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

Marginal note:Difference payable

50 If the Minister requests under section 5 that the person referred to in subsection 29(2) provide additional information, the difference between the fee payable under subsection 29(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 4Fees for Right to Sell Drugs for Human Use

Non-application

Marginal note:Non-application

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

Fees and Remission

Marginal note:Annual fee

• 52 (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, in respect of the type of drug set out in column 1 of Schedule 6, as follows:

  • (a) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 6, 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 2 to 5 of Schedule 6, 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

53 Subject to section 54, remission is granted to the person referred to in subsection 52(2) of an amount equal to 25% of the fee that is payable under subsection 52(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

54 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

55 This Division applies to drug for veterinary use only.

Fees and Remission

Marginal note:Annual fee

• 56 (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

57 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

58 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.

DIVISION 6Fees for Right to Sell Biocides

Marginal note:Annual fee

• 58.1 (1) The annual fee that is payable for the right to sell a biocide for which a market authorization has been issued under section 11 of the Biocides Regulations is $1,535.

• Marginal note:Fee payable by person that sold biocide

  (2) The fee is payable by the person to which a market authorization was issued if the person has sold the biocide in the 12 months preceding October 1.

• Marginal note:Timing of payment

  (3) The fee is payable on October 1.

• Marginal note:Non-application — permanent discontinuance of sale

  (4) Subsection (1) does not apply to the person if they have informed the Minister, in accordance with section 47 of the Biocides Regulations, that they permanently discontinued the sale of the biocide in Canada in the 12 months preceding October 1.

Marginal note:Remission — small business

58.2 Subject to section 58.3, remission is granted to the person referred to in subsection 58.1(2) of an amount equal to 25% of the fee that is payable under subsection 58.1(1) if the person provides, with the information referred to in section 46 of the Biocides 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 the gross revenue 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 person’s 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

58.3 If the Minister requests under section 5 that the person referred to in subsection 58.1(2) provide additional information, the difference between the fee payable under subsection 58.1(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 Licence, an Amendment Application for a Licence or an Application to Amend an Authorization — Medical Device

Interpretation

Marginal note:Definitions

59 The following definitions apply in this Division.

authorization

authorization means an authorization for a medical device issued under section 68.12 of the Medical Devices Regulations, if the device

• (a) is a Class II, III or IV device; and

• (b) is not a UPHN medical device. (autorisation)

licence

licence means a medical device licence issued under paragraph 36(1)(a) of the Medical Devices Regulations. (homologation)