Food and Drug Regulations (C.R.C., c. 870)

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C.01.008 [Repealed, SOR/80-544, s. 2]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.

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.1 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.

• 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• (2) [Repealed, SOR/93-243, s. 2]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.

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.

• 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.

C.01.013.1 Section C.01.013 does not apply in respect of a veterinary health product.

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 under section C.01.014.6.

• (2) Subsection (1) does not apply in respect of a veterinary health product, a study drug as defined in section C.03.301 or a medicated feed as defined in subsection 2(1) of the Feeds Regulations, 1983.

• C.01.014.1 (1) A manufacturer of a drug may make an application for a drug identification number for that drug.

• (2) An application under subsection (1) shall be made to the Minister 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 another drug for which a drug identification number has been assigned 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 the other drug.

• (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.

• C.01.014.2 (1) Subject to subsection (2), if a manufacturer has provided all the information and material described in subsection C.01.014.1(2) or section C.08.002, C.08.002.01 or C.08.002.1, as the case may be, in respect of a drug, the Minister shall issue to the manufacturer a document that

  • (a) sets out

    • (i) the drug identification number assigned for the drug, preceded by the abbreviation “DIN”, or

    • (ii) if there are two or more brand names for the drug, the drug identification numbers assigned by the Minister for the drug, each of which pertains to one of the brand names and is preceded by the abbreviation “DIN”; and

  • (b) contains the information referred to in paragraphs C.01.014.1(2)(a) to (f).

• (2) The Minister may refuse to issue the document referred to in subsection (1) if he or she has reasonable grounds to believe that the product in respect of which an application referred to in section C.01.014.1 has been made

  • (a) is not a drug, or

  • (b) is a drug but its sale would cause injury to the health of the purchaser or consumer or would be a contravention of the Act or these Regulations.

• (3) If the Minister refuses to issue the document under subsection (2), the manufacturer may submit additional information or material and request the Minister to reconsider his or her decision.

• (4) On the basis of the additional information or material submitted under subsection (3), the Minister shall reconsider the grounds on which the refusal to issue the document was made.

• C.01.014.21 (1) The Minister may, at any time, impose terms and conditions on a drug identification number assigned for a Class B opioid or amend those terms and conditions.

• (1.1) The Minister may, at any time, impose terms and conditions on a drug identification number assigned for a designated COVID-19 drug, or amend those terms and conditions, if

  • (a) a notice of compliance was issued under section C.08.004 in respect of

    • (i) a new drug submission that was filed under section C.08.002 for the designated COVID-19 drug that contains the statement referred to in paragraph C.08.002(2.1)(a), or

    • (ii) a supplement to a new drug submission referred to in subparagraph (i) that was filed under section C.08.003 for the designated COVID-19 drug; or

  • (b) a notice of compliance was issued under section C.08.004 in respect of one of the following that was filed for the designated COVID-19 drug on the basis of a direct or indirect comparison to another designated COVID-19 drug referred to in paragraph (a):

    • (i) a new drug submission under section C.08.002,

    • (ii) an abbreviated new drug submission under section C.08.002.1, or

    • (iii) a supplement to a new drug submission or abbreviated new drug submission under section C.08.003.

• (2) The Minister shall notify, in writing, the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number of any terms and conditions imposed on the drug identification number and of any amendment to those terms and conditions.

• (3) The following definitions apply in this section.

  Class B opioid

  Class B opioid means a drug set out in Part B of the List of Opioids, published by the Government of Canada on its website, as amended from time to time. (opioïde de catégorie B)

  designated COVID-19 drug

  designated COVID-19 drug has the same meaning as in section C.08.001.1. (drogue désignée contre la COVID-19)

C.01.014.3 The manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug shall, within 30 days after the day on which the drug is first sold following the issuance by the Minister of the document, date and sign the document and return it to the Minister with a statement set out on it that the information it contains is correct and with an indication of the date of that first sale.

C.01.014.4 If the information referred to in subsection C.01.014.1(2) in respect of a drug is no longer correct owing to a change in the subject matter of the information,

• (a) in the case of a change in the subject matter of any of the information referred to in paragraphs C.01.014.1(2)(a) to (f)

  • (i) that occurs prior to the sale of the drug, a new application shall be made, or

  • (ii) that occurs after the sale of the drug, no further sale of the drug shall be made until a new application for a drug identification number in respect of that drug is made and a number is assigned; and

• (b) in the case of a change in the subject matter of any of the information referred to in paragraphs C.01.014.1(2)(g) to (k)

  • (i) that occurs prior to the sale of the drug, the particulars of the change shall be submitted with the return of the document referred to in section C.01.014.3, or

  • (ii) that occurs after the sale of the drug, the person to whom the drug identification number in respect of that drug was issued shall, within 30 days of the change, inform the Minister of the change.

• C.01.014.5 (1) The manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug shall, annually before the first day of October and in a form established by the Minister, provide the Minister with a notification that is signed by them and that

  • (a) indicates whether any of the following circumstances apply in respect of the drug:

    • (i) as of the day on which the notification is sent,

      • (A) the manufacturer sells the drug in Canada, or

      • (B) the manufacturer has discontinued the sale of the drug in Canada, or

    • (ii) the manufacturer has not sold the drug in Canada for a period that is greater than 12 months and a portion of that period is covered by the notification; and

  • (b) subject to subsection (2), confirms that the information that the manufacturer previously submitted with respect to the drug under subsection C.01.014.1(2), paragraph C.01.014.4(b) or section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, is correct as of the day on which the notification is sent.

• (2) If any of the information that the manufacturer submitted under a provision referred to in paragraph (1)(b) is not correct as of the day on which the notification is sent, the manufacturer shall update that information in the notification.