GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Controlled Substances Regulations — 213
Application 213 (1) A government laboratory must submit to the Minister, before each exportation of a controlled substance, an application for an export permit that contains the following information and document: (a) the government laboratory’s name and municipal address; (b) the name and municipal address of the proposed customs broker for the government laboratory, if any; (c) the name of the customs office where the exportation is anticipated and the proposed date of exportation; (d) the name and municipal address of the importer in the country of final destination; (e) the name of the carrier that is proposed to transport the controlled substance from the customs office where the exportation is anticipated; (f) each proposed mode of transportation and any proposed country of transit or transhipment; (g) in the case of a controlled substance set out in any of Schedules 1 to 4, (i) its name, (ii) its CAS registry number, if any, (iii) if it is a salt, the name of the salt, (iv) its form, (v) its purity and anhydrous content, and (vi) its quantity; (h) in the case of a mixture or finished product, (i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains, (ii) its form, its strength, the number of containers and, if applicable, the number of units per container, and (iii) its drug identification number, if any; and (i) a copy of the import authorization 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. Signature and attestation (2) The application must (a) be signed and dated by the person in charge of the government laboratory; and (b) include an attestation by that person that, to the best of their knowledge, (i) the exportation does not contravene the laws of the country of final destination or any country of transit or transhipment, and (ii) all of the information and documents submitted in support of the application are correct and complete. Additional information and documents (3) The government laboratory 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.
Controlled Substances Regulations — 214
Issuance 214 (1) Subject to section 216 , on completion of the review of the export permit application, the Minister must issue to the government laboratory an export permit that contains (a) the permit number; (b) the information set out in paragraphs 213 (1)(a) to (h) and the number of the import authorization referred to in paragraph 213 (1)(i); (c) the effective date of the permit; (d) the expiry date of the permit, being the earliest of (i) a date specified by the Minister that is not more than 180 days after its effective date, and (ii) the expiry date of the import authorization issued by the competent authority in the country of final destination; and (e) any terms and conditions that the Minister has reasonable grounds to believe are necessary to (i) ensure that an international obligation is respected, or (ii) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use. Permit integrity (2) A person must not alter or deface in any manner an export permit.
Controlled Substances Regulations — 215
Validity 215 An export permit is valid until the earliest of (a) the expiry date set out in the permit, (b) the date of the suspension or revocation of the permit under section 219 or 220 , and (c) the date of the expiry, suspension or revocation of the import authorization that applies to the controlled substance to be exported and that is issued by the competent authority in the country of final destination.
Controlled Substances Regulations — 216
Refusal 216 (1) The Minister must refuse to issue an export permit if (a) the Minister has reasonable grounds to believe that the exportation would contravene an international obligation; (b) the government laboratory has not provided the Minister with the information or documents required under subsection 213 (3) or before the date specified in the written request referred to in that subsection, or the information or documents that it has provided before that date are not sufficient to complete the review of the permit application; (c) the Minister has reasonable grounds to believe that the government laboratory has submitted false or misleading information or false or falsified documents in or in support of the permit application; (d) the Minister has reasonable grounds to believe that the exportation would not be in conformity with the import authorization issued by the competent authority of the country of final destination; (e) the Minister has reasonable grounds to believe that the exportation would contravene the laws of the country of final destination or any country of transit or transhipment; or (g) the Minister has reasonable grounds to believe that the issuance of the permit would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use. Prior notice (2) Before refusing to issue an export permit, the Minister must (a) provide the government laboratory with a prior written notice that sets out the Minister’s reasons and gives the government laboratory an opportunity to be heard; and (b) consider the government laboratory’s submissions, if applicable.
Controlled Substances Regulations — 217
Providing copy of permit 217 The holder of an export permit must provide a copy of the permit to the customs office at the time of exportation.
Controlled Substances Regulations — 218
Declaration 218 The holder of an export permit must provide the Minister, within 15 days after the day of export of the controlled substance specified in the permit, with a declaration that contains the following information: (a) the permit holder’s name; (b) the number of the export permit; (c) the name of the customs office from which the controlled substance was exported and the date of export; (d) in the case of a controlled substance set out in any of Schedules 1 to 4, (i) its name, (ii) if it is a salt, the name of the salt, (iii) its form, and (iv) its quantity; and (e) in the case of a mixture or finished product, (i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains, (ii) its form, its strength, the number of containers and, if applicable, the number of units per container, and (iii) its drug identification number, if any.
Controlled Substances Regulations — 219
Suspension 219 (1) Subject to subsection (2), the Minister must immediately suspend an export permit if (a) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use; or (b) the Minister has reasonable grounds to believe that the exportation would contravene the laws of the country of final destination or any country of transit or transhipment. Notice (2) The suspension takes effect as soon as the Minister provides the government laboratory with a written notice that (a) sets out the reasons for the suspension; (b) gives the government laboratory an opportunity to be heard; and (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out. Reinstatement of permit (3) The Minister must reinstate the export permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.
Controlled Substances Regulations — 220
Revocation 220 (1) The Minister must revoke an export permit if (a) the government laboratory requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit; (b) the government laboratory does not carry out the corrective measures specified by the Minister under paragraph 219 (2)(c) by the specified date; or (c) the Minister has reasonable grounds to believe that the government laboratory submitted misleading information or falsified documents in or in support of the application for the permit. Prior notice (2) Before revoking an export permit, the Minister must (a) provide the government laboratory with a prior written notice that sets out the Minister’s reasons and gives the government laboratory an opportunity to be heard; and (b) consider the government laboratory’s submissions, if applicable.
Controlled Substances Regulations — 221
Authorization 221 A particular person may sell or provide a controlled substance to a licensed dealer, pharmacist or police force for the purposes of destruction.
Controlled Substances Regulations — 222
Authorization 222 A particular person may deliver, send or transport a controlled substance to a licensed dealer, pharmacist or police force for the purposes of destruction.
Controlled Substances Regulations — 223
Transportation and provision 223 An individual who has obtained, in accordance with the provisions of the Act and its regulations, a controlled substance identified in a prescription for another individual named in that prescription may deliver, transport, sell or provide the substance to that individual.
Controlled Substances Regulations — 224
Return for destruction 224 An individual who has reasonable grounds to believe that a controlled substance in their possession was obtained in accordance with the provisions of the Act and its regulations may, for the purposes of destruction, deliver, transport, sell or provide the substance directly to one of the following persons: (a) a pharmacist or pharmacy technician, other than one who is practising in a hospital; (b) a practitioner, other than one who is practising in a hospital; (c) a hospital; or (d) a particular person.
Controlled Substances Regulations — 225
Import 225 On entering Canada, an individual may import a substance containing a controlled substance set out in any of Schedules 1 to 3 that is in their actual possession or that forms part of their baggage if (a) the individual is importing the substance (i) for their own use, (ii) for the use and on the behalf of an accompanying individual, or (iii) for administration to an animal for which the individual is responsible and that is accompanying the individual; (b) the substance is declared to a customs officer at the port of entry into Canada; (c) the substance, except a finished product referred to in subsection 98 (2) that contains low-dose codeine phosphate, is in a container obtained from a health care provider and that container carries a label on which the following information appears: (i) the name of the individual for whom, or the animal for which, the substance was lawfully obtained, (ii) the name of the health care provider who authorized the substance to be obtained, (iii) with respect to the substance, (A) its name or, if applicable, brand name, (B) its form, strength and quantity, and (C) its drug identification number, if any, and (iv) the daily dose of the substance authorized by the health care provider; and (d) the imported quantity of the substance does not exceed a 90-day supply required to treat a condition, based on the daily dose shown on the label.
Controlled Substances Regulations — 226
Export 226 On departing Canada, an individual may export a substance containing a controlled substance set out in any of Schedules 1 to 3 that is in their actual possession or that forms part of their baggage if (a) the individual is exporting the substance (i) for their own use, (ii) for the use and on the behalf of an accompanying individual, or (iii) for administration to an animal for which the individual is responsible and that is accompanying the individual; (b) the substance, except a finished product referred to in subsection 98 (2) that contains low-dose codeine phosphate, is in a container obtained from a health care provider and that container carries a label on which the following information appears: (i) the name of the individual for whom, or the animal for which, the substance was lawfully obtained, (ii) the name of the health care provider who authorized the substance to be obtained, (iii) with respect to the substance, (A) its name or, if applicable, brand name, (B) its form, strength and quantity, and (C) its drug identification number, if any, and (iv) the daily dose of the substance authorized by the health care provider; and (c) the exported quantity of the substance does not exceed a 90-day supply required to treat a condition, based on the daily dose shown on the label.
Controlled Substances Regulations — 227
Application 227 Only sections 1 , 7 to 33 and 228 to 234 apply to a test kit.
Controlled Substances Regulations — 228
Requirement to obtain registration number 228 The following persons are required to obtain a registration number for a test kit: (a) a person that intends to produce a test kit; and (b) a person for whom another person, in accordance with a custom order, intends to produce a test kit.
Controlled Substances Regulations — 229
Application for registration number 229 (1) An application to obtain a registration number for a test kit must be submitted to the Minister and contain the following information with respect to the test kit: (a) its brand name; (b) a detailed description of its design and construction; (c) with respect to the controlled substance set out in any of Schedules 1 to 4 and any other substance it contains, their names, forms and quantities; (d) a description of its proposed use; and (e) its directions for use. Signature and attestation (2) The application must (a) be signed and dated by the person authorized by the applicant for that purpose; and (b) include an attestation by that person that all of the information submitted in support of the application is correct and complete to the best of their knowledge. Additional information and documents (3) The applicant 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.
Controlled Substances Regulations — 230
Issuance of registration number 230 (1) Subject to section 231 , on completion of the review of the application for a registration number, the Minister must issue to the applicant a document that sets out a registration number for the test kit, preceded by the letters “TK”, if the Minister determines that the test kit will only be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose. Registration number integrity (2) A person must not alter or deface in any manner the document that sets out the registration number.
Controlled Substances Regulations — 231
Refusal to issue registration number 231 (1) The Minister must refuse to issue a registration number for a test kit if the Minister has reasonable grounds to believe that (a) the test kit poses a risk to public health or safety, including the risk that the controlled substance in the test kit could be diverted to an illicit market or use, because (i) the total amount of the controlled substance is too high, or (ii) the adulterating or denaturing agent in the test kit is not likely to prevent or deter the consumption of the controlled substance in the test kit by an individual or animal or the administration of that substance to an individual or animal; or (b) the test kit will be used for a purpose other than one referred to in subsection 230 (1). Prior notice (2) Before refusing to issue a registration number, the Minister must (a) provide the applicant with a prior written notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard; and (b) consider the applicant’s submissions, if applicable.
Controlled Substances Regulations — 232
Notice to Minister 232 A person must inform the Minister in writing of any of the following facts within 30 days after their occurrence: (a) the person has ceased to conduct all activities authorized under section 234 with respect to the test kit; (b) the person has transferred the production of the test kit to another person; (c) the person has increased the quantity of the controlled substance in the test kit; (d) the person has changed the brand name of the test kit; (e) the person has altered in any manner the adulterating or denaturing agent in the test kit or changed the quantity of either agent in it; or (f) the person has substituted the adulterating or denaturing agent with another one.
Controlled Substances Regulations — 233
Cancellation of registration number 233 (1) The Minister must cancel the registration number of a test kit if (a) the Minister receives a notice from the person to whom the document that sets out the registration number was issued, stating that production of the test kit has ceased; or (b) the Minister has reasonable grounds to believe that one of the circumstances referred to in paragraph 231 (1)(a) or (b) exists. Prior notice (2) Before cancelling a registration number, the Minister must (a) provide the person to whom the document that sets out the registration number was issued with a prior written notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard; and (b) consider the person’s submissions, if applicable. Effect of cancellation (3) The following rules apply when the registration number of a test kit is cancelled: (a) in the case of a test kit produced before a cancellation under paragraph (1)(a), (i) the activities set out in section 234 remain authorized, and (ii) the registration number must remain on the label of the test kit; and (b) in the case of a test kit produced either before or after a cancellation under paragraph (1)(b), the registration number must not be displayed on its label.
Controlled Substances Regulations — 234
Authorized activities 234 (1) Any person, other than a person referred to in subsection (2), may possess, sell, provide, transport, send, deliver, import or export a test kit if the following conditions are met: (a) subject to subparagraph 233 (3)(a)(i), the registration number of the test kit has not been cancelled under subsection 233 (1); (b) the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and (c) the test kit carries a label on which the following information appears: (i) the registration number of the test kit, and (ii) in the case of a test kit that is not subject to the labelling requirements set out in the Medical Devices Regulations , (A) the name and municipal address of the person that produced the test kit or, if the test kit is produced in accordance with a custom order, of the other person for whom the test kit was produced, and (B) its brand name. Member of police force (2) A person referred to in section 2 may possess a test kit.
Controlled Substances Regulations — 235
Restrictions 235 A person that advertises a controlled substance may only do so if (a) the substance is not a restricted drug; (b) the advertisement is directed to a person that is not part of the general public; and (c) in the case of a written advertisement, (i) the advertisement appears in a document distributed to, or in a trade publication for, (A) a licensed dealer, (B) a pharmacist, pharmacy technician or practitioner, or (C) a hospital, and (ii) the advertisement contains, in a conspicuous place, a legible and intelligible statement that the substance is a controlled substance.
Controlled Substances Regulations — 236
Written notification 236 (1) For the purposes of subsection 24(1) of the Act, the prior notification of an application for an order of restoration given to the Attorney General must be made in writing and provided by registered mail at least 15 days before the date on which the application is to be made to a justice. Content of notification (2) The prior notification must specify (a) the name of the justice to whom the application is to be made; (b) the time and place at which the application is to be heard; (c) details concerning the controlled substance or other thing in respect of which the application is to be made; and (d) the evidence on which the applicant intends to rely to establish that the applicant is entitled to possession of the controlled substance or other thing referred to in paragraph (c).
Controlled Substances Regulations — 238
238 The following regulations are repealed: (a) the Narcotic Control Regulations 2 ; (b) the Regulations Exempting Certain Precursors and Controlled Substances from the Application of the Controlled Drugs and Substances Act 3 ; (c) the Benzodiazepines and Other Targeted Substances Regulations 4 ; and (d) the New Classes of Practitioners Regulations 5 . 2 C.R.C., c. 1041; SOR/2019-169, s. 1 3 SOR/97-229 4 SOR/2000-217; SOR/2003-38, s. 1 5 SOR/2012-230
Controlled Substances Regulations — 239
October 1, 2026 239 These Regulations come into force on October 1, 2026.
Controlled Substances Regulations — 2
2 Part 3 of Schedule 4 to the Controlled Substances Regulations 2 is amended by adding the following: 2 SOR/2025-242 Item Column 1 Column 2 Substance Period 1 Spirobrorphine (8-[1-(4-bromophenyl)ethyl]-1-phenyl-1,3,8-triazaspiro[4.5]decan-4-one) and its salts October 1, 2026 to June 4, 2027 2 Spirochlorphine (8-[1-(4-chlorophenyl)ethyl]-1-phenyl-1,3,8-triazaspiro[4.5]decan-4-one) and its salts October 1, 2026 to June 4, 2027
Exemption Order in Respect of Foods for a Special Dietary Purpose — Exemption Order in Respect of Foods for a Special Dietary Purpose
Whereas the Minister of Health believes on reasonable grounds that the annexed Order is necessary for a health or safety purpose or is otherwise in the public interest;
Exemption Order in Respect of Foods for a Special Dietary Purpose — Exemption Order in Respect of Foods for a Special Dietary Purpose
And whereas the Minister of Health believes on reasonable grounds that, having regard to its benefits and conditions, the annexed Order is unlikely to result in unacceptable health, safety or, if applicable, environmental risks or an unacceptable degree of uncertainty respecting health, safety or, if applicable, environmental risks;
Exemption Order in Respect of Foods for a Special Dietary Purpose — a
Therefore, the Minister of Health makes the annexed Exemption Order in Respect of Foods for a Special Dietary Purpose under section 30.05 a of the Food and Drugs Act b . a S.C. 2024, c. 17, s. 326 b R.S., c. F-27
Exemption Order in Respect of Foods for a Special Dietary Purpose — Exemption Order in Respect of Foods for a Special Dietary Purpose
Ottawa, November 26, 2025 La ministre de la Santé, Marjorie Michel Minister of Health
Exemption Order in Respect of Foods for a Special Dietary Purpose — 1
Definitions 1 (1) The following definitions apply in this Order. List means the document entitled List of Human Milk Fortifiers, Infant Formulas and Formulated Liquid Diets for Exceptional Importation and Sale in the Case of a Shortage or Risk of Shortage that is published by the Government of Canada on its website, as amended from time to time. ( Liste ) Regulations means the Food and Drug Regulations . ( Règlement ) shortage , in respect of a human milk fortifier, human milk substitute or formulated liquid diet that is sold in Canada, means a situation in which the supply of a category of that food is insufficient to meet the demand for it. ( pénurie ) References to manufacturer (2) In sections 6 to 10 , with the exception of paragraph 7 (a), a reference to manufacturer is to be read as a reference to a manufacturer of a human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 3 applies. Words and expressions (3) Unless the context otherwise requires, words and expressions used in this Order have the same meaning as in Part A, B or D of the Regulations, as applicable.