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

Regulations are current to 2018-12-12 and last amended on 2018-11-23. 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)(b)(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.

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 and C.01.014.10.

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 means, in respect of a drug, 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. (pénurie)

  • SOR/2016-139, s. 5;
  • SOR/2017-259, s. 8;
  • SOR/2018-69, ss. 17, 40.
  •  (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.

  • SOR/2016-139, s. 5;
  • SOR/2017-259, s. 9.
  •  (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.
 
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