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

Regulations are current to 2021-02-15 and last amended on 2020-04-01. Previous Versions

PART 1General (continued)

Performance Standard and Remission

Marginal note:Remission — performance standard

  •  (1) If the Minister determines that the performance standard has not been met in relation to a fee that is payable under this Order, remission is granted to the person that must pay the fee

    • (a) of an amount equal to 25% of the fee; or

    • (b) of an amount equal to 25% of the amount that is payable, in the case where remission is granted of part of the fee under any other provision of this Order.

  • Marginal note:Exceptions

    (2) Subsection (1) does not apply to a fee for the examination of

    • (a) an application or submission referred to in this Order in respect of which a joint or parallel review is conducted by the Minister and a foreign regulatory authority; or

    • (b) an application for a licence that is filed under section 32 of the Medical Devices Regulations if

      • (i) the medical device to which the application relates includes a component that is a drug, and

      • (ii) the Minister has made a decision in respect of the application to issue or amend a medical device licence under section 36 of those Regulations, or to refuse to issue or amend such a licence under section 38 of those Regulations.

PART 2Drugs

DIVISION 1Fees for Examination of a Submission — Drugs for Human Use

Interpretation

Marginal note:Definition of submission

 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 new drug submission that is filed under section C.08.002 of those Regulations;

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

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

Non-application

Marginal note:Non-application

 This Division does not apply to drugs for veterinary use only.

Fees and Remissions

Marginal note:Fee for examination

  •  (1) Subject to paragraph 10(b) and section 12, the fee for the examination of a submission is, in respect of the applicable submission class set out in column 1 of Schedule 1 and described in column 2, as follows:

    • (a) in the case of a fee that is payable in a fiscal year set out in any of columns 3 to 6 of Schedule 1, the 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 6 of Schedule 1, 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

 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 9(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 9(2) stating that the submission has been found to be incomplete.

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

 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 9(2) stating that the submission has been received.

Marginal note:Fee — filing in previous fiscal year

 For the purposes of subsection 9(1), if the Minister issues a notice referred to in section 10 or 11 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:Deferred payment — notice of compliance

 Despite sections 10 and 11, if the person referred to in subsection 9(2) files an application for authorization under section C.07.003 of the Food and Drug Regulations at the same time that the person files the submission, payment of the fee is deferred until the issuance to the person of a notice of compliance under section C.08.004 of those Regulations or of a document setting out the drug identification number assigned for the drug under subsection C.01.014.2(1) of those Regulations.

Marginal note:Remission — urgent public health need

 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 — General Council Decision

 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

 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

 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.

 
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