Guidance Document: Inspection Guide for Licensed Dealers of Controlled Substances (CS-GD-016)

Narcotic

NCR 70(c)
NCR 70 It is prohibited to
(c) publish any written advertisement respecting a narcotic unless that advertisement displays the symbol “N” in a clear and conspicuous colour and size in the upper left quarter of its first page.

Identification
24 A licensed dealer must include their name, as set out in their dealer’s licence, on all the means by which they identify themself in regard to their activities in relation to narcotics, including labels, orders, shipping documents, invoices and advertising.

Controlled Drugs

FDR Part G, G.06.004(b)
G.06.004 lt is prohibited to
(b) publish any written advertisement respecting a controlled drug unless that advertisement displays the following symbol in a clear and conspicuous colour and size in the upper left quarter of its first page:

Identification
FDR Part G, G.02.050
G.02.050 A licensed dealer must include their name, as set out in their dealer’s licence, on all the means by which they identify themself in regard to their activities in relation to controlled drugs, including labels, orders, shipping documents, invoices and advertising

Restricted Drugs

FDR Part J, J.01 .063
J.01.063 (1) A licensed dealer that sells or provides a restricted drug must ensure that its package is labelled so that its inner and outer labels show
(a) the proper name or, if there is no proper name, the name of the drug;
(b) the net contents of the package;
(c) the unit strength of the drug and the number of units per package, if applicable;
(d) the lot number of the drug;
(e) the expression "Restricted Drug"; and
(f) the name and municipal address of the manufacturer or assembler of the drug.

Identification
J.01.058 A licensed dealer must include their name, as set out in their dealer’s licence, on all the means by which they identify themself in regard to their activities in relation to restricted drugs, including labels, orders, shipping documents, invoices and advertising.

Benzodiazepines and Other Targeted Substances

BOTSR 78(b)
78 It is prohibited to
(b) publish any written advertisement respecting a targeted substance unless the advertisement
(i) is published in literature distributed to, or in a trade publication for, licensed dealers, pharmacists, practitioners or hospitals, and
(ii) displays the following symbol in a clear and conspicuous colour and size in the upper left quarter of its first page:

Identification

BOTSR 31
A licensed dealer must include their name, as set out in their dealer’s licence, on all the means by which they identify themself in regard to their activities in relation to targeted substances, including labels, orders, shipping documents, invoices and advertising.

Narcotic

NCR 70
70 It is prohibited to
(a) advertise a narcotic to the general public;

Controlled Drug

FDR Part G, G. 06.004
G.06.004 lt is prohibited to
(a) advertise a controlled drug to the general public;

Benzodiazepines and Other Targeted Substances

BOTSR 78(a)
78 It is prohibited to
(a) advertise a targeted substance to the general public;

Narcotics

Packaging - sale and provision
NCR 26 (1)
(1)A licensed dealer that sells or provides a narcotic, other than a preparation described in section 36, must securely package it in its immediate container, which must be sealed in such a manner that the container cannot be opened without breaking the seal.

Exception
(3) Subsection (1) does not apply to a test kit that contains a narcotic and that has a registration number.

Controlled Drugs

Packaging - sale and provision
G.02.060 (1) A licensed dealer that sells or provides a controlled drug must securely package it in its immediate container, which must be sealed in such a manner that the container cannot be opened without breaking the seal.

Exception
(3) Subsection (1) does not apply to a test kit that contains a controlled drug and that has a registration number.

Restricted Drugs

Packaging - sale and provision
J.01.062 (1) A licensed dealer that sells or provides a restricted drug must securely package it in its immediate container, which must be sealed in such a manner that the container cannot be opened without breaking the seal.

Exception
(3) Subsection (1) does not apply to a test kit that contains a restricted drug and that has a registration number.

Benzodiazepines and Other Targeted Substances

Packaging - sale and provision
34 (1) A licensed dealer that sells or provides a targeted substance must securely package it in its immediate container, which must be sealed in such a manner that the container cannot be opened without breaking the seal.

Exception
(3) Subsection (1) does not apply to a test kit that contains a targeted substance and that has a registration number.

Narcotics

NCR 13(1)(a)
(1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:
(a) a change affecting the security measures in place at the site specified in the dealer’s licence;

Controlled Drugs

FDR Part G, G.02.018(1)(a)
G.02.018(1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written request to the Minister:
(a) a change affecting the security measures at the site specified in the dealer’s licence;

Restricted Drugs

FDR Part J, J.01.026 (1)(a)
J.01.026 (1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:
(a) a change affecting the security measures in place at the site specified in the dealer’s licence;

 Benzodiazepines and Other Targeted Substances

BOTSR 20 (1)
(1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:
(a) a change affecting the security measures in place at the site specified in the dealer’s licence;

Narcotics

Protective measures
NCR 27 A licensed dealer must take any measures that are necessary to ensure the security of any narcotic in their possession and any licence or permit in their possession.

Theft or loss - licences and permits
NCR 27.1 A licensed dealer that becomes aware of a theft or loss of their licence or permit must provide a written report to the Minister within 72 hours after becoming aware of it.

Theft or unexplainable loss – narcotics
NCR 27.2 A licensed dealer that becomes aware of a theft of a narcotic or of a loss of a narcotic that cannot be explained on the basis of normally accepted business activities must
(a) provide a written report to a member of a police force within 24 hours after becoming aware of the theft or loss; and
(b) provide a written report to the Minister within 72 hours after becoming aware of the theft or loss and include a confirmation that the report required under paragraph (a) has been provided.

Explainable loss of narcotic
NCR 28.3 A licensed dealer that becomes aware of a loss of a narcotic that can be explained on the basis of normally accepted business activities must record the following information:
(a) the name of the lost narcotic and, if applicable, the brand name of the product or the name of the compound containing it;
(b) the form and quantity of the narcotic and, if applicable, the form of the product or compound containing it, the strength per unit of the narcotic in the product or compound, the number of units per package and the number of packages;
(c) the date on which the dealer became aware of the loss; and
(d) the explanation for the loss.

Controlled Drugs

Protective measures
FDR G.02.062 A licensed dealer must take any measures that are necessary to ensure the security of any controlled drug in their possession and any licence or permit in their possession.

Theft or loss - licence and permit
FDR G.02.063 A licensed dealer that becomes aware of a theft or loss of their licence or permit must provide a written report to the Minister within 72 hours after becoming aware of it.

Theft or unexplainable loss - controlled drug
FDR G.02.064 A licensed dealer that becomes aware of a theft of a controlled drug or of a loss of a controlled drug that cannot be explained on the basis of normally accepted business activities must
(a) provide a written report to a member of a police force within 24 hours after becoming aware of the theft or loss; and
(b) provide a written report to the Minister within 72 hours after becoming aware of the theft or loss and include a confirmation that the report required under paragraph (a) has been provided.

Explainable loss of controlled drug
FDR G.02.074 A licensed dealer that becomes aware of a loss of a controlled drug that can be explained on the basis of normally accepted business activities must record the following information:
(a) the name of the lost controlled drug and, if applicable, the brand name of the product or the name of the compound containing it;
(b) the form and quantity of the controlled drug and, if applicable, the form of the product or compound containing it, the strength per unit of the controlled drug in the product or compound, the number of units per package and the number of packages;
(c) the date on which the dealer became aware of the loss; and
(d) the explanation for the loss.

Restricted Drugs

Protective measures - licences and permits
FDR J.01.065 A licensed dealer must take any measures that are necessary to ensure the security of any licence or permit in their possession.

Protective measures - restricted drugs
FDR J.01.066 The following persons must take any measures that are necessary to ensure the security of any restricted drugs in their possession:
(a) a licensed dealer;

Theft or loss - licences and permits
FDR J.01 .067 A licensed dealer that becomes aware of a theft or loss of their licence or permit must provide a written report to the Minister within 72 hours after becoming aware of it.

Theft or loss - restricted drugs
FDR J.01.068 (1) Subject to subsection (2), any person referred to in section J.01.066 who becomes aware of a theft or loss of a restricted drug must
(a) provide a written report to a member of a police force within 24 hours after becoming aware of the theft or loss; and
(b) provide a written report to the Minister within 72 hours after becoming aware of the theft or loss and include a confirmation that the report required under paragraph (a) has been provided.

Explainable loss - licensed dealer
(2) Subsection (1) does not apply to a licensed dealer that becomes aware of a loss of a restricted drug that can be explained on the basis of normally accepted business activities.

Explainable loss of restricted drug
FDR J.01.077 A licensed dealer that becomes aware of a loss of a restricted drug that can be explained on the basis of normally accepted business activities must record the following information:
(a) the name of the lost restricted drug and, if applicable, the brand name of the product or the name of the compound containing it;
(b) the form and quantity of the restricted drug and, if applicable, the form of the product or compound containing it, the strength per unit of the restricted drug in the product or compound, the number of units per package and the number of packages;
(c) the date on which the dealer became aware of the loss; and
(d) the explanation for the loss.

Benzodiazepines and Other Targeted Substances

Protective measures
BOTSR 35 A licensed dealer must take any measures that are necessary to ensure the security of any targeted substance in their possession and any licence or permit in their possession.

Theft or loss - licences and permits
BOTSR 35. 1 A licensed dealer that becomes aware of a theft or loss of their licence or permit must provide a written report to the Minister within 72 hours after becoming aware of it.

Theft or unexplainable loss - targeted substances
BOTSR 35.2 A licensed dealer that becomes aware of a theft of a targeted substance or of a loss of a targeted substance that cannot be explained on the basis of normally accepted business activities must
(a) provide a written report to a member of a police force within 24 hours after becoming aware of the theft or loss; and
(b) provide a written report to the Minister within 72 hours after becoming aware of the theft or loss and include a confirmation that the report required under paragraph (a) has been provided.

Explainable loss of targeted substance
BOTSR 43 A licensed dealer that becomes aware of a loss of a targeted substance that can be explained on the basis of normally accepted business activities must record the following information:
(a) the name of the lost targeted substance and, if applicable, the brand name of the product or the name of the compound containing it;
(b) the form and quantity of the targeted substance and, if applicable, the form of the product or compound containing it, the strength per unit of the targeted substance in the product or compound, the number of units per package and the number of packages;
(c) the date on which the dealer became aware of the loss; and
(d) the explanation for the loss.

Narcotics

Suspicious transaction
NCR 27.3 (1) A licensed dealer must provide a written report containing the following information to the Minister within 72 hours after becoming aware of a transaction occurring in the course of their activities that they have reasonable grounds to suspect may be related to the diversion of a narcotic to an illicit market or use:
(a) their name, municipal address, telephone number and, if the licensed dealer is a corporation, the position held by the individual making the report;
(b) the name and municipal address of the other party to the transaction;
(c) details of the transaction, including its date and time, its type, the name and quantity of the narcotic and, in the case of a product or compound, the quantity of every narcotic that it contains;
(d) in the case of a product that contains the narcotic, other than a test kit, the drug identification number that is assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any; and
(e) a detailed description of the reasons for those suspicions.

Good faith
NCR (2) No civil proceedings lie against a licensed dealer for having provided the report in good faith.

Non-disclosure
NCR (3) A licensed dealer must not disclose that they have provided the report or disclose details of it, with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun.

Partial protection against self-incrimination
NCR 27.4 A report made under any of sections 27.1 to 27.3, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Controlled Drugs

Suspicious transaction
FDR G.02.065 (1) A licensed dealer must provide a written report containing the following information to the Minister within 72 hours after becoming aware of a transaction occurring in the course of their activities that they have reasonable grounds to suspect may be related to the diversion of a controlled drug to an illicit market or use:
(a) their name, municipal address, telephone number and, if the licensed dealer is a corporation, the position held by the individual making the report;
(b) the name and municipal address of the other party to the transaction;
(c) details of the transaction, including its date and time, its type, the name and quantity of the controlled drug and, in the case of a product or compound, the quantity of every controlled drug that it contains;
(d) in the case of a product that contains the controlled drug, other than a test kit, the drug identification number that is assigned to the product under section C.01.014.2; and
(e) a detailed description of the reasons for those suspicions.

Good faith
(2) No civil proceedings lie against a licensed dealer for having provided the report in good faith.

Non-disclosure
(3) A licensed dealer must not disclose that they have provided the report or disclose details of it, with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun.

Partial protection against self-incrimination
FDR G.02.066  A report made under any of sections G.02.063 to G.02.065, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Restricted Drugs

Suspicious transaction
FDR J.01.069 (1) A licensed dealer must provide a written report containing the following information to the Minister within 72 hours after becoming aware of a transaction occurring in the course of their activities that they have reasonable grounds to suspect may be related to the diversion of a restricted drug to an illicit market or use:
(a) their name, municipal address, telephone number and, if the licensed dealer is a corporation, the position held by the individual making the report;
(b) the name and municipal address of the other party to the transaction;
(c) details of the transaction, including its date and time, its type, the name and quantity of the restricted drug and, in the case of a product or compound, the quantity of every restricted drug that it contains;
(d) in the case of a product that contains the restricted drug, other than a test kit, the drug identification number that is assigned to the product under section C.01.014.2, if any; and
(e) a detailed description of the reasons for those suspicions.

Good faith
(2) No civil proceedings lie against a licensed dealer for having provided the report in good faith.

Non-disclosure
(3) A licensed dealer must not disclose that they have provided the report or disclose details of it, with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun.

Partial protection against self-incrimination
FDR J.01.070 A report made under any of sections J.01.067 to J.01.069, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Benzodiazepines and Other Targeted Substances

Suspicious transaction
BOTSR 35.3 (1) A licensed dealer must provide a written report containing the following information to the Minister within 72 hours after becoming aware of a transaction occurring in the course of their activities that they have reasonable grounds to suspect may be related to the diversion of a targeted substance to an illicit market or use:
(a) their name, municipal address, telephone number and, if the licensed dealer is a corporation, the position held by the individual making the report;
(b) the name and municipal address of the other party to the transaction;
(c) details of the transaction, including its date and time, its type, the specified name and quantity of the targeted substance and, in the case of a product or compound, the quantity of every targeted substance that it contains;
(d) in the case of a product that contains the targeted substance, other than a test kit, the drug identification number that is assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any; and
(e) a detailed description of the reasons for those suspicions.

Good faith
(2) No civil proceedings lie against a licensed dealer for having provided the report in good faith.

Non-disclosure
(3) A licensed dealer must not disclose that they have provided the report or disclose details of it, with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun.

Partial protection against self-incrimination
BOTSR 35.4 A report made under any of sections 35.1 to 35.3, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Narcotics

Transport
NCR 26.1 (1) A licensed dealer must, in taking delivery of a narcotic that they have imported or in making delivery of a narcotic,
(a) take any measures that are necessary to ensure the security of the narcotic while it is being transported;
(b) subject to subsection (2), use a method of transportation that permits an accurate record to be kept of all handling of the narcotic as well as of the signatures of every person handling the narcotic until it is delivered to the consignee;
(c) in the case of an imported narcotic, transport it directly to the site specified in their licence after it is released under the Customs Act; and
(d) in the case of a narcotic that is to be exported, transport it directly from the site specified in their licence to the customs office where it will be exported.

Exception
(2) A licensed dealer may have a verbal prescription narcotic transported by a common carrier.

Controlled Drugs

Transport
FDR G.02.061 (1) A licensed dealer must, in taking delivery of a controlled drug that they have imported or in making delivery of a controlled drug,
(a) take any measures that are necessary to ensure the security of the drug while it is being transported;
(b) subject to subsection (2), use a method of transportation that permits an accurate record to be kept of all handling of the drug as well as the signatures of every person handling it until it is delivered to the consignee;
(c) in the case of an imported drug, transport it directly to the site specified in their licence after it is released under the Customs Act; and
(d) in the case of a drug to be exported, transport it directly from the site specified in their licence to the customs office where it will be exported.

Exception
(2) A licensed dealer may have a preparation transported by a common carrier.

Restricted Drugs

Transport
FDR J.01.064 A licensed dealer must, in taking delivery of a restricted drug that they have imported or in making delivery of a restricted drug,
(a) take any measures that are necessary to ensure the security of the drug while it is being transported;
(b) use a method of transportation that permits an accurate record to be kept of all handling of the drug as well as of the signatures of every person handling it until it is delivered to the consignee;
(c) in the case of an imported drug, transport it directly to the site specified in their licence after it is released under the Customs Act; and
(d) in the case of a drug to be exported, transport it directly from the site specified in their licence to the customs office where it will be exported.

Benzodiazepines and Other Targeted Substances

Transport
BOTSR 34.1 A licensed dealer must, in taking delivery of a targeted substance that they have imported or in making delivery of a targeted substance,
(a) take any measures that are necessary to ensure the security of the targeted substance while it is being transported; 
(b) in the case of an imported targeted substance, transport it directly to the site specified in their licence after it is released under the Customs Act; and
(c) in the case of a targeted substance that is to be exported, transport it directly from the site specified in their licence to the customs office where it will be exported.

Narcotics

Authorized persons
NCR 3(1)(a)(i)
3 (1) A person is authorized to possess a narcotic if the person has obtained the narcotic in accordance with these Regulations, in the course of activities conducted in connection with the administration or enforcement of an Act or regulation, 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 narcotic, and the person
(a) requires the narcotic for their business or profession and is
(i) a licensed dealer,

General
8 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a narcotic if they comply with these Regulations and the terms and conditions of their dealer’s licence and any permit issued under these Regulations.

Controlled Drugs

Authorized persons
G.01.005(1)(a)(i)
G.01.005 (1) A person is authorized to possess a controlled drug set out in any of items 1 to 3, 8 to 10, 12 to 14, 16 and 17 of Part I of the schedule to this Part if the person has obtained the controlled drug in accordance with these Regulations, in the course of activities conducted in connection with the administration or enforcement of an Act or regulation, 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 controlled drug, and the person
(a) requires the controlled drug for their business or profession and is
(i) a licensed dealer,

General
G.02.001 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a controlled drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part.

Restricted Drugs

Authorized persons
FDR, Part J, J.01.004(1)(a) 
J.01.004 (1) The following persons are authorized to possess a restricted drug listed in Part I of the schedule to this Part or referred to in paragraph (b) of the definition restricted drug in section J.01.001:
(a) a licensed dealer;

General
J.01.009 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a restricted drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part.

Benzodiazepines and Other Targeted Substances

Authorized persons
3 (1) A person is authorized to possess a targeted substance set out in Part 2 of Schedule 1 if the person has obtained the targeted substance in accordance with these Regulations, in the course of activities conducted in connection with the administration or enforcement of an Act or regulation, 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 targeted substance, and the person
(a) requires the targeted substance for their business or profession and is
(i) a licensed dealer,

General
12 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a targeted substance if they comply with these Regulations and the terms and conditions of their dealer’s licence and any permit issued under these Regulations.

Alteration prohibited
74 A person must not make any mark on or alter or deface in any manner any licence, permit or registration number issued under these Regulations.

Narcotics

Qualified person in charge present
NCR 8 (2) A licensed dealer may conduct an activity in relation to a narcotic at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

Senior person in charge
NCR 9.1 An applicant for a dealer’s licence must designate only one individual as the senior person in charge, who has overall responsibility for management of the activities with respect to narcotics that are specified in the licence application. The applicant may designate themself if the applicant is an individual.

Qualified person in charge
NCR 9.2 (1) An applicant for a dealer’s licence must designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to narcotics that are specified in the licence application and for ensuring that those activities comply with these Regulations. The applicant may designate themself if the applicant is an individual.

Alternate qualified person in charge
(2) An applicant for a dealer’s licence may designate an individual as an alternate qualified person in charge, who is authorized to replace the qualified person in charge when that person is absent. The applicant may designate themself if the applicant is an individual.

Qualifications
(3) Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge:
(a) they work at the site specified in the dealer’s licence;
(b) they
(i) are entitled or, if applicable, registered and entitled by a provincial professional licensing authority or a professional association in Canada and entitled to practise a profession that is relevant to their duties, such as pharmacist, practitioner, pharmacy technician or laboratory technician,
(ii) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or
(iii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and hold
(A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or
(B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province;
(c) they have sufficient knowledge of and experience with the use and handling of the narcotics specified in the dealer’s licence to properly carry out their duties; and
(d) they have sufficient knowledge of the provisions of the Act and these Regulations that are applicable to the activities specified in the dealer’s licence to properly carry out their duties.

Exception
(4) An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements of paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if
(a) no other individual working at the site meets those requirements;
(b) those requirements are not necessary for the activities specified in the licence; and
(c) the individual has sufficient knowledge — acquired from a combination of education, training or work experience — to properly carry out their duties.

Controlled Drugs

Qualified person in charge present
FDR Part G, G.02.001 (2)
(2) A licensed dealer may conduct an activity in relation to a controlled drug at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

Senior person in charge
FDR Part G, G.02.003
G.02.003 An applicant for a dealer’s licence must designate only one individual as the senior person in charge, who has overall responsibility for management of the activities with respect to controlled drugs that are specified in the licence application. The applicant may designate themself if the applicant is an individual.

Qualified person in charge
FDR Part G, G.02.004
G.02.004 (1) An applicant for a dealer’s licence must designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to controlled drugs that are specified in the licence application and for ensuring that those activities comply with this Part. The applicant may designate themself if the applicant is an individual.

Alternate qualified person in charge
(2) An applicant for a dealer’s licence may designate an individual as an alternate qualified person in charge, who is authorized to replace the qualified person in charge when that person is absent. The applicant may designate themself if the applicant is an individual.

Qualifications
(3) Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge:
(a) they work at the site specified in the dealer’s licence;
(b) they
(i) are a person entitled or, if applicable, registered and entitled by a provincial professional licensing authority or a professional association in Canada and entitled to practise a profession that is relevant to their duties, such as pharmacist, practitioner, pharmacy technician or laboratory technician,
(ii) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or
(iii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and hold
(A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or
(B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province;
(c) they have sufficient knowledge of and experience with the use and handling of the controlled drugs specified in the dealer’s licence to properly carry out their duties; and
(d) they have sufficient knowledge of the provisions of the Act and this Part that are applicable to the activities specified in the dealer’s licence to properly carry out their duties.

Exception
(4) An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements of paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if
(a) no other individual working at the site meets those requirements;
(b) those requirements are not necessary for the activities specified in the licence; and
(c) the individual has sufficient knowledge — acquired from a combination of education, training or work experience — to properly carry out their duties.

Restricted Drugs

Qualified person in charge present
FDR, Part J, J.01.009(2)
(2) A licensed dealer may conduct an activity in relation to a restricted drug at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

Senior person in charge
J.01 .011 An applicant for a dealer’s licence must designate only one individual as the senior person in charge, who has overall responsibility for management of the activities with respect to restricted drugs that are specified in the licence application. The applicant may designate themself if the applicant is an individual.

Qualified person in charge
J.01 .012 (1) An applicant for a dealer’s licence must designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to restricted drugs that are specified in the licence application and for ensuring that those activities comply with this Part. The applicant may designate themself if the applicant is an individual.

Alternate qualified person in charge
(2) An applicant for a dealer’s licence may designate an individual as an alternate qualified person in charge, who is authorized to replace the qualified person in charge when that person is absent. The applicant may designate themself if the applicant is an individual.

Qualifications
(3) Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge:
(a) they work at the site specified in the dealer's licence;
(b) they
(i) are a person entitled or, if applicable, registered and entitled by a provincial professional licensing authority or a professional association in Canada and entitled to practise a profession that is relevant to their duties, such as pharmacist, practitioner, pharmacy technician or laboratory technician,
(ii) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or
(iii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and hold
(A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or
(B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province;
(c) they have sufficient knowledge of and experience with the use and handling of the controlled drugs specified in the dealer’s licence to properly carry out their duties; and
(d) they have sufficient knowledge of the provisions of the Act and this Part that are applicable to the activities specified in the dealer’s licence to properly carry out their duties.

Exception
(4) An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements of paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if
(a) no other individual working at the site meets those requirements;
(b) those requirements are not necessary for the activities specified in the licence; and
(c) the individual has sufficient knowledge — acquired from a combination of education, training or work experience — to properly carry out their duties.

Benzodiazepines and Other Targeted Substances

Qualified person in charge present
BOTSR 12(2)
(2) A licensed dealer may conduct an activity in relation to a targeted substance at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

Senior person in charge
BOTSR 14
An applicant for a dealer’s licence must designate only one individual as the senior person in charge, who has overall responsibility for management of the activities with respect to targeted substances that are specified in the licence application. The applicant may designate themself if the applicant is an individual

Qualified person in charge
BOTSR 15
(1) An applicant for a dealer’s licence must designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to targeted substances that are specified in the licence application and for ensuring that those activities comply with these Regulations. The applicant may designate themself if the applicant is an individual.

Alternate qualified person in charge
(2) An applicant for a dealer’s licence may designate an individual as an alternate qualified person in charge, who is authorized to replace the qualified person in charge when that person is absent. The applicant may designate themself if the applicant is an individual.

Qualifications
(3) Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge:
(a) they work at the site specified in the dealer’s licence;
(b) they
(i) are entitled or, if applicable, registered and entitled by a provincial professional licensing authority or a professional association in Canada and entitled to practise a profession that is relevant to their duties, such as pharmacist, practitioner, pharmacy technician or laboratory technician,
(ii) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or
(iii)  hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and hold
(A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or
(B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province;
(c) they have sufficient knowledge of and experience with the use and handling of the targeted substances specified in the dealer’s licence to properly carry out their duties; and
(d)  they have sufficient knowledge of the provisions of the Act and these Regulations that are applicable to the activities specified in the dealer’s licence to properly carry out their duties.

Exception
(4) An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements of paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if
(a) no other individual working at the site meets those requirements;
(b) those requirements are not necessary for the activities specified in the licence; and
(c) the individual has sufficient knowledge — acquired from a combination of education, training or work experience — to properly carry out their duties.

Narcotics

Application
13 (1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:
(b) the replacement of the senior person in charge;
(c) the replacement of the qualified person in charge; Or
(d) the replacement or addition of an alternate qualified person in charge.

Notice - five days
14.1 A licensed dealer must notify the Minister in writing within five days after a person ceases to act as the qualified person in charge or an alternate qualified person in charge.

Notice - 10 days
14.2 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(a) a person ceases to act as the senior person in charge;

Controlled Drugs

Application
FDR Part G, G.02.018(1)
G.02.018(1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written request to the Minister:
(b) the replacement of the senior person in charge;
(c) the replacement of the qualified person in charge; or
(d) the replacement or addition of an alternate qualified person in charge.

Notice - five days
FDR Part G, G.02.022
G.02.022 A licensed dealer must notify the Minister in writing within five days after a person ceases to act as the qualified person in charge or an alternate qualified person in charge.

Notice - ten days
FDR Part G, G.02.023
G.02.023 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(a) a person ceases to act as the senior person in charge;

Restricted Drugs

Application
FDR, Part J, J.01.026
J.01.026 (1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:
(b) the replacement of the senior person in charge;
(c) the replacement of the qualified person in charge; or
(d) the replacement or addition of an alternate qualified person in charge.

Notice - five days
FDR, Part J, J.01.030
J.01.030 A licensed dealer must notify the Minister in writing within five days after a person ceases to act as the qualified person in charge or an alternate qualified person in charge.

Notice - ten days
J.01.031 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(a) a person ceases to act as the senior person in charge;

Benzodiazepines and Other Targeted Substances

Application
20 (1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:
(b) the replacement of the senior person in charge;
(c) the replacement of the qualified person in charge; or
(d) the replacement or addition of an alternate qualified person in charge.

Notice - five days
21.1 A licensed dealer must notify the Minister in writing within five days after a person ceases to act as the qualified person in charge or an alternate qualified person in charge.

Notice - 10 days
21.2 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(a) a person ceases to act as the senior person in charge;

Narcotics

Method of recording information
NCR 28 A licensed dealer must record any information that they are required to record under these Regulations using a method that permits an audit of it to be made at any time.

Information - general
28.1 A licensed dealer must record the following information:
(a) the name, form and quantity of any narcotic that the dealer orders, the name of the person who placed the order on the dealer’s behalf and the date of the order;
(b) the name, form and quantity of any narcotic that the dealer receives, the name and municipal address of the person who sold or provided it and the date on which it was received;
(c) in the case of a narcotic that the dealer sells or provides,
(i) the brand name of the product or the name of the compound containing the narcotic and the name of the narcotic,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any,
(iii) the form and quantity of the narcotic and, if applicable, the strength per unit of the narcotic in the product or compound, the number of units per package and the number of packages,
(iv) the name and municipal address of the person to whom it was sold or provided, and
(v) the date on which it was sold or provided;
(d) the name, form and quantity of any narcotic that the dealer manufactures or assembles and the date on which it was placed in stock and, if applicable, the strength per unit of the narcotic in the product or compound, the number of units per package and the number of packages;
(e) the name and quantity of any narcotic that the dealer uses in the manufacturing or assembling of a product or compound, as well as the brand name and quantity of the product or the name and quantity of the compound, and the date on which the product or compound was placed in stock;
(f) the name, form and quantity of any narcotic in stock at the end of each month;
(g) the name, form and quantity of any narcotic that the dealer delivers, transports or sends, the name and municipal address of the consignee and the date on which it was delivered, transported or sent;
(h) the name, form and quantity of any narcotic that the dealer imports, the date on which it was imported, the name and municipal address of the exporter, the country of exportation and any country of transit or transhipment; and
(i) the name, form and quantity of any narcotic that the dealer exports, the date on which it was exported, the name and municipal address of the importer, the country of final destination and any country of transit or transhipment.

Retention period
29 A licensed dealer and a former licensed dealer must keep any document containing the information that they are required to record under these Regulations, including every declaration and a copy of every report, for a period of two years following the day on which the last record is recorded in the document and in a manner that permits an audit of the document to be made at any time.

Location
29. 1 The documents must be kept
(a) in the case of a licensed dealer, at the site specified in their licence; and
(b) in the case of a former licensed dealer, at a location in Canada.

Quality of documents
29.2 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Controlled Drugs

Method of recording information
G.02.071 A licensed dealer must record any information that they are required to record under this Part using a method that permits an audit of it to be made at any time.

Information - general
G.02.072 A licensed dealer must record the following information:
(a) the name, form and quantity of any controlled drug that the dealer orders, the name of the person who placed the order on the dealer’s behalf and the date of the order;
(b) the name, form and quantity of any controlled drug that the dealer receives, the name and municipal address of the person who sold or provided it and the date on which it was received;
(c) in the case of a controlled drug that the dealer sells or provides,
(i) the brand name of the product or the name of the compound containing the controlled drug and the name of the controlled drug,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any,
(iii) he form and quantity of the controlled drug and, if applicable, the strength per unit of the controlled drug in the product or compound, the number of units per package and the number of packages,
(iv) the name and municipal address of the person to whom it was sold or provided, and
(v) the date on which it was sold or provided;
(d) the name, form and quantity of any controlled drug that the dealer manufactures or assembles and the date on which it was placed in stock and, if applicable, the strength per unit of the controlled drug in the product or compound, the number of units per package and the number of packages;
(e) the name and quantity of any controlled drug that the dealer uses in the manufacturing or assembling of a product or compound, as well as the brand name and quantity of the product or the name and quantity of the compound, and the date on which the product or compound was placed in stock;
(f) the name, form and quantity of any controlled drug in stock at the end of each month;
(g)  the name, form and quantity of any controlled drug that the dealer delivers, transports or sends, the name and municipal address of the consignee and the date on which it was delivered, transported or sent;
(h) the name, form and quantity of any controlled drug that the dealer imports, the date on which it was imported, the name and municipal address of the exporter, the country of exportation and any country of transit or transhipment; and
(i) the name, form and quantity of any controlled drug that the dealer exports, the date on which it was exported, the name and municipal address of the importer, the country of final destination and any country of transit or transhipment.

Retention period
G.02.077 A licensed dealer and a former licensed dealer must keep any document containing the information that they are required to record under this Part, including every declaration and a copy of every report, for a period of two years following the day on which the last record is recorded in the document and in a manner that permits an audit of the document to be made at any time.

Location
G.02.078 The documents must be kept
(a) in the case of a licensed dealer, at the site specified in their licence; and
(b) in the case of a former licensed dealer, at a location in Canada.

Quality of documents
G.02.079 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Restricted Drugs

Method of recording information
J.01.075 A licensed dealer must record any information that they are required to record under this Part using a method that permits an audit of it to be made at any time.

Information - general
J.01.076 A licensed dealer must record the following information:
(a) the name, form and quantity of any restricted drug that the dealer orders, the name of the person who placed the order on the dealer’s behalf and the date of the order;
(b) the name, form and quantity of any restricted drug that the dealer receives, the name and municipal address of the person who sold or provided it and the date on which it was received;
(c) in the case of a restricted drug that the dealer sells or provides,
(i) the brand name of the product or the name of the compound containing the restricted drug and the name of the restricted drug,
(ii)  the drug identification number that has been assigned to the product under section C.01.014.2, if any,
(iii) the form and quantity of the restricted drug and, if applicable, the strength per unit of the restricted drug in the product or compound, the number of units per package and the number of packages,
(iv) the name and municipal address of the person to whom it was sold or provided, and
(v) the date on which it was sold or provided;
(d) the name, form and quantity of any restricted drug that the dealer manufactures or assembles and the date on which it was placed in stock and, if applicable, the strength per unit of the restricted drug in the product or compound, the number of units per package and the number of packages;
(e) the name and quantity of any restricted drug that the dealer uses in the manufacturing or assembling of a product or compound, as well as the brand name and quantity of the product or the name and quantity of the compound, and the date on which the product or compound was placed in stock;
(f) the name, form and quantity of any restricted drug in stock at the end of each month;
(g) the name, form and quantity of any restricted drug that the dealer delivers, transports or sends, the name and municipal address of the consignee and the date on which it was delivered, transported or sent;
(h) the name, form and quantity of any restricted drug imported, the date on which it was that the dealer imports, the name and municipal address of the exporter, the country of exportation and any country of transit or transhipment; and
(i) the name, form and quantity of any restricted drug that the dealer exports, the date on which it was exported, the name and municipal address of the importer, the country of final destination and any country of transit or transhipment.

Retention period
J.01.084 A licensed dealer, a former licensed dealer, an institution and a person referred to in section J.01.083 must keep any document containing the information that they are required to record under this Part, including every declaration and a copy of every report, for a period of two years following the day on which the last record is recorded in the document and in a manner that permits an audit of the document to be made at any time.

Location
J.01 .085 The documents must be kept
(a) in the case of a licensed dealer, at the site specified in their licence;
(d) in the case of a former licensed dealer, at a location in Canada.

Quality of documents
J.01.086 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Benzodiazepines and Other Targeted Substances

Method of recording information
40 A licensed dealer must record any information that they are required to record under these Regulations using a method that permits an audit of it to be made at any time.

Information - general
41 A licensed dealer must record the following information:
(a) the specified name, the form and the quantity of any targeted substance that the dealer orders, the name of the person who placed the order on the dealer’s behalf and the date of the order;
(b) the specified name, the form and the quantity of any targeted substance that the dealer receives, the name and municipal address of the person who sold or provided it and the date on which it was received;
(c) in the case of a targeted substance that the dealer sells or provides,
(i) the brand name of the product or the name of the compound containing the targeted substance and the specified name of the targeted substance,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any,
(iii) the form and quantity of the targeted substance and, if applicable, the strength per unit of the targeted substance in the product or compound, the number of units per package and the number of packages,
(iv) the name and municipal address of the person to whom it was sold or provided, and
(v) the date on which it was sold or provided;
(d) the specified name, the form and the quantity of any targeted substance that the dealer produces and the date on which it was placed in stock and, if applicable, the strength per unit of the targeted substance in the product or compound, the number of units per package and the number of packages
(e) the specified name and the quantity of any targeted substance that the dealer uses in the manufacturing or assembling of a product or compound, as well as the brand name and quantity of the product or the name and quantity of the compound, and the date on which the product or compound was placed in stock;
(f) the specified name, the form and the quantity of any targeted substance in stock at the end of each month;
(g) the specified name, the form and the quantity of any targeted substance that the dealer delivers, transports or sends, the name and municipal address of the consignee and the date on which it was delivered, transported or sent;
(h) the specified name, the form and the quantity of any targeted substance that the dealer imports, the date on which it was imported, the name and municipal address of the exporter, the country of exportation and any country of transit or transhipment; and
(i) the specified name, the form and the quantity of any targeted substance that the dealer exports, the date on which it was exported, the name and municipal address of the importer, the country of final destination and any country of transit or transhipment.

Retention period
75 A person must keep any document containing all of the information that they are required to record under these Regulations, including every declaration and a copy of every report, for a period of two years following the day on which the last record is recorded in the document and in a manner that permits an audit of the document to be made at any time.

Location
76 The documents must be kept
(a) in the case of a licensed dealer, at the site specified in their licence; and
(b) in the case of a former licensed dealer or any other person, at a location in Canada.

Quality of documents
77 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Narcotics

Annual report
28.5 (1) Subject to subsections (2) and (3), a licensed dealer must provide to the Minister, within three months after the end of each calendar year, an annual report that contains
(a) the name, form and total quantity of each narcotic that they receive, produce, sell, provide, import, export or destroy during the calendar year, as well as the name and total quantity of each narcotic that they use to manufacture or assemble a product or compound;
(b) the name, form and quantity of each narcotic in physical inventory taken at the site specified in their licence at the end of the calendar year; and
(c) the name, form and quantity of any narcotic that has been lost or stolen in the course of conducting activities during the calendar year.

Non-renewal or revocation within first three months
(2) If a licensed dealer’s licence expires without being renewed or is revoked during the first three months of a calendar year, the dealer must provide to the Minister
(a) within three months after the end of the preceding calendar year, the annual report in respect of that year; and
(b) within three months after the expiry or revocation, a report in respect of the portion of the current calendar year during which the licence was valid that contains the information referred to in subsection (1), in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Non-renewal or revocation after third month
(3) If a licensed dealer’s licence expires without being renewed or is revoked after the first three months of a calendar year, the dealer must provide to the Minister, within three months after the expiry or revocation, a report in respect of the portion of the calendar year during which the licence was valid that contains the information referred to in subsection (1) for that period, in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Controlled Drugs

Annual report
G.02.076 (1) Subject to subsections (2) and (3), a licensed dealer must provide to the Minister, within three months after the end of each calendar year, an annual report that contains
(a) the name, form and total quantity of each controlled drug that they receive, produce, sell, provide, import, export or destroy during the calendar year, as well as the name and total quantity of each controlled drug that they use to manufacture or assemble a product or compound;
(b) the name, form and quantity of each controlled drug in physical inventory taken at the site specified in their licence at the end of the calendar year; and
(c) the name, form and quantity of any controlled drug that has been lost or stolen in the course of conducting activities during the calendar year.

Non-renewal or revocation within first three months
(2) If a licensed dealer’s licence expires without being renewed or is revoked during the first three months of a calendar year, the dealer must provide to the Minister
(a) within three months after the end of the preceding calendar year, the annual report in respect of that year; and
(b) within three months after the expiry or revocation, a report in respect of the portion of the current calendar year during which the licence was valid that contains the information referred to in subsection (1), in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Non-renewal or revocation after third month
(3) If a licensed dealer’s licence expires without being renewed or is revoked after the first three months of a calendar year, the dealer must provide to the Minister, within three months after the expiry or revocation, a report in respect of the portion of the calendar year during which the licence was valid that contains the information referred to in subsection (1) for that period, in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Restricted Drugs

Annual report
J.01.079 (1) Subject to subsections (2) and (3), a licensed dealer must provide to the Minister, within three months after the end of each calendar year, an annual report that contains
(a) the name, form and total quantity of each restricted drug that they receive, produce, sell, provide, import, export or destroy during the calendar year, as well as the name and total quantity of each restricted drug that they use to manufacture or assemble a product or compound;
(b) the name, form and quantity of each restricted drug in physical inventory taken at the site specified in their licence at the end of the calendar year; and
(c) the name, form and quantity of any restricted drug that has been lost in the course of conducting activities during the calendar year.

Non-renewal or revocation within first three months
(2) If a licensed dealer’s licence expires without being renewed or is revoked during the first three months of a calendar year, the dealer must provide to the Minister
(a) within three months after the end of the preceding calendar year, the annual report in respect of that year; and
(b) within three months after the expiry or revocation, a report in respect of the portion of the current calendar year during which the licence was valid that contains the information referred to in subsection (1), in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Non-renewal or revocation after third month
(3) If a licensed dealer’s licence expires without being renewed or is revoked after the first three months of a calendar year, the dealer must provide to the Minister, within three months after the expiry or revocation, a report in respect of the portion of the calendar year during which the licence was valid that contains the information referred to in subsection (1) for that period, in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Benzodiazepines and Other Targeted Substances

Annual report
45 (1) Subject to subsections (2) and (3), a licensed dealer must provide to the Minister, within three months after the end of each calendar year, an annual report that contains
(a) the specified name, the form and the total quantity of each targeted substance that they receive, produce, assemble, sell, provide, import, export or destroy during the calendar year, as well as the name and total quantity of each targeted substance that they use to manufacture or assemble a product or compound;
(b) the specified name, the form and the quantity of each targeted substance in physical inventory taken at the site specified in their licence at the end of the calendar year; and
(c) the specified name, the form and the quantity of any targeted substance that has been lost or stolen in the course of conducting activities during the calendar year.

Non-renewal or revocation within first three months
(2) If a licensed dealer’s licence expires without being renewed or is revoked during the first three months of a calendar year, the dealer must provide to the Minister
(a) within three months after the end of the preceding calendar year, the annual report in respect of that year; and
(b) within three months after the expiry or revocation, a report in respect of the portion of the current calendar year during which the licence was valid that contains the information referred to in subsection (1), in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Non-renewal or revocation after third month
(3)  If a licensed dealer’s licence expires without being renewed or is revoked after the first three months of a calendar year, the dealer must provide to the Minister, within three months after the expiry or revocation, a report in respect of the portion of the calendar year during which the licence was valid that contains the information referred to in subsection (1) for that period, in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Narcotics

Sale to another licensed dealer
NCR 25 A licensed dealer may sell or provide a narcotic to another licensed dealer.

Sale to pharmacist
NCR 25.1 (1) Subject to subsection (2), a licensed dealer may sell or provide a narcotic to a pharmacist.
(2) A licensed dealer must not sell or provide to a pharmacist who is named in a notice issued under subsection 48(1) the narcotics referred to in the notice
(3) Subsection (2) does not apply to a licensed dealer that has received a notice of retraction issued under section 49 in respect of a pharmacist named in a notice issued under subsection 48(1)

Sale to practitioner
NCR 25.2 (1) Subject to subsections (2) and (3), a licensed dealer may sell or provide to a practitioner a narcotic other than diacetylmorphine (heroin)
(2) A licensed dealer may sell or provide diacetylmorphine (heroin) to the following practitioners:
(a) a practitioner of medicine;
(b) a practitioner of dentistry, if practising in a hospital that provides care or treatment to persons; or
(c) a nurse practitioner
(3) A licensed dealer must not sell or provide to a practitioner who is named in a notice issued under subsection 59(1) the narcotics referred to in the notice unless the dealer has received a notice of retraction issued under section 60.

Provision to hospital employee
NCR 25.3 (1) Subject to subsection (2), a licensed dealer may provide a narcotic to a hospital employee.
(2) A licensed dealer may provide diacetylmorphine (heroin) to a hospital employee only if that hospital provides care or treatment to persons.

Sale to exempted person
NCR 25.4 A licensed dealer may sell or provide a narcotic to a person who is exempted under section 56 of the Act with respect to the possession of that narcotic.

Sale to Minister
NCR 25.5 A licensed dealer may sell or provide a narcotic to the Minister.   

Controlled Drugs

Sale to another licensed dealer
G.02.051 A licensed dealer may sell or provide a controlled drug to another licensed dealer.

Sale to pharmacist
G.02.052 (1) Subject to subsection (2), a licensed dealer may sell or provide a controlled drug to a pharmacist.
(2) A licensed dealer must not sell or provide to a pharmacist named in a notice issued under section G.03.017.2 the controlled drugs referred to in the notice unless the dealer has received a notice of retraction issued under section G.03.017.3.

Sale to practitioner
G.02.053 (1) Subject to subsection (2), a licensed dealer may sell or provide a controlled drug to a practitioner.
(2) A licensed dealer must not sell or provide to a practitioner who is named in a notice issued under section G.04.004.2 the controlled drugs referred to in the notice, unless the dealer has received a notice of retraction issued under section G.04.004.3.

Provision to hospital employee
G.02.054 A licensed dealer may provide a controlled drug to a hospital employee.

Sale to exempted person
G.02.055 A licensed dealer may sell or provide a controlled drug to a person who is exempted under section 56 of the Act with respect to the possession of that drug.

Sale to Minister
G.02.056 A licensed dealer may sell or provide a drug to the Minister.

Restricted Drugs

J.01.059 (1) Despite section C.08.002 and subject to subsections (3) and (4), a licensed dealer may sell a restricted drug to an institution for one of the following purposes if the institution submits to the dealer or the Minister an application to purchase the drug and the Minister issues a prior written authorization for the sale:
(a) clinical testing in the institution by qualified investigators for the purpose of determining the hazards and efficacy of the drug; or
(b) laboratory research in the institution by qualified investigators.

J.01.060 A licensed dealer may sell or provide a restricted drug to the Minister.

Benzodiazepines and Other Targeted Substances

 BOTSR 32 (1)
(1) Subject to subsection (2), a licensed dealer may sell or provide a targeted substance to
(a) another licensed dealer,
(b) a pharmacist,
(c) a practitioner,
(d) a hospital,
(e) a person to whom an exemption relating to the substance has been granted under section 56 of the Act; or
(f) the Minister.  

BOTSR 32(2)
(2) The licensed dealer must not sell or provide a targeted substance to a pharmacist or practitioner named in a notice issued under section 79, unless the dealer has received a notice of retraction issued under section 80.

Narcotics

Written order
NCR 25.6 A licensed dealer may sell or provide a narcotic under any of sections 25 to 25.5 if
(a) the dealer has received a written order that specifies the name and quantity of the narcotic to be supplied and is signed and dated
(i) in the case of a narcotic to be provided to a hospital employee or a practitioner in a hospital, by the pharmacist in charge of the hospital’s pharmacy or by a practitioner authorized by the person in charge of the hospital to sign the order, and
(ii) in any other case, by the person to whom the narcotic is to be sold or provided; and
(b) the dealer has verified the signature, if it is unknown to them.

Verbal order
NCR 25.7 (1)
(1) A licensed dealer may sell or provide a verbal prescription narcotic under sections 25 to 25.5 if
(a) the dealer has received a verbal order that specifies the name and quantity of the narcotic to be supplied; and
(b) in the case of the provision of the narcotic to a hospital employee or a practitioner in a hospital, the order has been placed by the pharmacist in charge of the hospital’s pharmacy or by a practitioner authorized by the person in charge of the hospital to place the order.

Receipt
(2) A licensed dealer that receives a verbal order from a pharmacist or practitioner must, within five working days after filling the order, obtain and keep a receipt that includes
(a) the signature of the pharmacist or practitioner who received the narcotic;
(b) the date on which the pharmacist or practitioner received the narcotic; and
(c) the name and quantity of the narcotic.

No further sale without receipt
(3) If the licensed dealer has not obtained the receipt within five working days, the dealer must not sell or provide a narcotic to the pharmacist or practitioner in accordance with a further verbal order received from them until after obtaining the receipt. 

Records
Verbal prescription narcotic
28.2 A licensed dealer that receives a verbal order for a verbal prescription narcotic and sells or provides it to a pharmacist, a practitioner or a hospital employee must immediately record
(a) the name of the person who placed the order;
(b) the date on which the order was received; and
(c) the name of the person recording the order.

Controlled Drugs

Written order
FDR Part G, G.02.057
G.02.057 A licensed dealer may sell or provide a controlled drug under any of sections G.02.051 to G.02.055 if
(a) the dealer has received a written order that specifies the name and quantity of the drug to be supplied and is signed and dated
(i) in the case of a drug to be provided to a hospital employee or a practitioner in a hospital, by the pharmacist in charge of the hospital’s pharmacy or by a practitioner authorized by the person in charge of the hospital to sign the order, and
(ii) in any other case, by the person to whom the drug is to be sold or provided; and
(b) the dealer has verified the signature, if it is unknown to them.

Verbal order
G.02.058 (1) A licensed dealer may sell or provide a controlled drug listed in Part II or III of the schedule to this Part if
(a) the dealer has received a verbal order that specifies the name and quantity of the drug to be supplied; and
(b) in the case of the provision of the drug to a hospital employee or a practitioner in a hospital, the order has been placed by the pharmacist in charge of the hospital’s pharmacy or by a practitioner authorized by the person in charge of the hospital to place the order.

Receipt
(2) A licensed dealer that has received a verbal order from a pharmacist or practitioner must, within five working days after filling the order, obtain and keep a receipt that includes
(a) the signature of the pharmacist or practitioner who received the controlled drug;
(b) the date on which the pharmacist or practitioner received the controlled drug; and
(c) the name and quantity of the controlled drug.

No further sale without receipt
(3) If the licensed dealer has not obtained the receipt within five working days, the dealer must not sell or provide a controlled drug to the pharmacist or practitioner in accordance with a further verbal order received from them until after obtaining the receipt.

Documents - Verbal order
G.02.073 A licensed dealer that receives a verbal order for a controlled drug listed in Part II or III of the schedule to this Part and sells or provides it to a pharmacist, practitioner or hospital employee must immediately record,
(a) the name of the person who placed the order;
(b) the date on which the order was received; and
(c) the name of the person recording the order.

Restricted Drugs

Not applicable

Benzodiazepines and Other Targeted Substances

Verification of Identity
Order
70 Every person who fills an order or prescription for a targeted substance must verify the identity of the person who gave the order or issued the prescription if
(a) the signature on the order or prescription is unknown to the person; or
(b) the order or prescription is verbal and the person placing it is not known to the person.

Order required
33 (1) A licensed dealer may sell or provide a targeted substance in accordance with section 32 if the dealer has received from one of the following persons a written or verbal order indicating the specified name and the quantity of the substance and, in the case of a written order, the conditions specified in subsection (2) are met:
(a) in the case of a licensed dealer, a person who is authorized to place an order for the substance on their behalf;
(b) in the case of a hospital, the pharmacist in charge of the hospital’s pharmacy or a practitioner authorized by the person in charge of the hospital to sign the order; or
(c) in any other case, the person to whom the substance is to be sold or provided.

Conditions
(2) The following conditions apply to a written order:
(a) it must be signed and dated by one of the persons referred to in subsection (1) and
(b) the licensed dealer must verify the signature if it is unknown to them.

Documents - Verbal order
42 A licensed dealer that receives a verbal order for a targeted substance must immediately record the following information:
(a) the name of the person who placed the order;
(b) the date on which the order was received; and
(c) the name of the person recording the order.

Narcotics

Not applicable

Controlled Drugs

Anticipated multiple sales
G.02.059 (1) A licensed dealer may sell or provide a controlled drug more than once in respect of one order if the order indicates
(a) the number of sales or provisions, not exceeding four;
(b) the specific quantity for each sale or provision; and
(c) the intervals between each sale or provision.

Multiple sales - insufficient stock
(2) A licensed dealer may sell or provide a controlled drug more than once in respect of one order if, at the time of receipt of the order, the dealer temporarily does not have in stock the quantity of the drug ordered, in which case the dealer may sell or provide against the order the quantity of the drug that the dealer has available and deliver the balance later.

Restricted Drugs

Not applicable

Benzodiazepines and Other Targeted Substances

Anticipated multiple sales
33.1 (1) A licensed dealer may sell or provide a targeted substance more than once in respect of one order if the order indicates
(a) the number of sales or provisions, not exceeding four;
(b) the specific quantity for each sale or provision; and
(c) the intervals between each sale and provision.

Multiple sales - insufficient stock
(2) A licensed dealer may sell or provide a targeted substance more than once in respect of one order if, at the time of receipt of the order, the dealer temporarily does not have in stock the quantity of the substance ordered, in which case the dealer may sell or provide against the order the quantity of the substance that the dealer has available and deliver the balance later.

Narcotics

General
NCR 8(1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a narcotic if they comply with these Regulations and the terms and conditions of their dealer’s licence and any permit issued under these Regulations.

Permit - import and export
NCR 8(3) A licensed dealer must obtain a permit in order to import or export a narcotic.

Possession for export
NCR 8(4) A licensed dealer may possess a narcotic for the purpose of exporting it if they have obtained it in accordance with these Regulations.

Import Permits
Application
18 (1) A licensed dealer must submit to the Minister, before each importation of a narcotic, an application for an import permit that contains the following information:
(a) their name, municipal address and dealer's licence number;
(b) with respect to the narcotic to be imported,
(i) its name, as specified in the dealer's licence,
(ii) it is a salt, the name of the salt,
(iii) its quantity, and
(iv) in the case of a raw material, its purity and its anhydrous content;
(c) if the narcotic is contained in a product to be imported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
(iii) the strength per unit of the narcotic in the product, the number of units per package and the number of packages;
(d) the name and municipal address of the exporter in the country of export from whom the narcotic is being obtained;
(e) the name of the customs office where the importation is anticipated; and
(f) each proposed mode of transportation and any proposed country of transit or transhipment.

Return of permit
18.3 If an import permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.

Export Permits
Application
NCR 21 (1)
(1) A licensed dealer must submit to the Minister, before each exportation of a narcotic, an application for an export permit that contains the following information and document:

(a) their name, municipal address and dealer’s licence number;
(b) with respect to the narcotic to be exported,
(i) its name, as specified in the dealer’s license
(ii) if it is a salt, the name of the salt,
(iii) its quantity, and
(iv) in the case of raw material, its purity and its anhydrous content;
(c) in the case of the exportation of a product that contains the narcotic,
(i) the brand of the product
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
(iii) the strength per unit of the narcotic in the product, the number of units per package and the number of packages;
(d) the name and municipal address of the importer in the country of final destination;
(e) the name of the customs office where the exportation is anticipated
(f) each proposed mode of transportation to be used and any proposed country of transit or transhipment; and
(g) a copy of the import permit issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country.

Return of permit
21.3 If an export permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.

Controlled Drugs

General
G.02.001 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a controlled drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part.

Permit - import and export
FDR Part G, G.02.001(3) 
G.02.001(3) A licensed dealer must obtain a permit to import or export a controlled drug.

Possession for export
FDR Part G, G.02.001(4) 
G.02.001(4) A licensed dealer may possess a controlled drug for the purpose of exporting it if they have obtained it in accordance with this Part.

Import Permits
Application
FDR Part G, G.02.030 
(1) A licensed dealer must submit to the Minister, before each importation of a controlled drug, an application for an import permit that contains the following information:
(a) their name, municipal address and dealer’s licence number;
(b) with respect to the controlled drug to be imported,
(i) its name, as specified in the dealer’s license
(ii) if it is a salt, the name of the salt,
(iii) its quantity, and
(iv) in the case of raw material, its purity and its anhydrous content;
(c) if the controlled drug is contained in a product to be imported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and
(iii) the strength per unit of the controlled drug in the product, the number of units per package and the number of packages;
(d) the name and municipal address, in the country of export, of the exporter from whom the controlled drug is being obtained;
(e) the name of the customs office where the importation is anticipated; and
(f) each proposed mode of transportation and any proposed country of transit or transhipment.

Return of permit
FDR Part G, G.02.033
G.02.033 If an import permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.

Export permits
Application
FDR Part G, G.02.040
G.02.040 (1) A licensed dealer must submit to the Minister, before each exportation of a controlled drug, an application for an export permit that contains the following information and document:
(a) their name, municipal address and dealer's licence number;
(b) with respect to the controlled drug to be exported,
(i) its name, as specified in the dealer's licence,
(ii) if it is a salt, the name of the salt,
(iii) its quantity, and
(iv) in the case of a raw material, its purity and its anhydrous content;
(c) if the controlled drug is contained in a product to be exported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and
(iii) the strength per unit of the controlled drug in the product, the number of units per package and the number of packages;
(d) the name and municipal address of the importer in the country of final destination;
(e) the name of the customs office where the exportation is anticipated;
(f) each proposed mode of transportation and any proposed country of transit or transhipment; and
(g) a copy of the import permit issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country.

Return of permit
FDR Part G, G.02.043 
G.02.043 If an export permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.

Restricted Drugs

General
J.01.009 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a restricted drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part.

Permit - import and export
FDR, Part J, J.01.009(3)
(3) A licensed dealer must obtain a permit to import or export a restricted drug.

Possession for export
FDR, Part J, J.01.009(4)
(4) A licensed dealer may possess a restricted drug for the purpose of exporting it if they have obtained it in accordance with this Part.

Import Permits
Application
J.01.038 (1) A licensed dealer must submit to the Minister, before each importation of a restricted drug, an application for an import permit that contains the following information:
(a) their name, municipal address and dealer's licence number;
(b) with respect to the restricted drug to be imported,
(i) its name, as specified in the dealer's licence,
(ii) if it is a salt, the name of the salt,
(iii) its quantity, and
(iv) in the case of a raw material, its purity and its anhydrous content;
(c) if the restricted drug is contained in a product to be imported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and
(iii) the strength per unit of the restricted drug in the product, the number of units per package and the number of packages;
(d) the name and municipal address, in the country of export, of the exporter from whom the restricted drug is being obtained;
(e) the name of the customs office where the importation is anticipated; and
(f) each proposed mode of transportation and any proposed country of transit or transhipment.

Return of permit
J.01.041 If an import permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.

Export Permits
Application
J.01.048 (1) A licensed dealer must submit to the Minister, before each exportation of a restricted drug, an application for an export permit that contains the following information and document:
(a) their name, municipal address and dealer's licence number;
(b) with respect to the restricted drug to be exported,
(i) its name, as specified in the dealer's licence,
(ii) if it is a salt, the name of the salt,
(iii) its quantity, and
(iv) in the case of a raw material, its purity and its anhydrous content;
(c) if the restricted drug is contained in a product to be exported,
(ii the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.0 1.014.2, if any, and
(iii) the strength per unit of the restricted drug in the product, the number of units per package and the number of packages;
(d) the name and municipal address of the importer in the country of final destination;
(e) the name of the customs office where the exportation is anticipated;
(f) each proposed mode of transportation and any proposed country of transit or transhipment; and
(g) a copy of the import permit issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country.

Return of permit
J.01.051 If an export permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.

Benzodiazepines and Other Targeted Substances

Authorized Activities
BOTSR 12 (3)
(3) A licensed dealer must obtain a permit in order to import or export a targeted substance.
(4) A licensed dealer may possess a targeted substance for the purpose of exporting it if they have obtained it in accordance with these Regulations.

Import permits
Application
25 (1) A licensed dealer must submit to the Minister, before each importation of a targeted substance, an application for an import permit that contains the following information:
(a) their name, municipal address and dealer's licence number;
(b) with respect to the targeted substance to be imported,
(i) its specified name, as set out in the dealer's licence,
(ii) if it is a salt, the name of the salt,
(iii) its quantity, and
(iv) in the case of a raw material, its purity and its anhydrous content;
(c) if the targeted substance is contained in a product to be imported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
(iii) the strength per unit of the targeted substance in the product, the number of units per package and the number of packages;
(d) the name and municipal address, in the country of export, of the exporter from whom the targeted substance is being obtained;
(e) the name of the customs office where the importation is anticipated; and
(f) each proposed mode of transportation and any proposed country of transit or transhipment.

Return of permit
25.3 If an import permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.

Export permits
Application
BOTSR 28 (1)
(1) A licensed dealer must submit to the Minister, before each exportation of a targeted substance, an application for an export permit that contains the following information and document:
(a) their name, municipal address and dealer’s licence number;
(b) with respect to the targeted substance to be exported,
(i) its specified name, as set out in the dealer’s licence,
(ii) if it is a salt, the name of the salt
(iii) its quantity, and
(iv) in the case of a raw material, its purity and its anhydrous content;
(c) if the targeted substance is contained in a product to be exported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.0142 of the Food and Drug Regulations, if any, and
(iii) the strength per unit of the targeted substance in the product, the number of units per package and the number of packages; and
(d) the name and municipal address of the importer in the country of final destination;
(e) the name of the customs office where the exportation is anticipated;
(f) each proposed mode of transportation to be used and any proposed country of transit or transhipment; and
(g) a copy of the import permit issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country.

Return of permit
28.3 If an export permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.

Narcotics

Packaging - transport and export
NCR 26 (2) A licensed dealer that transports or exports a narcotic must ensure that its package is sealed in such a manner that the package cannot be opened without breaking the seal.

Controlled Drugs

Packaging - transport and export
G.02.060 (2) A licensed dealer that transports or exports a controlled drug must ensure that its package is sealed in such a manner that the package cannot be opened without breaking the seal.

Restricted Drugs

Packaging - transport and export
J.01.062 (2) A licensed dealer that transports or exports a restricted drug must ensure that its package is sealed in such a manner that the package cannot be opened without breaking the seal.

Benzodiazepines and Other Targeted Substances

Packaging - transport and export
34(2) A licensed dealer that transports or exports a targeted substance must ensure that its package is sealed in such a manner that the package cannot be opened without breaking the seal

Narcotics

Import Permits
Declaration
18.6 The holder of an import permit must provide the Minister, within 15 days after the day of release of the narcotic specified in the permit in accordance with the Customs Act, with a declaration that contains the following information:
(a) their name and the numbers of their dealer's licence and the import permit that applies to the narcotic;
(b) with respect to the narcotic,
(i) its name, as set out in the dealer's licence,
(ii) if it is a salt, the name of the salt, and
(iii) its quantity;
(c) if the narcotic is contained in a product that they have imported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
(iii) the strength per unit of the narcotic in the product, the number of units per package and the number of packages; and
(d) the name of the customs office from which the narcotics was released and the date of the release

Export permits
Declaration
21.6 The holder of an export permit must provide the Minister, within 15 days after the day of export of the narcotic specified in the permit, with a declaration that contains the following information:
(a) their name and the numbers of their dealer's licence and the export permit that applies to the narcotic;
(b) with respect to the narcotic,
(i) its name, as specified in the dealer's licence,
(ii) if it is a salt, the name of the salt, and
(iii) its quantity;
(c) if the narcotic is contained in a product that they have exported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
(iii) the strength per unit of the narcotic in the product, the number of units per package and the number of packages; and
(d) the name of the customs office from which the narcotic was exported and the date of export.

Controlled Drugs

Import permits
Declaration
FDR Part G, G.02.036
G.02.036 The holder of an import permit must provide the Minister, within 15 days after the day of release of the controlled drug specified in the permit in accordance with the Customs Act, with a declaration that contains the following information:
(a) their name and the numbers of their dealer’s licence and the import permit that applies to the controlled drug;
(b) with respect to the controlled drug,
(i) its name, as set out in the dealer's licence,
(ii) it is a salt, the name of the salt, and
(iii) its quantity;
(c) if the controlled drug is contained in a product that they have imported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and
(iii) the strength per unit of the controlled drug in the product, the number of units per package and the number of packages; and
(d) the name of the customs office from which the controlled drug was released and the date of the release.

Export Permits
Declaration
FDR Part G, G.02.046 
G.02.046 The holder of an export permit must provide the Minister, within 15 days after the day of export of the controlled drug specified in the permit, with a declaration that contains the following information:
(a) their name and the numbers of their dealer's licence and the export permit that applies to the controlled drug;
(b) with respect to the controlled drug,
(i) its name, as specified in the dealer's licence,
(ii) if it is a salt, the name of the salt, and
(iii) its quantity;
(c) if the controlled drug is contained in a product that they have exported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.O1.014.2, if any, and
(iii) the strength per unit of the controlled drug in the product, the number of units per package and the number of packages; and
(d) the name of the customs office from which the controlled drug was exported and the date of export.

Restricted Drugs

Import Permits
Declaration
J.01.044 The holder of an import permit must provide the Minister, within 15 days after the day of release of the restricted drug specified in the permit in accordance with the Customs Act, with a declaration that contains the following information:
(a) their name and the numbers of their dealer's licence and the import permit that applies to the restricted drug;
(b) with respect to the restricted drug,
(i) its name, as set out in the dealer's licence,
(ii) if it is a salt, the name of the salt, and
(iii) its quantity;
(c) if the restricted drug is contained in a product that they have imported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and
(iii) the strength per unit of the restricted drug in the product, the number of units per package and the number of packages; and
(d) the name of the customs office from which the restricted drug was released and the date of the release.

Export Permits
Declaration
J.01.054 The holder of an export permit must provide the Minister, within 15 days after the day of export of the restricted drug specified in the permit, with a declaration that contains the following information:
(a) their name and the numbers of their dealer's licence and the export permit that applies to the restricted drug;
(b) with respect to the restricted drug,
(i) its name, as specified in the dealer's licence,
(ii) if it is a salt, the name of the salt, and
(iii) its quantity;
(c) if the restricted drug is contained in a product that they have exported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and
(iii) the strength per unit of the restricted drug in the product, the number of units per package and the number of packages; and
(d) the name of the customs office from which the restricted drug was exported and the date of export.

Benzodiazepines and Other Targeted Substances

Import Permits
Declaration
25.6 The holder of an import permit must provide the Minister, within 15 days after the day of release of the targeted substance specified in the permit in accordance with the Customs Act, with a declaration that contains the following information:
(a) their name and the numbers of their dealer's licence and the import permit that applies to the targeted substance;
(b) with respect to the targeted substance,
(i) its specified name, as set out in the dealer's licence,
(ii) if it is a salt, the name of the salt, and
(iii) its quantity;
(c) if the targeted substance is contained in a product that they have imported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
(iii) the strength per unit of the targeted substance in the product, the number of units per package and the number of packages; and
(d) the name of the customs office from which the targeted substance was released and the date of the release.

Export Permits
Declaration
28.6 The holder of an export permit must provide the Minister, within 15 days after the day of export of the targeted substance specified in the permit, with a declaration that contains the following information:
(a) their name and the numbers of their dealer's licence and the export permit that applies to the targeted substance;
(b) with respect to the targeted substance,
(i) its specified name, as set out in the dealer's licence,
(ii) if it is a salt, the name of the salt, and
(iii) its quantity;
(c) if the targeted substance is contained in a product that they have exported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
(iii) the strength per unit of the targeted substance in the product, the number of units per package and the number of packages; and
(d) the name of the customs office from which the targeted substance was exported and the date of export.

Narcotics

NCR 4
4 A person may sell, possess or otherwise deal in a test kit if the following conditions are met:
(a) a registration number has been issued for the test kit under section 6 and has not been cancelled under section 7;
(b) the test kit bears, on its external surface,
(i) the manufacturer's name,
(ii) the trade name or trademark, and
(iii) the registration number; and
(c) the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

Controlled Drugs

FDR Part G, G.01.006
G.01.006 A person may sell, possess or otherwise deal in a test kit if the following conditions are met:
(a) a registration number has been issued for the test kit under section G.01.008 and has not been cancelled under section G.01.009;
(b) the test kit bears, on its external surface,
(i) the name of the manufacturer,
(ii) the trade name or trademark, and
(iii) the registration number; and
(c) the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

Restricted Drugs

FDR Part J, J.01 .005
J.01.005 A person may sell, possess or otherwise deal in a test kit if the following conditions are met:
(a) a registration number has been issued for the test kit under section J.01.007 and has not been cancelled under section J.01.008;
(b) the test kit bears, on its external surface,
(i) the name of the manufacturer,
(ii) the trade name or trademark, and
(iii) the registration number; and
(c) the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

Benzodiazepines and Other Targeted Substances

BOTSR 4
4 A person may sell, possess or otherwise deal in a test kit if the following conditions are met:
(a) a registration number has been issued for the test kit under section 6 or subsection 10(2) and has not been cancelled under subsection 9(1)
(b) the test kit is labelled with
(i) the registration number, and
(ii) in the case of a test kit that is not subject to the labelling requirements of the Medical Devices Regulations,
(A) the name and address of the manufacturer or assembler or, if the test kit is manufactured or assembled in accordance with a custom order, the name and address of the person for whom the test kit was manufactured or assembled, and
(B) its brand name; and
(c) the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

Narcotics

NCR 8(1)
8 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a narcotic if they comply with these Regulations and the terms and conditions of their dealer’s licence and any permit issued under these Regulations.

Opium poppy - production
(5) A licensed dealer may cultivate, propagate or harvest opium poppy only for scientific purposes.

Notice – ten days
14.2 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(b) the licensed dealer ceases to manufacture or assemble a product or compound that is set out in the most recent version of the list referred to in paragraph 10(1)(f) that has been submitted to the Minister.

Notice of cessation of activities
14.3 (1) A licensed dealer that intends to cease conducting activities at their site — whether on or before the expiry of their licence — must notify the Minister in writing to that effect at least 30 days before ceasing those activities.

Controlled Drugs

FDR Part G, G.02.001 (1)
G.02.001 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a controlled drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part.

Notice - ten days
FDR Part G, G.02.023
G.02.023 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(b) the licensed dealer ceases to manufacture or assemble a product or compound that is set out in the most recent version of the list referred to in paragraph G.02.006(1)(f) has been submitted to the Minister.

Notice of cessation of activities
FDR Part G, G.02.024 (1)
G.02.024 (1) A licensed dealer that intends to cease conducting activities at their site — whether on or before the expiry of their licence — must notify the Minister in writing to that effect at least 30 days before ceasing those activities.

Restricted Drugs

J.01.009 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a restricted drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part.

Notice - ten days
J.01.031 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(b) the licensed dealer ceases to manufacture or assemble a product or compound that is set out in the most recent version of the list referred to in paragraph J.01.014(1)(f) that has been submitted to the Minister.

Notice of cessation of activities
J.01.032 (1) A licensed dealer that intends to cease conducting activities at their site — whether on or before the expiry of their licence — must notify the Minister in writing to that effect at least 30 days before ceasing those activities.

Benzodiazepines and Other Targeted Substances

BOTSR 12(1)
(1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a targeted substance if they comply with these Regulations and the terms and conditions of their dealer’s licence and any permit issued under these Regulations.

Notice – ten days
21.2 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(b) he licensed dealer ceases to manufacture or assemble a product or compound that is set out in the most recent version of the list referred to in paragraph 17(1)(f) that has been submitted to the Minister.

Notice of cessation of activities
21.3 (1) A licensed dealer that intends to cease conducting activities at their site — whether on or before the expiry of their licence — must notify the Minister in writing to that effect at least 30 days before ceasing those activities.