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

Regulations are current to 2017-07-03 and last amended on 2017-06-20. Previous Versions

  •  (1) Subject to subsection (2), if a manufacturer or importer has provided all the information 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 Director shall issue to the manufacturer or importer a document that

    • (a) sets out

      • (i) the drug identification number assigned for the drug, preceded by the letters “DIN”, or

      • (ii) if there are two or more brand names for the drug, the drug identification numbers assigned by the Director for the drug, each of which pertains to one of the brand names and is preceded by the letters “DIN”; and

    • (b) contains the information referred to in paragraphs C.01.014.1(2)(a) to (f).

  • (2) Where the Director believes on reasonable grounds that a 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 that its sale would cause injury to the health of the consumer or purchaser or would be a violation of the Act or these Regulations,

    he may refuse to issue the document referred to in subsection (1).

  • (3) Where the Director, pursuant to subsection (2), refuses to issue the document, the applicant may submit additional information and request the Director to reconsider his decision.

  • (4) On the basis of the additional information submitted pursuant to subsection (3), the Director 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.

 The manufacturer or importer, as the case may be, or a person authorized by the manufacturer or importer, shall, within 30 days after the day on which the drug is first sold in Canada, date and sign the document referred to in subsection C.01.014.2(1) and return it with a statement set out on it that the information it contains is correct and with an indication of the date on which the drug was first sold in Canada.

  • SOR/81-248, s. 2;
  • SOR/98-423, s. 5;
  • SOR/2014-158, s. 8.

 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 Director of the change.

  • SOR/81-248, s. 2;
  • SOR/92-230, s. 2;
  • SOR/98-423, s. 6;
  • SOR/2016-139, s. 2(F).

 Every manufacturer of a drug shall, annually before the first day of October and in a form authorized by the Director, furnish the Director with a notification signed by the manufacturer or by a person authorized to sign on his behalf, confirming that all the information previously supplied by the manufacturer with respect to that drug is correct.

  • SOR/81-248, s. 2.
  •  (1) The Director shall cancel the assignment of a drug identification number for a drug where

    • (a) the person to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug advises under section C.01.014.7 that they have discontinued the sale of the drug;

    • (b) the drug is a new drug in respect of which the notice of compliance has been suspended pursuant to section C.08.006; or

    • (c) it has been determined that the product in respect of which the number was assigned is not a drug.

  • (2) The Director may cancel the assignment of a drug identification number for a drug where

    • (a) the manufacturer of the drug has failed to comply with section C.01.014.5; or

    • (b) the manufacturer to whom the number was assigned has been notified pursuant to section C.01.013 that the evidence he submitted in respect of the drug is insufficient.

  • SOR/81-248, s. 2;
  • SOR/2016-139, s. 3.

Shortages of Drugs and Interruption and Discontinuation of Sale of Drugs

 The person 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 under that subsection;

  • (b) the date on which the person discontinued the sale of the drug; and

  • (c) the latest expiration date of the drug that the person sold and the lot number of that drug.

  • SOR/81-248, s. 2;
  • SOR/2016-139, s. 5.

 The following definitions apply in this section and in sections C.01.014.9 to C.01.014.12.

drug

drug means

  • (a) any of the following drugs for human use in respect of which a drug identification number was assigned under subsection C.01.014.2(1):

    • (i) drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act,

    • (ii) prescription drugs,

    • (iii) drugs that are listed in Schedule D to the Act, and

    • (iv) drugs that are permitted to be sold without a prescription but that are administered only under the supervision of a practitioner; or

  • (b) a drug that is listed in Schedule C to the Act. (drogue)

shortage

shortage means a situation in which an authorization holder for a drug is unable to meet the demand for the drug. (pénurie)

  • SOR/2016-139, s. 5.
  •  (1) If a shortage of a drug exists or is likely to occur, the authorization holder 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 authorization holder’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 under subsection C.01.014.2(1), if applicable;

    • (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 authorization holder will be able to meet the demand for the drug, if the authorization holder can anticipate that date; and

    • (l) the actual or anticipated reason for the shortage.

  • (2) The authorization holder 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 an authorization holder 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 authorization holder is able to meet the demand for the drug, they shall post information on the website to that effect.

  • SOR/2016-139, s. 5.
 
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