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Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2022-06-20 and last amended on 2022-03-02. Previous Versions

PART CDrugs (continued)

DIVISION 1 (continued)

Assignment and Cancellation of Drug Identification Numbers (continued)

  •  (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

Shortages of Drugs and Interruption and Discontinuation of Sale of Drugs

 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

 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

 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

 The following definitions apply in this section and in sections C.01.014.9 to C.01.014.14.

drug

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

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)

  •  (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.

  •  (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

 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
  •  (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.

 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.

  •  (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.

Tablet Disintegration Times

  •  (1) Subject to subsection (2), no person shall sell for human use a drug in the form of a tablet that is intended to be swallowed whole unless, when tested by the official method DO-25, Determination of the Disintegration Time of Tablets, dated July 5, 1989,

    • (a) in the case of an uncoated tablet, the tablet disintegrates in not more than 45 minutes;

    • (b) in the case of a plain coated tablet, the tablet disintegrates in not more than 60 minutes; and

    • (c) in the case where the label of the drug indicates that the tablet carries an enteric coating or a coating designed to serve a purpose similar to that of an enteric coating, the tablet does not disintegrate when exposed for 60 minutes to simulated gastric fluid, but when it is subsequently exposed for a continuous period to simulated intestinal fluid, the tablet disintegrates in not more than 60 minutes.

  • (2) Subsection (1) does not apply in respect of a drug in the form of a tablet where

    • (a) a notice of compliance in respect of the drug in the form of a tablet has been issued under section C.08.004 or C.08.004.01;

    • (b) [Repealed, SOR/98-423, s. 7]

    • (c) a dissolution or disintegration test for the drug in the form of a tablet is prescribed in Division 6 of this Part;

    • (d) the drug is labelled as complying with a standard contained in a publication referred to in Schedule B to the Act;

    • (e) the drug has been demonstrated by an acceptable method to be available to the body; or

    • (f) representations regarding the drug are made on its label, or in any advertisement, with respect to the site, rate or extent of release to the body of a medicinal ingredient of that drug, or the availability to the body of a medicinal ingredient of that drug.

  • SOR/89-429, s. 2
  • SOR/89-455, s. 3
  • SOR/94-36, s. 2
  • SOR/98-423, s. 7
  • SOR/2011-88, s. 4

Prohibition

 No manufacturer shall sell a drug unless the manufacturer complies with the conditions set out in sections C.01.017 to C.01.019.

  • SOR/95-521, s. 2
  • SOR/2011-31, s. 1

Serious Adverse Drug Reaction Reporting — Manufacturers

[
  • SOR/2019-190, s. 1
]

 The manufacturer shall submit to the Minister a report of all information relating to the following serious adverse drug reactions within 15 days after receiving or becoming aware of the information, whichever occurs first:

  • (a) any serious adverse drug reaction that has occurred in Canada with respect to the drug; and

  • (b) any serious unexpected adverse drug reaction that has occurred outside Canada with respect to the drug.

  • SOR/95-521, s. 2
  • SOR/2011-31, s. 1
 
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