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Version of document from 2020-09-28 to 2021-12-21:

Establishment Licence Fees Remission Order (Indication of an Activity in respect of a COVID-19 Drug)

SOR/2020-213

FOOD AND DRUGS ACT

Registration 2020-09-28

Establishment Licence Fees Remission Order (Indication of an Activity in respect of a COVID-19 Drug)

The Minister of Health, pursuant to section 30.63Footnote a of the Food and Drugs ActFootnote b, makes the annexed Establishment Licence Fees Remission Order (Indication of an Activity in respect of a COVID-19 Drug).

Ottawa, September 16, 2020

Patricia A. Hajdu
Minister of Health

Interpretation

Marginal note:Definitions

  •  (1) The following definitions apply in this Order.

    activity

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

    COVID-19

    COVID-19 means the coronavirus disease 2019. (COVID-19)

    COVID-19 drug

    COVID-19 drug means a drug that is manufactured, sold or represented for use in relation to COVID-19. (drogue contre la COVID-19)

    drug

    drug means a drug other than

    Regulations

    Regulations means the Food and Drug Regulations. (Règlement)

  • Marginal note:Other words and expressions

    (2) Unless the context otherwise requires, words and expressions used in this Order have the meanings assigned by the Regulations or the Fees in Respect of Drugs and Medical Devices Order, as the case may be.

Remissions

Marginal note:Establishment licence

  •  (1) Subject to subsection (2), remission of an amount equal to the fee referred to in subsection 29(1) of the Fees in Respect of Drugs and Medical Devices Order for the examination of one of the following applications or, if applicable, of the amount referred to in section 49 of that Order is granted to a person described in subsection 29(2) of that Order:

    • (a) an application for an establishment licence referred to in subsection 20(1) of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 that includes a statement to the effect that the application relates solely to activities in respect of a COVID-19 drug; or

    • (b) an application for the amendment of an establishment licence referred to in subsection 20(2) of that Interim Order that includes such a statement.

  • Marginal note:Conditions

    (2) The remission is granted on the condition that

    • (a) in the case of an application for an establishment licence in respect of a building located in Canada or for the amendment of an establishment licence to add a building located in Canada, each activity specified in the application that is proposed to be conducted in the building will be conducted solely in respect of a COVID-19 drug; and

    • (b) the person who submits the application provides the Minister, on written request, with documents that demonstrate that each activity specified in the application and conducted in the building is conducted solely in respect of a COVID-19 drug.

Marginal note:Annual review

  •  (1) Subject to subsection (4), remission is granted of the amounts referred to in subsections (2) and (3) to the person described in subsection 29(2) of the Fees in Respect of Drugs and Medical Devices Order that submits an application for the annual review of an establishment licence that was issued or amended by the Minister under section C.01A.008 of the Regulations after examination of an application referred to in paragraph 2(1)(a) or (b), as the case may be.

  • Marginal note:Amount — building located in Canada

    (2) The amount that is remitted in respect of each building located in Canada is

    • (a) in the case of an establishment licence issued by the Minister under section C.01A.008 of the Regulations after examination of an application referred to in paragraph 2(1)(a) and, if applicable, amended only after examination of an application referred to in paragraph 2(1)(b), an amount equal to the fee referred to in subsection 29(1) of the Fees in Respect of Drugs and Medical Devices Order for the examination of the application for the annual review of the establishment licence or, if applicable, the amount referred to in section 49 of that Order; or

    • (b) in the case of one of the following amended establishment licences, an amount equal to the difference between the fee referred to in subsection 29(1) of the Fees in Respect of Drugs and Medical Devices Order for the examination of the application for the annual review of the establishment licence that would be payable if the activities conducted in respect of any COVID-19 drug were the only activities specified in the licence or, if applicable, the amount referred to in section 49 of that Order and the fee that would be payable if the activities conducted in respect of any other drug were the only activities specified in the licence, if the fee that would be payable for the activities conducted in respect of any COVID-19 drug is higher than the fee that would be payable for the activities conducted in respect of any other drug

      • (i) an establishment licence issued by the Minister under section C.01A.008 of the Regulations after examination of an application referred to in paragraph 2(1)(a) and amended after examination of an application other than one referred to in paragraph 2(1)(b), or

      • (ii) an establishment licence issued by the Minister under section C.01A.008 of the Regulations after examination of an application other than one referred to in paragraph 2(1)(a) and amended after examination of an application referred to in paragraph 2(1)(b).

  • Marginal note:Amount — building located outside Canada

    (3) The amount that is remitted in respect of each building located outside Canada is an amount equal to the fee referred to in section 40 of the Fees in Respect of Drugs and Medical Devices Order for the examination of an application for the annual review of an establishment licence that was issued by the Minister under section C.01A.008 of the Regulations after examination of an application referred to in paragraph 2(1)(a) or (b) or, if applicable, the amount referred to in section 49 of that Order.

  • Marginal note:Conditions

    (4) The remission is granted on the condition that

    • (a) each activity specified in an application referred to in paragraph 2(2)(a) that is conducted in the building listed on the establishment licence is conducted solely in respect of a COVID-19 drug;

    • (b) each activity that is conducted in the building referred to in subsection (3) for the person who submits the application for the annual licence review is conducted solely in respect of a COVID-19 drug;

    • (c) the person who submits the application provides the Minister, on written request, with documents that demonstrate that the conditions set out in paragraphs (a) and (b) are met; and

    • (d) the Minister has not, under section C.01A.008 of the Regulations, issued another establishment licence or amended the establishment licence referred to in subsection (1) after examination of an application that contains the same documents and information as an application referred to in paragraph 2(1)(a) or (b), as the case may be, but that does not include the statement referred to in that paragraph.

Coming into Force

Marginal note:Registration

 This Order comes into force on the day on which it is registered.

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