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

Information to the Minister

  • C.04.421. (1) A fabricator shall notify the Minister of any serious adverse reaction

    • (a) within 24 hours after the fabricator becomes aware of the occurrence, in the case of a fatality; and

    • (b) within 15 days after the fabricator becomes aware of the occurrence, in any other case.

  • (2) In the case of a verbal notice under subsection (1), the fabricator shall submit a written report of the serious adverse reaction to the Minister within 24 hours after submitting the notice.

  • (3) The notice, if in writing, or the written report shall include a description of the serious adverse reaction and any steps taken to address it.

  • SOR/78-545, s. 1;
  • SOR/2006-353, s. 1.
Previous Version

C.04.422. If a fabricator recalls source plasma for a reason involving product safety, the fabricator shall provide the Minister with a written report stating the reason for the recall, the number of units involved and the location from which the units were recalled.

  • SOR/78-545, s. 1;
  • SOR/2006-353, s. 1.
Previous Version

C.04.423. In order to prevent injury to the health and safety of donors and recipients of products manufactured from source plasma, a fabricator shall, on request, provide the Minister with a copy of any record pertaining to plasmapheresis, specific immunization or source plasma that is required by sections C.04.401 to C.04.422 to be kept by the fabricator.

  • SOR/78-545, s. 1;
  • SOR/2006-353, s. 1.
Previous Version

C.04.424. [Repealed, SOR/2006-353, s. 1]

Previous Version

C.04.425. [Repealed, SOR/2006-353, s. 1]

Previous Version

C.04.426. [Repealed, SOR/2006-353, s. 1]

Previous Version

C.04.427. [Repealed, SOR/97-12, s. 50]

C.04.428. [Repealed, SOR/2006-353, s. 1]

Previous Version

Insulin Preparations

[SOR/82-769, s. 5]

  • C.04.550. (1) “Insulin” means the active principle of the pancreas that affects the metabolism of carbohydrates in the animal body and that is of value in the treatment of diabetes mellitus.

  • (2) The Canadian Reference Standard for insulin shall be the International Standard therefor.

  • (3) The insulin preparations described in these Regulations shall contain insulin to which may be added only such ingredients as are prescribed in these Regulations.

  • (4) The potency of an insulin preparation shall be expressed in units per cubic centimetre and each unit per cubic centimetre shall provide one International Unit of insulin per cubic centimetre.

  • SOR/82-769, s. 4.