Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
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Regulations are current to 2024-11-26 and last amended on 2024-01-03. Previous Versions
Fees in Respect of Drugs and Medical Devices Order
SOR/2019-124
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
Return to footnote aS.C. 2017, c. 20, s. 317
Return to footnote bR.S., c. F-27
PART 1General
Interpretation
Marginal note:Definitions
1 (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 on its website, dated September 11, 2023. (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
2 (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;
(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; and
(e) the examination of an application to amend an authorization in respect of a Class II, III or IV medical device that is not a UPHN medical device or the right to sell such a device 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
3 (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
4 (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
5 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
6 (1) If the Minister determines that the performance standard has not been met in relation to a fee that is payable under this Order, remission is granted to the person that must pay the fee
(a) of an amount equal to 25% of the fee; or
(b) of an amount equal to 25% of the amount that is payable, in the case where remission is granted of part of the fee under any other provision of this Order.
Marginal note:Exceptions
(2) Subsection (1) does not apply to a fee for the examination of
(a) an application or submission referred to in this Order in respect of which a joint or parallel review is conducted by the Minister and a foreign regulatory authority;
(b) an application for a licence that is filed under section 32 of the Medical Devices Regulations if
(i) the medical device to which the application relates includes a component that is a drug, and
(ii) the Minister has made a decision in respect of the application to issue or amend a medical device licence under section 36 of those Regulations, or to refuse to issue or amend such a licence under section 38 of those Regulations; or
(c) a new drug submission for a designated COVID-19 drug if subsection C.08.002(2.3) of the Food and Drug Regulations applies to that submission.
PART 2Drugs
DIVISION 1Fees for Examination of a Submission — Drugs for Human Use
Interpretation
Marginal note:Definition of submission
7 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
8 This Division does not apply to drugs for veterinary use only.
Fees and Remissions
Marginal note:Fee for examination
9 (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
10 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
11 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
12 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
13 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
14 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 — designated COVID-19 drug
14.1 (1) 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
(a) filed an application for a designated COVID-19 drug under the ISAD Interim Order; and
(b) subsequently filed a submission for that drug.
Marginal note:Remission — no previous submission
(2) The remission referred to in subsection (1) is granted if the person has not previously filed a submission for the designated COVID-19 drug.
Marginal note:Remission — General Council Decision
15 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
16 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
17 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
18 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
19 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
20 This Division applies to drugs for veterinary use only.
Fees and Remissions
Marginal note:Fee for examination
21 (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
22 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
23 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
24 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
25 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
26 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
27 If the Minister requests under section 5 that the person referred to in subsection 21(2) provide additional information, the fee — or the difference between the fee payable under subsection 21(1) and the amount already paid, as the case may be — is immediately payable if
(a) the person has not provided, within the period specified in section 5, the Minister with additional information for the purpose of demonstrating that the person met the definition small business in subsection 1(1) in the applicable fiscal year; or
(b) the person has provided, within the period specified in section 5, the Minister with additional information for the purpose of demonstrating that the person met the definition in the applicable fiscal year but the Minister determines, after the period ends, that the person has not provided sufficient information to demonstrate that they met that definition in the applicable fiscal year.
DIVISION 3Fees for Examination of an Application for an Establishment Licence — Drugs
Interpretation
Marginal note:Definitions
28 The following definitions apply in this Division.
- activity
activity means an activity set out in Table I to section C.01A.008 of the Food and Drug Regulations. (activité)
- drug
drug has the same meaning as in subsection C.01A.001(2) of the Food and Drug Regulations. (drogue)
- establishment licence
establishment licence means a licence issued under section C.01A.008 of the Food and Drug Regulations. (licence d’établissement)
Fees and Remission
Marginal note:Fee for examination
29 (1) Subject to section 48, the fee for the examination of an application for an establishment licence or for the annual review of an establishment licence is the sum of the applicable fees referred to in sections 33 to 40 and the fee payable for the examination of an application to amend an establishment licence to add a building is the sum of the applicable fees referred to in sections 41 to 47.
Marginal note:Fee paid by person that files application
(2) The fee is payable by the person that files the application.
Marginal note:Timing of payment
30 The fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 29(2) stating that the application has been accepted for further examination.
Marginal note:Reinstatement
31 Every provision of this Division that applies to an application for an establishment licence also applies to a request to have such a licence reinstated following the correction of the situation that gave rise to its suspension.
Marginal note:Interpretation
32 In sections 33 to 39, a reference to the examination of an application for an establishment licence includes an examination of an application for the annual review of an establishment licence.
Marginal note:Fee — licence authorizing sterile fabrication
33 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including fabricating drugs in sterile dosage form, the fee is as follows:
(a) in respect of drugs for human use,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 1 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 5 of Schedule 3, the amount that is calculated in accordance with subsection 4(2); and
(b) in respect of drugs for veterinary use only,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 1 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).
Marginal note:Fee — licence authorizing importation
34 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including importing drugs — but not fabricating drugs in sterile dosage form — the fee is as follows:
(a) in respect of drugs for human use,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 2 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 5 of Schedule 3, the amount that is calculated in accordance with subsection 4(2); and
(b) in respect of drugs for veterinary use only,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 2 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).
Marginal note:Fee — licence authorizing non-sterile fabrication
35 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including fabricating drugs that are not in sterile dosage form — but not fabricating drugs in sterile dosage form or importing drugs — the fee is as follows:
(a) in respect of drugs for human use,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 3, the fee set out in item 3 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 5 of Schedule 3, the amount that is calculated in accordance with subsection 4(2); and
(b) in respect of drugs for veterinary use only,
(i) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 8 of Schedule 4, the fee set out in item 3 for that fiscal year, and
(ii) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 8 of Schedule 4, the amount that is calculated in accordance with subsection 4(2).
Marginal note:Fee — licence authorizing distribution
36 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
37 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
38 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
39 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
40 (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
41 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
42 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
43 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
44 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
45 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
46 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
47 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
48 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
49 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
50 If the Minister requests under section 5 that the person referred to in subsection 29(2) provide additional information, the difference between the fee payable under subsection 29(1) and the amount already paid is immediately payable if
(a) the person has not provided, within the period specified in section 5, the Minister with additional information for the purpose of demonstrating that the person met the definition small business in subsection 1(1) in the applicable fiscal year; or
(b) the person has provided, within the period specified in section 5, the Minister with additional information for the purpose of demonstrating that the person met the definition in the applicable fiscal year but the Minister determines, after the period ends, that the person has not provided sufficient information to demonstrate that they met that definition in the applicable fiscal year.
DIVISION 4Fees for Right to Sell Drugs for Human Use
Non-application
Marginal note:Non-application
51 This Division does not apply to drugs for veterinary use only.
Fees and Remission
Marginal note:Annual fee
52 (1) The annual fee that is payable for the right to sell a drug for which a drug identification number has been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations is, in respect of the type of drug set out in column 1 of Schedule 6, as follows:
(a) in the case of a fee that is payable in a fiscal year set out in any of columns 2 to 5 of Schedule 6, the fee set out in that column; and
(b) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 2 to 5 of Schedule 6, the amount that is calculated in accordance with subsection 4(2).
Marginal note:Fee payable by person after first sale
(2) The fee is payable by the person to which a document was issued under subsection C.01.014.2(1) of the Food and Drug Regulations that sets out the drug identification number assigned for the drug if the person has sold the drug following the issuance of the document.
Marginal note:Timing of payment
(3) The fee is payable on October 1.
Marginal note:Non-application — interruption of sale
(4) Subject to subsection (5), subsection (1) does not apply to the person if they notified the Minister in accordance with section C.01.014.71 of the Food and Drug Regulations in the 12 months preceding October 1.
Marginal note:Resumption of sale
(5) Subsection (4) ceases to apply on the day on which the person notifies the Minister in accordance with section C.01.014.72 of the Food and Drug Regulations.
Marginal note:Remission — small business
53 Subject to section 54, remission is granted to the person referred to in subsection 52(2) of an amount equal to 25% of the fee that is payable under subsection 52(1) if the person provides with the notification provided under subsection C.01.014.5(1) of the Food and Drug Regulations, in a form established by the Minister,
(a) in the case where the person has completed their first fiscal year,
(i) a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, and
(ii) the following information:
(A) a list of the persons with which the person was affiliated in the person’s last completed fiscal year,
(B) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person was affiliated in the person’s last completed fiscal year,
(C) the number of employees of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year, and
(D) the gross revenue of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year; and
(b) in the case where the person has not completed their first fiscal year,
(i) a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, and
(ii) the following information:
(A) a list of the persons with which the person is affiliated in the person’s first fiscal year,
(B) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person is affiliated in the person’s first fiscal year,
(C) the number of employees of the person in their first fiscal year and of the persons with which the person is affiliated in those persons’ last completed fiscal year, and
(D) the projected gross revenue of the person in their first fiscal year and the gross revenue of the persons with which the person is affiliated in those persons’ last completed fiscal year.
Marginal note:Difference payable
54 If the Minister requests under section 5 that the person referred to in subsection 52(2) provide additional information, the difference between the fee payable under subsection 52(1) and the amount already paid is immediately payable if
(a) the person has not provided, within the period specified in section 5, the Minister with additional information for the purpose of demonstrating that the person met the definition small business in subsection 1(1) in the applicable fiscal year; or
(b) the person has provided, within the period specified in section 5, the Minister with additional information for the purpose of demonstrating that the person met the definition in the applicable fiscal year but the Minister determines, after the period ends, that the person has not provided sufficient information to demonstrate that they met that definition in the applicable fiscal year.
DIVISION 5Fees for Right to Sell Drugs for Veterinary Use Only
Application
Marginal note:Application
55 This Division applies to drug for veterinary use only.
Fees and Remission
Marginal note:Annual fee
56 (1) The annual fee that is payable for the right to sell a drug for which a drug identification number has been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations is as follows:
(a) in the case of a fee that is payable in a fiscal year set out in any of columns 1 to 4 of Schedule 7, the fee set out in that column; and
(b) in the case of a fee that is payable in a fiscal year other than one set out in any of columns 1 to 4 of Schedule 7, the amount that is calculated in accordance with subsection 4(2).
Marginal note:Fee payable by person after first sale
(2) The fee is payable by the person to which a document was issued under subsection C.01.014.2(1) of the Food and Drug Regulations that sets out the drug identification number assigned for the drug if the person has sold the drug following the issuance of the document.
Marginal note:Timing of payment
(3) The fee is payable on October 1.
Marginal note:Non-application — interruption of sale
(4) Subject to subsection (5), subsection (1) does not apply to the person if they notified the Minister in accordance with section C.01.014.71 of the Food and Drug Regulations in the 12 months preceding October 1.
Marginal note:Resumption of sale
(5) Subsection (4) ceases to apply on the day on which the person notifies the Minister in accordance with section C.01.014.72 of the Food and Drug Regulations.
Marginal note:Remission — small business
57 Subject to section 58, remission is granted to the person referred to in subsection 56(2) of an amount equal to 25% of the fee that is payable under subsection 56(1) if the person provides with the notification provided under subsection C.01.014.5(1) of the Food and Drug Regulations, in a form established by the Minister,
(a) in the case where the person has completed their first fiscal year,
(i) a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, and
(ii) the following information:
(A) a list of the persons with which the person was affiliated in the person’s last completed fiscal year,
(B) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person was affiliated in the person’s last completed fiscal year,
(C) the number of employees of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year, and
(D) the gross revenue of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year; and
(b) in the case where the person has not completed their first fiscal year,
(i) a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, and
(ii) the following information:
(A) a list of the persons with which the person is affiliated in the person’s first fiscal year,
(B) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person is affiliated in the person’s first fiscal year,
(C) the number of employees of the person in their first fiscal year and of the persons with which the person is affiliated in those persons’ last completed fiscal year, and
(D) the projected gross revenue of the person in their first fiscal year and the gross revenue of the persons with which the person is affiliated in those persons’ last completed fiscal year.
Marginal note:Difference payable
58 If the Minister requests under section 5 that the person referred to in subsection 56(2) provide additional information, the difference between the fee payable under subsection 56(1) and the amount already paid is immediately payable if
(a) the person has not provided, within the period specified in section 5, the Minister with additional information for the purpose of demonstrating that the person met the definition small business in subsection 1(1) in the applicable fiscal year; or
(b) the person has provided, within the period specified in section 5, the Minister with additional information for the purpose of demonstrating that the person met the definition in the applicable fiscal year but the Minister determines, after the period ends, that the person has not provided sufficient information to demonstrate that they met that definition in the applicable fiscal year.
PART 3Medical Devices
DIVISION 1Fees for Examination of an Application for a Licence, an Amendment Application for a Licence or an Application to Amend an Authorization — Medical Device
Interpretation
Marginal note:Definitions
59 The following definitions apply in this Division.
- authorization
authorization means an authorization for a medical device issued under section 68.12 of the Medical Devices Regulations, if the device
(a) is a Class II, III or IV device; and
(b) is not a UPHN medical device. (autorisation)
- licence
licence means a medical device licence issued under paragraph 36(1)(a) of the Medical Devices Regulations. (homologation)
Fees and Remissions
Marginal note:Fee for examination
60 (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, an application for a licence amendment that is filed under section 34 or an application to amend an authorization filed under section 68.14 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:Exception
(1.1) Subsection (1) does not apply in respect of an application to amend an authorization for a medical device if the purpose of the application is to authorize the device in relation to a medical condition that qualified it as a UPHN medical device when the application was submitted.
Marginal note:Fee payable by person that files application
(2) The fee is payable by the person that files the application.
Marginal note:Reinstatement
61 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
62 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
63 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
64 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
65 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
66 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
67 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
68 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
69 In this Division, establishment licence means a licence issued under section 46 of the Medical Devices Regulations.
Application
Marginal note:Applicable classes
70 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
71 (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
72 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
73 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
74 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
75 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 or Authorized Class II, III or IV Medical Devices
Interpretation
Marginal note:Definitions
76 The following definitions apply in this Division.
- authorization
authorization means an authorization for a medical device issued under section 68.12 of the Medical Devices Regulations, if the device
(a) is a Class II, III or IV device; and
(b) is not a UPHN medical device. (autorisation)
- licence
licence means a medical device licence issued under paragraph 36(1)(a) of the Medical Devices Regulations. (homologation)
Marginal note:Annual fee
77 (1) The annual fee that is payable for the right to sell a licensed Class II, III or IV medical device or an authorized Class II, III or IV medical device that is not a UPHN medical device is $381.
Marginal note:Fee payable by holder
(2) The fee is payable either 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, or by the person that holds the authorization.
Marginal note:Timing of payment
78 The fee is payable on December 20.
Marginal note:Remission — small business
79 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 the Minister with the statement provided under subsection 43(1) or section 68.24 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
80 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 *81 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.
Return to footnote *[Note: Regulations in force April 1, 2020.]
SCHEDULE 1(Section 9)
Fees for Examination of a Submission — Drugs for Human Use
| Item | Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | Column 6 |
|---|---|---|---|---|---|---|
| Submission Class | Description | Fee ($) | Fee ($) | Fee ($) | Fee ($) | |
| Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | |||
| 2020-2021 | 2021-2022 | 2022-2023 | 2023-2024 | |||
| 1 | New active substance | Submissions 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 polymorphFootnote for Fees for Examination of a Submission — Drugs for Human Use1 | 400,288 | 437,884 | 475,481 | 513,077 |
| 2 | Clinical or non-clinical data and chemistry and manufacturing data | Submissions based on clinical or non-clinical data and chemistry and manufacturing data for a drug that does not include a new active substance | 204,197 | 224,691 | 245,185 | 265,678 |
| 3 | Clinical or non-clinical data only | Submissions based only on clinical or non-clinical data for a drug that does not include a new active substance | 90,864 | 95,987 | 101,110 | 106,232 |
| 4 | Comparative studies | Submissions 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 substance | 53,836 | 55,848 | 57,859 | 59,870 |
| 5 | Chemistry and manufacturing data only | Submissions based only on chemistry and manufacturing data for a drug that does not include a new active substance | 27,587 | 30,670 | 33,752 | 36,835 |
| 6 | Clinical or non-clinical data only, in support of safety updates to the labelling | Submissions 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 substance | 19,442 | 19,442 | 19,442 | 19,442 |
| 7 | Labelling only | Submissions, 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) | 3,816 | 4,328 | 4,841 | 5,353 |
| 8 | Labelling 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 assessment | 2,010 | 2,010 | 2,010 | 2,010 |
| 9 | Administrative submission | Submissions 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) | 432 | 540 | 676 | 845 |
| 10 | Disinfectant — full review | Submissions, other than those described in item 11, that include data in support of a disinfectant | 5,712 | 7,140 | 8,925 | 11,157 |
| 11 | Labelling 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 drug | 2,507 | 2,507 | 2,507 | 2,507 |
| 12 | Drug identification number application — labelling standards | Applications, 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 data | 1,616 | 1,616 | 1,616 | 1,616 |
Return to footnote 1A medicinal ingredient is not considered to be approved in a drug by reason of the Minister having issued or amended an authorization under the ISAD Interim Order in respect of a COVID-19 drug that contains the medicinal ingredient.
SCHEDULE 2(Section 21)
Fees for Examination of a Submission — Drugs for Veterinary Use Only
| Item | Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | Column 6 | Column 7 | Column 8 | Column 9 |
|---|---|---|---|---|---|---|---|---|---|
| Type of Submission | Component | Fee ($) | Fee ($) | Fee ($) | Fee ($) | Fee ($) | Fee ($) | Fee ($) | |
| Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | |||
| 2020-2021 | 2021-2022 | 2022-2023 | 2023-2024 | 2024-2025 | 2025-2026 | 2026-2027 | |||
| 1 | Application for drug identification number | Information, 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 required | 918 | 1,148 | 1,436 | 1,714 | 1,959 | 2,204 | 2,448 |
| 2 | Application for drug identification number | Published references or other data | 638 | 798 | 998 | 1,191 | 1,361 | 1,532 | 1,701 |
| 3 | Application for drug identification number | Documentation 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 Only1 | 320 | 400 | 500 | 596 | 681 | 765 | 850 |
| 4 | Notification — veterinary health product | Information contained in a notification filed under subsection C.01.615(1) of the Food and Drug Regulations in respect of a veterinary health product | 486 | 486 | 486 | 486 | 486 | 486 | 486 |
| 5 | New drug submission | Efficacy 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) | 20,375 | 25,469 | 31,837 | 38,033 | 43,467 | 48,900 | 54,333 |
| 6 | New drug submission | Efficacy 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 species | 12,342 | 15,428 | 19,286 | 23,039 | 26,331 | 29,622 | 32,913 |
| 7 | New drug submission | Efficacy 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 species | 29,631 | 37,040 | 46,300 | 55,312 | 63,214 | 71,116 | 79,017 |
| 8 | New drug submission | Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species | 40,125 | 50,157 | 62,697 | 74,899 | 85,599 | 96,299 | 106,998 |
| 9 | New drug submission | Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration | 3,698 | 4,623 | 5,779 | 6,903 | 7,889 | 8,876 | 9,861 |
| 10 | New drug submission | Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength | 612 | 765 | 957 | 1,143 | 1,306 | 1,469 | 1,632 |
| 11 | New drug submission | For 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 species | 27,783 | 34,729 | 43,412 | 51,861 | 59,270 | 66,678 | 74,086 |
| 12 | New drug submission | For 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 species | 37,040 | 46,300 | 57,875 | 69,140 | 79,017 | 88,893 | 98,770 |
| 13 | New drug submission | For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration | 3,698 | 4,623 | 5,779 | 6,903 | 7,889 | 8,876 | 9,861 |
| 14 | New drug submission | For 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 species | 18,513 | 23,142 | 28,928 | 34,558 | 39,495 | 44,432 | 49,368 |
| 15 | New drug submission | Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug | 6,171 | 7,715 | 9,644 | 11,520 | 13,166 | 14,811 | 16,456 |
| 16 | New drug submission | Chemistry and manufacturing data to support one strength of a single dosage form | 6,171 | 7,715 | 9,644 | 11,520 | 13,166 | 14,811 | 16,456 |
| 17 | New drug submission | Chemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as item 16 | 3,086 | 3,858 | 4,823 | 5,760 | 6,584 | 7,407 | 8,229 |
| 18 | New drug submission | Documentation to support a change of manufacturerFootnote for Fees for Examination of a Submission — Drugs for Veterinary Use Only2 | 320 | 400 | 500 | 596 | 681 | 765 | 850 |
| 19 | Supplement to a new drug submission | Efficacy data to support an additional indication in one animal species | 16,053 | 20,067 | 25,084 | 29,965 | 34,246 | 38,527 | 42,807 |
| 20 | Supplement to a new drug submission | Efficacy 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 species | 12,342 | 15,428 | 19,286 | 23,039 | 26,331 | 29,622 | 32,913 |
| 21 | Supplement to a new drug submission | Efficacy and safety data (in the intended species) to support an indication in another animal species | 20,375 | 25,469 | 31,837 | 38,033 | 43,467 | 48,900 | 54,333 |
| 22 | Supplement to a new drug submission | Efficacy 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 species | 29,631 | 37,040 | 46,300 | 55,312 | 63,214 | 71,116 | 79,017 |
| 23 | Supplement to a new drug submission | Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species | 40,125 | 50,157 | 62,697 | 74,899 | 85,599 | 96,299 | 106,998 |
| 24 | Supplement to a new drug submission | Efficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species | 9,869 | 12,336 | 15,421 | 18,422 | 21,053 | 23,685 | 26,316 |
| 25 | Supplement to a new drug submission | Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration | 3,698 | 4,623 | 5,779 | 6,903 | 7,889 | 8,876 | 9,861 |
| 26 | Supplement to a new drug submission | Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength | 612 | 765 | 957 | 1,143 | 1,306 | 1,469 | 1,632 |
| 27 | Supplement to a new drug submission | For 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 species | 3,698 | 4,623 | 5,779 | 6,903 | 7,889 | 8,876 | 9,861 |
| 28 | Supplement to a new drug submission | For 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 species | 18,513 | 23,142 | 28,928 | 34,558 | 39,495 | 44,432 | 49,368 |
| 29 | Supplement to a new drug submission | For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, a maximum residue limit and a withdrawal period | 9,257 | 11,571 | 14,464 | 17,279 | 19,748 | 22,216 | 24,684 |
| 30 | Supplement to a new drug submission | For 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 required | 7,409 | 9,261 | 11,576 | 13,829 | 15,804 | 17,780 | 19,755 |
| 31 | Supplement to a new drug submission | Chemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process | 6,171 | 7,715 | 9,644 | 11,520 | 13,166 | 14,811 | 16,456 |
| 32 | Supplement to a new drug submission | Chemistry and manufacturing data to support a change in formulation or dosage form | 3,086 | 3,858 | 4,823 | 5,760 | 6,584 | 7,407 | 8,229 |
| 33 | Supplement to a new drug submission | Chemistry and manufacturing data to support a change in the packaging or sterilization process | 2,462 | 3,078 | 3,848 | 4,595 | 5,250 | 5,906 | 6,562 |
| 34 | Supplement to a new drug submission | Chemistry and manufacturing data to support an extension of the expiry date | 1,850 | 2,313 | 2,891 | 3,452 | 3,945 | 4,437 | 4,930 |
| 35 | Supplement to a new drug submission | Chemistry and manufacturing data to support the concurrent use of two drugs | 1,850 | 2,313 | 2,891 | 3,452 | 3,945 | 4,437 | 4,930 |
| 36 | Supplement to a new drug submission | Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage form | 612 | 765 | 957 | 1,143 | 1,306 | 1,469 | 1,632 |
| 37 | Supplement to a new drug submission | Documentation to support a change to the brand name of a drugFootnote for Fees for Examination of a Submission — Drugs for Veterinary Use Only3 | 320 | 400 | 500 | 596 | 681 | 765 | 850 |
| 38 | Abbreviated new drug submission or supplement to an abbreviated new drug submission | Comparative (pharmacodynamic, clinical or bioavailability) data to support a single route of administration and dosage form | 3,698 | 4,623 | 5,779 | 6,903 | 7,889 | 8,876 | 9,861 |
| 39 | Abbreviated new drug submission or supplement to an abbreviated new drug submission | For 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 product | 3,698 | 4,623 | 5,779 | 6,903 | 7,889 | 8,876 | 9,861 |
| 40 | Abbreviated new drug submission or supplement to an abbreviated new drug submission | Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug | 6,171 | 7,715 | 9,644 | 11,520 | 13,166 | 14,811 | 16,456 |
| 41 | Abbreviated new drug submission or supplement to an abbreviated new drug submission | Chemistry and manufacturing data to support a single dosage form | 6,171 | 7,715 | 9,644 | 11,520 | 13,166 | 14,811 | 16,456 |
| 42 | Abbreviated new drug submission or supplement to an abbreviated new drug submission | Documentation to support
| 320 | 400 | 500 | 596 | 681 | 765 | 850 |
| 43 | Preclinical submission | Efficacy 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 species | 6,171 | 7,715 | 9,644 | 11,520 | 13,166 | 14,811 | 16,456 |
| 44 | Preclinical submission | Efficacy 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 treated | 4,935 | 6,169 | 7,712 | 9,211 | 10,527 | 11,843 | 13,158 |
| 45 | Preclinical submission | For 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 species | 18,513 | 23,142 | 28,928 | 34,558 | 39,495 | 44,432 | 49,368 |
| 46 | Preclinical submission | For 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 species | 27,783 | 34,729 | 43,412 | 51,861 | 59,270 | 66,678 | 74,086 |
| 47 | Preclinical submission | For 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 species | 37,040 | 46,300 | 57,875 | 69,140 | 79,017 | 88,893 | 98,770 |
| 48 | Preclinical submission | For 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 species | 9,257 | 11,571 | 14,464 | 17,279 | 19,748 | 22,216 | 24,684 |
| 49 | Preclinical submission | Chemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient | 6,171 | 7,715 | 9,644 | 11,520 | 13,166 | 14,811 | 16,456 |
| 50 | Preclinical submission | Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient | 3,086 | 3,858 | 4,823 | 5,760 | 6,584 | 7,407 | 8,229 |
| 51 | Sale of new drug for emergency treatment | Information and material to support the sale of a new drug to be used in the emergency treatment of a non-food-producing animal | 51 | 51 | 51 | 51 | 51 | 51 | 51 |
| 52 | Sale of new drug for emergency treatment | Information and material to support the sale of a new drug to be used in the emergency treatment of a food-producing animal | 102 | 102 | 102 | 102 | 102 | 102 | 102 |
| 53 | Experimental studies certificate | Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal | 980 | 980 | 980 | 980 | 980 | 980 | 980 |
| 54 | Experimental studies certificate | Information 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 animal | 490 | 490 | 490 | 490 | 490 | 490 | 490 |
| 55 | Experimental studies certificate | Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal | 2,958 | 2,958 | 2,958 | 2,958 | 2,958 | 2,958 | 2,958 |
| 56 | Experimental studies certificate | Information 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 animal | 490 | 490 | 490 | 490 | 490 | 490 | 490 |
| 57 | Notifiable change | Information and material to support an application for a notifiable change | 1,658 | 2,073 | 2,591 | 3,095 | 3,537 | 3,978 | 4,420 |
| 58 | Protocol | A 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 certificate | 1,658 | 2,073 | 2,591 | 3,095 | 3,537 | 3,978 | 4,420 |
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
| Item | Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
|---|---|---|---|---|---|
| Activity | Fee ($) | Fee ($) | Fee ($) | Fee ($) | |
| Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | ||
| 2020-2021 | 2021-2022 | 2022-2023 | 2023-2024 | ||
| 1 | Fabrication — sterile dosage form | 41,626 | 41,730 | 41,834 | 41,937 |
| 2 | Importation | 27,359 | 29,033 | 30,707 | 32,380 |
| 3 | Fabrication — non-sterile dosage form | 27,000 | 28,364 | 29,727 | 31,091 |
| 4 | Distribution | 12,560 | 13,882 | 15,205 | 16,527 |
| 5 | Wholesaling | 4,937 | 6,171 | 7,715 | 9,644 |
| 6 | Packaging/labelling | 6,061 | 6,061 | 6,061 | 6,061 |
| 7 | Testing | 2,560 | 3,200 | 4,001 | 5,002 |
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
| Item | Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | Column 6 | Column 7 | Column 8 |
|---|---|---|---|---|---|---|---|---|
| Activity | Fee ($) | Fee ($) | Fee ($) | Fee ($) | Fee ($) | Fee ($) | Fee ($) | |
| Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | ||
| 2020-2021 | 2021-2022 | 2022-2023 | 2023-2024 | 2024-2025 | 2025-2026 | 2026-2027 | ||
| 1 | Fabrication — sterile dosage form | 40,198 | 40,487 | 40,777 | 41,068 | 41,357 | 41,647 | 41,937 |
| 2 | Importation | 10,715 | 13,393 | 16,742 | 20,927 | 26,158 | 32,380 | 32,380 |
| 3 | Fabrication — non-sterile dosage form | 8,782 | 10,978 | 13,722 | 17,152 | 21,440 | 26,800 | 31,091 |
| 4 | Distribution | 4,835 | 6,043 | 7,555 | 9,443 | 11,803 | 14,754 | 16,527 |
| 5 | Wholesaling | 1,933 | 2,416 | 3,020 | 3,774 | 4,718 | 5,898 | 7,372 |
| 6 | Packaging/labelling | 6,061 | 6,061 | 6,061 | 6,061 | 6,061 | 6,061 | 6,061 |
| 7 | Testing | 1,315 | 1,644 | 2,055 | 2,569 | 3,210 | 4,013 | 5,002 |
SCHEDULE 5(Section 48)
Fee Reduction — Application for an Establishment Licence — Drugs
| Item | Column 1 | Column 2 |
|---|---|---|
| Percentage of Fee Reduction | Filing Period | |
| 1 | 25% | July 1 to September 30 |
| 2 | 50% | October 1 to December 31 |
| 3 | 75% | January 1 to March 31 |
Note: The fee payable under subsection 30(1) of this Order is not reduced if an application is filed on or after April 1 and up to and including June 30.
SCHEDULE 6(Section 52)Fees for Right to Sell Drugs for Human Use
Interpretation
Marginal note:Definition of disinfectant
1 In this Schedule, disinfectant has the meaning assigned by the definition antimicrobial agent in subsection C.01A.001(1) of the Food and Drug Regulations.
Item Column 1 Column 2 Column 3 Column 4 Column 5 Type of Drug Fee ($) Fee ($) Fee ($) Fee ($) Fiscal Year Fiscal Year Fiscal Year Fiscal Year 2020-2021 2021-2022 2022-2023 2023-2024 1 Disinfectant 1,285 1,344 1,403 1,462 2 Non-prescription drug 1,623 2,022 2,421 2,820 3 Drug other than one referred to in item 1 or 2 1,836 2,754 4,080 4,679
SCHEDULE 7(Section 56)
Fees for Right to Sell Drugs for Veterinary Use Only
| Item | Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|---|
| Fee ($) | Fee ($) | Fee ($) | Fee ($) | |
| Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | |
| 2020-2021 | 2021-2022 | 2022-2023 | 2023-2024 | |
| 1 | 312 | 367 | 422 | 477 |
SCHEDULE 8(Section 60)Fees for Examination of an Application for a Licence, an Amendment Application for a Licence or an Application to Amend an Authorization — Medical Device
Interpretation
Marginal note:Definition of private label medical device
1 In this Schedule, private label medical device means a medical device that is identical in every respect to a medical device in respect of which a licence has been issued, except that the device is labelled with the name and address of another manufacturer and the name and identifier of the device that the other manufacturer is proposing to sell under its own name or under a trademark, design, trade-name or other name or mark owned or controlled by it.
| Item | Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | Column 6 |
|---|---|---|---|---|---|---|
| Category | Description | Fee ($) | Fee ($) | Fee ($) | Fee ($) | |
| Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | |||
| 2020-2021 | 2021-2022 | 2022-2023 | 2023-2024 | |||
| 1 | Applications for Class II licence | Applications for Class II medical device licence other than those referred to in item 10 | 450 | 478 | 505 | 533 |
| 2 | Applications for Class II licence amendment or applications to amend Class II authorization | Applications for amendment of Class II medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class II medical device that is not a UPHN medical device, other than applications referred to in item 10 | 272 | 272 | 272 | 272 |
| 3 | Applications for Class III licence | Applications for Class III medical device licence other than those referred to in item 4 or 10 | 7,477 | 8,912 | 10,347 | 11,783 |
| 4 | Applications for Class III licence (near patient) | Applications for Class III medical device licence for a near patient in vitro diagnostic device | 12,851 | 16,064 | 20,081 | 25,102 |
| 5 | Applications for Class III licence amendment or applications to amend Class III authorization — changes in manufacturing | Applications for amendment of Class III medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class III medical device that is not a UPHN medical device — changes in manufacturing process, facility or equipment or manufacturing quality control procedures | 1,903 | 2,379 | 2,974 | 3,717 |
| 6 | Applications for Class III licence amendment or applications to amend Class III authorization — significant changes not related to manufacturing | Applications for amendment of Class III medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class III medical device that is not a UPHN medical device — significant changes other than those referred to in item 5 | 6,608 | 7,558 | 8,508 | 9,458 |
| 7 | Applications for Class IV licence | Applications for Class IV medical device licence other than those referred to in item 10 | 24,345 | 24,748 | 25,151 | 25,554 |
| 8 | Applications for Class IV licence amendment or applications to amend Class IV authorization — changes in manufacturing | Applications for amendment of Class IV medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class IV medical device that is not a UPHN medical device — changes referred to in paragraph 34(a) or 68.13(a) of the Medical Devices Regulations that relate to manufacturing | 1,903 | 2,379 | 2,974 | 3,717 |
| 9 | Applications for Class IV licence amendment or applications to amend Class IV authorization — significant changes not related to manufacturing | Applications for amendment of Class IV medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for Class IV medical device that is not a UPHN medical device — any other changes referred to in paragraph 34(a) or (b) or 68.13(a) or (b) of the Medical Devices Regulations | 8,057 | 9,983 | 11,752 | 13,521 |
| 10 | Applications for Class II, III or Class IV licence, applications to amend such a licence or applications to amend Class II, III or Class IV authorization — private label medical device | Applications for Class II, III or IV medical device licence, applications to amend Class II, III or IV licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class II, III or Class IV medical device that is not a UPHN medical device — private label medical device | 147 | 147 | 147 | 147 |
AMENDMENTS NOT IN FORCE
— SOR/2024-121, s. 1
1 (1) The definition performance standard in subsection 1(1) of the Fees in Respect of Drugs and Medical Devices OrderFootnote 1 is replaced by the following:
Return to footnote 1SOR/2019-124
- performance standard
performance standard means the document entitled Performance Standards for the Fees in Respect of Drugs and Medical Devices Order that is published by the Government of Canada on its website, dated February 16, 2024. (norme de rendement)
(2) Paragraph (a) of the definition fiscal year in subsection 1(1) of the Order is replaced by the following:
(a) for the purposes of sections 16, 17, 25, 26, 27.6, 27.7, 49, 53, 57, 58.2, 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
(3) Subsection 1(2) of the Order is replaced by the following:
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, the Medical Devices Regulations or the Biocides Regulations, as the case may be.
— SOR/2024-121, s. 2
2 Subsection 2(1) of the Order is amended by adding the following after paragraph (b):
(b.1) in respect of biocides, the examination of an application for a market authorization submitted under section 10 of the Biocides Regulations, an application for a notice of acceptance in respect of a major change submitted under subsection 15(2) of those Regulations, the examination of a written description of a minor change provided to the Minister under subsection 17(1) of those Regulations, other than a change to contact information referred to in paragraph (a) of the definition of minor change in subsection 1(1) of those Regulations or a change referred to in paragraph (f) of that definition, or the examination of an application for a market authorization for a biocide that is based on a comparison to a biocide that is authorized for sale by a foreign regulatory authority submitted under section 26 of those Regulations;
(b.2) the right to sell a biocide under the Biocides Regulations;
— SOR/2024-121, s. 3
3 (1) Section 5 of the Order is amended by adding the following after paragraph (d):
(d.1) subparagraph 27.6(a)(ii) or (b)(ii);
(d.2) clause 27.7(b)(i)(B) or (ii)(B);
(2) Section 5 of the Order is amended by adding the following after paragraph (g):
(g.1) subparagraph 58.2(a)(ii) or (b)(ii);
— SOR/2024-121, s. 4
4 Paragraph 17(a) of the Order is replaced by the following:
(a) the person has not previously filed
(i) a submission in respect of a drug; or
(ii) an application as defined in section 27.1 in respect of a biocide; and
— SOR/2024-121, s. 5
5 Paragraph 26(a) of the Order is replaced by the following:
(a) the person has not previously filed
(i) a submission in respect of a drug; or
(ii) an application as defined in section 27.1 in respect of a biocide; and
— SOR/2024-121, s. 6
6 The Order is amended by adding the following after section 27:
DIVISION 2.1Fees for Examination of an Application — Biocides
Definition
Definition of application
27.1 In this Division, application means any of the following:
(a) an application for a market authorization for a biocide submitted under section 10 of the Biocides Regulations;
(b) an application for a notice of acceptance in respect of a major change submitted under subsection 15(2) of those Regulations;
(c) a written description of a minor change provided under subsection 17(1) of those Regulations, other than a change to contact information referred to in paragraph (a) of the definition of minor change in subsection 1(1) of those Regulations, or a change referred to in paragraph (f) of that definition;
(d) an application for a market authorization for a biocide that is based on a comparison to a biocide that is authorized for sale by a foreign regulatory authority submitted under section 26 of those Regulations.
Fees and Remissions
Fee for examination
27.2 (1) Subject to paragraph 27.3(b) and section 27.5, the fee for the examination of an application in respect of a class set out in column 1 of Schedule 2.1 and described in column 2 is the fee set out in column 3 of that Schedule.
Fee paid by Person that files application
(2) The fee is payable by the person that files the application.
Fee and timing of payment — Preliminary examination
27.3 If a preliminary examination is conducted in respect of an application,
(a) the full fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 27.2(2) stating that the application has been found to be complete and has been accepted for further examination; or
(b) 10% of the fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 27.2(2) stating that the application has been found to be incomplete.
Fee and timing of payment — No preliminary examination
27.4 If a preliminary examination is not conducted in respect of an application, the fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 27.2(2) stating that the application has been received.
Fee — filing in previous fiscal year
27.5 For the purposes of subsection 27.2(1), if the Minister issues a notice referred to in section 27.3 or 27.4 in the fiscal year that follows the fiscal year in which the application was filed, the fee that is payable is the fee that was payable in the fiscal year in which the application was filed.
Remission — small business
27.6 Subject to section 27.8, remission is granted to the person referred to in subsection 27.2(2) of an amount equal to 50% of the fee that is payable under subsection 27.2(1) if the person provides with their application, in a form established by the Minister,
(a) in the case where the person has completed their first fiscal year,
(i) a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, and
(ii) the following information:
(A) a list of the persons with which the person was affiliated in the person’s last completed fiscal year,
(B) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person was affiliated in the person’s last completed fiscal year,
(C) the number of employees of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year, and
(D) the gross revenue of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year; and
(b) in the case where the person has not completed their first fiscal year,
(i) a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, and
(ii) the following information:
(A) a list of the persons with which the person is affiliated in the person’s first fiscal year,
(B) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person is affiliated in the person’s first fiscal year,
(C) the number of employees of the person in their first fiscal year and of the persons with which the person is affiliated in those persons’ last completed fiscal year, and
(D) the projected gross revenue of the person in their first fiscal year and the gross revenue of the persons with which the person is affiliated in those persons’ last completed fiscal year.
Remission — first application by small business
27.7 Subject to section 27.8, remission is granted to the person referred to in subsection 27.2(2) of an amount equal to the fee that is payable under subsection 27.2(1) if the following conditions are met:
(a) the person has not previously filed
(i) an application in respect of a biocide;
(ii) a submission as defined in section 7 in respect of a drug; or
(iii) a submission as defined in section 19 in respect of a drug; and
(b) the person provides with their application, in a form established by the Minister,
(i) in the case where the person has completed their first fiscal year,
(A) a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, and
(B) the following information:
(I) a list of the persons with which the person was affiliated in the person’s last completed fiscal year,
(II) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person was affiliated in the person’s last completed fiscal year,
(III) the number of employees of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year, and
(IV) the gross revenue of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year, and
(ii) in the case where the person has not completed their first fiscal year,
(A) a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, and
(B) the following information:
(I) a list of the persons with which the person is affiliated in the person’s first fiscal year,
(II) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person is affiliated in the person’s first fiscal year,
(III) the number of employees of the person in their first fiscal year and of the persons with which the person is affiliated in those persons’ last completed fiscal year, and
(IV) the projected gross revenue of the person in their first fiscal year and the gross revenue of the persons with which the person is affiliated in those persons’ last completed fiscal year.
Fee or difference payable
27.8 If the Minister requests under section 5 that the person referred to in subsection 27.2(2) provide additional information, the fee — or the difference between the fee payable under subsection 27.2(1) and the amount already paid, as the case may be — is immediately payable if
(a) the person has not provided, within the period specified in section 5, the Minister with additional information, for the purpose of demonstrating that the person met the definition small business in subsection 1(1) in the applicable fiscal year; or
(b) the person has provided, within the period specified in section 5, the Minister with additional information, for the purpose of demonstrating that the person met the definition in the applicable fiscal year but the Minister determines, after the period ends, that the person has not provided sufficient information to demonstrate that they met that definition in the applicable fiscal year.
— SOR/2024-121, s. 7
7 The Order is amended by adding the following after section 58:
DIVISION 6Fees for Right to Sell Biocides
Annual fee
58.1 (1) The annual fee that is payable for the right to sell a biocide for which a market authorization has been issued under section 11 of the Biocides Regulations is $1,535.
Fee payable by person that sold biocide
(2) The fee is payable by the person to which a market authorization was issued if the person has sold the biocide in the 12 months preceding October 1.
Timing of payment
(3) The fee is payable on October 1.
Non-application — permanent discontinuance of sale
(4) Subsection (1) does not apply to the person if they have informed the Minister, in accordance with section 47 of the Biocides Regulations, that they permanently discontinued the sale of the biocide in Canada in the 12 months preceding October 1.
Remission — small business
58.2 Subject to section 58.3, remission is granted to the person referred to in subsection 58.1(2) of an amount equal to 25% of the fee that is payable under subsection 58.1(1) if the person provides, with the information referred to in section 46 of the Biocides Regulations, in a form established by the Minister,
a) in the case where the person has completed their first fiscal year,
(i) a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, and
(ii) the following information:
(A) a list of the persons with which the person was affiliated in the person’s last completed fiscal year,
(B) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person was affiliated in the person’s last completed fiscal year,
(C) the number of employees of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year, and
(D) the gross revenue of the person in their last fiscal year and the gross revenue of the persons with which the person was affiliated in those persons’ last completed fiscal year; and
(b) in the case where the person has not completed their first fiscal year,
(i) a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, and
(ii) the following information:
(A) a list of the persons with which the person is affiliated in the person’s first fiscal year,
(B) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person is affiliated in the person’s first fiscal year,
(C) the number of employees of the person in their first fiscal year and of the persons with which the person is affiliated in those persons’ last completed fiscal year, and
(D) the person’s projected gross revenue of the person in their first fiscal year and the gross revenue of the persons with which the person is affiliated in those persons’ last completed fiscal year.
Difference payable
58.3 If the Minister requests under section 5 that the person referred to in subsection 58.1(2) provide additional information, the difference between the fee payable under subsection 58.1(1) and the amount already paid is immediately payable if
(a) the person has not provided, within the period specified in section 5, the Minister with additional information for the purpose of demonstrating that the person met the definition small business in subsection 1(1) in the applicable fiscal year; or
(b) the person has provided, within the period specified in section 5, the Minister with additional information for the purpose of demonstrating that the person met the definition in the applicable fiscal year, but the Minister determines, after the period ends, that the person has not provided sufficient information to demonstrate that they met that definition in the applicable fiscal year.
— SOR/2024-121, s. 8
8 Items 10 and 11 of Schedule 1 to the Order are repealed.
— SOR/2024-121, s. 9
9 The portion of item 1 of Schedule 1 to the Order in column 2 is replaced by the following:
Column 2 Item Description 1 Submissions in support of a drug 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 polymorph1
— SOR/2024-121, s. 10
10 The Order is amended by adding, after Schedule 2, the Schedule 2.1 set out in the schedule to this Order.
SCHEDULE 2.1(Subsection 27.2(1))
Fees for Examination of an Application — Biocides
Column 1 Column 2 Column 3 Item Class Description Fee ($) 1 Biocide full review — novel biocide An application for a market authorization or for a notice of acceptance in respect of a major change, other than an application based on a comparison referred to in item 7, if the biocide has a novel active ingredient, a novel combination of active ingredients, or a novel physical form, use, purpose or method of application 41,685 2 Biocide full review — tier I An application for a market authorization or for a notice of acceptance in respect of a major change, other than an application referred to in item 1, that contains 25 or fewer reports of tests and studies with respect to efficacy data 8,595 3 Biocide full review — tier II An application for a market authorization or for a notice of acceptance in respect of a major change, other than an application referred to in item 1, that contains 26 to 50 reports of tests and studies with respect to efficacy data 11,469 4 Biocide full review — tier III An application for a market authorization or for a notice of acceptance in respect of a major change, other than an application referred to in item 1, that contains at least 51 reports of tests and studies with respect to efficacy data 13,523 5 Biocide comparison — labelling only An application for a market authorization or for a notice of acceptance in respect of a major change that is based on a comparison and requires a review of labelling 2,748 6 Biocide comparison — administrative application An application for a market authorization or for a notice of acceptance in respect of a major change that is based on a comparison between the biocide and another biocide that is the subject of a market authorization in cases where only the brand name of the biocide, the name of the applicant or the name of the holder of the market authorization, or any combination thereof, differs from the corresponding information in respect of the other biocide 975 7 Biocide — use of foreign decisions An application for a market authorization that is based on a comparison between the biocide and a biocide that is authorized for sale by a foreign regulatory authority or an application for a notice of acceptance in respect of a major change to the biocide that is the subject of such a market authorization 3,100 8 Biocide monograph An application for a market authorization or for a notice of acceptance in respect of a major change that includes an attestation of compliance with a biocide monograph prepared by the Minister and requires supporting information for aspects of the biocide that are outside the parameters of the monograph 1,861 9 Biocide major change — monograph An application for a notice of acceptance in respect of a major change that includes an attestation of compliance with a biocide monograph prepared by the Minister and that does not require supporting information because the aspects of the biocide that are impacted by the change are within the parameters of the monograph 1,363 10 Biocide major change — quality and risks An application for a notice of acceptance in respect of a major change that does not include reports of tests and studies with respect to efficacy data 4,955 11 Biocide minor change The examination of a written description of a minor change 1,363
— SOR/2024-121, s. 11
11 Section 1 and the heading before it of Schedule 6 to the Order are repealed.
— SOR/2024-121, s. 12
12 Item 1 of Schedule 6 to the Order is repealed.
— SOR/2024-121, s. 13
13 The portion of item 3 of Schedule 6 to the Order in column 1 is replaced by the following:
Column 1 Item Description 3 Drug, other than a biocide and other than one referred to in item 2
— SOR/2024-121, s. 14
14 A person that submits an application, under subsection 10(1) of the Biocides Regulations, for a market authorization for a biocide, as defined in subsection 1(1) of those Regulations, is not required to pay the fee for the examination of the application referred to in subsection 27.2(1) of the Fees in Respect of Drugs and Medical Devices Order if the biocide is the subject of one of the exceptions set out in section 67 or 69 of those Regulations.
- Date modified: