GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — C.08.004.01
C.08.004.01 (1) Subject to section C.08.004.1, the Minister shall, after completing an examination of an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission, (a) if that submission or supplement complies with section C.08.002.01, 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.08.002.01, 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 an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission does not comply with section C.08.002.01, 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.08.004.01(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 an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission, (a) if that submission or supplement complies with section C.08.002.01, 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.08.002.01, 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 for extraordinary use 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/2011-88, s. 15 SOR/2019-62, s. 2
Food and Drug Regulations — C.08.004.1
n or a supplement to an abbreviated new drug submission by the manufacturer before the end of the period of six years specified in that paragraph. (7) Paragraph (3)(a) does not apply to a manufacturer if the manufacturer files an application for authorization to sell its new drug under section C.07.003. (8) Paragraph (3)(b) does not apply to a manufacturer if the innovator consents to the issuance of a notice of compliance to the manufacturer before the end of the period of eight years specified in that paragraph or of eight years and six months specified in subsection (4). (9) The Minister shall maintain a register of innovative drugs that includes information relating to the matters specified in subsections (3) and (4). SOR/95-411, s. 6; SOR/2006-241, s. 1; SOR/2011-88, s. 16; SOR/2014-124, s. 1 SOR/2020-74, s. 6 SOR/2021-45, s. 16
Food and Drug Regulations — Food and Drug Regulations
abbreviated new drug submission includes an abbreviated extraordinary use new drug submission. ( présentation abrégée de drogue nouvelle )
Food and Drug Regulations — Food and Drug Regulations
innovative drug means a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. ( drogue innovante )
Food and Drug Regulations — Food and Drug Regulations
new drug submission includes an extraordinary use new drug submission. ( présentation de drogue nouvelle )
Food and Drug Regulations — Food and Drug Regulations
pediatric populations means the following groups: premature babies born before the 37th week of gestation; full-term babies from 0 to 27 days of age; and all children from 28 days to 2 years of age, 2 years plus 1 day to 11 years of age and 11 years plus 1 day to 18 years of age. ( population pédiatrique )
Food and Drug Regulations — C.08.005
ng subsection (1), no manufacturer shall sell a new drug to a qualified investigator if the Minister has notified the manufacturer of that drug that such sales are prohibited. (5) Paragraph (1)(c) does not apply to a radiopharmaceutical as defined in section C.03.201 or to a component or kit as defined in section C.03.205. SOR/79-236, s. 5; SOR/85-143, s. 4; SOR/87-511, s. 1; SOR/93-202, s. 26; SOR/95-411, s. 7; SOR/2001-203, s. 6; SOR/2018-69, s. 27
Food and Drug Regulations — C.08.007
C.08.007 (1) Where a manufacturer has received a notice of compliance issued in respect of 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 manufacturer shall establish and maintain records, in a manner that enables an audit to be made, respecting (a) animal or clinical experience, studies, investigations and tests conducted by the manufacturer or reported to him by any person concerning that new drug; (b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that new drug; (c) experience, investigations, studies and tests involving the chemical or physical properties or any other properties of that new drug; (d) any substitution of another substance for that new drug or any mixing of another substance with that new drug; (e) any error in the labelling of that new drug or in the use of the labels designed for that new drug; (f) any bacteriological or any significant chemical or physical or other change or deterioration in any lot of that new drug; (g) any failure of one or more distributed lots of the new drug to meet the specifications established for that new drug in the submission or supplement; and (h) any unusual failure in efficacy of that new drug. (i) [Repealed, SOR/95-521, s. 3] (1.1) The manufacturer shall retain the records respecting the information referred to in subsection (1) for at least seven years from the day on which they were established. (2) A manufacturer or importer who sells a new drug for extraordinary use in accordance with section C.08.002.02 shall retain the written order for at least 15 years from the day on which the order was filled. SOR/95-411, s. 10; SOR/95-521, s. 3; SOR/2011-88, s. 19; SOR/2014-125, s. 2
Food and Drug Regulations — C.08.008
C.08.008 No manufacturer shall sell a new drug unless the manufacturer has, with respect to all the manufacturer’s previous sales of that new drug, furnished to the Minister (a) a summary of a record respecting any information referred to in paragraphs C.08.007(1)(a) to (c), on receipt of a request from the Minister for the summary; (b) a summary of a record respecting any information referred to in paragraph C.08.007(1)(d) to (f), immediately on the manufacturer establishing the record; and (c) a summary of a record respecting any information referred to in paragraph C.08.007(1)(g) or (h), within 15 days after the day on which the manufacturer established the record. SOR/95-411, s. 11; SOR/95-521, s. 4; SOR/2014-125, s. 3; SOR/2018-84, s. 12
Food and Drug Regulations — C.08.008.1
C.08.008.1 Where a manufacturer has received a notice of compliance issued in respect of an extraordinary use new drug submission, an abbreviated extraordinary use new drug submission or a supplement to either of those submissions, the manufacturer (a) shall adhere to the plan referred to in subparagraph C.08.002.01(2)(b)(ix); and (b) shall, before the first day of October in each year and whenever requested to do so by the Minister for the purposes of assessing the safety and effectiveness of the drug to which the notice of compliance relates, provide a report on the use of the drug, including a critical analysis of any available updated information respecting the drug’s safety and effectiveness. SOR/2011-88, s. 20
Food and Drug Regulations — C.08.009
C.08.009 (1) Where the Minister has decided (a) to notify the manufacturer of a new drug for veterinary use that the sale of that drug to qualified investigators is prohibited, or (b) to suspend a notice of compliance issued under section C.08.004 or C.08.004.01, the manufacturer, if dissatisfied with that decision, may require the Minister to provide him with the reasons for the decision. (2) Where the manufacturer has received the reasons for a decision of the Minister pursuant to subsection (1), he may require the Minister to refer that decision to a New Drug Committee and thereupon shall provide the Minister with a statement of the reasons for his dissatisfaction and any information and material upon which he relies in support of those reasons. (3) Where the Minister has been required to refer a decision to a New Drug Committee pursuant to subsection (2), he shall appoint a member of the New Drug Committee, the dissatisfied manufacturer shall appoint a member of the New Drug Committee and the two members so appointed shall appoint a third member of the New Drug Committee who shall be chairman, or, if they are unable to do so within a reasonable time, the Minister shall appoint a third member of the New Drug Committee who shall be chairman. (4) Any person who is in the full-time employment of the Department or in the full-time employment of the dissatisfied manufacturer shall not be appointed a member of a New Drug Committee. (4.1) A member of a New Drug Committee shall, on appointment, sign an undertaking not to disclose or use any information, material, data, evidence or representations considered pursuant to subsection (6). (5) The Minister shall pay the reasonable fees and costs incurred by the member of the New Drug Committee appointed by the Minister, and the dissatisfied manufacturer shall pay the reasonable fees and costs incurred by the member appointed by the dissatisfied manufacturer, and the Minister and the dissatisfied manufacturer shall each pay half of the reasonable fees and costs incurred by the chairman. (6) The New Drug Committee formed pursuant to subsection (3) shall consider the reasons for the decision of the Minister, the reasons for the dissatisfaction of the dissatisfied manufacturer and any information or material in support of the reasons of the Minister or the dissatisfied manufacturer and may consider other evidence, material, information or representations. (7) The New Drug Committee formed pursuant to subsection (3) shall report its findings and recommendations to the Minister. (7.1) No member of a New Drug Committee shall disclose or use any information, material, data, evidence or representations considered pursuant to subsection (6). (8) Where the Minister has received the findings and recommendations of a New Drug Committee, he may reconsider the decision to which those findings and recommendations relate. SOR/95-411, s. 12; SOR/2001-203, s. 9; SOR/2011-88, s. 21
Food and Drug Regulations — C.08.009.01
C.08.009.01 The following definitions apply in sections C.08.009.03 to C.08.009.05. Chief Public Health Officer means the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act . ( administrateur en chef de la santé publique ) dosage form class has the same meaning as in subsection C.01A.001(1). ( classe de forme posologique ) fabricate has the same meaning as in subsection C.01A.001(1). ( manufacturer ) foreign regulatory authority means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with the applicable legal requirements. ( autorité réglementaire étrangère ) package/label has the same meaning as in subsection C.01A.001(1). ( emballer-étiqueter ) SOR/2021-45, s. 17 SOR/2024-238, s. 34
Food and Drug Regulations — Food and Drug Regulations
Chief Public Health Officer means the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act . ( administrateur en chef de la santé publique )
Food and Drug Regulations — Food and Drug Regulations
dosage form class has the same meaning as in subsection C.01A.001(1). ( classe de forme posologique )
Food and Drug Regulations — Food and Drug Regulations
fabricate has the same meaning as in subsection C.01A.001(1). ( manufacturer )
Food and Drug Regulations — Food and Drug Regulations
foreign regulatory authority means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with the applicable legal requirements. ( autorité réglementaire étrangère )
Food and Drug Regulations — Food and Drug Regulations
package/label has the same meaning as in subsection C.01A.001(1). ( emballer-étiqueter )
Food and Drug Regulations — C.08.009.02
C.08.009.02 Sections C.08.009.03 to C.08.009.05 apply in respect of a public health emergency drug if (a) a notice of compliance has not been issued in respect of the drug under section C.08.004 or C.08.004.01; and (b) His Majesty in right of Canada has entered into a contract for the procurement of the drug. SOR/2021-45, s. 17 SOR/2024-238, s. 35
Food and Drug Regulations — C.08.009.03
C.08.009.03 (1) The holder of an establishment licence may import a public health emergency drug if (a) the Chief Public Health Officer provides the Minister with (i) the name and contact information of the holder, (ii) the name and contact information of the public health emergency drug’s manufacturer, (iii) the name of the public health emergency drug and a description of it, (iv) information indicating that the public health emergency drug is the subject of a new drug submission, a supplement to a new drug submission or an application made to a foreign regulatory authority to authorize its sale, (v) information specifying the quantity of the public health emergency drug to be imported, and (vi) the civic address of the place where the public health emergency drug will be stored after it is imported; (b) the holder provides the Minister with (i) the name and contact information of each fabricator, packager/labeller and tester of the public health emergency drug and the civic address of each building at which the drug will be fabricated, packaged/labelled or tested, specifying for each building (A) the activities referred to in Table I to section C.01A.008 that apply to the public health emergency drug, (B) the categories referred to in Table II to that section that apply to the public health emergency drug, and (C) for each of those categories, the dosage form classes, if any, and, in the case of a public health emergency drug that will be sterile, an indication to that effect, and (ii) a certificate from an inspector indicating that the buildings, equipment, practices and procedures of each fabricator, packager/labeller and tester meet the applicable requirements set out in Divisions 2 to 4 or, alternatively, other evidence establishing that those requirements are met; and (c) the public health emergency drug belongs to a category of drugs that are authorized to be imported under the establishment licence. (2) Paragraph (1)(b) does not apply to the holder of an establishment licence in respect of a building referred to in subparagraph (1)(b)(i) if (a) the building is listed in the licence; and (b) the information referred to in clauses (1)(b)(i)(A) to (C) that the holder submitted in respect of the building in their application for the licence under section C.01A.005 or in an application to amend the licence under section C.01A.006, has not changed. (3) If the conditions set out in subsection (1) are met, the Minister shall send a letter to the Chief Public Health Officer to that effect. SOR/2021-45, s. 17 SOR/2024-238, s. 36
Food and Drug Regulations — C.08.009.04
C.08.009.04 Sections A.01.040, C.01.004.1 and C.01A.006 and Divisions 2 to 4 of this Part, other than the following provisions, do not apply in respect of the importation of a public health emergency drug under section C.08.009.03 by the holder of an establishment licence: (a) sections C.02.003.1, C.02.004 and C.02.006, as they apply to the storage of the public health emergency drug by the holder; (b) subsection C.02.012(1); (c) section C.02.012.1, as it applies to the storage of the public health emergency drug by the holder; (d) sections C.02.013 and C.02.014; (e) section C.02.015, as it applies to the storage and transportation of the public health emergency drug by the holder; (f) subsection C.02.021(1), as it applies to the storage of the public health emergency drug by the holder; (g) subsection C.02.022(1); (h) section C.02.023; (i) subsection C.02.024(1); and (j) section C.03.013. SOR/2021-45, s. 17 SOR/2024-238, s. 37
Food and Drug Regulations — C.08.009.05
C.08.009.05 Despite anything in these Regulations, the holder of an establishment licence may distribute a public health emergency drug that they have imported under section C.08.009.03 if (a) the Chief Public Health Officer provides the Minister with the name of the public health emergency drug and the civic address of the place where it will be stored after distribution; and (b) the public health emergency drug is distributed to a person who will store it at that place. SOR/2021-45, s. 17 SOR/2024-238, s. 37
Food and Drug Regulations — C.08.009.1
C.08.009.1 (1) In sections C.08.009.2 and C.08.009.3, information in respect of a clinical trial means information in respect of a clinical trial , within the meaning of section C.05.001, that is contained in a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission for a new drug for human use filed under section C.08.002, C.08.002.01 or C.08.002.1 or in a supplement to any of those submissions filed under section C.08.003. (2) For greater certainty, the definition information in respect of a clinical trial includes information that is contained in a submission or supplement referred to in that definition and that is in respect of clinical testing involving human subjects in regards to which an application was filed under this Division before September 1, 2001. SOR/2019-62, s. 3
Food and Drug Regulations — C.08.009.2
C.08.009.2 (1) Information in respect of a clinical trial that is confidential business information ceases to be confidential business information when one of the following circumstances occurs with respect to the submission or supplement: (a) the Minister issues a notice of compliance under section C.08.004 or C.08.004.01; (b) in the case where the Minister issues a notice to the manufacturer under paragraph C.08.004(1)(b) or C.08.004.01(1)(b) and the manufacturer does not amend the submission or supplement under subsection C.08.004(2) or C.08.004.01(2), the applicable period referred to in the relevant subsection expires; (c) the Minister issues a notice to the manufacturer under paragraph C.08.004(3)(b) or C.08.004.01(3)(b). (2) Subsection (1) does not apply to information in respect of a clinical trial that (a) was not used by the manufacturer in the submission or supplement to support the proposed conditions of use for the new drug or the purpose for which the new drug is recommended; or (b) describes tests, methods or assays that are used exclusively by the manufacturer. SOR/2019-62, s. 3
Food and Drug Regulations — C.08.009.3
C.08.009.3 The Minister may disclose, without notifying the person to whose business or affairs the information relates or obtaining their consent, any information in respect of a clinical trial that has ceased to be confidential business information. SOR/2019-62, s. 3
Food and Drug Regulations — C.08.010
C.08.010 (1) The Minister may issue a letter of authorization to a manufacturer of a new drug authorizing the sale of a specified quantity of the new drug for human or veterinary use to a practitioner, for use in the emergency treatment of an animal or a person under the care of that practitioner, if (a) the practitioner provides the following information to the Minister: (i) the name of the new drug and details concerning the medical emergency for which the new drug is required, (ii) the quantity of the new drug that is required, (iii) subject to subsection (2), the information in the possession of the practitioner in respect of the use, safety and efficacy of the new drug, (iv) the name and the civic address of the person to whom the new drug is to be shipped, and (v) any other information the Minister may request to enable the Minister to determine whether to issue the letter of authorization; (b) the practitioner agrees to (i) provide a report to the manufacturer of the new drug and to the Minister describing the results obtained following the use of the new drug to address the medical emergency, including information respecting any adverse drug reactions observed by the practitioner, and (ii) account to the Minister, on request, for all quantities of the new drug received; (c) in the case of a new drug for human use, the person referred to in subparagraph (a)(iv) is a practitioner or a pharmacist; and (d) in the case of a new drug for veterinary use, the person referred to in subparagraph (a)(iv) is a practitioner, a pharmacist or a person who may sell a medicated feed pursuant to section C.08.012. (2) Subparagraph (1)(a)(iii) does not apply if the following conditions are met: (a) the sale of the new drug has been authorized under subsection (1) to address the same medical emergency on at least one previous occasion; (b) the European Medicines Agency or the United States Food and Drug Administration has authorized the sale of the new drug without terms or conditions, for the same use in its jurisdiction; and (c) the Minister has not cancelled the assignment of a drug identification number for the new drug under paragraph C.01.014.6(2)(b) or (c) or subsection C.01.014.6(3). (3) [Repealed, SOR/2021-271, s. 4] (4) The letter of authorization must contain the following information: (a) the name of the practitioner to whom the new drug may be sold; (b) the name and the civic address of the person to whom the new drug may be shipped; (c) the name of the new drug and the medical emergency in respect of which it may be sold; and (d) the quantity of the new drug that may be sold to the practitioner to address the medical emergency. (5) For the purposes of this section, the practitioner is not required to know the identity of the animal or the person under the care of that practitioner at the time the letter of authorization is issued. SOR/2013-172, s. 11; SOR/2018-69, ss. 31(E), 32(F) SOR/2020-212, s. 2 SOR/2021-271, s. 4
Food and Drug Regulations — C.08.011
C.08.011 (1) Despite section C.08.002, the manufacturer may sell a new drug in accordance with a letter of authorization issued under subsection C.08.010(1). (2) In the case of the sale under subsection (1) of a new drug for veterinary use that contains an active pharmaceutical ingredient set out in List A and that was not imported under section C.08.011.2, an annual report identifying the total quantity of the new drug that was sold, including an estimate of the quantity sold in respect of each animal species for which the drug is intended, must be submitted to the Minister by the manufacturer, if the new drug was present in Canada at the time of sale, otherwise by the practitioner. (3) The sale of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and these Regulations other than this section. (4) The annual report described in subsection (2) is for a period of one calendar year and must be submitted on or before March 31 of the year following the calendar year covered by the report, beginning with the first full calendar year during which the drug is first sold. SOR/2020-212, s. 2 SOR/2023-247, s. 3