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

Regulations are current to 2019-01-30 and last amended on 2019-01-15. Previous Versions

PART CDrugs (continued)

DIVISION 1 (continued)

Assignment and Cancellation of Drug Identification Numbers

  •  (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.

  • SOR/81-248, s. 2;
  • SOR/97-12, s. 3;
  • SOR/2013-179, s. 1;
  • SOR/2017-259, s. 3;
  • SOR/2018-77, s. 3.
  •  (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.

  • 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;
  • SOR/2017-259, s. 4;
  • SOR/2018-69, ss. 27, 33(F).
  •  (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.

  • SOR/81-248, s. 2;
  • SOR/92-230, s. 1;
  • SOR/98-423, s. 4;
  • SOR/2011-88, s. 3;
  • SOR/2017-259, s. 5;
  • SOR/2018-69, ss. 16, 27, 37.
  •  (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.

  • (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) In subsection (1), 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.

  • SOR/2018-77, s. 4.

 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.

  • SOR/81-248, s. 2;
  • SOR/98-423, s. 5;
  • SOR/2014-158, s. 8;
  • SOR/2017-259, s. 6;
  • SOR/2018-69, s. 38.

 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.

  • SOR/81-248, s. 2;
  • SOR/92-230, s. 2;
  • SOR/98-423, s. 6;
  • SOR/2016-139, s. 2(F);
  • SOR/2018-69, s. 27.
  •  (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.

  • SOR/81-248, s. 2;
  • SOR/2017-259, s. 7;
  • SOR/2018-69, ss. 27, 39.
 
Date modified: