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

Marginal note:Fee or difference payable

27 If the Minister requests under section 5 that the person referred to in subsection 21(2) provide additional information, the fee — or the difference between the fee payable under subsection 21(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 2.1Fees for Examination of an Application — Biocides

Definition

Marginal note:Definition of application

27.1 In this Division, application means any of the following:

• (a) an application for a market authorization for a biocide submitted under section 10 of the Biocides Regulations;

• (b) an application for a notice of acceptance in respect of a major change submitted under subsection 15(2) of those Regulations;

• (c) a written description of a minor change provided under subsection 17(1) of those Regulations, other than a change to contact information referred to in paragraph (a) of the definition of minor change in subsection 1(1) of those Regulations, or a change referred to in paragraph (f) of that definition;

• (d) an application for a market authorization for a biocide that is based on a comparison to a biocide that is authorized for sale by a foreign regulatory authority submitted under section 26 of those Regulations.

Fees and Remissions

Marginal note:Fee for examination

• 27.2 (1) Subject to paragraph 27.3(b) and section 27.5, the fee for the examination of an application in respect of a class set out in column 1 of Schedule 2.1 and described in column 2 is the fee set out in column 3 of that Schedule.

• Marginal note:Fee paid by Person that files application

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

Marginal note:Fee and timing of payment — Preliminary examination

27.3 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 27.2(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 27.2(2) stating that the application has been found to be incomplete.

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

27.4 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 27.2(2) stating that the application has been received.

Marginal note:Fee — filing in previous fiscal year

27.5 For the purposes of subsection 27.2(1), if the Minister issues a notice referred to in section 27.3 or 27.4 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.

Marginal note:Remission — small business

27.6 Subject to section 27.8, remission is granted to the person referred to in subsection 27.2(2) of an amount equal to 50% of the fee that is payable under subsection 27.2(1) if the person provides with their application, 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 application by small business

27.7 Subject to section 27.8, remission is granted to the person referred to in subsection 27.2(2) of an amount equal to the fee that is payable under subsection 27.2(1) if the following conditions are met:

• (a) the person has not previously filed

  • (i) an application in respect of a biocide;

  • (ii) a submission as defined in section 7 in respect of a drug; or

  • (iii) a submission as defined in section 19 in respect of a drug; and

• (b) the person provides with their application, 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

27.8 If the Minister requests under section 5 that the person referred to in subsection 27.2(2) provide additional information, the fee — or the difference between the fee payable under subsection 27.2(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 3Fees for Examination of an Application for an Establishment Licence — Drugs

Interpretation

Marginal note:Definitions

28 The following definitions apply in this Division.

activity

activity means an activity set out in Table I to section C.01A.008 of the Food and Drug Regulations. (activité)

drug

drug has the same meaning as in subsection C.01A.001(2) of the Food and Drug Regulations. (drogue)

establishment licence

establishment licence means a licence issued under section C.01A.008 of the Food and Drug Regulations. (licence d’établissement)

Fees and Remission

Marginal note:Fee for examination

• 29 (1) Subject to section 48, the fee for the examination of an application for an establishment licence or for the annual review of an establishment licence is the sum of the applicable fees referred to in sections 33 to 40 and the fee payable for the examination of an application to amend an establishment licence to add a building is the sum of the applicable fees referred to in sections 41 to 47.

• Marginal note:Fee paid by person that files application

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

Marginal note:Timing of payment

30 The fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 29(2) stating that the application has been accepted for further examination.

Marginal note:Reinstatement

31 Every provision of this Division that applies to an application for an establishment licence 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:Interpretation

32 In sections 33 to 39, a reference to the examination of an application for an establishment licence includes an examination of an application for the annual review of an establishment licence.

Marginal note:Fee — licence authorizing sterile fabrication

33 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including fabricating drugs in sterile dosage form, the fee is as follows:

• (a) in respect of drugs for human use,

  • (i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 1 for that fiscal year, and

  • (ii) 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 3, the amount that is calculated in accordance with subsection 4(2); and

• (b) in respect of drugs for veterinary use only,

  • (i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 1 for that fiscal year, and

  • (ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).

Marginal note:Fee — licence authorizing importation

34 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including importing drugs — but not fabricating drugs in sterile dosage form — the fee is as follows:

• (a) in respect of drugs for human use,

  • (i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 2 for that fiscal year, and

  • (ii) 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 3, the amount that is calculated in accordance with subsection 4(2); and

• (b) in respect of drugs for veterinary use only,

  • (i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 2 for that fiscal year, and

  • (ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).

Marginal note:Fee — licence authorizing non-sterile fabrication

35 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including fabricating drugs that are not in sterile dosage form — but not fabricating drugs in sterile dosage form or importing drugs — the fee is as follows:

• (a) in respect of drugs for human use,

  • (i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 3 for that fiscal year, and

  • (ii) 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 3, the amount that is calculated in accordance with subsection 4(2); and

• (b) in respect of drugs for veterinary use only,

  • (i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 3 for that fiscal year, and

  • (ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).