GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — C.01.014.1
C.01.014.1 (1) A manufacturer of a drug may make an application for a drug identification number for that drug. (2) An application under subsection (1) shall be made to the Minister in writing and shall include the following information and material: (a) the name of the manufacturer of the drug as it will appear on the label; (b) the pharmaceutical form in which the drug is to be sold; (c) in the case of any drug other than a drug described in paragraph (d), the recommended route of administration; (d) in the case of a drug for disinfection in premises, the types of premises for which its use is recommended; (e) a quantitative list of the medicinal ingredients contained in the drug by their proper names or, if they have no proper names, by their common names; (f) the brand name under which the drug is to be sold; (g) an indication of whether the drug is for human use or veterinary use; (h) the name and quantity of each colouring ingredient that is not a medicinal ingredient; (i) the use or purpose for which the drug is recommended; (j) the recommended dosage of the drug; (k) the address of the manufacturer referred to in paragraph (a) and, where the address is outside the country, the name and address of the importer of the drug; (l) the name and address of any individual, firm, partnership or corporation, other than the names and addresses referred to in paragraphs (a) and (k), that will appear on the label of the drug; (m) in the case of a drug for veterinary use, the written text of every label to be used in connection with the drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the drug; (m.1) in the case of a drug for human use, mock-ups of every label to be used in connection with the drug — including any package insert and any document that is provided on request and that sets out supplementary information on the use of the drug — and mock-ups of the drug’s packages; (n) the name and title of the person who signed the application and the date of signature; and (o) in the case of a drug for human use, an assessment as to whether there is a likelihood that the drug will be mistaken for another drug for which a drug identification number has been assigned due to a resemblance between the brand name that is proposed to be used in respect of the drug and the brand name, common name or proper name of the other drug. (3) In the case of a new drug, a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission filed under section C.08.002, C.08.002.01 or C.08.002.1 shall be regarded as an application for a drug identification number. SOR/81-248, s. 2; SOR/93-202, s. 4; SOR/98-423, s. 3; SOR/2011-88, s. 2; SOR/2014-158, s. 7; SOR/2017-259, s. 4; SOR/2018-69, ss. 27, 33(F)
Food and Drug Regulations — C.01.014.2
C.01.014.2 (1) Subject to subsection (2), if a manufacturer has provided all the information and material described in subsection C.01.014.1(2) or section C.08.002, C.08.002.01 or C.08.002.1, as the case may be, in respect of a drug, the Minister shall issue to the manufacturer a document that (a) sets out (i) the drug identification number assigned for the drug, preceded by the abbreviation “DIN”, or (ii) if there are two or more brand names for the drug, the drug identification numbers assigned by the Minister for the drug, each of which pertains to one of the brand names and is preceded by the abbreviation “DIN”; and (b) contains the information referred to in paragraphs C.01.014.1(2)(a) to (f). (2) The Minister may refuse to issue the document referred to in subsection (1) if he or she has reasonable grounds to believe that the product in respect of which an application referred to in section C.01.014.1 has been made (a) is not a drug, or (b) is a drug but its sale would cause injury to the health of the purchaser or consumer or would be a contravention of the Act or these Regulations. (3) If the Minister refuses to issue the document under subsection (2), the manufacturer may submit additional information or material and request the Minister to reconsider his or her decision. (4) On the basis of the additional information or material submitted under subsection (3), the Minister shall reconsider the grounds on which the refusal to issue the document was made. SOR/81-248, s. 2; SOR/92-230, s. 1; SOR/98-423, s. 4; SOR/2011-88, s. 3; SOR/2017-259, s. 5; SOR/2018-69, ss. 16, 27, 37
Food and Drug Regulations — C.01.014.21
C.01.014.21 (1) The Minister may, at any time, impose terms and conditions on a drug identification number assigned for a Class B opioid or amend those terms and conditions. (1.1) The Minister may, at any time, impose terms and conditions on a drug identification number assigned for a public health emergency drug or amend such terms and conditions if (a) a notice of compliance was issued under section C.08.004 in respect of (i) a new drug submission that was filed for the public health emergency drug under section C.08.002 and contains the statement referred to in paragraph C.08.002(2.1)(a), or (ii) a supplement to any new drug submission that was filed for the public health emergency drug under section C.08.003 and contains the statement referred to in paragraph C.08.003(5)(a); or (b) a notice of compliance was issued under section C.08.004 in respect of one of the following submissions or supplements that was filed in respect of the public health emergency drug on the basis of a direct or indirect comparison to another public health emergency drug referred to in paragraph (a): (i) a new drug submission under section C.08.002, (ii) an abbreviated new drug submission under section C.08.002.1, or (iii) a supplement to a new drug submission or abbreviated new drug submission under section C.08.003. (2) The Minister shall notify, in writing, the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number of any terms and conditions imposed on the drug identification number and of any amendment to those terms and conditions. (3) The following definitions apply in this section. Class B opioid means a drug set out in Part B of the List of Opioids , published by the Government of Canada on its website, as amended from time to time. ( opioïde de catégorie B ) designated COVID-19 drug [Repealed, SOR/2024-238, s. 7] public health emergency drug has the same meaning as in section C.08.001.1. ( drogue pour urgence de santé publique ) SOR/2018-77, s. 4 SOR/2021-45, s. 2 SOR/2024-238, s. 7
Food and Drug Regulations — Food and Drug Regulations
Class B opioid means a drug set out in Part B of the List of Opioids , published by the Government of Canada on its website, as amended from time to time. ( opioïde de catégorie B )
Food and Drug Regulations — Food and Drug Regulations
designated COVID-19 drug [Repealed, SOR/2024-238, s. 7]
Food and Drug Regulations — Food and Drug Regulations
public health emergency drug has the same meaning as in section C.08.001.1. ( drogue pour urgence de santé publique )
Food and Drug Regulations — C.01.014.3
C.01.014.3 The manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug shall, within 30 days after the day on which the drug is first sold following the issuance by the Minister of the document, date and sign the document and return it to the Minister with a statement set out on it that the information it contains is correct and with an indication of the date of that first sale. SOR/81-248, s. 2; SOR/98-423, s. 5; SOR/2014-158, s. 8; SOR/2017-259, s. 6; SOR/2018-69, s. 38
Food and Drug Regulations — C.01.014.4
C.01.014.4 If the information referred to in subsection C.01.014.1(2) in respect of a drug is no longer correct owing to a change in the subject matter of the information, (a) in the case of a change in the subject matter of any of the information referred to in paragraphs C.01.014.1(2)(a) to (f) (i) that occurs prior to the sale of the drug, a new application shall be made, or (ii) that occurs after the sale of the drug, no further sale of the drug shall be made until a new application for a drug identification number in respect of that drug is made and a number is assigned; and (b) in the case of a change in the subject matter of any of the information referred to in paragraphs C.01.014.1(2)(g) to (k) (i) that occurs prior to the sale of the drug, the particulars of the change shall be submitted with the return of the document referred to in section C.01.014.3, or (ii) that occurs after the sale of the drug, the person to whom the drug identification number in respect of that drug was issued shall, within 30 days of the change, inform the Minister of the change. SOR/81-248, s. 2; SOR/92-230, s. 2; SOR/98-423, s. 6; SOR/2016-139, s. 2(F); SOR/2018-69, s. 27
Food and Drug Regulations — C.01.014.5
C.01.014.5 (1) The manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug shall, annually before the first day of October and in a form established by the Minister, provide the Minister with a notification that is signed by them and that (a) indicates whether any of the following circumstances apply in respect of the drug: (i) as of the day on which the notification is sent, (A) the manufacturer sells the drug in Canada, or (B) the manufacturer has discontinued the sale of the drug in Canada, or (ii) the manufacturer has not sold the drug in Canada for a period that is greater than 12 months and a portion of that period is covered by the notification; and (b) subject to subsection (2), confirms that the information that the manufacturer previously submitted with respect to the drug under subsection C.01.014.1(2), paragraph C.01.014.4(b) or section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, is correct as of the day on which the notification is sent. (2) If any of the information that the manufacturer submitted under a provision referred to in paragraph (1)(b) is not correct as of the day on which the notification is sent, the manufacturer shall update that information in the notification. SOR/81-248, s. 2; SOR/2017-259, s. 7; SOR/2018-69, ss. 27, 39
Food and Drug Regulations — C.01.014.6
C.01.014.6 (1) The Minister shall cancel the assignment of a drug identification number for a drug if (a) the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number advises under section C.01.014.7 that they discontinued the sale of the drug; or (c) the Minister determines that the product for which the drug identification number has been assigned is not a drug. (2) The Minister may cancel the assignment of a drug identification number for a drug if (a) the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number contravenes section C.01.014.5; (b) the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number has been notified under section C.01.013 that the evidence that they submitted with respect to the drug is not sufficient; or (c) the drug is a new drug in respect of which the notice of compliance has been suspended under section C.08.006. (3) The Minister may cancel the assignment of a drug identification number for a drug if, after he or she has, under section 21.31 of the Act, ordered the holder of a therapeutic product authorization referred to in subparagraph C.01.052(1)(a)(i) or (iii) to conduct an assessment of the drug in order to provide evidence establishing that the benefits associated with the drug outweigh the risks of injury to health, (a) the holder fails to comply with the order; or (b) the holder complies with the order but the Minister determines that the results of the assessment are not sufficient to establish that the benefits associated with the drug outweigh the risks of injury to health. (4) For greater certainty, the Minister’s power to cancel the assignment of a drug identification number (a) under paragraph (2)(b) is not affected by his or her power to cancel the assignment of such a number under subsection (3); and (b) under subsection (3) is not affected by his or her power to cancel the assignment of such a number under paragraph (2)(b). SOR/81-248, s. 2; SOR/2016-139, s. 3; SOR/2017-259, s. 7; SOR/2018-69, ss. 27, 39; SOR/2018-84, ss. 1, 13 SOR/2020-262, s. 1
Food and Drug Regulations — C.01.014.7
C.01.014.7 The manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug shall, within 30 days after the day on which they discontinue the sale of the drug, submit the following information to the Minister: (a) the drug identification number assigned for the drug; (b) the date on which the manufacturer discontinued the sale of the drug; and (c) the latest expiration date of the drug that the manufacturer sold and the lot number of that drug. SOR/81-248, s. 2; SOR/2016-139, s. 5; SOR/2017-259, s. 8
Food and Drug Regulations — C.01.014.71
C.01.014.71 If a period of 12 months has elapsed since the day on which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug as defined in section C.01.014.8 last sold the drug, the manufacturer shall so notify the Minister in writing within 30 days after the day on which that period ends. SOR/2017-259, s. 8
Food and Drug Regulations — C.01.014.72
C.01.014.72 If the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug resumes the sale of the drug after a period of 12 months has elapsed since the day on which they last sold the drug, the manufacturer shall so notify the Minister in writing within 30 days after the day on which they resume the sale of the drug. SOR/2017-259, s. 8
Food and Drug Regulations — C.01.014.8
C.01.014.8 The following definitions apply in this section and in sections C.01.014.9 to C.01.014.14. drug means any of the following drugs for human use for which a drug identification number has been assigned: (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 ) shortage , in respect of a drug, means a situation in which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug is unable to meet the demand for the drug in Canada. ( pénurie ) SOR/2016-139, s. 5; SOR/2017-259, s. 8; SOR/2018-69, ss. 17, 40 SOR/2021-199, s. 1
Food and Drug Regulations — (a)
drug means any of the following drugs for human use for which a drug identification number has been assigned: (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
shortage , in respect of a drug, means a situation in which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug is unable to meet the demand for the drug in Canada. ( pénurie )
Food and Drug Regulations — C.01.014.9
C.01.014.9 (1) If a shortage of a drug exists or is likely to occur, the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug shall post the following information in English and French on a website that is operated by a party for that purpose with whom Her Majesty in right of Canada has entered into a contract to make that information available to the public: (a) the manufacturer’s name and their telephone number, email address, website address, postal address or any other information that enables communication with them; (b) the drug identification number assigned for the drug; (c) the drug’s brand name and proper name or, if it does not have a proper name, its common name; (d) the proper names of the drug’s medicinal ingredients or, if they do not have proper names, their common names; (e) the drug’s therapeutic classification according to the Anatomical Therapeutic Chemical classification system (ATC), established by the World Health Organization Collaborating Centre for Drug Statistics Methodology — namely the level 3 description of, and level 4 code for, the drug; (f) the drug’s strength; (g) the drug’s dosage form; (h) the quantity of the drug contained in its package; (i) the drug’s route of administration; (j) the date when the shortage began or is anticipated to begin; (k) the anticipated date when the manufacturer will be able to meet the demand for the drug, if they can anticipate that date; and (l) the actual or anticipated reason for the shortage. (2) The manufacturer shall post the information (a) if they anticipate that a shortage will begin in more than six months, at least six months before the day on which they anticipate it to begin; (b) if they anticipate that a shortage will begin in six months or less, within five days after the day on which they anticipate it; or (c) if they did not anticipate the shortage, within five days after the day on which they become aware of it. (3) If any of the information that was posted by the manufacturer changes, they shall update that information on the website within two days after the day on which they make or become aware of the change. (4) Within two days after the day on which the manufacturer is able to meet the demand for the drug, they shall post information on the website to that effect. (5) This section does not apply in respect of a shortage of a drug that results from a decision by the manufacturer to discontinue its sale. SOR/2016-139, s. 5; SOR/2017-259, s. 9 SOR/2021-199, s. 2
Food and Drug Regulations — C.01.014.10
C.01.014.10 (1) If the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug decides to discontinue the sale of the drug, they shall post the following information in English and French on the website referred to in subsection C.01.014.9(1): (a) the manufacturer’s name and their telephone number, email address, website address, postal address or any other information that enables communication with them; (b) the drug identification number assigned for the drug; (c) the drug’s brand name and proper name or, if it does not have a proper name, its common name; (d) the proper names of the drug’s medicinal ingredients or, if they do not have proper names, their common names; (e) the drug’s therapeutic classification according to the Anatomical Therapeutic Chemical classification system (ATC), established by the World Health Organization Collaborating Centre for Drug Statistics Methodology — namely the level 3 description of, and level 4 code for, the drug; (f) the drug’s strength; (g) the drug’s dosage form; (h) the quantity of the drug contained in its package; (i) the drug’s route of administration; (j) the date on which the manufacturer will discontinue the sale of the drug; and (k) the reason for the discontinuation of sale. (2) The manufacturer shall post the information (a) if they decide to discontinue the sale of the drug in more than six months, at least six months before the day on which they will discontinue its sale; and (b) if they decide to discontinue the sale of the drug in six months or less, within five days after the day on which that decision is made. (3) If any of the information that was posted by the manufacturer changes, they shall update that information on the website within two days after the day on which they make or become aware of the change. SOR/2016-139, s. 5; SOR/2017-259, s. 10
Food and Drug Regulations — C.01.014.11
C.01.014.11 The Minister shall ensure that a hyperlink to the website referred to in subsection C.01.014.9(1) is on the Government of Canada website. SOR/2016-139, s. 5; SOR/2017-259, s. 11
Food and Drug Regulations — C.01.014.12
C.01.014.12 (1) The Minister may request that the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug — or any person who holds an establishment licence in respect of a drug — provide the Minister with information that is in their control if the Minister has reasonable grounds to believe that (a) there is a shortage or risk of shortage of the drug; (b) the information is necessary to establish or assess (i) the existence of a shortage or risk of shortage of the drug, (ii) the reason for a shortage or risk of shortage of the drug, (iii) the effects or potential effects on human health of a shortage of the drug, or (iv) measures that could be taken to prevent or alleviate a shortage of the drug; and (c) the manufacturer or licensee will not provide the information without a legal obligation to do so. (2) The manufacturer or licensee shall provide the requested information electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister. SOR/2021-199, s. 3
Food and Drug Regulations — C.01.014.13
C.01.014.13 No person who holds an establishment licence shall distribute a drug for consumption or use outside Canada unless the licensee has reasonable grounds to believe that the distribution will not cause or exacerbate a shortage of the drug. SOR/2021-199, s. 3
Food and Drug Regulations — C.01.014.14
C.01.014.14 (1) If a person who holds an establishment licence distributes a drug for consumption or use outside Canada, the licensee shall immediately create a detailed record of the information that they relied on to determine that the distribution of the drug is not prohibited by section C.01.014.13. (2) The licensee shall retain the record for at least one year after the latest expiration date of the drug that they distributed. SOR/2021-199, s. 3