Food and Drug Regulations (C.R.C., c. 870)
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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.
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.
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.
C.04.424. [Repealed, SOR/2006-353, s. 1]
C.04.425. [Repealed, SOR/2006-353, s. 1]
C.04.426. [Repealed, SOR/2006-353, s. 1]
C.04.427. [Repealed, SOR/97-12, s. 50]
C.04.428. [Repealed, SOR/2006-353, s. 1]
Insulin Preparations
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.
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