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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 2Drugs (continued)

DIVISION 4Fees for Right to Sell Drugs for Human Use (continued)

Fees and Remission (continued)

Marginal note:Difference payable

 If the Minister requests under section 5 that the person referred to in subsection 52(2) provide additional information, the difference between the fee payable under subsection 52(1) and the amount already paid 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 5Fees for Right to Sell Drugs for Veterinary Use Only

Application

Marginal note:Application

 This Division applies to drug for veterinary use only.

Fees and Remission

Marginal note:Annual fee

  •  (1) The annual fee that is payable for the right to sell a drug for which a drug identification number has been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations is as follows:

    • (a) in the case of a fee that is payable in a fiscal year set out in any of columns 1 to 4 of Schedule 7, 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 1 to 4 of Schedule 7, the amount that is calculated in accordance with subsection 4(2).

  • Marginal note:Fee payable by person after first sale

    (2) The fee is payable by the person to which a document was issued under subsection C.01.014.2(1) of the Food and Drug Regulations that sets out the drug identification number assigned for the drug if the person has sold the drug following the issuance of the document.

  • Marginal note:Timing of payment

    (3) The fee is payable on October 1.

  • Marginal note:Non-application — interruption of sale

    (4) Subject to subsection (5), subsection (1) does not apply to the person if they notified the Minister in accordance with section C.01.014.71 of the Food and Drug Regulations in the 12 months preceding October 1.

  • Marginal note:Resumption of sale

    (5) Subsection (4) ceases to apply on the day on which the person notifies the Minister in accordance with section C.01.014.72 of the Food and Drug Regulations.

Marginal note:Remission — small business

 Subject to section 58, remission is granted to the person referred to in subsection 56(2) of an amount equal to 25% of the fee that is payable under subsection 56(1) if the person provides with the notification provided under subsection C.01.014.5(1) of the Food and Drug Regulations, 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:Difference payable

 If the Minister requests under section 5 that the person referred to in subsection 56(2) provide additional information, the difference between the fee payable under subsection 56(1) and the amount already paid 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.

PART 3Medical Devices

DIVISION 1Fees for Examination of an Application for a Medical Device Licence

Interpretation

Marginal note:Definition of licence

 In this Division, licence means a medical device licence issued under paragraph 36(1)(a) of the Medical Devices Regulations.

Fees and Remissions

Marginal note:Fee for examination

  •  (1) Subject to paragraph 62(b) and section 64, the fee for the examination of an application for a licence that is filed under section 32 of the Medical Devices Regulations or for the examination of an application for a licence amendment that is filed under section 34 of those Regulations is, in respect of the applicable category set out in column 1 of Schedule 8 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 8, 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 8, the amount that is calculated in accordance with subsection 4(2).

  • Marginal note:Fee payable by person that files application

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

Marginal note:Reinstatement

 Every provision of this Division that applies to an application for a licence for a Class II, III or IV medical device filed under section 32 of the Medical Devices Regulations also applies to a request to have such a licence reinstated following the correction of the situation that gave rise to its suspension.

Marginal note:Fee and timing of payment — preliminary examination

 If a preliminary examination is conducted in respect of an application,

  • (a) the full fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 60(2) stating that the application 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 60(2) stating that the application 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 an application, the fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 60(2) stating that the application has been received.

Marginal note:Fee — filing in previous fiscal year

 For the purposes of subsection 60(1), if the Minister issues a notice referred to in section 62 or 63 in the fiscal year that follows the fiscal year in which the application was filed, the fee that is payable is the fee that was payable in the fiscal year in which the application was filed.

 
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