PART CDrugs (continued)
DIVISION 3 (continued)
Positron-emitting Radiopharmaceuticals (continued)
(a) information provided by the sponsor under section C.03.307, C.03.308 or C.03.313 proves to be inaccurate or incomplete;
(b) the sponsor fails to provide the Minister with sufficient information to establish the safety of the study drug pursuant to a written request under section C.03.313, by the date specified in the request;
(c) the sponsor fails to notify the Minister of an adverse reaction or file a report in respect of an adverse reaction in accordance with section C.03.314; or
(d) the sponsor contravenes a provision of these Regulations or any provision of the Act in relation to the study drug.
(2) In determining whether to suspend an authorization in its entirety or in respect of a study site, the Minister shall consider whether the reason for the suspension affects the study in its entirety or affects only a certain study site.
(3) Before suspending an authorization, the Minister shall send the sponsor a notice that
(a) specifies whether the suspension is of the study authorization in its entirety or in respect of a study site and sets out the reasons for the proposed suspension and the effective date;
(b) if applicable, specifies the corrective action that the sponsor must take and the period within which it must be taken; and
(c) gives the sponsor a reasonable opportunity to be heard in writing concerning the proposed suspension.
(4) Despite subsection (3), the Minister shall immediately suspend an authorization if she or he has reason to believe that it is necessary to do so to prevent injury to the health of a study subject or any other person.
(5) When the Minister suspends an authorization under subsection (4), the Minister must send the sponsor a notice that
- SOR/2012-129, s. 5.
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:
(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.
(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.
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 means a drug that is listed in Schedule D to the Act that is in dosage form or a drug that is an active ingredient that can be used in the preparation of a drug listed in that Schedule; (drogue)
licence or Canadian licence[Repealed, SOR/97-12, s. 31]
manufacturer [Repealed, SOR/97-12, s. 31]
- SOR/97-12, s. 31;
- SOR/2013-74, s. 16.
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.
C.04.002 This Division does not apply to a drug in oral dosage form that contains micro-organisms if the drug is recommended solely for restoring, normalizing or stabilizing the intestinal flora.
- SOR/97-12, s. 33.
C.04.003 The date of issue of a drug shall be the date on which the finished product is removed from cold storage but in any case shall be, not later than
(a) six months after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 10°C;
(b) 12 months after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 5°C; or
(c) two years after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 0°C.
C.04.004 to C.04.006 [Repealed, SOR/97-12, s. 34]
C.04.007 [Repealed, SOR/97-12, s. 67]
C.04.008 to C.04.012 [Repealed, SOR/97-12, s. 36]
C.04.013 Every fabricator and packager/labeller shall safely segregate all work with spore-bearing, pathogenic micro-organisms and other infectious agents known to require special precautions in manipulation and shall take such care of equipment and arrangements for supervision that the possibility of contamination of other drugs is avoided.
- SOR/97-12, s. 63.
C.04.014 No person shall conduct laboratory procedures of a diagnostic nature in their premises unless those procedures are entirely segregated from the fabrication, packaging/labelling and testing of drugs.
- SOR/97-12, s. 37.
C.04.015 On written request from the Minister, every fabricator, packager/labeller, tester, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall submit protocols of tests together with samples of any lot of the drug before it is sold, and no person shall sell any lot of that drug if the protocol or sample fails to meet the requirements of these Regulations.
- SOR/97-12, s. 37;
- SOR/2018-69, s. 27.
C.04.016 All animals from which drugs are prepared and preserved shall be
(a) under the direct supervision of competent medical or veterinary personnel;
(b) kept in quarantine by the fabricator for at least seven days before use; and
(c) healthy and free from infectious disease.
- SOR/97-12, s. 38.
C.04.017 A fabricator shall keep necropsy records of all animals that die or are killed after having been used in the production of a drug.
- SOR/97-12, s. 61.
C.04.018 A fabricator shall immediately segregate, and report the fact to the Minister, any animal with actual or suspected vesicular stomatitis, foot and mouth disease, encephalomyelitis, infectious anaemia, glanders, anthrax, tetanus or any other serious infectious disease.
- SOR/97-12, s. 61.
- Date modified: