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

Regulations are current to 2017-04-12 and last amended on 2017-03-14. Previous Versions

  •  (1) If an authorization holder 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 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 that 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 on which the authorization holder will discontinue the sale of the drug; and

    • (k) the reason for the discontinuation of sale.

  • (2) The authorization holder 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 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.

  • SOR/2016-139, s. 5.

 The Minister shall maintain a hyperlink to the website referred to in subsection C.01.014.9(1) on the Department of Health website.

  • SOR/2016-139, s. 5.
  •  (1) If a period of 12 months has elapsed since an authorization holder for a drug last sold the drug, they shall notify the Minister of that fact within 30 days after the day on which that period ends.

  • (2) The authorization holder shall, within 30 days after the day on which they resume the sale of the drug, notify the Minister of that fact.

  • SOR/2016-139, s. 5.

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

 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.

Annual Summary Report and Case Reports

  •  (1) The manufacturer shall prepare an annual summary report of all information relating to adverse drug reactions and serious adverse drug reactions to the drug that it received or became aware of during the previous 12 months.

  • (2) The annual summary report shall contain a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to the drug.

  • (3) In preparing the annual summary report, the manufacturer shall determine, on the basis of the analysis referred to in subsection (2), whether there has been a significant change in what is known about the risks and benefits of the drug during the period covered by the report and shall include its conclusions in this regard in the summary report.

  • (4) If, in preparing the annual summary report, the manufacturer concludes that there has been a significant change, it shall notify the Minister without delay, in writing, unless this has already been done.

  • (5) The Minister may, for the purposes of assessing the safety and effectiveness of the drug, request in writing that the manufacturer submit to the Minister one or both of the following:

    • (a) the annual summary reports;

    • (b) the case reports relating to the adverse drug reactions and serious adverse drug reactions to the drug that are known to the manufacturer.

  • (6) The Minister shall, after giving the manufacturer an opportunity to be heard, specify a period for the submission of the annual summary reports or case reports, or both, that is reasonable in the circumstances, and the manufacturer shall submit the reports within that period.

  • SOR/2011-31, s. 1.

Issue-Related Summary Report

  •  (1) The Minister may, for the purposes of assessing the safety and effectiveness of the drug, request in writing that the manufacturer submit to the Minister an issue-related summary report.

  • (2) The report shall contain a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to the drug, as well as case reports of all or specified adverse drug reactions and serious adverse drug reactions to the drug that are known to the manufacturer in respect of the issue that the Minister directs the manufacturer to analyze in the report.

  • (3) The Minister shall, after giving the manufacturer an opportunity to be heard, specify a period for the submission of the report that is reasonable in the circumstances. The Minister may only specify a period that is less than 30 days if the Minister needs the information in the report to determine whether the drug poses a serious and imminent risk to human health.

  • (4) The manufacturer shall submit the report within the specified period.

  • SOR/2011-31, s. 1;
  • SOR/2017-18, s. 14.

Maintenance of Records

  •  (1) The manufacturer shall maintain records of the reports and case reports referred to in sections C.01.017 to C.01.019.

  • (2) The manufacturer shall retain the records for 25 years after the day on which they were created.

  • SOR/2011-31, s. 1.
 
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