GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — C.06.250
C.06.250 Thyroid shall be the cleaned, dried, powdered thyroid glands of domestic animals used for food, and shall contain not less than 0.17 per cent, and not more than 0.23 per cent iodine and no added iodine in either inorganic or organic form, and (a) its characters are Description , — (i) General , — thyroid occurs as a cream-coloured, amorphous powder; the odour and taste are faint and meat-like, and (ii) Microscopical , — when suitably mounted and examined under the microscope, thyroid shows the following: numerous smooth to striated hyaline fragments of colloids, of angular to irregular shape, that are colourless to pale yellow in water mounts, brown in Mallory’s stain and pink in solution of eosin , some of these fragments containing granules, minute vacuoles, crystalloidal bodies and cells; numerous irregular fragments of follicular epithelium staining brown with Mallory’s stain , the individual cells more or less polygonal to rounded-angular or irregularly cuboidal, often with prominent nuclei staining dark blue, their cytoplasm purplish with Delafield’s solution of haematoxylin ; slender glistening segments of capillaries of closely undulate outline; numerous slender segments of neuraxons; numerous aggregates of particles of intercellular substance and slender, mostly straight connective tissue fibres staining blue to greenish blue with a mixture of Mallory’s stain and solution of phosphotungstic acid , the bundles of fibres often appearing reddish in Mallory’s stain ; few glistening fragments of blood vessels with serrated or crenated ends as viewed in water mounts; and (b) the tests for its purity are (i) Inorganic iodine , — add to one gram of thyroid 10 millilitres of a saturated solution of zinc sulphate in water , shake, allow to stand five minutes, and filter through a fritted glass filter; add to five millilitres of the filtrate 0.5 millilitre of mucilage of starch and four drops each of a 10 per cent w/v solution of sodium nitrite in water and dilute sulphuric acid , shaking after each addition: no blue colour is produced, and (ii) Moisture , — thyroid loses not more than six per cent moisture.
Food and Drug Regulations — C.06.251
C.06.251 Thyroid shall be (a) assayed by official method DO-26, Thyroid, October 15, 1981; and (b) stored in a cool place and in a tightly-closed container. SOR/82-429, s. 8
Food and Drug Regulations — C.06.260 to C.06.264
C.06.260 to C.06.264 [Repealed, SOR/80-544, s. 12]
Food and Drug Regulations — C.06.270 to C.06.280
C.06.270 to C.06.280 [Repealed, SOR/80-544, s. 12]
Food and Drug Regulations — C.07.001
C.07.001 The definitions in this section apply in this Division. Commissioner of Patents means the Commissioner of Patents appointed under subsection 4(1) of the Patent Act. ( commissaire aux brevets ) General Council Decision has the meaning assigned by subsection 30(6) of the Act. ( décision du Conseil général ) SOR/2005-141, s. 1
Food and Drug Regulations — Food and Drug Regulations
Commissioner of Patents means the Commissioner of Patents appointed under subsection 4(1) of the Patent Act. ( commissaire aux brevets )
Food and Drug Regulations — Food and Drug Regulations
General Council Decision has the meaning assigned by subsection 30(6) of the Act. ( décision du Conseil général )
Food and Drug Regulations — C.07.002
C.07.002 This Division applies to the sale of drugs for the purposes of implementing the General Council Decision. SOR/2005-141, s. 1
Food and Drug Regulations — C.07.003
C.07.003 An application by a manufacturer for authorization to sell a drug under this Division shall be submitted to the Minister and shall contain the following information and documents: (a) a statement that the manufacturer intends to file an application with the Commissioner of Patents under section 21.04 of the Patent Act ; (b) in respect of a new drug, the submission number and date of filing of the new drug submission or abbreviated new drug submission filed under section C.08.002 or C.08.002.1, respectively, and of any supplement filed under section C.08.003 in respect of the drug; (c) in respect of a drug that is not a new drug, (i) the application number and date of filing of the application that has been filed under section C.01.014.1 in respect of the drug, or (ii) the drug identification number, if one has been assigned in respect of the drug pursuant to section C.01.014.2; (d) for a drug in a solid dosage form, the manner in which the drug is marked in accordance with paragraph C.07.008(a) and evidence that such manner does not alter the safety and efficacy of the drug; (e) for a drug in a dosage form that is not solid, the manner in which the immediate container is marked in accordance with paragraph C.07.008(a); and (f) a sample of the label for the drug that includes the information required by paragraph C.07.008(c). SOR/2005-141, s. 1
Food and Drug Regulations — C.07.004
C.07.004 The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the manufacturer’s drug meets the requirements of the Act and these Regulations if (a) the manufacturer has submitted to the Minister an application in accordance with section C.07.003 and a copy of the application filed by the manufacturer with the Commissioner of Patents under section 21.04 of the Patent Act ; (b) in respect of a new drug, an examination of the new drug submission or abbreviated new drug submission or supplement to either submission by the Minister demonstrates that the submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1; (c) in respect of a drug that is not a new drug, a drug identification number has been assigned pursuant to section C.01.014.2; and (d) the Minister is satisfied that the manufacturer and the drug comply with the Act and these Regulations. SOR/2005-141, s. 1
Food and Drug Regulations — C.07.005
C.07.005 Despite sections C.01.014, C.08.002 and C.08.003, a manufacturer may sell a drug under this Division if (a) the Minister has notified the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the drug meets the requirements of the Act and these Regulations; and (b) the manufacturer has received authorization under section 21.04 of the Patent Act . SOR/2005-141, s. 1
Food and Drug Regulations — C.07.006
C.07.006 Sections C.01.005 and C.01.014.1 to C.01.014.4 do not apply to new drugs sold under this Division. SOR/2005-141, s. 1
Food and Drug Regulations — C.07.007
C.07.007 The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.13(b) of the Patent Act in the event that the Minister is of the opinion that the manufacturer’s drug authorized to be sold under this Division has ceased to meet the requirements of the Act and these Regulations. SOR/2005-141, s. 1
Food and Drug Regulations — C.07.008
C.07.008 No person shall sell a drug under this Division unless (a) the drug itself permanently bears the mark “XCL”, in the case of a drug in a solid dosage form, or the immediate container permanently bears the mark “XCL”, in the case of a drug in a dosage form that is not solid; (b) the colour of the drug itself is significantly different from the colour of the version of the drug sold in Canada, in the case of a drug in a solid dosage form; and (c) the label of the drug permanently bears the mark “XCL”, followed by the export tracking number assigned by the Minister under section C.07.009 and the words “FOR EXPORT UNDER THE GENERAL COUNCIL DECISION. NOT FOR SALE IN CANADA.” or “ POUR EXPORTATION AUX TERMES DE LA DÉCISION DU CONSEIL GÉNÉRAL. VENTE INTERDITE AU CANADA .” SOR/2005-141, s. 1
Food and Drug Regulations — C.07.009
C.07.009 The Minister shall assign an export tracking number to each drug in respect of which the Minister has notified the Commissioner of Patents under section C.07.004. SOR/2005-141, s. 1
Food and Drug Regulations — C.07.010
C.07.010 The manufacturer shall, with respect to a drug authorized to be sold under this Division, (a) establish and maintain records, in a manner that enables an audit to be made, respecting the information referred to in subsection C.08.007(1), and retain those records for at least seven years from the day on which they were established; and (b) provide to the Minister the summaries referred to in section C.08.008. SOR/2005-141, s. 1; SOR/2014-125, s. 1
Food and Drug Regulations — C.07.011
C.07.011 The manufacturer shall notify the Minister in writing not less than 15 days before commencing the manufacture of the first lot of a drug authorized to be sold under this Division and not less than 15 days before the exportation of each subsequent lot of the drug. SOR/2005-141, s. 1
Food and Drug Regulations — C.08.001
C.08.001 For the purposes of the Act and this Division, new drug means a drug, other than a veterinary health product, (a) that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug; (b) that is a combination of two or more drugs, with or without other ingredients, and that has not been sold in that combination or in the proportion in which those drugs are combined in that drug, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug; or (c) with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration or duration of action, and that has not been sold for that use or condition of use in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug. SOR/95-172, s. 2; SOR/2017-76, s. 10
Food and Drug Regulations — C.08.001.1
C.08.001.1 For the purposes of this Division, Canadian reference product means (a) a drug in respect of which a notice of compliance is issued under section C.08.004 or C.08.004.01 and which is marketed in Canada by the innovator of the drug, (b) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, where a drug in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01 cannot be used for that purpose because it is no longer marketed in Canada, or (c) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, in comparison to a drug referred to in paragraph (a); ( produit de référence canadien ) designated COVID-19 drug [Repealed, SOR/2024-238, s. 24] List of Conditions that Threaten Public Health means the List of Conditions that Threaten Public Health in Canada , published on the Government of Canada’s website, as amended from time to time; ( Liste d’affections qui menacent la santé publique ) pharmaceutical equivalent means a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients; ( équivalent pharmaceutique ) public health emergency drug means a new drug for which the purpose and conditions of use recommended by the manufacturer relate to a condition that is described in the List of Conditions that Threaten Public Health; ( drogue pour urgence de santé publique ) specifications means a detailed description of a new drug and of its ingredients and includes (a) a statement of all properties and qualities of the ingredients that are relevant to the manufacture and use of the new drug, including the identity, potency and purity of the ingredients, (b) a detailed description of the methods used for testing and examining the ingredients, and (c) a statement of the tolerances associated with the properties and qualities of the ingredients. ( spécifications ) SOR/95-411, s. 3; SOR/2011-88, s. 9 SOR/2021-45, s. 13 SOR/2024-238, s. 24
Food and Drug Regulations — (a)
Canadian reference product means (a) a drug in respect of which a notice of compliance is issued under section C.08.004 or C.08.004.01 and which is marketed in Canada by the innovator of the drug, (b) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, where a drug in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01 cannot be used for that purpose because it is no longer marketed in Canada, or (c) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, in comparison to a drug referred to in paragraph (a); ( produit de référence canadien )
Food and Drug Regulations — Food and Drug Regulations
designated COVID-19 drug [Repealed, SOR/2024-238, s. 24]
Food and Drug Regulations — Food and Drug Regulations
List of Conditions that Threaten Public Health means the List of Conditions that Threaten Public Health in Canada , published on the Government of Canada’s website, as amended from time to time; ( Liste d’affections qui menacent la santé publique )
Food and Drug Regulations — Food and Drug Regulations
pharmaceutical equivalent means a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients; ( équivalent pharmaceutique )
Food and Drug Regulations — Food and Drug Regulations
public health emergency drug means a new drug for which the purpose and conditions of use recommended by the manufacturer relate to a condition that is described in the List of Conditions that Threaten Public Health; ( drogue pour urgence de santé publique )
Food and Drug Regulations — (a)
specifications means a detailed description of a new drug and of its ingredients and includes (a) a statement of all properties and qualities of the ingredients that are relevant to the manufacture and use of the new drug, including the identity, potency and purity of the ingredients, (b) a detailed description of the methods used for testing and examining the ingredients, and (c) a statement of the tolerances associated with the properties and qualities of the ingredients. ( spécifications )
Food and Drug Regulations — C.08.001.2
C.08.001.2 (1) The Minister may add a condition to the List of Conditions that Threaten Public Health only if the Minister has reasonable grounds to believe that (a) the condition presents, or is the result of, a significant risk to public health in Canada; and (b) immediate action is required to deal with the risk. (2) However, the Minister may add COVID-19 to the List of Conditions that Threaten Public Health, even if the criteria set out in subsection (1) are not met with respect to COVID-19 at the time of the addition, as long as the Minister has reasonable grounds to believe that the addition is necessary to protect public health or safety. SOR/2024-238, s. 25
Food and Drug Regulations — C.08.001.3
C.08.001.3 If a condition that is on the List of Conditions that Threaten Public Health is removed from the list, a public health emergency drug that relates to that condition continues to be considered a public health emergency drug for the purposes of this Division if (a) in respect of the public health emergency drug, a new drug submission has been filed under section C.08.002 or a supplement to a new drug submission has been filed under section C.08.003; (b) the condition is removed from the List after the submission or supplement is filed; and (c) the Minister has not issued, in respect of the submission or supplement, a notice of compliance under section C.08.004 or a notice under paragraph C.08.004(3)(b). SOR/2024-238, s. 25
Food and Drug Regulations — C.08.002.01
the Minister, be added to the extraordinary use new drug submission, including (a) the names and addresses of the manufacturers of each of the ingredients of the new drug and the names and addresses of the manufacturers of the new drug in the dosage form in which it is proposed to be sold; (b) samples of the ingredients of the new drug; (c) samples of the new drug in the dosage form in which it is proposed to be sold; and (d) any information omitted by virtue of subsection (3). (5) If an extraordinary use new drug submission is in respect of a new purpose for a new drug for which a notice of compliance has been issued under section C.08.004, the information and material referred to in subparagraph (2)(b)(i) may be omitted unless any of it is different from that which was originally submitted. SOR/2011-88, s. 11; SOR/2014-158, s. 11
Food and Drug Regulations — C.08.002.02
C.08.002.02 Despite sections C.08.002 and C.08.003, no manufacturer or importer shall sell a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01 except to (a) the Government of Canada or the government of a province for the use of a department or agency of that government, on receipt of a written order signed by the minister responsible for the department or by the person in charge of the agency, or by their duly authorized representative; or (b) a municipal government, or an institution of such a government, on receipt of a written order signed by a senior official of the government or institution or by his or her duly authorized representative. SOR/2011-88, s. 11
Food and Drug Regulations — C.08.003.01
C.08.003.01 (1) The following definitions apply in this section. submission means (a) a new drug submission that is filed under section C.08.002; (b) an extraordinary use new drug submission that is filed under section C.08.002.01; (c) an abbreviated new drug submission that is filed under section C.08.002.1; or (d) an abbreviated extraordinary use new drug submission that is filed under section C.08.002.1. ( présentation ) supplement means a supplement to a submission that is filed under section C.08.003. ( supplément ) (2) Despite sections C.08.002, C.08.002.01, C.08.002.1 and C.08.003 and subject to subsection (3), the manufacturer of a new drug is not permitted to file a submission or supplement for the new drug on the basis of a direct or indirect comparison to any new drug in respect of which an authorization was issued under the ISAD Interim Order. (3) Subsection (2) does not prevent the manufacturer of a new drug from filing a submission or supplement for the new drug on the basis of a direct or indirect comparison to another new drug in respect of which an authorization was issued under the ISAD Interim Order if (a) a notice of compliance is issued under section C.08.004 or C.08.004.01 in respect of a submission or supplement for that other new drug; and (b) the comparison is in respect of the matters that were approved by the notice of compliance. SOR/2021-45, s. 15
Food and Drug Regulations — (a)
submission means (a) a new drug submission that is filed under section C.08.002; (b) an extraordinary use new drug submission that is filed under section C.08.002.01; (c) an abbreviated new drug submission that is filed under section C.08.002.1; or (d) an abbreviated extraordinary use new drug submission that is filed under section C.08.002.1. ( présentation )
Food and Drug Regulations — Food and Drug Regulations
supplement means a supplement to a submission that is filed under section C.08.003. ( supplément )
Food and Drug Regulations — C.08.003.1
C.08.003.1 In examining a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions, the Minister may, for the purpose of assessing the safety and effectiveness of the new drug for which the submission or supplement was filed, examine (a) information or material provided by any person under the Act; (b) information or material obtained from sites at which the new drug or any active ingredient , as defined in subsection C.01A.001(1), of the new drug is or is proposed to be fabricated or packaged/labelled within the meaning of those terms in that subsection, or tested; and (c) information or material obtained directly or indirectly from a foreign regulatory authority , as defined in subsection C.10.001(1). SOR/95-411, s. 6; SOR/2001-203, s. 5; SOR/2011-88, s. 14 SOR/2024-238, s. 30
Food and Drug Regulations — C.08.004
C.08.004 (1) Subject to section C.08.004.1, the Minister shall, after completing an examination of a new drug submission or abbreviated new drug submission or a supplement to either submission, (a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or (b) if that submission or supplement does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, issue a notice to the manufacturer to that effect. (2) If a new drug submission or an abbreviated new drug submission or a supplement to either submission does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, the manufacturer who filed the submission or supplement may amend the submission or supplement by filing additional information or material within 90 days after the day on which the Minister issues a notice to the manufacturer under paragraph C.08.004(1)(b) or within any longer period specified by the Minister. (3) Subject to section C.08.004.1, the Minister shall, after completing an examination of any additional information or material filed in respect of a new drug submission or an abbreviated new drug submission or a supplement to either submission, (a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or (b) if that submission or supplement does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, issue a notice to the manufacturer to that effect. (4) A notice of compliance issued in respect of a new drug on the basis of information and material contained in a submission filed pursuant to section C.08.002.1 shall state the name of the Canadian reference product referred to in the submission and shall constitute a declaration of equivalence for that new drug. SOR/84-267, ss. 1 to 3; SOR/85-143, s. 3; SOR/86-1009, s. 1; SOR/86-1101, s. 1; SOR/88-42, s. 1; SOR/88-257, s. 1; SOR/95-411, s. 6 SOR/2019-62, s. 1