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

Reinstatement

  • C.03.318 (1) Subject to subsection (2), the Minister shall reinstate the authorization if the sponsor provides the Minister with sufficient evidence to establish that the study does not present a risk of injury to the health of study subjects or other persons, within the following periods:

    • (a) in the case of a suspension under subsection C.03.317(1), 30 days after the day on which the suspension is effective; or

    • (b) in the case of a suspension under subsection C.03.317(4), the period specified in the notice sent under subsection C.03.317(5).

  • (2) If the Minister does not reinstate any part of an authorization that was suspended, the Minister shall amend the authorization to remove that part.

  • SOR/2012-129, s. 5.

Cancellation

  • C.03.319. (1) The Minister shall cancel an authorization, in its entirety or in respect of a study site, in either of the following circumstances:

    • (a) the study is discontinued in its entirety or at that study site by the sponsor under section C.03.316; or

    • (b) the sponsor fails to provide the Minister with the evidence required by subsection C.03.318(1) within the specified period.

  • (2) When the Minister cancels all or part of an authorization, she or he shall send the sponsor a notice that sets out the reasons for the cancellation and the effective date.

  • SOR/2012-129, s. 5.

Division 4

Schedule D Drugs

C.04.001. In this Division,

“date of manufacture”

“date of manufacture” means

  • (a) in the case of a product for which a standard of potency exists, the date it satisfactorily passes a potency test,

  • (b) in the case of an animal product for which no standard of potency exists, the date of its removal from the animal, and

  • (c) in the case of a product other than an animal product for which no standard of potency exists, the date of cessation of growth; (date de fabrication)

“drug”

“drug” means a drug listed in Schedule D to the Act that is in dosage form, or a drug that is a bulk process intermediate that can be used in the preparation of a drug listed in Schedule D to the Act; (drogue)

“licence”

“licence” or “Canadian licence”[Repealed, SOR/97-12, s. 31]

“manufacturer”

“manufacturer” [Repealed, SOR/97-12, s. 31]

  • SOR/97-12, s. 31.

C.04.001.1 No distributor referred to in paragraph C.01A.003(b) or importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with this Division.

  • SOR/97-12, s. 32.