Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Full Document:
- HTMLFull Document: Fees in Respect of Drugs and Medical Devices Order (Accessibility Buttons available) |
- XMLFull Document: Fees in Respect of Drugs and Medical Devices Order [322 KB] |
- PDFFull Document: Fees in Respect of Drugs and Medical Devices Order [616 KB]
Regulations are current to 2024-10-14 and last amended on 2024-01-03. Previous Versions
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: