C.01.011. (1) A drug referred to in subsection 10(2) of the Act shall be exempt from the standard for any drug contained in any publication mentioned in Schedule B to the Act to the extent that such drug differs from that standard with respect to colour, flavour, shape and size, if such difference does not interfere with any method of assay prescribed in any such publication.
(2) [Repealed, SOR/93-243, s. 2]
(3) Where a manufacturer’s standard is used for a drug, the manufacturer shall make available to the Director, on request, details of that standard and of a method of analysis for the drug acceptable to the Director.
(4) No person shall use a manufacturer’s standard for a drug that provides
(a) a lesser degree of purity than the highest degree of purity, or
(b) a greater variation in potency than the least variation in potency,
provided for that drug in any publication mentioned in Schedule B to the Act.
- SOR/93-243, s. 2.
C.01.012. A manufacturer who makes representations on a label of a drug in oral dosage form, or in any advertisement, with respect to the site, rate or extent of release to the body of a medicinal ingredient of the drug, or the availability to the body of a medicinal ingredient of the drug, shall
(a) before making the representations, conduct such investigations, using an acceptable method, as may be necessary to demonstrate that the site, rate or extent of release to the body of the medicinal ingredient of the drug and the availability to the body of the medicinal ingredient of the drug, correspond to the representations; and
(b) on request submit the record of such investigations to the Director.
- SOR/89-455, s. 2;
- SOR/94-36, s. 1.
C.01.013. (1) Where the manufacturer of a drug is requested in writing by the Director to submit on or before a specified day evidence with respect to a drug, the manufacturer shall make no further sales of that drug after that day unless he has submitted the evidence requested.
(2) Where the Director is of the opinion that the evidence submitted by a manufacturer, pursuant to subsection (1), is not sufficient, he shall notify the manufacturer in writing that the evidence is not sufficient.
(3) Where, pursuant to subsection (2), a manufacturer is notified that the evidence with respect to a drug is not sufficient, he shall make no further sales of that drug unless he submits further evidence and is notified in writing by the Director that that further evidence is sufficient.
(4) A reference in this section to evidence with respect to a drug means evidence to establish the safety of the drug under the conditions of use recommended and the effectiveness of the drug for the purposes recommended.
Assignment and Cancellation of Drug Identification Numbers
C.01.014. (1) No manufacturer shall sell a drug in dosage form unless a drug identification number has been assigned for that drug and the assignment of the number has not been cancelled pursuant to section C.01.014.6.
(2) Subsection (1) does not apply in respect of a drug listed in Schedule C to the Act, whole blood and its components, or a medicated feed as defined in section 2 of the Feeds Regulations, 1983.
- SOR/81-248, s. 2;
- SOR/97-12, s. 3.
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