PART CDrugs (continued)
DIVISION 1 (continued)
C.01.004.03 In addition to the requirements of section C.01.004, the inner label of a drug to which section C.01.004.02 applies shall display on any panel
(a) adequate directions for use of the drug;
(b) a quantitative list of the drug’s medicinal ingredients by their proper names or, if they have no proper names, by their common names; and
(c) the information referred to in subsection C.01.004.01(1).
- SOR/2014-158, s. 5.
(2) No person who imports a drug in dosage form into Canada shall sell any lot or batch of the drug unless the name of the person who imports it, and the address of the principal place of business in Canada of the person responsible for its sale, appears on the inner and outer labels of the drug.
- SOR/82-524, s. 1;
- SOR/93-475, s. 1;
- SOR/97-12, s. 2.
C.01.005 (1) The principal display panel of both the inner label and outer label of a drug in dosage form shall show the drug identification number assigned for that drug, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”.
(2) Subsection (1) does not apply to
(a) a drug in dosage form that is compounded by a pharmacist under a prescription or by a practitioner; or
(b) a drug in dosage form that is sold under a prescription if the following information appears on the drug’s label:
(3) In this section and in sections C.01.005.1 and C.01.014, drug in dosage form means a drug in a form in which it is ready for use by the consumer without requiring any further manufacturing.
(4) and (5) [Repealed, SOR/81-248, s. 1]
- SOR/81-248, s. 1;
- SOR/93-202, s. 3;
- SOR/98-423, s. 2;
- SOR/2001-181, s. 4;
- SOR/2017-259, s. 2;
- SOR/2018-69, s. 27;
- SOR/2018-77, s. 1.
(2) Subsection (1) does not apply in respect of the sale of a Class A opioid by a pharmacist or practitioner if
(3) The following definitions apply in this section.
- Class A opioid
Class A opioid means a drug in dosage form set out in Part A of the List of Opioids, published by the Government of Canada on its website, as amended from time to time. (opioïde de catégorie A)
- source document
source document means the document entitled Information for Patients Concerning Opioids, published by the Government of Canada on its website, as amended from time to time. (document source)
- SOR/2018-77, s. 2.
C.01.006 Where a package of a drug has only one label, that label shall contain all the information required by these Regulations to be shown on both the inner and the outer labels.
C.01.007 No reference, direct or indirect, to the Act or to these Regulations shall be made upon any label of or in any advertisement for a drug unless such reference is a specific requirement of the Act or these Regulations.
C.01.008 [Repealed, SOR/80-544, s. 2]
C.01.009 If any Act of Parliament or any of its regulations prescribes a standard or grade for a drug and that standard or grade is given a name or designation in the Act or regulation, no person shall, on a label of or in any advertisement for that drug, use that name or designation unless the drug conforms with the standard or grade.
- SOR/2017-18, s. 13.
C.01.010 If it is necessary to provide adequate directions for the safe use of a parenteral drug or prescription drug that is used in the treatment or prevention of any disease, disorder or abnormal physical state mentioned in Schedule A to the Act, the disease, disorder or abnormal physical state may be mentioned on the drug’s labels, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the drug, and, in that respect, the drug is exempt from subsections 3(1) and (2) of the Act.
- SOR/2013-122, s. 6;
- SOR/2014-158, s. 6;
- SOR/2017-18, s. 21(F);
- SOR/2018-69, s. 14(F).
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 Minister, on request, details of that standard and of a method of analysis for the drug acceptable to the Minister.
(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;
- SOR/2018-69, ss. 31(E), 32(F).
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 Minister.
- SOR/89-455, s. 2;
- SOR/94-36, s. 1;
- SOR/2018-69, s. 27.
C.01.013 (1) Where the manufacturer of a drug is requested in writing by the Minister 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) If the Minister determines that the evidence submitted by a manufacturer under subsection (1) is not sufficient, he or she shall so notify the manufacturer in writing.
(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 Minister 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.
- SOR/2018-69, ss. 15, 27.
C.01.013.1 Section C.01.013 does not apply in respect of a veterinary health product.
- SOR/2017-76, s. 2.
- Date modified: