Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)

Marginal note:Remission — urgent public health need

14 Remission is granted to a person referred to in subsection 9(2) that files a new drug submission under section C.08.002 of the Food and Drug Regulations or an application for a drug identification number under section C.01.014.1 of those Regulations of the amount of the fee that is payable under subsection 9(1) if, as of the day on which the person filed the new drug submission or application,

• (a) the drug has the same medicinal ingredient, strength and route of administration and is in a comparable dosage form as a drug that may be imported under subsection C.10.001(2) of those Regulations;

• (b) a drug identification number has not been assigned under subsection C.01.014.2(1) of those Regulations for the drug or for another drug that has the same medicinal ingredient, strength and route of administration and is in a comparable dosage form; and

• (c) a notice of compliance has not been issued under section C.08.004 of those Regulations in respect of the drug or another drug that has the same medicinal ingredient, strength and route of administration and is in a comparable dosage form.

Marginal note:Remission — designated COVID-19 drug

• 14.1 (1) Remission is granted to the person referred to in subsection 9(2) of the amount of the fee that is payable under subsection 9(1) if the person has

  • (a) filed an application for a designated COVID-19 drug under the ISAD Interim Order; and

  • (b) subsequently filed a submission for that drug.

• Marginal note:Remission — no previous submission

  (2) The remission referred to in subsection (1) is granted if the person has not previously filed a submission for the designated COVID-19 drug.

Marginal note:Remission — General Council Decision

15 Remission is granted to the person referred to in subsection 9(2) of the amount of the fee that is payable under subsection 9(1) if the person has received an authorization under section 21.04 of the Patent Act in respect of the drug.

Marginal note:Remission — small business

16 Subject to section 18, remission is granted to the person referred to in subsection 9(2) of an amount equal to 50% of the fee that is payable under subsection 9(1) if the person provides with their submission, in a form established by the Minister,

• (a) in the case where the person has completed their first fiscal year,

  • (i) a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, and

  • (ii) the following information:

    • (A) a list of the persons with which the person was affiliated in the person’s last completed fiscal year,

    • (B) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person was affiliated in the person’s last completed fiscal year,

    • (C) the number of employees of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year, and

    • (D) the gross revenue of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year; and

• (b) in the case where the person has not completed their first fiscal year,

  • (i) a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, and

  • (ii) the following information:

    • (A) a list of the persons with which the person is affiliated in the person’s first fiscal year,

    • (B) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person is affiliated in the person’s first fiscal year,

    • (C) the number of employees of the person in their first fiscal year and of the persons with which the person is affiliated in those persons’ last completed fiscal year, and

    • (D) the projected gross revenue of the person in their first fiscal year and the gross revenue of the persons with which the person is affiliated in those persons’ last completed fiscal year.

Marginal note:Remission — first submission by small business

17 Subject to section 18, remission is granted to the person referred to in subsection 9(2) of an amount equal to the fee that is payable under subsection 9(1) if the following conditions are met:

• (a) the person has not previously filed a submission in respect of a drug; and

• (b) the person provides with their submission, in a form established by the Minister,

  • (i) in the case where the person has completed their first fiscal year,

    • (A) a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, and

    • (B) the following information:

      • (I) a list of the persons with which the person was affiliated in the person’s last completed fiscal year,

      • (II) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person was affiliated in the person’s last completed fiscal year,

      • (III) the number of employees of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year, and

      • (IV) the gross revenue of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year, and

  • (ii) in the case where the person has not completed their first fiscal year,

    • (A) a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, and

    • (B) the following information:

      • (I) a list of the persons with which the person is affiliated in the person’s first fiscal year,

      • (II) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person is affiliated in the person’s first fiscal year,

      • (III) the number of employees of the person in their first fiscal year and of the persons with which the person is affiliated in those persons’ last completed fiscal year, and

      • (IV) the projected gross revenue of the person in their first fiscal year and the gross revenue of the persons with which the person is affiliated in those persons’ last completed fiscal year.

Marginal note:Fee or difference payable

18 If the Minister requests under section 5 that the person referred to in subsection 9(2) provide additional information, the fee — or the difference between the fee payable under subsection 9(1) and the amount already paid, as the case may be — is immediately payable if

• (a) the person has not provided, within the period specified in section 5, the Minister with additional information for the purpose of demonstrating that the person met the definition small business in subsection 1(1) in the applicable fiscal year; or

• (b) the person has provided, within the period specified in section 5, the Minister with additional information for the purpose of demonstrating that the person met the definition in the applicable fiscal year but the Minister determines, after the period ends, that the person has not provided sufficient information to demonstrate that they met that definition in the applicable fiscal year.

DIVISION 2Fees for Examination of a Submission — Drugs for Veterinary Use Only

Interpretation

Marginal note:Definition of submission

19 In this Division, submission means any of the following:

• (a) an application for a drug identification number that is filed under section C.01.014.1 of the Food and Drug Regulations;

• (b) a notification that is filed under subsection C.01.615(1) of those Regulations in respect of a veterinary health product;

• (c) a new drug submission that is filed under section C.08.002 of those Regulations;

• (d) an abbreviated new drug submission that is filed under section C.08.002.1 of those Regulations;

• (e) a supplement to a new drug submission or an abbreviated new drug submission that is filed under section C.08.003 of those Regulations;

• (f) a preclinical submission that is filed under subsection C.08.005(1) of those Regulations;

• (g) information that is filed under section C.08.010 of those Regulations for the purpose of obtaining a letter of authorization;

• (h) information and material that is filed under section C.08.014 of those Regulations for the purpose of obtaining an experimental studies certificate;

• (i) information and material that is filed with the Minister in respect of a notifiable change; or

• (j) a protocol that is filed with the Minister and may support any of the matters referred to in paragraphs (c) to (f) or (h).

Application

Marginal note:Application

20 This Division applies to drugs for veterinary use only.

Fees and Remissions

Marginal note:Fee for examination

• 21 (1) Subject to paragraph 22(b) and section 24, the fee that is payable in respect of a submission that is of a type set out in column 1 of Schedule 2, for the examination of each component set out in column 2 that is included in the submission, is as follows:

  • (a) in the case of a fee that is payable in a fiscal year set out in any of columns 3 to 9 of Schedule 2, the applicable fee set out in that column; and

  • (b) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 3 to 9 of Schedule 2, the amount that is calculated in accordance with subsection 4(2).

• Marginal note:Fee paid by person that files submission

  (2) The fee is payable by the person that files the submission.

Marginal note:Fee and timing of payment — preliminary examination

22 If a preliminary examination is conducted in respect of a submission,

• (a) the full fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 21(2) stating that the submission has been found to be complete and has been accepted for further examination; or

• (b) 10% of the fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 21(2) stating that the submission has been found to be incomplete.

Marginal note:Fee and timing of payment — no preliminary examination

23 If a preliminary examination is not conducted in respect of a submission, the fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 21(2) stating that the submission has been received.

Marginal note:Fee — filing in previous fiscal year

24 For the purposes of subsection 21(1), if the Minister issues a notice referred to in section 22 or 23 in the fiscal year that follows the fiscal year in which the submission was filed, the fee that is payable is the fee that was payable in the fiscal year in which the submission was filed.

Marginal note:Remission — small business

25 Subject to section 27, remission is granted to the person referred to in subsection 21(2) of an amount equal to 50% of the fee that is payable under subsection 21(1) if the person provides with their submission, in a form established by the Minister,

• (a) in the case where the person has completed their first fiscal year,

  • (i) a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, and

  • (ii) the following information:

    • (A) a list of the persons with which the person was affiliated in the person’s last completed fiscal year,

    • (B) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person was affiliated in the person’s last completed fiscal year,

    • (C) the number of employees of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year, and

    • (D) the gross revenue of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year; and

• (b) in the case where the person has not completed their first fiscal year,

  • (i) a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, and

  • (ii) the following information:

    • (A) a list of the persons with which the person is affiliated in the person’s first fiscal year,

    • (B) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person is affiliated in the person’s first fiscal year,

    • (C) the number of employees of the person in their first fiscal year and of the persons with which the person is affiliated in those persons’ last completed fiscal year, and

    • (D) the projected gross revenue of the person in their first fiscal year and the gross revenue of the persons with which the person is affiliated in those persons’ last completed fiscal year.

Marginal note:Remission — first submission by small business

26 Subject to section 27, remission is granted to the person referred to in subsection 21(2) of an amount equal to the fee that is payable under subsection 21(1) if the following conditions are met:

• (a) the person has not previously filed a submission in respect of a drug; and

• (b) the person provides with their submission, in a form established by the Minister,

  • (i) in the case where the person has completed their first fiscal year,

    • (A) a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, and

    • (B) the following information:

      • (I) a list of the persons with which the person was affiliated in the person’s last completed fiscal year,

      • (II) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person was affiliated in the person’s last completed fiscal year,

      • (III) the number of employees of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year, and

      • (IV) the gross revenue of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year, and

  • (ii) in the case where the person has not completed their first fiscal year,

    • (A) a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, and

    • (B) the following information:

      • (I) a list of the persons with which the person is affiliated in the person’s first fiscal year,

      • (II) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person is affiliated in the person’s first fiscal year,

      • (III) the number of employees of the person in their first fiscal year and of the persons with which the person is affiliated in those persons’ last completed fiscal year, and

      • (IV) the projected gross revenue of the person in their first fiscal year and the gross revenue of the persons with which the person is affiliated in those persons’ last completed fiscal year.