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

Regulations are current to 2020-09-09 and last amended on 2020-04-01. 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; or

    • (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.

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.

Marginal note:Remission — General Council Decision

 Remission is granted to the person referred to in subsection 9(2) of the amount of the fee that is payable under subsection 9(1) if the person has received an authorization under section 21.04 of the Patent Act in respect of the drug.

Marginal note:Remission — small business

 Subject to section 18, remission is granted to the person referred to in subsection 9(2) of an amount equal to 50% of the fee that is payable under subsection 9(1) if the person provides with their submission, 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 submission by small business

 Subject to section 18, remission is granted to the person referred to in subsection 9(2) of an amount equal to the fee that is payable under subsection 9(1) if the following conditions are met:

  • (a) the person has not previously filed a submission in respect of a drug; and

  • (b) the person provides with their submission, 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

 If the Minister requests under section 5 that the person referred to in subsection 9(2) provide additional information, the fee — or the difference between the fee payable under subsection 9(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 2Fees for Examination of a Submission — Drugs for Veterinary Use Only

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 notification that is filed under subsection C.01.615(1) of those Regulations in respect of a veterinary health product;

  • (c) a new drug submission that is filed under section C.08.002 of those Regulations;

  • (d) an abbreviated new drug submission that is filed under section C.08.002.1 of those Regulations;

  • (e) a supplement to a new drug submission or an abbreviated new drug submission that is filed under section C.08.003 of those Regulations;

  • (f) a preclinical submission that is filed under subsection C.08.005(1) of those Regulations;

  • (g) information that is filed under section C.08.010 of those Regulations for the purpose of obtaining a letter of authorization;

  • (h) information and material that is filed under section C.08.014 of those Regulations for the purpose of obtaining an experimental studies certificate;

  • (i) information and material that is filed with the Minister in respect of a notifiable change; or

  • (j) a protocol that is filed with the Minister and may support any of the matters referred to in paragraphs (c) to (f) or (h).

Application

Marginal note:Application

 This Division applies to drugs for veterinary use only.

Fees and Remissions

Marginal note:Fee for examination

  •  (1) Subject to paragraph 22(b) and section 24, the fee that is payable in respect of a submission that is of a type set out in column 1 of Schedule 2, for the examination of each component set out in column 2 that is included in the submission, is as follows:

    • (a) in the case of a fee that is payable in a fiscal year set out in any of columns 3 to 9 of Schedule 2, the applicable 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 9 of Schedule 2, 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 21(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 21(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 21(2) stating that the submission has been received.

Marginal note:Fee — filing in previous fiscal year

 For the purposes of subsection 21(1), if the Minister issues a notice referred to in section 22 or 23 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:Remission — small business

 Subject to section 27, remission is granted to the person referred to in subsection 21(2) of an amount equal to 50% of the fee that is payable under subsection 21(1) if the person provides with their submission, 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 submission by small business

 Subject to section 27, remission is granted to the person referred to in subsection 21(2) of an amount equal to the fee that is payable under subsection 21(1) if the following conditions are met:

  • (a) the person has not previously filed a submission in respect of a drug; and

  • (b) the person provides with their submission, 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

 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 3Fees for Examination of an Application for an Establishment Licence — Drugs

Interpretation

Marginal note:Definitions

 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

  •  (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

 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

 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

 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

 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

 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

 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).

Marginal note:Fee — licence authorizing distribution

 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including distributing drugs — but not fabricating drugs in sterile dosage form, importing drugs or fabricating drugs that are not 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 4 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 4 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 wholesaling

 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including wholesaling drugs — but not fabricating drugs in sterile dosage form, importing drugs, fabricating drugs that are not in sterile dosage form or distributing 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 5 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 5 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 packaging/labelling

 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including packaging/labelling drugs — but not fabricating drugs in sterile dosage form, importing drugs, fabricating drugs that are not in sterile dosage form, distributing drugs or wholesaling 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 6 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 6 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 testing

 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including testing drugs — but not fabricating drugs in sterile dosage form, importing drugs, fabricating drugs that are not in sterile dosage form, distributing drugs, wholesaling drugs or packaging/labelling 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 7 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 7 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 — application for licence — building outside Canada

  •  (1) For the examination of an application for an establishment licence referred to in section 33 or 34, the fee for each building located outside Canada that is listed on the application is

    • (a) in respect of drugs for human use, $918; and

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

      • (i) in the case of a fee that is payable in the fiscal year 2020-2021, $765; and

      • (ii) in the case of a fee that is payable in any subsequent fiscal year, $918.

  • Marginal note:Fee — application for annual review — building outside Canada

    (2) For the examination of an application for the annual review of an establishment licence referred to in section 33 or 34, the fee for each building located outside Canada that is listed on the establishment licence is the applicable fee set out in paragraph (1)(a) or (b).

Marginal note:Fee — amendment — licence authorizing sterile fabrication

 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to fabricate drugs in sterile dosage form at that building, the fee for the examination of the application for each building to be added 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 — amendment — licence authorizing importation

 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to import drugs — but not to fabricate drugs in sterile dosage form — at that building, the fee for the examination of the application for each building to be added 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 — amendment — licence authorizing non-sterile fabrication

 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to fabricate drugs that are not in sterile dosage form — but not to fabricate drugs in sterile dosage form or import drugs — at that building, the fee for the examination of the application for each building to be added 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).

Marginal note:Fee — amendment — licence authorizing distribution

 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to distribute drugs — but not to fabricate drugs in sterile dosage form, import drugs or fabricate drugs that are not in sterile dosage form — at that building, the fee for the examination of the application for each building to be added 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 4 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 4 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 — amendment — licence authorizing wholesaling

 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to wholesale drugs — but not to fabricate drugs in sterile dosage form, import drugs, fabricate drugs that are not in sterile dosage form or distribute drugs — at that building, the fee for the examination of the application for each building to be added 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 5 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 5 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 — amendment — licence authorizing packaging/labelling

 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to package/label drugs — but not to fabricate drugs in sterile dosage form, import drugs, fabricate drugs that are not in sterile dosage form, distribute drugs or wholesale drugs — at that building, the fee for the examination of the application for each building to be added 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 6 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 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 6 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 — amendment — licence authorizing testing

 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to test drugs — but not to fabricate drugs in sterile dosage form, import drugs, fabricate drugs that are not in sterile dosage form, distribute drugs, wholesale drugs or package/label drugs — at that building, the fee for the examination of the application for each building to be added 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 7 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 7 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:Prorated fee

 The fee that is payable under subsection 29(1) is reduced by the percentage set out in column 1 of Schedule 5 if the person referred to in subsection 29(2) files, in the period set out in column 2,

  • (a) an application for an establishment licence and has not previously filed such an application; or

  • (b) an application to amend an establishment licence that seeks to add a building.

Marginal note:Remission — small business

 Subject to section 50, remission is granted to the person referred to in subsection 29(2) of an amount equal to 25% of the fee that is payable under subsection 29(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:Difference payable

 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

 This Division does not apply to drugs 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, 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

 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

 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.

Marginal note:Remission — General Council Decision

 Remission is granted to the person referred to in subsection 60(2) of an amount equal to the fee that is payable under subsection 60(1) if the person has received an authorization under section 21.04 of the Patent Act in respect of the medical device.

Marginal note:Remission — small business

 Subject to section 68, remission is granted to the person referred to in subsection 60(2) of an amount equal to 50% of the fee that is payable under subsection 60(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

 Subject to section 68, remission is granted to the person referred to in subsection 60(2) of an amount equal to the fee that is payable under subsection 60(1) if the following conditions are met:

  • (a) the person has not previously filed an application for a licence under section 32 of the Medical Devices Regulations; 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

 If the Minister requests under section 5 that the person referred to in subsection 60(2) provide additional information, the fee — or the difference between the fee payable under subsection 60(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 2Fees for Examination of an Application for an Establishment Licence — Medical Devices

Interpretation

Marginal note:Definition of establishment licence

 In this Division, establishment licence means a licence issued under section 46 of the Medical Devices Regulations.

Application

Marginal note:Applicable classes

 This Division applies to persons that import or sell medical devices that are subject to the Medical Devices Regulations, other than persons that import or sell only medical devices that are subject to Part 2 or 3 of those Regulations.

Fee and Remission

Marginal note:Fee for examination

  •  (1) The fee that is payable for the examination of an application for an establishment licence filed under section 45 of the Medical Devices Regulations or for the annual review of such a licence filed under section 46.1 of those Regulations is $4,590.

  • 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

 The fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 71(2) stating that the application has been accepted for further examination.

Marginal note:Reinstatement

 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:Remission — small business

 Subject to section 75, remission is granted to the person referred to in subsection 71(2) of an amount equal to 25% of the fee that is payable under subsection 71(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:Difference payable

 If the Minister requests under section 5 that the person referred to in subsection 71(2) provide additional information, the difference between the fee payable under subsection 71(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 3Fees for Right to Sell Licensed Class II, III or IV Medical Devices

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 Remission

Marginal note:Annual fee

  •  (1) The annual fee that is payable for the right to sell a licensed Class II, III or IV medical device is $381.

  • Marginal note:Fee payable by holder — licence not suspended

    (2) The fee is payable by the person that holds the licence for the Class II, III or IV medical device if the licence is not suspended under section 40 or 41 of the Medical Devices Regulations.

Marginal note:Timing of payment

 The fee is payable on December 20.

Marginal note:Remission — small business

 Subject to section 80, remission is granted to the person referred to in subsection 77(2) of an amount equal to 25% of the fee that is payable under subsection 77(1) if the person provides with the statement provided under subsection 43(1) of the Medical Devices 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 77(2) provide additional information, the difference between the fee payable under subsection 77(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.

Coming into Force

Marginal note:SOR/96-143

Footnote * This Order comes into force on the day on which the Veterinary Drug Evaluation Fees Regulations are repealed but if it is registered after that day, it comes into force on the day on which it is registered.

SCHEDULE 1(Section 9)

Fees for Examination of a Submission — Drugs for Human Use

ItemColumn 1Column 2Column 3Column 4Column 5Column 6
Submission ClassDescriptionFee ($)Fee ($)Fee ($)Fee ($)
Fiscal YearFiscal YearFiscal YearFiscal Year
2020-20212021-20222022-20232023-2024
1New active substanceSubmissions in support of a drug, other than a disinfectant, that contains a medicinal ingredient not previously approved in a drug for sale in Canada and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph400,288437,884475,481513,077
2Clinical or non-clinical data and chemistry and manufacturing dataSubmissions based on clinical or non-clinical data and chemistry and manufacturing data for a drug that does not include a new active substance204,197224,691245,185265,678
3Clinical or non-clinical data onlySubmissions based only on clinical or non-clinical data for a drug that does not include a new active substance90,86495,987101,110106,232
4Comparative studiesSubmissions based on comparative studies (e.g., clinical or non-clinical data, bioavailability data and data on the pharmacokinetics and pharmacodynamics of the drug) with or without chemistry and manufacturing data for a drug that does not include a new active substance53,83655,84857,85959,870
5Chemistry and manufacturing data onlySubmissions based only on chemistry and manufacturing data for a drug that does not include a new active substance27,58730,67033,75236,835
6Clinical or non-clinical data only, in support of safety updates to the labellingSubmissions based only on clinical or non-clinical data, in support of safety updates to the labelling materials for a new drug that does not include a new active substance19,44219,44219,44219,442
7Labelling onlySubmissions, other than those described in item 8, 11 or 12, of labelling material, that include data in support of the following: brand name assessment, standardized or published test methods, in vitro or in vivo photostability or applications for a drug identification number in support of changes to brand names of non-prescription drugs (but not including examination of other supporting clinical or non-clinical data, comparative data, or chemistry and manufacturing data)3,8164,3284,8415,353
8Labelling only (generic drugs)Submissions in support of a change to the labelling to be consistent with the Canadian reference product that do not include any additional labelling updates requiring a labelling assessment2,0102,0102,0102,010
9Administrative submissionSubmissions in support of a change in the manufacturer’s name or brand name, including the following: changes in ownership of the drug, request for an additional brand name or changes resulting from a licensing agreement being entered into by two manufacturers that do not require an assessment of labelling material or brand name (e.g., post-authorization label changes filed by licensees to remain identical to licensor’s drug and post-authorization chemistry and manufacturing updates for drugs listed in Schedule C or D of the Food and Drugs Act)432540676845
10Disinfectant — full reviewSubmissions, other than those described in item 11, that include data in support of a disinfectant5,7127,1408,92511,157
11Labelling only (disinfectants)Submissions in support of changes to the labelling of disinfectants that do not require supporting data, submissions in support of safety updates for disinfectants that are new drugs or submissions in support of a change in the manufacturer’s name or brand name that requires a review of labelling material due to deviations from the previously authorized labelling or drug2,5072,5072,5072,507
12Drug identification number application — labelling standardsApplications, including those that pertain to changes to brand names for non-prescription drugs, that include an attestation of compliance with a labelling standard or Category IV Monograph for a drug and that do not include clinical or non-clinical data or chemistry and manufacturing data1,6161,6161,6161,616

SCHEDULE 2(Section 21)

Fees for Examination of a Submission — Drugs for Veterinary Use Only

ItemColumn 1Column 2Column 3Column 4Column 5Column 6Column 7Column 8Column 9
Type of SubmissionComponentFee ($)Fee ($)Fee ($)Fee ($)Fee ($)Fee ($)Fee ($)
Fiscal YearFiscal YearFiscal YearFiscal YearFiscal YearFiscal YearFiscal Year
2020-20212021-20222022-20232023-20242024-20252025-20262026-2027
1Application for drug identification numberInformation, other than that referred to in item 2, to support an application for a drug identification number, including the submission of labelling material for a second review, if required9181,1481,4361,7141,9592,2042,448
2Application for drug identification numberPublished references or other data6387989981,1911,3611,5321,701
3Application for drug identification numberDocumentation to support a change of manufacturer, a change to the name of a manufacturer or a change to the brand name of a drugFootnote for Fees for Examination of a Submission — Drugs for Veterinary Use Only1320400500596681765850
4Notification — veterinary health productInformation contained in a notification filed under subsection C.01.615(1) of the Food and Drug Regulations in respect of a veterinary health product486486486486486486486
5New drug submissionEfficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in one animal species (in the case of an antiparasitic drug, several indications in one food animal species)20,37525,46931,83738,03343,46748,90054,333
6New drug submissionEfficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species12,34215,42819,28623,03926,33129,62232,913
7New drug submissionEfficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration and dosage form and two indications in one animal species29,63137,04046,30055,31263,21471,11679,017
8New drug submissionEfficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species40,12550,15762,69774,89985,59996,299106,998
9New drug submissionComparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration3,6984,6235,7796,9037,8898,8769,861
10New drug submissionComparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength6127659571,1431,3061,4691,632
11New drug submissionFor food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species27,78334,72943,41251,86159,27066,67874,086
12New drug submissionFor food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species37,04046,30057,87569,14079,01788,89398,770
13New drug submissionFor food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration3,6984,6235,7796,9037,8898,8769,861
14New drug submissionFor food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in an additional species18,51323,14228,92834,55839,49544,43249,368
15New drug submissionChemistry and manufacturing data for a non-compendial medicinal ingredient of a drug6,1717,7159,64411,52013,16614,81116,456
16New drug submissionChemistry and manufacturing data to support one strength of a single dosage form6,1717,7159,64411,52013,16614,81116,456
17New drug submissionChemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as item 163,0863,8584,8235,7606,5847,4078,229
18New drug submissionDocumentation to support a change of manufacturerFootnote for Fees for Examination of a Submission — Drugs for Veterinary Use Only2320400500596681765850
19Supplement to a new drug submissionEfficacy data to support an additional indication in one animal species16,05320,06725,08429,96534,24638,52742,807
20Supplement to a new drug submissionEfficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species12,34215,42819,28623,03926,33129,62232,913
21Supplement to a new drug submissionEfficacy and safety data (in the intended species) to support an indication in another animal species20,37525,46931,83738,03343,46748,90054,333
22Supplement to a new drug submissionEfficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration and dosage form and two indications in one animal species29,63137,04046,30055,31263,21471,11679,017
23Supplement to a new drug submissionEfficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species40,12550,15762,69774,89985,59996,299106,998
24Supplement to a new drug submissionEfficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species9,86912,33615,42118,42221,05323,68526,316
25Supplement to a new drug submissionComparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration3,6984,6235,7796,9037,8898,8769,861
26Supplement to a new drug submissionComparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength6127659571,1431,3061,4691,632
27Supplement to a new drug submissionFor food-producing animals, residue depletion studies to establish a new withdrawal period for a change in the dosage or route of administration of an approved dosage form in one species3,6984,6235,7796,9037,8898,8769,861
28Supplement to a new drug submissionFor food-producing animals, metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage and route of administration of an approved dosage form in an additional species18,51323,14228,92834,55839,49544,43249,368
29Supplement to a new drug submissionFor food-producing animals, toxicity studies to support a change of an established acceptable daily intake, a maximum residue limit and a withdrawal period9,25711,57114,46417,27919,74822,21624,684
30Supplement to a new drug submissionFor the concurrent use of two drugs in a species of food-producing animals, residue depletion studies to determine if an extension to existing withdrawal periods is required7,4099,26111,57613,82915,80417,78019,755
31Supplement to a new drug submissionChemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process6,1717,7159,64411,52013,16614,81116,456
32Supplement to a new drug submissionChemistry and manufacturing data to support a change in formulation or dosage form3,0863,8584,8235,7606,5847,4078,229
33Supplement to a new drug submissionChemistry and manufacturing data to support a change in the packaging or sterilization process2,4623,0783,8484,5955,2505,9066,562
34Supplement to a new drug submissionChemistry and manufacturing data to support an extension of the expiry date1,8502,3132,8913,4523,9454,4374,930
35Supplement to a new drug submissionChemistry and manufacturing data to support the concurrent use of two drugs1,8502,3132,8913,4523,9454,4374,930
36Supplement to a new drug submissionChemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage form6127659571,1431,3061,4691,632
37Supplement to a new drug submissionDocumentation to support a change to the brand name of a drugFootnote for Fees for Examination of a Submission — Drugs for Veterinary Use Only3320400500596681765850
38Abbreviated new drug submission or supplement to an abbreviated new drug submissionComparative (pharmacodynamic, clinical or bioavailability) data to support a single route of administration and dosage form3,6984,6235,7796,9037,8898,8769,861
39Abbreviated new drug submission or supplement to an abbreviated new drug submissionFor food-producing animals, residue depletion studies to confirm that the withdrawal periods for each species fall within the conditions of use for the Canadian reference product3,6984,6235,7796,9037,8898,8769,861
40Abbreviated new drug submission or supplement to an abbreviated new drug submissionChemistry and manufacturing data for a non-compendial medicinal ingredient of a drug6,1717,7159,64411,52013,16614,81116,456
41Abbreviated new drug submission or supplement to an abbreviated new drug submissionChemistry and manufacturing data to support a single dosage form6,1717,7159,64411,52013,16614,81116,456
42Abbreviated new drug submission or supplement to an abbreviated new drug submission

Documentation to support

320400500596681765850
43Preclinical submissionEfficacy and safety data (in the intended species) and protocol to support the conduct of clinical studies relative to a single dosage form, route of administration and indication in one species6,1717,7159,64411,52013,16614,81116,456
44Preclinical submissionEfficacy data and protocol to support the conduct of clinical studies relative to a single route of administration and indication with a dosage form for which a notice of compliance has been issued for use in the species to be treated4,9356,1697,7129,21110,52711,84313,158
45Preclinical submissionFor food-producing animals, toxicity, metabolism and residue depletion studies to establish a temporary acceptable daily intake, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species18,51323,14228,92834,55839,49544,43249,368
46Preclinical submissionFor food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species27,78334,72943,41251,86159,27066,67874,086
47Preclinical submissionFor food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species37,04046,30057,87569,14079,01788,89398,770
48Preclinical submissionFor food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism studies to establish a withdrawal period for a single dosage form, dosage and route of administration in an additional species9,25711,57114,46417,27919,74822,21624,684
49Preclinical submissionChemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient6,1717,7159,64411,52013,16614,81116,456
50Preclinical submissionChemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient3,0863,8584,8235,7606,5847,4078,229
51Sale of new drug for emergency treatmentInformation and material to support the sale of a new drug to be used in the emergency treatment of a non-food-producing animal51515151515151
52Sale of new drug for emergency treatmentInformation and material to support the sale of a new drug to be used in the emergency treatment of a food-producing animal102102102102102102102
53Experimental studies certificateInformation and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal980980980980980980980
54Experimental studies certificateInformation and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a non-food-producing animal490490490490490490490
55Experimental studies certificateInformation and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal2,9582,9582,9582,9582,9582,9582,958
56Experimental studies certificateInformation and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a food-producing animal490490490490490490490
57Notifiable changeInformation and material to support an application for a notifiable change1,6582,0732,5913,0953,5373,9784,420
58ProtocolA protocol that is filed with the Minister and may support a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission or abbreviated new drug submission, a preclinical submission or information and material that is filed for the purpose of obtaining an experimental studies certificate1,6582,0732,5913,0953,5373,9784,420
  • Return to footnote 1This item applies only to an application for a drug identification number that does not include either of the components set out in items 1 and 2.

  • Return to footnote 2This item applies only to a new drug submission that does not include any of the components set out in items 5 to 17.

  • Return to footnote 3This item applies only to a supplement to a new drug submission that does not include any of the components set out in items 19 to 36.

  • Return to footnote 4This item applies only to an abbreviated new drug submission or a supplement to an abbreviated new drug submission that does not include any of the components set out in items 38 to 41.

SCHEDULE 3(Sections 33 to 39 and 41 to 47)

Fees for Examination of an Application for an Establishment Licence — Drugs for Human Use

ItemColumn 1Column 2Column 3Column 4Column 5
ActivityFee ($)Fee ($)Fee ($)Fee ($)
Fiscal YearFiscal YearFiscal YearFiscal Year
2020-20212021-20222022-20232023-2024
1Fabrication — sterile dosage form41,62641,73041,83441,937
2Importation27,35929,03330,70732,380
3Fabrication — non-sterile dosage form27,00028,36429,72731,091
4Distribution12,56013,88215,20516,527
5Wholesaling4,9376,1717,7159,644
6Packaging/labelling6,0616,0616,0616,061
7Testing2,5603,2004,0015,002

SCHEDULE 4(Sections 33 to 39 and 41 to 47)

Fees for Examination of an Application for an Establishment Licence — Drugs for Veterinary Use Only

ItemColumn 1Column 2Column 3Column 4Column 5Column 6Column 7Column 8
ActivityFee ($)Fee ($)Fee ($)Fee ($)Fee ($)Fee ($)Fee ($)
Fiscal YearFiscal YearFiscal YearFiscal YearFiscal YearFiscal YearFiscal Year
2020-20212021-20222022-20232023-20242024-20252025-20262026-2027
1Fabrication — sterile dosage form40,19840,48740,77741,06841,35741,64741,937
2Importation10,71513,39316,74220,92726,15832,38032,380
3Fabrication — non-sterile dosage form8,78210,97813,72217,15221,44026,80031,091
4Distribution4,8356,0437,5559,44311,80314,75416,527
5Wholesaling1,9332,4163,0203,7744,7185,8987,372
6Packaging/labelling6,0616,0616,0616,0616,0616,0616,061
7Testing1,3151,6442,0552,5693,2104,0135,002

SCHEDULE 5(Section 48)

Fee Reduction — Application for an Establishment Licence — Drugs

ItemColumn 1Column 2
Percentage of Fee ReductionFiling Period
125%July 1 to September 30
250%October 1 to December 31
375%January 1 to March 31
  • Note: The fee payable under subsection 30(1) of this Order is not reduced if an application is filed on or after April 1 and up to and including June 30.

SCHEDULE 6(Section 52)Fees for Right to Sell Drugs for Human Use

Interpretation

  • Marginal note:Definition of disinfectant

    1 In this Schedule, disinfectant has the meaning assigned by the definition antimicrobial agent in subsection C.01A.001(1) of the Food and Drug Regulations.

    ItemColumn 1Column 2Column 3Column 4Column 5
    Type of DrugFee ($)Fee ($)Fee ($)Fee ($)
    Fiscal YearFiscal YearFiscal YearFiscal Year
    2020-20212021-20222022-20232023-2024
    1Disinfectant1,2851,3441,4031,462
    2Non-prescription drug1,6232,0222,4212,820
    3Drug other than one referred to in item 1 or 21,8362,7544,0804,679

SCHEDULE 7(Section 56)

Fees for Right to Sell Drugs for Veterinary Use Only

ItemColumn 1Column 2Column 3Column 4
Fee ($)Fee ($)Fee ($)Fee ($)
Fiscal YearFiscal YearFiscal YearFiscal Year
2020-20212021-20222022-20232023-2024
1312367422477

SCHEDULE 8(Section 60)Fees for Examination of an Application for a Medical Device Licence

Interpretation

  • Marginal note:Definition of private label medical device

    1 In this Schedule, private label medical device means a medical device that is identical in every respect to a medical device in respect of which a licence has been issued, except that the device is labelled with the name and address of another manufacturer and the name and identifier of the device that the other manufacturer is proposing to sell under its own name or under a trademark, design, trade-name or other name or mark owned or controlled by it.

ItemColumn 1Column 2Column 3Column 4Column 5Column 6
CategoryDescriptionFee ($)Fee ($)Fee ($)Fee ($)
Fiscal YearFiscal YearFiscal YearFiscal Year
2020-20212021-20222022-20232023-2024
1Applications for Class II licenceApplications for Class II medical device licence other than those referred to in item 10450478505533
2Applications for Class II licence amendmentApplications for amendment of Class II medical device licence other than those referred to in item 10272272272272
3Applications for Class III licenceApplications for Class III medical device licence other than those referred to in item 4 or 107,4778,91210,34711,783
4Applications for Class III licence (near patient)Applications for Class III medical device licence for a near patient in vitro diagnostic device12,85116,06420,08125,102
5Applications for Class III licence amendment — changes in manufacturingApplications for amendment of Class III medical device licence — changes in manufacturing process, facility or equipment or manufacturing quality control procedures1,9032,3792,9743,717
6Applications for Class III licence amendment — significant changes not related to manufacturingApplications for amendment of Class III medical device licence — significant changes other than those referred to in item 56,6087,5588,5089,458
7Applications for Class IV licenceApplications for Class IV medical device licence other than those referred to in item 1024,34524,74825,15125,554
8Applications for Class IV licence amendment — changes in manufacturingApplications for amendment of Class IV medical device licence — changes referred to in paragraph 34(a) of the Medical Devices Regulations that relate to manufacturing1,9032,3792,9743,717
9Applications for Class IV licence amendment — significant changes not related to manufacturingApplications for amendment of Class IV medical device licence — any other changes referred to in paragraph 34(a) or (b) of the Medical Devices Regulations8,0579,98311,75213,521
10Applications for Class II, III or Class IV licence or licence amendment — private label medical deviceApplications for Class II, III or IV medical device licence or applications for amendment of such a licence — private label medical device147147147147
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