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

Regulations are current to 2013-06-10 and last amended on 2013-05-31. Previous Versions

C.01.014.7. Where a person who has been assigned a drug identification number for a drug discontinues sale of the drug in Canada, he shall, within 30 days of such discontinuation, inform the Director that he is no longer selling the drug.

  • SOR/81-248, s. 2.

Tablet Disintegration Times

  • C.01.015. (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    • (b) [Repealed, SOR/98-423, s. 7]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.
Previous Version

Prohibition

C.01.016. 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.
Previous Version

Serious Adverse Drug Reaction Reporting

C.01.017. 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.
Previous Version