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

Regulations are current to 2022-11-16 and last amended on 2021-03-19. Previous Versions

Fees in Respect of Drugs and Medical Devices Order

SOR/2019-124

FOOD AND DRUGS ACT

Registration 2019-05-08

Fees in Respect of Drugs and Medical Devices Order

Whereas, pursuant to section 30.62Footnote a of the Food and Drugs ActFootnote b, the Minister of Health has consulted with any persons that the Minister considers to be interested in the matter;

Therefore, the Minister of Health, pursuant to subsections 30.61(1)Footnote a and 30.63(1)Footnote a of the Food and Drugs ActFootnote b, makes the annexed Fees in Respect of Drugs and Medical Devices Order.

Ottawa, May 3, 2019

Ginette C. Petitpas Taylor
Minister of Health

PART 1General

Interpretation

Marginal note:Definitions

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

    entity

    entity has the meaning assigned by the definition organization in section 2 of the Criminal Code. (entité)

    fiscal year

    fiscal year means

    • (a) for the purposes of sections 16, 17, 25, 26, 49, 53, 57, 66, 67, 74 and 79, the fiscal year of a person that provides information under that section or of a person with which the person is affiliated; and

    • (b) for the purposes of any other section, the period beginning on April 1 in one year and ending on March 31 in the next year. (exercice)

    performance standard

    performance standard means the document entitled Performance Standards for the Fees in Respect of Drugs and Medical Devices Order, published by the Government of Canada, dated November 22, 2018. (norme de rendement)

    small business

    small business means a person in respect of which either of the following criteria applies:

    • (a) the total of the number of employees of the person and of the persons with which the person is affiliated is fewer than 100; or

    • (b) the total of the gross revenue of the person and of the persons with which the person is affiliated is $30,000 or more but less than $5 million. (petite entreprise)

  • Marginal note:Other words and expressions

    (2) Unless the context otherwise requires, other words and expressions used in this Order have the meanings assigned to them by the Food and Drug Regulations or the Medical Devices Regulations, as the case may be.

  • Marginal note:Affiliation

    (3) For the purposes of this Order,

    • (a) one entity is affiliated with another entity if one of them is the subsidiary of the other or both are subsidiaries of the same entity or each of them is controlled by the same entity or individual;

    • (b) if two entities are affiliated with the same entity at the same time, they are deemed to be affiliated with each other; and

    • (c) an individual is affiliated with an entity if the individual controls the entity.

  • Marginal note:Subsidiary entity

    (4) For the purposes of this Order, an entity is a subsidiary of another entity if it is controlled by that other entity.

  • Marginal note:Control

    (5) For the purposes of this Order,

    • (a) a corporation is controlled by an entity or an individual if

      • (i) securities of the corporation to which are attached more than 50% of the votes that may be cast to elect directors of the corporation are held, directly or indirectly, whether through one or more subsidiaries or otherwise, other than by way of security only, by or for the benefit of that entity or individual, and

      • (ii) the votes attached to those securities are sufficient, if exercised, to elect a majority of the directors of the corporation; and

    • (b) an entity other than a corporation is controlled by an entity or individual if the entity or individual, directly or indirectly, whether through one or more subsidiaries or otherwise, holds an interest in the entity that is not a corporation that entitles them to receive more than 50% of the profits of that entity or more than 50% of its assets on dissolution.

  • Marginal note:Deemed affiliation

    (6) For the purposes of this Order, if it may reasonably be considered that one of the main reasons for the separate existence of two or more corporations is so that one of them meets the applicable conditions for a remission of a fee fixed under this Order for which only small businesses are eligible, the two or more corporations are deemed to be affiliated with each other.

Purpose

Marginal note:Purpose — fees

  •  (1) The purpose of this Order is to fix the fees for the following:

    • (a) in respect of drugs for human use and drugs for veterinary use only, the examination of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission referred to in section C.08.002, C.08.002.1 or C.08.003 of the Food and Drug Regulations, as the case may be, an application in respect of an establishment licence filed under those Regulations or an application for a drug identification number filed under section C.01.014.1 of those Regulations;

    • (b) in respect of drugs for veterinary use only, the examination of a notification for a veterinary health product filed under subsection C.01.615(1) of the Food and Drug Regulations, a preclinical submission filed under subsection C.08.005(1) of those Regulations, information filed under section C.08.010 of those Regulations for the purpose of obtaining a letter of authorization, information and material filed under section C.08.014 of those Regulations for the purpose of obtaining an experimental studies certificate, information and material filed with the Minister in respect of a notifiable change or a protocol filed with the Minister;

    • (c) the right to sell a drug under the Food and Drug Regulations; and

    • (d) the examination of an application in respect of a medical device licence, the right to sell a medical device or the examination of an application in respect of an establishment licence under the Medical Devices Regulations.

  • Marginal note:Purpose — remission

    (2) The purpose of this Order is also to remit, in whole or in part, certain of those fees.

Non-application

Marginal note:Non-application

  •  (1) This Order does not apply in respect of

    • (a) publicly funded health care institutions;

    • (b) branches or agencies of the Government of Canada or of the government of a province; or

    • (c) drugs that are the subject of an extraordinary use new drug submission filed under section C.08.002.01 of the Food and Drug Regulations or of an abbreviated extraordinary use new drug submission filed under section C.08.002.1 of those Regulations.

  • Marginal note:Definition of publicly funded health care institution

    (2) For the purposes of subsection (1), publicly funded health care institution means an institution that is funded by the Government of Canada or the government of a province and that is

    • (a) licensed, approved or designated by a province in accordance with the laws of the province to provide care or treatment to persons or animals suffering from any form of disease or illness; or

    • (b) owned or operated by the Government of Canada or the government of a province and that provides health services.

Annual Adjustment of Fees

Marginal note:Adjustment of fees

  •  (1) Beginning on April 1, 2021, every fee set out in this Order is to be adjusted in each fiscal year on April 1 by the percentage change over 12 months in the April All-items Consumer Price Index for Canada, as published by Statistics Canada under the Statistics Act, for the previous fiscal year and rounded up to the nearest dollar.

  • Marginal note:Formula

    (2) In the case of a fee that is payable under any of Divisions 1 to 5 of Part 2 or Division 1 of Part 3 in a fiscal year that is not set out in the applicable schedule, the amount of the fee is to be calculated, on April 1 of the fiscal year, in accordance with the following formula and rounded up to the nearest dollar:

    Fee = A + (A × B)

    where

    A
    is the amount of the fee that was payable in the previous fiscal year; and
    B
    is the percentage change over 12 months in the April All-items Consumer Price Index for Canada, as published by Statistics Canada under the Statistics Act, for the previous fiscal year.

Requests for Information — Remissions for Small Businesses

Marginal note:Information on request

 If the Minister determines, in respect of a person that provided information under any of the following provisions, that additional information is necessary to demonstrate that the person met the definition small business in subsection 1(1) in the applicable fiscal year, the Minister may request that the person provide him or her with additional information within 60 days after the day on which the request is made:

  • (a) subparagraph 16(a)(ii) or (b)(ii);

  • (b) clause 17(b)(i)(B) or (ii)(B);

  • (c) subparagraph 25(a)(ii) or (b)(ii);

  • (d) clause 26(b)(i)(B) or (ii)(B);

  • (e) subparagraph 49(a)(ii) or (b)(ii);

  • (f) subparagraph 53(a)(ii) or (b)(ii);

  • (g) subparagraph 57(a)(ii) or (b)(ii);

  • (h) subparagraph 66(a)(ii) or (b)(ii);

  • (i) clause 67(b)(i)(B) or (ii)(B);

  • (j) subparagraph 74(a)(ii) or (b)(ii); or

  • (k) subparagraph 79(a)(ii) or (b)(ii).

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;

    • (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; or

    • (c) a new drug submission for a designated COVID-19 drug if subsection C.08.002(2.3) of the Food and Drug Regulations applies to that submission.

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.

 
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