GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — C.10.004
C.10.004 (1) The following definitions apply in this section and in sections C.10.005 to C.10.011. designated drug means a drug that is set out in the List of Drugs for Exceptional Importation and Sale . ( drogue désignée ) drug means any of the following drugs for human use: (a) drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act ; (b) prescription drugs; (c) drugs that are listed in Schedule C or D to the Act; and (d) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner. ( drogue ) foreign regulatory authority has the same meaning as in subsection C.10.001(1). ( autorité réglementaire étrangère ) List of Drugs for Exceptional Importation and Sale means the List of Drugs for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. ( Liste des drogues destinées aux importations et aux ventes exceptionnelles ) (2) In sections C.10.006 and C.10.009, batch certificate , fabricate , MRA country , package/label and recognized building have the same meanings as in subsection C.01A.001(1). SOR/2021-199, s. 5
Food and Drug Regulations — Food and Drug Regulations
designated drug means a drug that is set out in the List of Drugs for Exceptional Importation and Sale . ( drogue désignée )
Food and Drug Regulations — (a)
drug means any of the following drugs for human use: (a) drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act ; (b) prescription drugs; (c) drugs that are listed in Schedule C or D to the Act; and (d) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner. ( drogue )
Food and Drug Regulations — Food and Drug Regulations
foreign regulatory authority has the same meaning as in subsection C.10.001(1). ( autorité réglementaire étrangère )
Food and Drug Regulations — Food and Drug Regulations
List of Drugs for Exceptional Importation and Sale means the List of Drugs for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. ( Liste des drogues destinées aux importations et aux ventes exceptionnelles )
Food and Drug Regulations — C.10.005
C.10.005 (1) The Minister may add a drug to the List of Drugs for Exceptional Importation and Sale only if the Minister has reasonable grounds to believe that (a) there is a shortage or risk of shortage of another drug for which a notice of compliance has been issued under section C.08.004 or C.08.004.01 or for which a drug identification number has been assigned under subsection C.01.014.2(1); and (b) the drug to be added to that list can be substituted for the drug referred to in paragraph (a). (2) In subsection (1), shortage has the same meaning as in section C.01.014.8. SOR/2021-199, s. 5
Food and Drug Regulations — C.10.006
C.10.006 (1) A person who holds an establishment licence that authorizes the importation of a drug may import a designated drug if the following conditions are met: (a) the licensee provides the Minister, electronically in a format specified by or acceptable to the Minister and not later than the third business day before the day on which the designated drug is imported, with a notification that contains the following information: (i) the licensee’s name and contact information, (ii) the name and contact information of each fabricator, packager/labeller and tester of the designated drug and the address of each building in which it is fabricated, packaged/labelled or tested, (iii) in respect of the designated drug, (A) its brand name, (B) its medicinal ingredients, (C) its dosage form, (D) its strength, (E) its route of administration, (F) its identifying code or number, if any, assigned in the country in which it is authorized for sale, and (G) a detailed description of its conditions of use, (iv) the intended port of entry into Canada, (v) the estimated date of arrival of the shipment of the designated drug, and (vi) the total quantity of the designated drug that is intended to be imported on the date referred to in subparagraph (v); (b) the designated drug is authorized to be sold by a foreign regulatory authority within its jurisdiction; (c) the designated drug is in the same category as the category for which the establishment licence was issued; (d) the following information is set out in the List of Drugs for Exceptional Importation and Sale in respect of the designated drug: (i) the licensee’s name, (ii) the information referred to in clauses (a)(iii)(A) to (F), (iii) the name of the foreign regulatory authority referred to in paragraph (b), and (iv) the date after which it may no longer be imported; (e) the lot number of the designated drug is set out in the list referred to in paragraph (d), if applicable; (f) the total quantity of the designated drug that the licensee imports does not exceed the maximum limit specified in the list referred to in paragraph (d) in respect of the drug, if applicable; (g) the designated drug is imported on or before the date referred to in subparagraph (d)(iv); and (h) the licensee has prepared a plan that specifies the measures to be taken in order for the licensee to comply with section C.10.011. (2) In subsection (1), business day means a day other than (a) a Saturday; or (b) a Sunday or other holiday. SOR/2021-199, s. 5
Food and Drug Regulations — C.10.007
C.10.007 Sections A.01.040, A.01.044 and C.01.004.1 do not apply in respect of the importation, under section C.10.006, of a designated drug by a person who holds an establishment licence. SOR/2021-199, s. 5
Food and Drug Regulations — C.10.008
C.10.008 (1) Subject to sections C.10.009 and C.10.010, a sale of a designated drug that is imported under section C.10.006 is exempt from the following provisions: (a) sections A.01.015, A.01.017 and A.01.051; and (b) the provisions of Part C other than (i) sections C.01.016, C.01.017, C.01.019 to C.01.020.1, C.01.040.3 to C.01.049.1 and C.01.051, (ii) the provisions of Divisions 1A and 2, and (iii) this section and sections C.10.009 to C.10.011. (2) For greater certainty, for the purposes of section C.01.016, the manufacturer of a designated drug is required to comply only with the requirements set out in sections C.01.017 and C.01.019 in respect of the drug. (3) Subsections (1) and (2) cease to apply in respect of the sale of a designated drug on its expiration date. SOR/2021-199, s. 5
Food and Drug Regulations — C.10.009
C.10.009 (1) Section C.02.019 does not apply to a person who holds an establishment licence in respect of a designated drug that they import under section C.10.006. (2) The licensee shall perform the finished product testing on a sample of the designated drug that is taken either (a) after receipt of each lot or batch of the designated drug on their premises in Canada; or (b) before receipt of each lot or batch of the designated drug on their premises in Canada if the following conditions are met: (i) the licensee has evidence satisfactory to the Minister to demonstrate that lots or batches of the designated drug sold to them by the vendor of the lot or batch are consistently manufactured in accordance with and consistently comply with the specifications for that drug, and (ii) the designated drug has not been transported or stored under conditions that may affect its compliance with the specifications for that drug. (3) In subsection (2), a reference to specifications is a reference to the specifications with which the designated drug is required to comply within the jurisdiction of the foreign regulatory authority referred to in paragraph C.10.006(1)(b). (4) If the licensee receives on their premises in Canada a lot or batch of a designated drug whose useful life is more than 30 days, they shall visually inspect the lot or batch to confirm the identity of the product. (5) Subsections (2) and (4) do not apply to the licensee if the designated drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building and the following conditions are met: (a) the address of the building is set out in their establishment licence; and (b) they retain a copy of the batch certificate for each lot or batch of the designated drug that they receive for at least one year after the expiration date of the lot or batch. (6) In this section, specifications has the same meaning as in section C.02.002. SOR/2021-199, s. 5
Food and Drug Regulations — C.10.010
C.10.010 (1) A person who holds an establishment license and who imports a designated drug under section C.10.006 is required to comply with paragraphs C.02.020(1)(a), (b) and (d) in respect of the drug but is not required to maintain the records referred to in those paragraphs on their premises in Canada. (2) The Minister may request that the licensee provide to the Minister any of the records referred to in paragraphs C.02.020(1)(a), (b) or (d) in respect of the designated drug. (3) The licensee shall provide the requested records electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister. SOR/2021-199, s. 5
Food and Drug Regulations — C.10.011
C.10.011 (1) A person who holds an establishment licence shall not sell a designated drug that they imported under section C.10.006 unless they ensure that the information referred to in clause C.10.006(1)(a)(iii)(G) is available in English and French and in a manner that permits the safe use of the drug. (2) The licensee shall ensure that the information is available in accordance with subsection (1) until at least the end of the day on the latest expiration date of the designated drug that they imported. SOR/2021-199, s. 5
Food and Drug Regulations — C.11.001
C.11.001 (1) The following definitions apply in this Division. foreign regulatory authority has the same meaning as in subsection C.10.001(1). ( autorité réglementaire étrangère ) initial public health official means the public health official named in an authorization issued under subsection C.11.003(1). ( responsable de la santé publique initial ) public health official means (a) the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act ; (b) the Chief Medical Officer of Health, or equivalent, of a province; (c) the Medical Officer of Health, or equivalent, of a municipality; (d) the Surgeon General of the Canadian Armed Forces; or (e) the Chief Medical Officer of Public Health for the Department of Indigenous Services. ( responsable de la santé publique ) subsequent public health official means any public health official, other than the initial public health official, who obtains the quantity of a drug, or a portion of the quantity, that is specified in an authorization issued under subsection C.11.003(1). ( responsable de la santé publique subséquent ) (2) This Division applies to a drug for human use in dosage form for which a drug identification number has not been assigned under subsection C.01.014.2(1) or for which a notice of compliance has not been issued under section C.08.004 or C.08.004.01, including drugs that have ceased to be considered to be natural health products by virtue of subsection 103.15(2) of the Natural Health Products Regulations . SOR/2023-18, s. 4
Food and Drug Regulations — Food and Drug Regulations
initial public health official means the public health official named in an authorization issued under subsection C.11.003(1). ( responsable de la santé publique initial )
Food and Drug Regulations — (a)
public health official means (a) the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act ; (b) the Chief Medical Officer of Health, or equivalent, of a province; (c) the Medical Officer of Health, or equivalent, of a municipality; (d) the Surgeon General of the Canadian Armed Forces; or (e) the Chief Medical Officer of Public Health for the Department of Indigenous Services. ( responsable de la santé publique )
Food and Drug Regulations — Food and Drug Regulations
subsequent public health official means any public health official, other than the initial public health official, who obtains the quantity of a drug, or a portion of the quantity, that is specified in an authorization issued under subsection C.11.003(1). ( responsable de la santé publique subséquent )
Food and Drug Regulations — C.11.003
C.11.003 (1) The Minister may, after review of the application, issue an authorization to a manufacturer authorizing the sale of a specified quantity of the drug to the public health official for the use described in the application. (2) In reviewing the application, the Minister must consider whether there is an alternative mechanism that would address the emergency, event or incident. (3) The authorization must (a) set out the date of issue; (b) set out the name and contact information of the public health official; (c) set out the name and contact information of the manufacturer; (d) describe the emergency, event or incident; (e) state whether the drug is for immediate use or stockpiling or both; (f) describe the use for which the sale of the drug is authorized in order to address the emergency, event or incident; (g) set out the civic address of the place to which the drug is to be shipped by the manufacturer; (h) set out the following information about the drug: (i) its brand name, if any, and either its proper name, common name and chemical name or its identifying name, code, number or mark, (ii) its medicinal ingredients, (iii) its strength, (iv) its dosage form, (v) its recommended dosage and route of administration, and (vi) its recommended storage conditions; and (i) specify the quantity of the drug that may be sold. SOR/2023-18, s. 4
Food and Drug Regulations — C.11.004
C.11.004 The initial public health official must notify the Minister, in writing, of any change to the information provided under paragraph C.11.002(2)(g), subparagraph C.11.002(2)(i)(iv), paragraph C.11.002(2)(j) or subsection C.11.002(3), within 30 days after the day on which they become aware of the change. SOR/2023-18, s. 4
Food and Drug Regulations — C.11.005
C.11.005 (1) Subject to subsection C.11.008(2), these Regulations, other than sections A.01.010, A.01.014 and A.01.045, subsections C.01.001(1) and (1.1) and this Division, do not apply to a drug that is sold in accordance with an authorization. (2) In the case of a drug described in Schedule C or D of the Act, a drug that is sold in accordance with an authorization is exempt from the application of section 12 of the Act. SOR/2023-18, s. 4
Food and Drug Regulations — C.11.006
C.11.006 (1) The initial public health official must ensure that the drug bears a label or is accompanied by a document that clearly sets out the following information in English and French: (a) the name and civic address of the drug’s manufacturer; (b) a statement that the Minister has authorized the sale of the drug to address the emergency, event or incident described in the authorization; (c) a statement that the drug is to be used only for the use described in the authorization; (d) the drug’s brand name, if any, and either its proper name, common name and chemical name or its identifying name, code, number or mark; (e) the drug’s medicinal ingredients; (f) the drug’s strength; (g) the drug’s dosage form; (h) the drug’s recommended dosage and route of administration; (i) the drug’s lot number, if known; (j) all warnings and precautions in respect of the use of the drug, if any; (k) the drug’s expiration date, or, if there is no expiration date, the stability testing date or the date on which the drug should be retested, as specified by the manufacturer; (l) the drug’s recommended storage conditions; and (m) the net contents of the drug’s container, in terms of the weight, volume, size or number of units of the drug in the container. (2) Any subsequent public health official must ensure that the drug bears the label or is accompanied by the document. (3) If the initial public health official becomes aware of a change to any of the information referred to in paragraph (1)(a), (h), (j), (k) or (l), they must (a) ensure that the information on the drug’s label or in the accompanying document is updated; and (b) notify of the change, in writing and without delay, any person to whom they have sold any quantity of the drug. (4) If the person notified under paragraph (3)(b) is a subsequent public health official, they must notify of the change, in writing and without delay, any person to whom they have sold any quantity of the drug. (5) Any person who is notified under paragraph (3)(b) or subsection (4) must ensure that the updated information accompanies, in writing, any quantity of the drug that remains in their possession. SOR/2023-18, s. 4
Food and Drug Regulations — C.11.007
C.11.007 (1) In addition to the information required under subsection C.11.006(1), the initial public health official or any subsequent public health official, as the case may be, must make the following information available to the following persons, in writing, in English and French: (a) to the persons to whom the drug is administered and the persons who administer the drug, the known and potential benefits and risks associated with the use for which the sale of the drug is authorized, the recommended duration of use, if any, of the drug and instructions on how to report serious adverse drug reactions; and (b) to the persons who administer the drug, the information referred to in paragraphs C.11.002(2)(a), (b) and (e) and subparagraphs C.11.002(2)(g)(v), (vii) and (viii), if that information is not set out on the drug’s label or accompanying document. (2) If the initial public health official becomes aware of a change to any of the information referred to in subsection (1), they must, in writing and without delay, notify the relevant persons of the change. SOR/2023-18, s. 4
Food and Drug Regulations — C.11.008
C.11.008 (1) If the initial public health official is a person referred to in paragraph (d) of the definition public health official in subsection C.11.001(1), they must submit a written report to the Minister in respect of any serious adverse drug reaction to the drug, and include in the report the information referred to in paragraphs C.01.020.1(2)(b) to (l), no later than the 30th day after the day on which they become aware of the reaction. (2) If the initial public health official is a person referred to in any of paragraphs (a) to (c) or (e) of the definition public health official in subsection C.11.001(1), the written report is not required and section C.01.020.1 applies in respect of the provision of information relating to serious adverse drug reactions. SOR/2023-18, s. 4
Food and Drug Regulations — C.11.009
C.11.009 (1) The initial public health official must monitor the response to the drug in the emergency, event or incident — including monitoring information they receive relating to serious adverse drug reactions — and must take reasonable steps to obtain information on that response. (2) The initial public health official must, on request of the Minister, submit a written report to the Minister on the monitoring of the response to the drug in the emergency, event or incident during the time period specified by the Minister, as well as on any corrective measures taken as a result of the monitoring. SOR/2023-18, s. 4
Food and Drug Regulations — C.11.010
C.11.010 (1) The initial public health official must maintain all information about the sale and use of the drug in a way that allows them to submit the information, notices and reports referred to in sections C.11.004 and C.11.008 and subsection C.11.009(2). (2) The initial public health official and any subsequent public health official must maintain all information about the sale and use of the drug in a way that allows them to communicate with persons to whom the drug has been administered if the health of those persons may be endangered by its use. SOR/2023-18, s. 4
Food and Drug Regulations — C.11.011
C.11.011 The initial public health official or any subsequent public health official, as the case may be, must retain the information, notices and reports referred to in sections C.11.004 and C.11.008, subsection C.11.009(2) and section C.11.010, as applicable, for 15 years after the end of the period to which the information, notices and reports relate. SOR/2023-18, s. 4
Food and Drug Regulations — C.11.012
C.11.012 The initial public health official must account to the Minister for any unused quantity of stockpiled drug remaining in their possession at the end of the preceding calendar year by the January 30 that follows the first full calendar year during which the drug is stockpiled and then by January 30 of each subsequent year. SOR/2023-18, s. 4
Food and Drug Regulations — C.11.013
C.11.013 (1) The Minister may cancel an authorization if the Minister has reasonable grounds to believe that the drug presents a serious or imminent risk of injury to human health. (2) If the Minister cancels an authorization, the initial public health official must, without delay, notify of the cancellation any person to whom they have directly distributed any quantity of the drug. (3) These Regulations apply to any unused quantity of the drug as of the day on which the cancellation takes effect. SOR/2023-18, s. 4
Food and Drug Regulations — C.11.014
C.11.014 (1) The Minister may issue an authorization that permits an initial public health official who is a person referred to in paragraph (a), (d) or (e) of the definition public health official in subsection C.11.001(1) to sell a specified quantity of a stockpiled drug to a practitioner for use in the emergency treatment of a person under the care of that practitioner, if (a) the manufacturer of the drug has been issued a letter of authorization under subsection C.08.010(1) that authorizes the sale of a specified quantity of the drug to that practitioner for the emergency treatment of that person; and (b) the use of the drug specified in the letter of authorization is the same as the use described in the authorization issued to the manufacturer under subsection C.11.003(1). (2) This Division, other than this section, does not apply to a drug sold in accordance with an authorization issued under subsection (1). SOR/2023-18, s. 4
Food and Drug Regulations — Food and Drug Regulations
advertise means to advertise to the general public; ( faire de la publicité )
Food and Drug Regulations — (a)
common name means, with reference to a salt or derivative of a vitamin, the name in English or French by which the salt or derivative is (a) commonly known, and (b) designated in scientific or technical journals; ( nom usuel )
Food and Drug Regulations — Food and Drug Regulations
Food Compositional Standards Document has the same meaning as in subsection B.01.001(1); ( Document sur les normes de composition des aliments )
Food and Drug Regulations — Food and Drug Regulations
human milk fortifier has the same meaning as in section B.25.001; ( fortifiant pour lait humain )
Food and Drug Regulations — Food and Drug Regulations
human milk substitute has the same meaning as in section B.25.001; ( succédané de lait humain )
Food and Drug Regulations — Food and Drug Regulations
prepackaged product means any food that is contained in a package in the manner in which it is ordinarily sold to, or used or purchased by, a person; ( produit préemballé )
Food and Drug Regulations — Food and Drug Regulations
reasonable daily intake , in respect of a food named in an item in Column I of Schedule K, means the amount of that food set out in Column II of that item; ( ration quotidienne normale )
Food and Drug Regulations — Food and Drug Regulations
recommended daily intake [Repealed, SOR/2016-305, s. 61]
Food and Drug Regulations — Food and Drug Regulations
supplemental ingredient has the same meaning as in section B.01.001; ( ingrédient supplémentaire )
Food and Drug Regulations — Food and Drug Regulations
supplemented food has the same meaning as in section B.01.001; ( aliment supplémenté )