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

Regulations are current to 2013-05-26 and last amended on 2013-03-21. Previous Versions

C.01.014.3. The manufacturer or importer or person authorized by the manufacturer or importer shall, within 30 days after commencing sale of a drug, date and sign the document issued pursuant to subsection C.01.014.2(1) in respect of the drug and return the document

  • (a) with a confirmation that the information recorded therein is correct;

  • (b) indicating the date on which the drug was first sold in Canada; and

  • (c) accompanied by samples or facsimiles of all labels and package inserts and any further prescribing information stated to be available on request.

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

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 Director of the change.

  • SOR/81-248, s. 2;
  • SOR/92-230, s. 2;
  • SOR/98-423, s. 6.

C.01.014.5. 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.

  • C.01.014.6. (1) The Director shall cancel the assignment of a drug identification number for a drug where

    • (a) the person to whom the number was assigned advises that the sale or import of the drug has been discontinued;

    • (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.