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 and outer label of a drug sold in dosage form shall show in a clear and legible manner the drug identification number assigned by the Director for that drug pursuant to subsection C.01.014.2(1), preceded by the words “Drug Identification Number” or “Drogue : identification numérique” or both, or the letters “DIN”.
(2) Subsection (1) does not apply to a drug
(a) compounded by a pharmacist pursuant to a prescription or by a practitioner; or
(b) sold pursuant to a prescription, where the label of that drug indicates:
(3) For the purposes of this section and section C.01.014, a 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(4) and (5) [Repealed, SOR/81-248, s. 1]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.
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C.01.008 [Repealed, SOR/80-544, s. 2]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).
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.
- SOR/81-248, s. 2;
- SOR/97-12, s. 3;
- SOR/2013-179, s. 1.
C.01.014.1 (1) A manufacturer of a drug, a person authorized by a manufacturer or, in the case of a drug to be imported into Canada, the importer of the drug may make an application for a drug identification number for that drug.
(2) An application under subsection (1) shall be made to the Director in writing and shall include the following information and material:
(a) the name of the manufacturer of the drug as it will appear on the label;
(b) the pharmaceutical form in which the drug is to be sold;
(c) in the case of any drug other than a drug described in paragraph (d), the recommended route of administration;
(d) in the case of a drug for disinfection in premises, the types of premises for which its use is recommended;
(e) a quantitative list of the medicinal ingredients contained in the drug by their proper names or, if they have no proper names, by their common names;
(f) the brand name under which the drug is to be sold;
(g) an indication of whether the drug is for human use or veterinary use;
(h) the name and quantity of each colouring ingredient that is not a medicinal ingredient;
(i) the use or purpose for which the drug is recommended;
(j) the recommended dosage of the drug;
(k) the address of the manufacturer referred to in paragraph (a) and, where the address is outside the country, the name and address of the importer of the drug;
(l) the name and address of any individual, firm, partnership or corporation, other than the names and addresses referred to in paragraphs (a) and (k), that will appear on the label of the drug;
(m) in the case of a drug for veterinary use, the written text of every label to be used in connection with the drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the drug;
(m.1) in the case of a drug for human use, mock-ups of every label to be used in connection with the drug — 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 mock-ups of the drug’s packages;
(n) the name and title of the person who signed the application and the date of signature; and
(o) in the case of a drug for human use, an assessment as to whether there is a likelihood that the drug will be mistaken for any of the following products due to a resemblance between the brand name that is proposed to be used in respect of the drug and the brand name, common name or proper name of any of those products:
(i) a drug in respect of which a drug identification number has been assigned,
(ii) a radiopharmaceutical, as defined in section C.03.201, in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01, and
(iii) a kit, as defined in section C.03.205, in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01.
(3) In the case of a new drug, a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission filed under section C.08.002, C.08.002.01 or C.08.002.1 shall be regarded as an application for a drug identification number.
- SOR/81-248, s. 2;
- SOR/93-202, s. 4;
- SOR/98-423, s. 3;
- SOR/2011-88, s. 2;
- SOR/2014-158, s. 7.
- Date modified: