GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — J.01.059
Sale to institution 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. Content of application (2) The application must contain the following information: (a) the name and the municipal address of the institution; (b) the names and qualifications of the qualified investigators; (c) the name, form, quantity and strength per unit of the restricted drug being requested; (d) details of the proposed use of the drug; and (e) the name and municipal address of the licensed dealer from whom the institution proposes to purchase the drug. Application to licensed dealer (3) If the institution submits the application to the licensed dealer, the dealer must provide a copy of it to the Minister. Authorization by Minister (4) After reviewing the application received from the institution or the copy of it received from the licensed dealer, the Minister may, subject to any terms and conditions that the Minister has reasonable grounds to believe are necessary, authorize in writing (a) the sale by the licensed dealer to the institution of the restricted drug applied for in the form, quantity and strength per unit specified by the Minister; and (b) the possession of the restricted drug by qualified investigators for clinical testing of the drug in the institution for the purpose of determining its hazards and efficacy or to conduct laboratory research with the drug in the institution. Authorized use only (5) The institution must use the restricted drug only in accordance with the written authorization. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.060
Sale to Minister J.01.060 A licensed dealer may sell or provide a restricted drug to the Minister. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.061
Provision for identification or analysis J.01.061 (1) Despite anything in this Part, a person may, for the purpose of identification or analysis of a restricted drug, provide or deliver it to (a) a practitioner of medicine; or (b) an agent or mandatary of a practitioner of medicine, if the agent or mandatary has been exempted under section 56 of the Act with respect to the possession of that restricted drug for that purpose. Agent or mandatary of practitioner of medicine (2) An agent or mandatary of a practitioner of medicine who receives the restricted drug must immediately provide or deliver it to (a) the practitioner; or (b) the Minister. Practitioner of medicine (3) A practitioner of medicine who receives the restricted drug must immediately provide or deliver it (a) for the purpose of its identification or analysis, to a person exempted under section 56 of the Act with respect to the possession of that restricted drug for that purpose; or (b) to the Minister. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.062
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. Packaging — transport and export (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. Exception (3) Subsection (1) does not apply to a test kit that contains a restricted drug and that has a registration number. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.063
Labelling 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. Exception (2) Subsection (1) does not apply to a test kit that contains a restricted drug and that has a registration number. Non-application (3) The labelling requirements set out in section C.01.004 do not apply to a restricted drug. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.064
Transport 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. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.065
Protective measures — licences and permits 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. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.066
Protective measures — restricted drugs 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; (b) an institution; (c) a qualified investigator who possesses the restricted drug for the purpose of clinical testing or laboratory research in an institution; and (d) a person exempted under section 56 of the Act with respect to the possession of the restricted drug. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.067
Theft or loss — licences and permits 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. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.068
Theft or loss — restricted drugs 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. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.069
Suspicious transaction 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. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.070
Partial protection against self-incrimination 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 . SOR/2019-171, s. 22
Food and Drug Regulations — J.01.071
Destruction at site J.01.071 A licensed dealer that intends to destroy a restricted drug at the site specified in their licence must ensure that the following conditions are met: (a) the licensed dealer obtains the prior approval of the Minister; (b) the destruction occurs in the presence of two of the following persons, at least one of whom must be a person referred to in subparagraph (i): (i) the senior person in charge, the qualified person in charge or an alternate qualified person in charge, and (ii) a person who works for or provides services to the licensed dealer and holds a senior position; (c) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and (d) as soon as the destruction is completed, the person who carried out the destruction and each of the two persons referred to in paragraph (b) who were present at the destruction sign and date a joint declaration attesting that the restricted drug was completely destroyed, to which each signatory must add their name in printed letters. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.072
Destruction elsewhere than at site J.01.072 A licensed dealer that intends to destroy a restricted drug elsewhere than at the site specified in their licence must ensure that the following conditions are met: (a) the licensed dealer obtains the prior approval of the Minister; (b) the licensed dealer takes any measures that are necessary to ensure the security of the restricted drug while it is being transported in order to prevent its diversion to an illicit market or use; (c) the destruction is carried out by a person working for a business that specializes in the destruction of dangerous goods and in the presence of another person working for that business; (d) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and (e) as soon as the destruction is completed, the person who carried out the destruction provides the licensed dealer with a dated declaration attesting that the restricted drug was completely destroyed and containing (i) the municipal address of the place of destruction, (ii) the name and quantity of the restricted drug and, if applicable, the brand name and quantity of the product containing it or the name and quantity of the compound containing it, (iii) the method of destruction, (iv) the date of destruction, and (v) the names in printed letters and signatures of that person and the other person who was present at the destruction. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.073
Application for prior approval J.01.073 (1) A licensed dealer must submit to the Minister an application that contains the following information in order to obtain the Minister’s prior approval to destroy a restricted drug: (a) their name, municipal address and dealer’s licence number; (b) the proposed date of destruction; (c) the municipal address of the place of destruction; (d) a brief description of the method of destruction; (e) if the destruction is to be carried out at the site specified in the dealer’s licence, the names of the persons proposed for the purpose of paragraph J.01.071(b) and information establishing that they meet the conditions of that paragraph; (f) the name of the restricted drug and, if applicable, the brand name of the product containing it or the name of the compound containing it; and (g) the form and quantity of the restricted drug or the product or compound containing it 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. Signature and attestation (2) The application must (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and (b) include an attestation by that person that (i) the proposed method of destruction complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction, and (ii) all of the information submitted in support of the application is correct and complete to the best of the signatory’s knowledge. Additional information and documents (3) The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.074
Approval J.01.074 On completion of the review of the application for approval, the Minister must approve the destruction of the restricted drug unless (a) in the case of a destruction that is to be carried out at the site specified in the dealer’s licence, the persons proposed for the purpose of paragraph J.01.071(b) do not meet the conditions of that paragraph; (b) the Minister has reasonable grounds to believe that the restricted drug would not be destroyed; (c) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the approval application; (d) the restricted drug or a portion of it is required for the purposes of a criminal or administrative investigation or a preliminary inquiry, trial or other proceeding under any Act or its regulations; or (e) the Minister has reasonable grounds to believe that the approval would likely create a risk to public health or safety, including the risk of the restricted drug being diverted to an illicit market or use. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.075
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. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.076
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. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.077
Explainable loss of restricted drug 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. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.078
Destruction J.01.078 A licensed dealer must record the following information concerning any restricted drug that they destroy at the site specified in their licence: (a) the municipal address of the place of destruction; (b) the name, form and quantity of the restricted drug and, if applicable, the brand name and quantity of the product containing the drug or the name and quantity of the compound containing the drug; (c) the method of destruction; and (d) the date of destruction. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.079
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. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.080
Method of recording information J.01.080 An institution must record any information that it is required to record under this Part using a method that permits an audit of the information to be made at any time. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.081
Information J.01.081 An institution must record the following information: (a) the name and quantity of any restricted drug that the institution orders, the name of the person who placed the order on the institution’s behalf and the date of the order; (b) the name and quantity of any restricted drug that the institution receives as well as the name and municipal address of the licensed dealer that sold or provided it and the date on which it was received; (c) details of the use of restricted drugs in the institution; (d) the names and qualifications of every person who makes use of a restricted drug in the institution; and (e) all clinical data with respect to the use of every restricted drug received by the institution. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.082
Method of recording information J.01.082 A person who records information in accordance with section J.01.083 must do so using a method that permits an audit of the information to be made at any time. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.083
Information J.01.083 A person who receives a restricted drug in accordance with section J.01.061 must record the following information: (a) the name and quantity of the restricted drug, as well as the name and municipal address of the person who provided it to them and the date on which it was received; (b) details regarding the identification or analysis of the restricted drug; and (c) the names of the persons who handled the restricted drug during the process of identifying or analyzing it. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.084
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. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.085
Location J.01.085 The documents must be kept (a) in the case of a licensed dealer, at the site specified in their licence; (b) in the case of an institution, at the institution; (c) in the case of a person referred to in section J.01.083, at a location in Canada; and (d) in the case of a former licensed dealer, at a location in Canada. SOR/2019-171, s. 22
Food and Drug Regulations — J.01.086
Quality of documents J.01.086 The documents must be complete and readily retrievable and the information in them must be legible and indelible. SOR/2019-171, s. 22