Food and Drug Regulations

C.01.051 (1) If a manufacturer who sells a drug in dosage form or an active ingredient or a person who imports into and sells a drug in dosage form or an active ingredient in Canada decides to recall any of those drugs without being ordered to do so by the Minister, the manufacturer or importer shall, within 24 hours after making the decision, provide the Minister with the following information in writing:

• (a) the drug’s proper name or the common name, if there is no proper name;

• (b) an indication as to whether the drug is a drug in dosage form or an active ingredient;

• (c) in the case of a drug in dosage form,

  • (i) the brand name,

  • (ii) the drug identification number assigned under subsection C.01.014.2(1),

  • (iii) the dosage form,

  • (iv) the strength,

  • (v) the names of the persons in Canada, other than consumers that purchased the drug at the retail level, to whom the drug was sold by the manufacturer or importer and the quantity sold to each of the named persons, and

  • (vi) an assessment of the effect that the recall may have on the manufacturer’s or importer’s ability to meet demand for the drug in Canada;

• (d) the lot numbers of the drug;

• (e) the dates of fabrication of the drug;

• (f) the expiration dates of the drug;

• (g) the quantity of the drug that was fabricated in Canada;

• (h) the quantity of the drug that was imported;

• (i) the quantity of the drug that the manufacturer or importer sold to persons in Canada and the period during which it was sold;

• (j) the quantity of the drug that the manufacturer or importer exported, as well as the quantity exported, by country;

• (k) the quantity of the drug in Canada that is in the possession or control of the manufacturer or importer;

• (l) an assessment of the risk of injury to human health posed by the drug, including because of a failure of its effectiveness;

• (m) the names and civic addresses of the manufacturer and fabricator of the drug and of any importers of the drug;

• (n) the name and contact information of the individual who is responsible for the recall;

• (o) the expected dates for the start and completion of the recall; and

• (p) the reasons for the recall and the date on which and manner in which the situation that prompted the recall was discovered.

(2) The manufacturer or importer shall

• (a) before starting the recall, provide the Minister with a copy of any communications that the manufacturer or importer intends to use in connection with the start of the recall; and

• (b) after starting the recall, provide the Minister, on request and within the time specified by the Minister, with a copy of any additional communications that the manufacturer or importer uses, or intends to use, in connection with the recall.

(3) The manufacturer or importer shall, within 72 hours after making the decision to recall the drug, provide the Minister with the following information in writing:

• (a) the strategy for conducting the recall, including the time and manner in which the Minister will be informed of the progress of the recall; and

• (b) a description of the measures that are intended to be taken to prevent a recurrence of the situation that prompted the recall.

(4) The manufacturer or importer shall, within 30 days after completing the recall, provide the Minister with the following information in writing:

• (a) the results of the recall; and

• (b) a description of the measures that have been or will be taken to prevent a recurrence of the situation that prompted the recall.

(5) In this section and in section C.01.051.1, active ingredient and fabricate have the same meaning as in subsection C.01A.001(1).