as the transferee) in a 30-day period a total quantity of fresh marihuana, dried marihuana and cannabis oil that, taking into account the dried marihuana equivalency factor determined under section 79, exceeds the equivalent of 30 times the daily quantity of dried marihuana referred to in paragraph 8(1)(d) that the practitioner has indicated in the medical document on the basis of which the transfer is made.

Definition of 30-day period

(2) In this section, 30-day period means

(a) the 30-day period beginning on the day on which the practitioner first transfers a substance to the transferee; and

the 30-day period beginning on the day on which the practitioner first transfers a substance to the transferee; and (b) every 30-day period after the period referred to in paragraph (a).



First 30-day period

(3) For the purpose of applying subsection (2), the first 30-day period begins on the day on which the practitioner first transfers a substance to the transferee after the day on which that subsection comes into force, even if the practitioner previously transferred a substance to them.

Additional limit

(4) A health care practitioner must not, at any one time, transfer to the transferee a quantity of the substance that, taking into account the dried marihuana equivalency factor determined under section 79, exceeds the equivalent of 150 g of dried marihuana.

Exclusion

(5) A quantity of the substance that the health care practitioner transfers to the transferee to replace a quantity of the substance that the transferee has returned under section 148 is to be excluded for the purpose of calculating the total quantity referred to in subsection (1).

General Provisions

Application of Narcotic Control Regulations

10 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.

Further information

11 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.

Police enforcement

12 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

13 It is prohibited to mark, alter or deface a medical document or other document issued under these Regulations.

Providing assistance in administration of substance

14 (1) While in the presence of a person who has obtained fresh or dried marihuana or cannabis oil — or who has produced or obtained a product referred to in paragraph 4(1)(b) or (c) — for their own medical purposes, another person may, for the purpose of providing assistance in the administration of the substance to that person, possess that substance.

Possession limit

(2) The person providing assistance must not possess a total quantity of substances that exceeds the equivalent of

(a) in the case of fresh or dried marihuana or cannabis oil, the daily quantity of dried marihuana that the other person is authorized to possess, namely the quantity referred to in paragraph 8(1)(d) of these Regulations or subparagraph 65.2(c)(iii) of the Narcotic Control Regulations; or

in the case of fresh or dried marihuana or cannabis oil, the daily quantity of dried marihuana that the other person is authorized to possess, namely the quantity referred to in paragraph 8(1)(d) of these Regulations or subparagraph 65.2(c)(iii) of the Narcotic Control Regulations; or (b) in the case of a product referred to in paragraph 4(1)(b) or (c), 5 g of dried marihuana.

Demonstrate authority to possess or produce

15 An individual who, in accordance with these Regulations, possesses or produces fresh or dried marihuana, cannabis oil or marihuana plants or seeds or a product referred to in paragraph 4(1)(b) or (c) must, on demand, demonstrate to a police officer that the possession or production is authorized.

Prohibition — obtaining from more than one source

16 (1) It is prohibited to seek or obtain fresh or dried marihuana, cannabis oil or marihuana plants or seeds from more than one source at a time on the basis of the same medical document.

Exception

(2) However, a registration certificate issued by the Minister under Part 2 on the basis of a medical document may be used to

(a) obtain an interim supply of fresh or dried marihuana or cannabis oil from a single licensed producer; and

obtain an interim supply of fresh or dried marihuana or cannabis oil from a single licensed producer; and (b) obtain marihuana plants or seeds from one or more licensed producers.

PART 1

Commercial Production

Interpretation

Definitions

17 (1) The following definitions apply in this Part.

advertisement has the same meaning as in subsection 2(1) of the Narcotic Control Regulations. (annonce)

brand name means, with reference to cannabis, the name, in English or French,

(a) that is assigned to it;

that is assigned to it; (b) that is used to distinguish it; and

that is used to distinguish it; and (c) under which it is sold, provided or advertised. ( marque nominative )

client means a person who is registered as a client with a licensed producer under section 133. (client)

competent authority has the same meaning as in subsection 2(1) of the Narcotic Control Regulations. (autorité compétente)

delta-9-tetrahydrocannabinol means Δ9-tetrahydrocannabinol ((6aR, 10aR)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo [b,d] pyran-1-ol). (delta-9-tétrahydrocannabinol)

hospital has the same meaning as in subsection 2(1) of the Narcotic Control Regulations. (hôpital)

immediate container means the container referred to in section 80. (contenant immédiat)

international obligation means an obligation in respect of cannabis set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres. (obligation internationale)

pest control product has the same meaning as in subsection 2(1) of the Pest Control Products Act. (produit antiparasitaire)

responsible person in charge means, for the purposes of Division 1 of this Part, the person designated under paragraph 32(1)(b). (personne responsable)

Security Directive means the Directive on Physical Security Requirements for Controlled Substances (Security Requirements for Licensed Dealers for the Storage of Controlled Substances) published by the Department of Health, as amended from time to time. (Directive en matière de sécurité)

senior person in charge means the person designated under paragraph 32(1)(a). (responsable principal)

site means

(a) a building or a place in a building used by a licensed producer; or

a building or a place in a building used by a licensed producer; or (b) an area occupied exclusively by buildings used by a licensed producer. ( installation )

Producer’s site

(2) In this Part, a reference to the site of a licensed producer is a reference to the site specified in the producer’s licence.

General Provisions

Marihuana

18 (1) Marihuana must not be sold or provided under this Part

(a) with any additives; or

with any additives; or (b) in any dosage form, such as in a roll or capsule.



Definition of additive

(2) For the purposes of paragraph (1)(a), additive means anything other than marihuana but does not include any residue of a pest control product or its components or derivatives unless the amount of the residue exceeds any maximum residue limit specified for the product, component or derivative under section 9 or 10 of the Pest Control Products Act.

Cannabis oil

19 (1) Cannabis oil must not be sold or provided under this Part

(a) with any additives other than those that are necessary to maintain the product’s quality and stability; or

with any additives other than those that are necessary to maintain the product’s quality and stability; or (b) in any dosage form other than a capsule or similar dosage form.



Definition of additive

(2) For the purposes of paragraph (1)(a), additive does not include any residue of a pest control product or its components or derivatives unless the amount of the residue exceeds any maximum residue limit specified for the product, component or derivative under section 9 or 10 of the Pest Control Products Act.

Notice of refusal or revocation

20 If the Minister proposes to refuse to issue, amend or renew a licence or permit or proposes to revoke a licence or permit, other than in the case of a revocation under section 45 or subsection 47(4), 101(1) or 108(1), the Minister must

(a) send the applicant or the holder of the licence or permit a notice that sets out the reasons for the refusal or revocation; and

send the applicant or the holder of the licence or permit a notice 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.

Inspection of site

21 In order to confirm any information submitted in support of an application for a licence or an amendment or renewal of a licence, 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.

DIVISION 1

Licensed Producers

SUBDIVISION A

Authorized Activities and General Obligations

Activities

22 (1) Subject to subsections (2) to (8) and to the other provisions of these Regulations, a licensed producer may

(a) possess, produce, sell, provide, ship, deliver, transport and destroy marihuana or cannabis oil;

possess, produce, sell, provide, ship, deliver, transport and destroy marihuana or cannabis oil; (b) possess and produce cannabis in its natural form, other than marihuana or cannabis oil, for the purpose of producing cannabis oil, and sell, provide, ship, deliver, transport and destroy that cannabis if it was obtained or produced for that purpose; and

possess and produce cannabis in its natural form, other than marihuana or cannabis oil, for the purpose of producing cannabis oil, and sell, provide, ship, deliver, transport and destroy that cannabis if it was obtained or produced for that purpose; and (c) possess and produce cannabis, other than marihuana or cannabis oil, for the purpose of conducting in vitro testing that is necessary to determine the cannabinoid content of marihuana or cannabis oil, and sell, provide, ship, deliver, transport and destroy that cannabis if it was obtained or produced for that purpose.



Cannabis

(2) A licensed producer may sell or provide a substance referred to in subsection (3) to

(a) another licensed producer;

another licensed producer; (b) a licensed dealer;

a licensed dealer; (c) the Minister; or

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 cannabis oil;

marihuana and cannabis oil; (b) cannabis in its natural form, other than marihuana or cannabis oil, that was obtained or produced for the purpose of producing cannabis oil; and

cannabis in its natural form, other than marihuana or cannabis oil, that was obtained or produced for the purpose of producing cannabis oil; and (c) cannabis, other than marihuana or cannabis oil, that was obtained or produced for the purpose of conducting in vitro testing that is necessary to determine the cannabinoid content of marihuana or cannabis oil.



Fresh or dried marihuana or cannabis oil

(4) A licensed producer may

(a) sell or provide fresh or dried marihuana or cannabis oil 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 substance is for the purposes of and in connection with their employment, or (iii) a person to whom an exemption relating to the substance has been granted under section 56 of the Act; and

sell or provide fresh or dried marihuana or cannabis oil to (b) ship fresh or dried marihuana or cannabis oil to a health care practitioner in the case referred to in subparagraph 130(1)(f)(iii).



Registered person

(5) A licensed producer may sell or provide marihuana plants or seeds to a client who is registered with them on the basis of a registration with the Minister made under Part 2 or to an individual who is responsible for the client.

Activities limited

(6) A licensed producer may conduct an activity referred to in subsection (1), (2), (4) or (5) if the producer

(a) is licensed to conduct the activity; and

is licensed to conduct the activity; and (b) conducts the activity in accordance with their licence.



Import

(7) A licensed producer may import marihuana or a substance referred to in paragraph (3)(c) if they do so in accordance with an import permit issued under section 95.

Export

(8) A licensed producer may

(a) possess marihuana or a substance referred to in paragraph (3)(c) for the purpose of export; and

possess marihuana or a substance referred to in paragraph (3)(c) for the purpose of export; and (b) export it if they do so in accordance with an export permit issued under section 103.



Dwelling place

23 A licensed producer must not conduct any activity referred to in section 22 at a dwelling place.

Activities — indoors and at site

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

Indoor storage only

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

Security Directive

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

Identification of licensed producer

26 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

27 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

28 A licensed producer must take any steps that are necessary to ensure the safekeeping of

(a) cannabis, when shipping, delivering or transporting it; and

cannabis, when shipping, delivering or transporting it; and (b) marihuana, cannabis oil or a substance referred to in paragraph 22(3)(c), when transporting it to a port of exit from Canada and when transporting it between the port of entry into Canada and the producer’s site.

Report of loss or theft

29 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

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

30 (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

in accordance with a method that (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

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.

SUBDIVISION B

Licensing

Eligible persons

31 The following persons are eligible to apply for a producer’s licence:

(a) an adult who ordinarily resides in Canada; and

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

32 (1) A licensed producer must designate

(a) one senior person in charge to have overall responsibility for management of the activities conducted by the licensed producer under their licence at their site — who may, if appropriate, be the licensed producer; and

one senior person in charge to have overall responsibility for management of the activities conducted 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 by the licensed producer under their licence at that site 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

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

33 (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;

if the applicant is (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 where the proposed activities are to be conducted;

the address, telephone number and, if applicable, the facsimile number and email address for (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);

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;

the name, date of birth and gender of each of the following persons: (e) the name and gender of each of the persons authorized to place an order for cannabis on behalf of the applicant;

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 22(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;

the activities among those referred to in subsection 22(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;

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 Subdivision C;

a detailed description of the security measures at the proposed site, as determined in accordance with the Security Directive and Subdivision C; (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 Division 5, (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;

a detailed description of the method that the applicant proposes to use for keeping records, which must permit (j) if applicable, the maximum quantity (expressed as the net weight in kilograms) of fresh marihuana, dried marihuana, cannabis oil and the substance referred to in paragraph 22(3)(b) to be produced by the applicant under the licence and the production period;

if applicable, the maximum quantity (expressed as the net weight in kilograms) of fresh marihuana, dried marihuana, cannabis oil and the substance referred to in paragraph 22(3)(b) to be produced by the applicant under the licence and the production period; (k) if applicable, the maximum quantity (expressed as the net weight in kilograms) of fresh marihuana, dried marihuana, cannabis oil and marihuana seeds to be sold or provided by the applicant under the licence under subsections 22(2), (4) and (5) and the period in which that quantity is to be sold or provided; and

if applicable, the maximum quantity (expressed as the net weight in kilograms) of fresh marihuana, dried marihuana, cannabis oil and marihuana seeds to be sold or provided by the applicant under the licence under subsections 22(2), (4) and (5) and the period in which that quantity is to be sold or provided; and (l) if applicable, the maximum number of marihuana plants to be sold or provided by the applicant under the licence under subsections 22(2) and (5) and the period in which that quantity is to be sold or provided.

Dried marihuana equivalency factor

(2) In the case of an application for a licence to sell or provide fresh marihuana or cannabis oil under subsection 22(4), the applicant must provide the Minister, before commencing to sell or provide the substance, with the dried marihuana equivalency factor determined under section 79 and the method that they used to determine it.

Multiple sites

(3) If the applicant intends to conduct an activity referred to in subsection 22(1) at more than one site, a separate application must be submitted for each proposed site.

Statement by signatory

(4) An application for a producer’s licence must

(a) be signed and dated by the proposed senior person in charge; and

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.



include a statement signed and dated by that person indicating that

Accompanying documents

(5) 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;

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;

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 incorporating instrument;

if the applicant is a corporation, a copy of the certificate of incorporation or other incorporating 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;

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;

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;

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 48 and specifying the names, titles and addresses of the senior officials to whom they were addressed and the dates on which they were provided, together with a copy of each notice;

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 48 and specifying the names, titles and addresses of the senior 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 75 that includes (i) a description of the person’s qualifications in respect of the matters referred to in subparagraph 75(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 Subdivision D comply with the requirements of that Subdivision; and

a document signed and dated by the quality assurance person referred to in section 75 that includes (i) floor plans for the proposed site.

Security clearance required

34 The following persons must hold a security clearance:

(a) the senior person in charge;

the senior person in charge; (b) the responsible person in charge;

the responsible person in charge; (c) if applicable, the alternate responsible person in charge;

if applicable, the alternate responsible person in charge; (d) if a producer’s licence is issued to an individual, that individual; and

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

35 Subject to section 36, the Minister must, after examining the information and documents required under section 33 and, if applicable, section 11, and after all of the security clearances required by section 34 have been granted under section 112, issue to the applicant a producer’s licence that indicates

(a) the licence number;

the licence number; (b) the name of the licence holder;

the name of the licence holder; (c) the list of authorized activities;

the list of authorized activities; (d) the address of the site and, if applicable, of each building within the site where the licensed producer may conduct the authorized activities;

the address of the site and, if applicable, of each building within the site where the licensed producer may conduct the authorized activities; (e) in respect of each building, the authorized 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;

in respect of each building, the authorized 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 location within the site where cannabis, other than marihuana plants, is stored;

the security level, determined in accordance with the Security Directive, of each location within the site where cannabis, other than marihuana plants, is stored; (g) the effective date of the licence;

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;

the expiry date of the licence, which must not be later than three years after its effective date; (i) if applicable, the maximum quantity (expressed as the net weight in kilograms) of fresh marihuana, dried marihuana, cannabis oil and the substance referred to in paragraph 22(3)(b) that may be produced under the licence in a specified period;

if applicable, the maximum quantity (expressed as the net weight in kilograms) of fresh marihuana, dried marihuana, cannabis oil and the substance referred to in paragraph 22(3)(b) that may be produced under the licence in a specified period; (j) if applicable, the maximum quantity (expressed as the net weight in kilograms) of fresh marihuana, dried marihuana, cannabis oil and marihuana seeds that may be sold or provided under the licence in a specified period in accordance with subsections 22(2), (4) and (5);

if applicable, the maximum quantity (expressed as the net weight in kilograms) of fresh marihuana, dried marihuana, cannabis oil and marihuana seeds that may be sold or provided under the licence in a specified period in accordance with subsections 22(2), (4) and (5); (k) if applicable, the maximum number of marihuana plants that may be sold or provided under the licence in a specified period in accordance with subsections 22(2) and (5); and

if applicable, the maximum number of marihuana plants that may be sold or provided under the licence in a specified period in accordance with subsections 22(2) and (5); and (l) 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 Subdivision C, or (iv) reduce any potential public health, safety or security risk, including the risk of cannabis being diverted to an illicit market or use.



if applicable, any conditions that the licence holder must meet in order to

Grounds for refusal

36 (1) The Minister must refuse to issue, renew or amend a producer’s licence in the following circumstances:

(a) the applicant is not eligible under section 31;

the applicant is not eligible under section 31; (b) the requirements of section 48 or 49 have not been met;

the requirements of section 48 or 49 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 21;

an inspector, who has requested an inspection, has not been given the opportunity by the applicant to conduct an inspection under section 21; (d) the Minister has reasonable grounds to believe that false or misleading information was submitted in, or false or falsified documents were submitted with, the application;

the Minister has reasonable grounds to believe that false or misleading information was submitted in, or false or falsified documents were submitted 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;

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 Subdivision C in respect of an activity for which the licence is sought;

the applicant does not have in place the security measures set out in the Security Directive and Subdivision C 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;

the applicant is in contravention of or has contravened in the past 10 years (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;

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;

any of the following persons does not hold a security clearance: (j) the proposed method of record keeping does not meet the requirements of paragraph 33(1)(i); or

the proposed method of record keeping does not meet the requirements of paragraph 33(1)(i); or (k) if applicable, the information required under section 11 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

37 A producer’s licence is valid until the earlier of

(a) the expiry date of the licence, and

the expiry date of the licence, and (b) the date on which the licence is revoked under any of sections 44 to 47.



Renewal application

38 (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

the original of the licence; and (b) a declaration signed and dated by the senior person in charge stating 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) the information shown on the producer’s licence as specified in paragraphs 35(a) to (f ) and (i) to (l) is correct and complete, and (B) if applicable, the requirements of sections 40 and 41 have been met.

a declaration signed and dated by the senior person in charge stating that as of the date of the application

Renewal

(2) Subject to section 36, the Minister must, after examining the information and documents required under subsection (1) and, if applicable, section 11, issue a renewed licence that contains the information set out in paragraphs 35(a) to (l).

Simultaneous processing of applications

(3) If a licensed producer submits an application under section 39 or paragraph 40(1)(a) together with an application under subsection (1), the Minister may process them together.

Amendment application

39 (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 33 that are relevant to the proposed amendment;

an application in writing describing the proposed amendment, as well as any information or documents mentioned in section 33 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 49 and specifying the names, titles and addresses of the senior officials to whom they were addressed and the dates on which they were provided, together with a copy of each notice; and

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 49 and specifying the names, titles and addresses of the senior 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

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.

include a statement signed and dated by that person indicating that

Issuance

(3) Subject to section 36, the Minister must, after examining the information and documents required under this section and, if applicable, section 11, amend the licence accordingly and may add any conditions that the licence holder must meet in order to

(a) comply with an international obligation;

comply with an international obligation; (b) provide the security level referred to in paragraph 35(f) or the new level applicable as a result of the amendment of the licence;

provide the security level referred to in paragraph 35(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 Subdivision C; or

put in place the security measures referred to in Subdivision C; 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

40 (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 33(1)(a)(ii), or (iv) an individual authorized to place an order for cannabis on behalf of the licensed producer;

apply for and obtain the Minister’s approval before making a change involving the replacement or the addition of (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) and (iv) ceases to carry out their duties; and

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) and (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 33(1)(d), and (ii) the declaration specified in paragraph 33(5)(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, (b) in the case of the replacement or addition of an officer or director, the information specified in subparagraph 33(1)(a)(ii) concerning that person; and

in the case of the replacement or addition of an officer or director, the information specified in subparagraph 33(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 33(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

41 (1) A licensed producer must, within five days after the change, notify the Minister of any change to

(a) the method used for keeping records;

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 where the activities are conducted under the licence; or

the telephone number and, if applicable, the facsimile number and email address for (c) the security of their site, other than a change that affects the security level of any location within the site where cannabis, other than marihuana plants, is stored.



Dried marihuana equivalency factor

(2) A licensed producer must provide the Minister with any new dried marihuana equivalency factor determined under section 79, and the method used to determine it, at least 10 days before selling or providing, under subsection 22(4), fresh marihuana or cannabis oil in respect of which the label referred to in section 84 or 88 indicates the new factor.

Statement by signatory of notice

42 An application or notification made under section 40 or 41, respectively, must

(a) be signed and dated by the senior person in charge; and

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.

include a statement signed and dated by that person indicating that

Suspension

43 (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

the failure that gave rise to the suspension has been rectified; or (b) the suspension was unfounded.

Revocation following suspension

44 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 43 or if the failure that gave rise to the suspension is not rectified.

Revocation — lost or stolen licence

45 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

46 (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 submitted in, or false or falsified documents submitted with, the application;

the Minister has reasonable grounds to believe that the licence was issued on the basis of false or misleading information submitted in, or false or falsified documents submitted 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 this Part;

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 this Part; (c) the licensed producer is no longer eligible under section 31;

the licensed producer is no longer eligible under section 31; (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

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 34 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

47 (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;

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;

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 (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

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 whom 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 cease 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

48 (1) Before submitting an application for a producer’s licence to the Minister under section 33, the applicant must provide a written notice to the following authorities in the area in which the site referred to in paragraph 33(1)(b) is located:

(a) the local government;

the local government; (b) the local fire authority; and

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;

the name of the applicant; (b) the date on which the applicant will submit the application to the Minister;

the date on which the applicant will submit the application to the Minister; (c) the activities referred to in subsection 22(1) for which the licence is to be sought, specifying that they are to be conducted in respect of cannabis; and

the activities referred to in subsection 22(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 where 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 provided.

Definition — local government

(4) In this section, local government includes

(a) an incorporated or unincorporated city, metropolitan area, town, village or municipality;

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

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.



Notice to local authorities — amendment application

49 (1) Before submitting a licence amendment application to the Minister under section 39 concerning a change referred to in subsection (2), a licensed producer must provide a written notice to the authorities referred to in paragraphs 48(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;

the name of the licensed producer; (b) the activities to be conducted by the producer under the licence; or

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 where 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;

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;

the date on which the producer will submit the application to the Minister; (c) the activities referred to in subsection 22(1) that are to be set out in the amended licence, specifying that they are to be conducted in respect of cannabis; and

the activities referred to in subsection 22(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 provided.

Notice to local authorities — various matters

50 (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 local authorities referred to in paragraphs 48(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

the name of the licensed producer and the address of their site; and (b) a description of the applicable event 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 provided.

Notice to licensing authorities

51 (1) Within 30 days after the issuance of its licence, a licensed producer must provide a written notice to each licensing authority that is responsible for the registration or authorization of persons to practise medicine or nursing in each province 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, the mailing address of their site and, if applicable, their email address; and

the name of the licensed producer, the mailing address of their site and, if applicable, their email address; and (b) the effective date of the licence.

SUBDIVISION C

Security Measures

General

Compliance with security measures

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

Unauthorized access

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

Perimeter of Site

Visual monitoring

54 (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 making a visible recording of any attempted or actual unauthorized access.

Intrusion detection system

55 The perimeter of the licensed producer’s site must be secured by means of 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

56 (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 54 or 55.

Record of detected occurrences

(2) If any such occurrence is detected, the personnel must make a record of

(a) the date and time of the occurrence; and

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

57 (1) Access to areas within a site where cannabis is present (referred to in this section and sections 58 to 61 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

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

Visual monitoring

59 (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 making a visible recording of illicit conduct.

Intrusion detection system

60 Those areas must be secured by means of 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

61 Those areas must be equipped with a system that filters air to prevent the escape of odours and, if present, pollen.

Monitoring by personnel

62 (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 59 or 60.

Record of detected occurrences

(2) If any such occurrence is detected, the personnel must make a record of

(a) the date and time of the occurrence; and

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.



SUBDIVISION D

Good Production Practices

Prohibition — sale, provision or export

63 (1) A licensed producer must not sell or provide fresh or dried marihuana, cannabis oil or marihuana plants or seeds under subsection 22(4) or (5) or export them, if applicable, unless the applicable requirements of this Subdivision have been met.

Research and development activity

(2) A licensed producer must not sell or provide those substances under subsection 22(4) or (5) if they have been used in research and development activity.

Microbial and chemical contaminants

64 The microbial and chemical contaminants of fresh or dried marihuana or cannabis oil 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.

Disintegration of capsule

65 A capsule or similar dosage form of cannabis oil that is intended to be swallowed whole or used as a suppository must meet the requirements of a disintegration test that is applicable to the formulation of the capsule or similar dosage form and that is set out in any publication referred to in Schedule B to the Food and Drugs Act.

Pest control product

66 Fresh or dried marihuana or marihuana plants or seeds must not be treated with a pest control product unless the product is registered for use on marihuana under the Pest Control Products Act or is otherwise authorized for use under that Act.

Maximum yield quantity — cannabis oil



67 (1) Cannabis oil must not exceed a maximum yield quantity of 30 mg of delta-9-tetrahydrocannabinol per millilitre of the oil in the immediate container, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol.

Capsule or other dosage form

(2) If cannabis oil is in a capsule or similar dosage form, each capsule or unit of the dosage form must not exceed a maximum yield quantity of 10 mg of delta-9-tetrahydrocannabinol, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol.

Solvents

68 (1) Cannabis oil must not contain residues of solvents other than Class 3 solvents listed in the Guidance Document — Impurities: Guideline for Residual Solvents, ICH Topic Q3C(R5), published by the Department of Health, as amended from time to time.

Residue limit

(2) Those residues must not exceed the limits established under that document.

Non-application of section 64

(3) Section 64 does not apply with respect to those residues.

Analytical testing

69 Analytical testing for the following must be conducted using validated methods:

(a) the contaminants referred to in section 64;

the contaminants referred to in section 64; (b) the disintegration referred to in section 65;

the disintegration referred to in section 65; (c) the residues of solvents referred to in section 68; and

the residues of solvents referred to in section 68; and (d) the content of delta-9-tetrahydrocannabinol, delta-9-tetrahydrocannabinolic acid, cannabidiol and cannabidiolic acid.

Premises

70 (1) Fresh or dried marihuana, cannabis oil or marihuana plants or seeds 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;

permits the premises to be kept clean and orderly; (b) permits the effective cleaning of all surfaces in the premises;

permits the effective cleaning of all surfaces in the premises; (c) permits the substance to be stored or processed appropriately;

permits the substance to be stored or processed appropriately; (d) prevents the contamination of the substance; and

prevents the contamination of the substance; and (e) prevents the addition of an extraneous substance to the substance.



Storage

(2) Those substances must be stored under conditions that will maintain their quality.

Equipment

71 Fresh or dried marihuana, cannabis oil or marihuana plants or seeds 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;

permits the effective cleaning of its surfaces; (b) permits it to function in accordance with its intended use;

permits it to function in accordance with its intended use; (c) prevents the contamination of the substance; and

prevents the contamination of the substance; and (d) prevents the addition of an extraneous substance to the substance.

Sanitation program

72 Fresh or dried marihuana, cannabis oil or marihuana plants or seeds 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;

procedures for effectively cleaning the premises in which those activities are conducted; (b) procedures for effectively cleaning the equipment used in those activities;

procedures for effectively cleaning the equipment used in those activities; (c) procedures for handling any substance used in those activities; and

procedures for handling any substance used in those activities; and (d) all requirements, in respect of the health, hygienic behaviour and 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

73 Fresh or dried marihuana, cannabis oil or marihuana plants or seeds 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 Subdivision.

Recall

74 A licensed producer must establish and maintain a system of control that permits the rapid and complete recall of every lot or batch of fresh or dried marihuana, cannabis oil or marihuana plants or seeds that has been made available for sale.

Quality assurance

75 (1) A licensed producer must

(a) have a quality assurance person who (i) is responsible for assuring the quality of the fresh or dried marihuana, cannabis oil or marihuana plants or seeds before they are made available for sale, and (ii) has the training, experience and technical knowledge relating to the activity conducted and the requirements of this Subdivision; and

have a quality assurance person who (b) investigate every complaint received in respect of the quality of those substances and, if necessary, take corrective and preventative measures.



Methods and procedures

(2) Those substances 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 those substances must be approved by a quality assurance person before it is made available for sale.

Returns

(4) Any of those substances that is sold or provided under subsection 22(4) or (5) and subsequently returned to the licensed producer must not be resold or provided again.

Sample of lot or batch

76 (1) Subject to subsection (3), if the Minister has reasonable grounds to believe that a lot or batch of fresh or dried marihuana, cannabis oil or marihuana plants or seeds made available for sale or provision by a licensed producer may — by reason of the manner in which the substance was produced, packaged, labelled or stored — pose a risk to the health of a person who obtains the substance 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 meets the requirements of sections 64 and 66 and, if applicable, sections 65, 67 and 68.

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.

Recall reporting

77 Before commencing a recall of fresh or dried marihuana, cannabis oil or marihuana plants or seeds, a licensed producer must provide the Minister with the following information in respect of the substance to be recalled:

(a) its brand name;

its brand name; (b) the number of each lot or batch to be recalled;

the number of each lot or batch to be recalled; (c) if known by the licensed producer, the name and address of each licensed producer who imported or produced any of it;

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;

the reasons for commencing the recall; (e) the quantity that was produced or imported into Canada by the licensed producer;

the quantity that was produced or imported into Canada by the licensed producer; (f) the quantity that was sold or provided in Canada by the licensed producer;

the quantity that was sold or provided in Canada by the licensed producer; (g) the quantity remaining in the possession of the licensed producer;

the quantity remaining in the possession of the licensed producer; (h) the number of persons referred to in subsections 22(2), (4) and (5) to whom it was sold or provided by the licensed producer; and

the number of persons referred to in subsections 22(2), (4) and (5) 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

78 (1) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil must provide the Minister with a case report for each serious adverse reaction to the substance, 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 fresh or dried marihuana or cannabis oil must prepare annually and maintain a summary report that contains a concise and critical analysis of all adverse reactions to the substance 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 fresh or dried marihuana or cannabis oil, the Minister has reasonable grounds to believe that it may — by reason of the manner in which it was produced, packaged, labelled or stored — pose a risk to the health of a person who in accordance with these Regulations obtains it 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

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 substance 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 means a noxious and unintended response to fresh or dried marihuana or cannabis oil. (réaction indésirable)

case report means a detailed record of all relevant data associated with the use of fresh or dried marihuana or cannabis oil by a person. (fiche d’observation)

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

SUBDIVISION E

Dried Marihuana Equivalency Factor

Equivalency factor

79 (1) A licensed producer who sells or provides fresh marihuana or cannabis oil under subsection 22(4) must determine the quantity of the marihuana or oil that is equivalent to one gram of dried marihuana.

Information

(2) The information about the dried marihuana equivalency factor must be made available on the licensed producer’s website and be provided on 