SOR/2019-12420195
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20256
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FOOD AND DRUGS ACTFees in Respect of Drugs and Medical Devices OrderWhereas, pursuant to section 30.62a of the Food and Drugs Actb, 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)a and 30.63(1)a of the Food and Drugs Actb, makes the annexed Fees in Respect of Drugs and Medical Devices Order.Ottawa, May 3, 2019Ginette C. Petitpas TaylorMinister of HealthS.C. 2017, c. 20, s. 317R.S., c. F-27GeneralInterpretation
DefinitionsThe following definitions apply in this Order.entity has the meaning assigned by the definition organization in section 2 of the Criminal Code. (entité)fiscal year meansfor 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; andfor 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 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)small business means a person in respect of which either of the following criteria applies:the total of the number of employees of the person and of the persons with which the person is affiliated is fewer than 100; orthe 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)Other words and expressionsUnless 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.AffiliationFor the purposes of this Order,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;if two entities are affiliated with the same entity at the same time, they are deemed to be affiliated with each other; andan individual is affiliated with an entity if the individual controls the entity.Subsidiary entityFor the purposes of this Order, an entity is a subsidiary of another entity if it is controlled by that other entity.ControlFor the purposes of this Order,a corporation is controlled by an entity or an individual ifsecurities 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, andthe votes attached to those securities are sufficient, if exercised, to elect a majority of the directors of the corporation; andan 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.Deemed affiliationFor 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.SOR/2023-21, s. 1SOR/2023-278, s. 1SOR/2024-121, s. 1
Purpose
Purpose — feesThe purpose of this Order is to fix the fees for the following: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;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;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;the right to sell a biocide under the Biocides Regulations;the right to sell a drug under the Food and Drug Regulations;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; andthe 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.Purpose — remissionThe purpose of this Order is also to remit, in whole or in part, certain of those fees.SOR/2023-21, s. 2SOR/2023-278, s. 6SOR/2024-121, s. 2
Non-application
Non-applicationThis Order does not apply in respect ofpublicly funded health care institutions;branches or agencies of the Government of Canada or of the government of a province; ordrugs 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.Definition of publicly funded health care institutionFor 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 islicensed, 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; orowned or operated by the Government of Canada or the government of a province and that provides health services.
Annual Adjustment of Fees
Adjustment of feesBeginning 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.FormulaIn 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)whereAis the amount of the fee that was payable in the previous fiscal year; andBis 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
Information on requestIf 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:subparagraph 16(a)(ii) or (b)(ii);clause 17(b)(i)(B) or (ii)(B);subparagraph 25(a)(ii) or (b)(ii);clause 26(b)(i)(B) or (ii)(B);subparagraph 27.6(a)(ii) or (b)(ii);clause 27.7(b)(i)(B) or (ii)(B);subparagraph 49(a)(ii) or (b)(ii);subparagraph 53(a)(ii) or (b)(ii);subparagraph 57(a)(ii) or (b)(ii);subparagraph 58.2(a)(ii) or (b)(ii);subparagraph 66(a)(ii) or (b)(ii);clause 67(b)(i)(B) or (ii)(B);subparagraph 74(a)(ii) or (b)(ii); orsubparagraph 79(a)(ii) or (b)(ii).SOR/2024-121, s. 3
Performance Standard and Remission
Remission — performance standardIf 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 feeof an amount equal to 25% of the fee; orof 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.ExceptionsSubsection (1) does not apply to a fee for the examination ofan 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;an application for a licence that is filed under section 32 of the Medical Devices Regulations ifthe medical device to which the application relates includes a component that is a drug, andthe 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; orthe following:a new drug submission for a public health emergency drug if subsection C.08.002(2.3) of the Food and Drug Regulations applies to that submission, ora supplement to any new drug submission if subsection C.08.003(7) of those Regulations applies to that supplement.SOR/2021-47, s. 1SOR/2023-21, s. 3(F)SOR/2024-247, s. 1
DrugsFees for Examination of a Submission — Drugs for Human UseInterpretation
Definition of submissionIn this Division, submission means any of the following:an application for a drug identification number that is filed under section C.01.014.1 of the Food and Drug Regulations;a new drug submission that is filed under section C.08.002 of those Regulations;an abbreviated new drug submission that is filed under section C.08.002.1 of those Regulations; ora supplement to a new drug submission or abbreviated new drug submission that is filed under section C.08.003 of those Regulations.
Non-application
Non-applicationThis Division does not apply to drugs for veterinary use only.
Fees and Remissions
Fee for examinationSubject 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: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; andin 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).Fee paid by person that files submissionThe fee is payable by the person that files the submission.
Fee and timing of payment — preliminary examinationIf a preliminary examination is conducted in respect of a submission,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; or10% 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.
Fee and timing of payment — no preliminary examinationIf 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.
Fee — filing in previous fiscal yearFor 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.
Deferred payment — notice of complianceDespite 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.
Remission — urgent public health needRemission 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,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;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; anda 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.SOR/2021-47, s. 2(F)
Remission — designated COVID-19 drugRemission 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 hasfiled, under the ISAD Interim Order, an application for a designated COVID-19 drug, as defined in section C.08.001.1 of the Food and Drug Regulations as that section read immediately before the day on which subsection 24(1) of the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) comes into force; andsubsequently filed a submission for that drug.Remission — no previous submissionThe remission referred to in subsection (1) is granted if the person has not previously filed a submission for that designated COVID-19 drug.SOR/2021-47, s. 3SOR/2024-247, s. 2
Remission — General Council DecisionRemission 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.
Remission — small businessSubject 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,in the case where the person has completed their first fiscal year,a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, andthe following information:a list of the persons with which the person was affiliated in the person’s last completed fiscal year,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,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, andthe 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; andin the case where the person has not completed their first fiscal year,a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, andthe following information:a list of the persons with which the person is affiliated in the person’s first fiscal year,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,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, andthe 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 submission by small businessSubject 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:the person has not previously fileda submission in respect of a drug; oran application as defined in section 27.1 in respect of a biocide; andthe person provides with their submission, in a form established by the Minister,in the case where the person has completed their first fiscal year,a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, andthe following information:a list of the persons with which the person was affiliated in the person’s last completed fiscal year,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,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, andthe 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, andin the case where the person has not completed their first fiscal year,a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, andthe following information:a list of the persons with which the person is affiliated in the person’s first fiscal year,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,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, andthe 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.SOR/2024-121, s. 4
Fee or difference payableIf 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 ifthe 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; orthe 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.
Fees for Examination of a Submission — Drugs for Veterinary Use OnlyInterpretation
Definition of submissionIn this Division, submission means any of the following:an application for a drug identification number that is filed under section C.01.014.1 of the Food and Drug Regulations;a notification that is filed under subsection C.01.615(1) of those Regulations in respect of a veterinary health product;a new drug submission that is filed under section C.08.002 of those Regulations;an abbreviated new drug submission that is filed under section C.08.002.1 of those Regulations;a supplement to a new drug submission or an abbreviated new drug submission that is filed under section C.08.003 of those Regulations;a preclinical submission that is filed under subsection C.08.005(1) of those Regulations;information that is filed under section C.08.010 of those Regulations for the purpose of obtaining a letter of authorization;information and material that is filed under section C.08.014 of those Regulations for the purpose of obtaining an experimental studies certificate;information and material that is filed with the Minister in respect of a notifiable change; ora protocol that is filed with the Minister and may support any of the matters referred to in paragraphs (c) to (f) or (h).
Application
ApplicationThis Division applies to drugs for veterinary use only.
Fees and Remissions
Fee for examinationSubject 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: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; andin 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).Fee paid by person that files submissionThe fee is payable by the person that files the submission.
Fee and timing of payment — preliminary examinationIf a preliminary examination is conducted in respect of a submission,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; or10% 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.
Fee and timing of payment — no preliminary examinationIf 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.
Fee — filing in previous fiscal yearFor 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.
Remission — small businessSubject 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,in the case where the person has completed their first fiscal year,a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, andthe following information:a list of the persons with which the person was affiliated in the person’s last completed fiscal year,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,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, andthe 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; andin the case where the person has not completed their first fiscal year,a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, andthe following information:a list of the persons with which the person is affiliated in the person’s first fiscal year,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,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, andthe 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 submission by small businessSubject 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:the person has not previously fileda submission in respect of a drug; oran application as defined in section 27.1 in respect of a biocide; andthe person provides with their submission, in a form established by the Minister,in the case where the person has completed their first fiscal year,a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, andthe following information:a list of the persons with which the person was affiliated in the person’s last completed fiscal year,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,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, andthe 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, andin the case where the person has not completed their first fiscal year,a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, andthe following information:a list of the persons with which the person is affiliated in the person’s first fiscal year,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,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, andthe 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.SOR/2024-121, s. 5
Fee or difference payableIf 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 ifthe 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; orthe 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.
Fees for Examination of an Application — BiocidesDefinition
Definition of applicationIn this Division, application means any of the following:an application for a market authorization for a biocide 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;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;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.SOR/2024-121, s. 6
Fees and Remissions
Fee for examinationSubject 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 applicationThe fee is payable by the person that files the application.SOR/2024-121, s. 6
Fee and timing of payment — Preliminary examinationIf a preliminary examination is conducted in respect of an application,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; or10% 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.SOR/2024-121, s. 6
Fee and timing of payment — No preliminary examinationIf 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.SOR/2024-121, s. 6
Fee — filing in previous fiscal yearFor 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.SOR/2024-121, s. 6
Remission — small businessSubject 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,in the case where the person has completed their first fiscal year,a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, andthe following information:a list of the persons with which the person was affiliated in the person’s last completed fiscal year,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,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, andthe 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; andin the case where the person has not completed their first fiscal year,a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, andthe following information:a list of the persons with which the person is affiliated in the person’s first fiscal year,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,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, andthe 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.SOR/2024-121, s. 6
Remission — first application by small businessSubject 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:the person has not previously filedan application in respect of a biocide;a submission as defined in section 7 in respect of a drug; ora submission as defined in section 19 in respect of a drug; andthe person provides with their application, in a form established by the Minister,in the case where the person has completed their first fiscal year,a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, andthe following information:a list of the persons with which the person was affiliated in the person’s last completed fiscal year,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,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, andthe 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, andin the case where the person has not completed their first fiscal year,a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, andthe following information:a list of the persons with which the person is affiliated in the person’s first fiscal year,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,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, andthe 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.SOR/2024-121, s. 6
Fee or difference payableIf 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 ifthe 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; orthe 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. 6
Fees for Examination of an Application for an Establishment Licence — DrugsInterpretation
DefinitionsThe following definitions apply in this Division.activity means an activity set out in Table I to section C.01A.008 of the Food and Drug Regulations. (activité)drug has the same meaning as in subsection C.01A.001(2) of the Food and Drug Regulations. (drogue)establishment licence means a licence issued under section C.01A.008 of the Food and Drug Regulations. (licence d’établissement)
Fees and Remission
Fee for examinationSubject 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.Fee paid by person that files applicationThe fee is payable by the person that files the application.
Timing of paymentThe 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.
ReinstatementEvery 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.
InterpretationIn 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.
Fee — licence authorizing sterile fabricationFor 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:in respect of drugs for human use,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, andin 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); andin respect of drugs for veterinary use only,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, andin 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).
Fee — licence authorizing importationFor 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:in respect of drugs for human use,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, andin 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); andin respect of drugs for veterinary use only,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, andin 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).
Fee — licence authorizing non-sterile fabricationFor 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:in respect of drugs for human use,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, andin 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); andin respect of drugs for veterinary use only,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, andin 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).
Fee — licence authorizing distributionFor 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:in respect of drugs for human use,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, andin 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); andin respect of drugs for veterinary use only,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, andin 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).
Fee — licence authorizing wholesalingFor 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:in respect of drugs for human use,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, andin 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); andin respect of drugs for veterinary use only,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, andin 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).
Fee — licence authorizing packaging/labellingFor 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:in respect of drugs for human use,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, andin 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); andin respect of drugs for veterinary use only,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, andin 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).
Fee — licence authorizing testingFor 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:in respect of drugs for human use,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, andin 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); andin respect of drugs for veterinary use only,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, andin 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).
Fee — application for licence — building outside CanadaFor 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 isin respect of drugs for human use, $918; andin respect of drugs for veterinary use only,in the case of a fee that is payable in the fiscal year 2020-2021, $765; andin the case of a fee that is payable in any subsequent fiscal year, $918.Fee — application for annual review — building outside CanadaFor 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).
Fee — amendment — licence authorizing sterile fabricationIf 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:in respect of drugs for human use,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, andin 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); andin respect of drugs for veterinary use only,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, andin 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).
Fee — amendment — licence authorizing importationIf 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:in respect of drugs for human use,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, andin 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); andin respect of drugs for veterinary use only,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, andin 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).
Fee — amendment — licence authorizing non-sterile fabricationIf 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:in respect of drugs for human use,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, andin 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); andin respect of drugs for veterinary use only,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, andin 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).
Fee — amendment — licence authorizing distributionIf 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:in respect of drugs for human use,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, andin 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); andin respect of drugs for veterinary use only,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, andin 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).
Fee — amendment — licence authorizing wholesalingIf 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:in respect of drugs for human use,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, andin 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); andin respect of drugs for veterinary use only,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, andin 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).
Fee — amendment — licence authorizing packaging/labellingIf 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:in respect of drugs for human use,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, andin 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); andin respect of drugs for veterinary use only,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, andin 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).
Fee — amendment — licence authorizing testingIf 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:in respect of drugs for human use,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, andin 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); andin respect of drugs for veterinary use only,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, andin 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).
Prorated feeThe 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,an application for an establishment licence and has not previously filed such an application; oran application to amend an establishment licence that seeks to add a building.
Remission — small businessSubject 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,in the case where the person has completed their first fiscal year,a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, andthe following information:a list of the persons with which the person was affiliated in the person’s last completed fiscal year,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,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, andthe 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; andin the case where the person has not completed their first fiscal year,a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, andthe following information:a list of the persons with which the person is affiliated in the person’s first fiscal year,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,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, andthe 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 payableIf 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 ifthe 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; orthe 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.
Fees for Right to Sell Drugs for Human UseNon-application
Non-applicationThis Division does not apply to drugs for veterinary use only.
Fees and Remission
Annual feeThe 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: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; andin 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).Fee payable by person after first saleThe 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.Timing of paymentThe fee is payable on October 1.Non-application — interruption of saleSubject 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.Resumption of saleSubsection (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.
Remission — small businessSubject 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,in the case where the person has completed their first fiscal year,a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, andthe following information:a list of the persons with which the person was affiliated in the person’s last completed fiscal year,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,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, andthe 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; andin the case where the person has not completed their first fiscal year,a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, andthe following information:a list of the persons with which the person is affiliated in the person’s first fiscal year,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,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, andthe 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 payableIf 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 ifthe 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; orthe 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.
Fees for Right to Sell Drugs for Veterinary Use OnlyApplication
ApplicationThis Division applies to drug for veterinary use only.
Fees and Remission
Annual feeThe 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: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; andin 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).Fee payable by person after first saleThe 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.Timing of paymentThe fee is payable on October 1.Non-application — interruption of saleSubject 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.Resumption of saleSubsection (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.
Remission — small businessSubject 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,in the case where the person has completed their first fiscal year,a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, andthe following information:a list of the persons with which the person was affiliated in the person’s last completed fiscal year,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,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, andthe 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; andin the case where the person has not completed their first fiscal year,a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, andthe following information:a list of the persons with which the person is affiliated in the person’s first fiscal year,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,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, andthe 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 payableIf 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 ifthe 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; orthe 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.
Fees for Right to Sell Biocides
Annual feeThe 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 biocideThe 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 paymentThe fee is payable on October 1.Non-application — permanent discontinuance of saleSubsection (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.SOR/2024-121, s. 7
Remission — small businessSubject 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,in the case where the person has completed their first fiscal year,a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, andthe following information:a list of the persons with which the person was affiliated in the person’s last completed fiscal year,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,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, andthe 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; andin the case where the person has not completed their first fiscal year,a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, andthe following information:a list of the persons with which the person is affiliated in the person’s first fiscal year,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,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, andthe 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.SOR/2024-121, s. 7
Difference payableIf 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 ifthe 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; orthe 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
Medical DevicesFees for Examination of an Application for a Licence, an Amendment Application for a Licence or an Application to Amend an Authorization — Medical DeviceInterpretation
DefinitionsThe following definitions apply in this Division.authorization means an authorization for a medical device issued under section 68.12 of the Medical Devices Regulations, if the deviceis a Class II, III or IV device; andis not a UPHN medical device. (autorisation)licence means a medical device licence issued under paragraph 36(1)(a) of the Medical Devices Regulations. (homologation)SOR/2023-21, s. 4SOR/2023-278, s. 2
Fees and Remissions
Fee for examinationSubject 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: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; andin 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).ExceptionSubsection (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.Fee payable by person that files applicationThe fee is payable by the person that files the application.SOR/2023-21, s. 5SOR/2023-278, s. 3
ReinstatementEvery 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.
Fee and timing of payment — preliminary examinationIf a preliminary examination is conducted in respect of an application,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; or10% 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.
Fee and timing of payment — no preliminary examinationIf 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.
Fee — filing in previous fiscal yearFor 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.
Remission — General Council DecisionRemission 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.
Remission — small businessSubject 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,in the case where the person has completed their first fiscal year,a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, andthe following information:a list of the persons with which the person was affiliated in the person’s last completed fiscal year,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,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, andthe 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; andin the case where the person has not completed their first fiscal year,a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, andthe following information:a list of the persons with which the person is affiliated in the person’s first fiscal year,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,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, andthe 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 businessSubject 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:the person has not previously filed an application for a licence under section 32 of the Medical Devices Regulations; andthe person provides with their application, in a form established by the Minister,in the case where the person has completed their first fiscal year,a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, andthe following information:a list of the persons with which the person was affiliated in the person’s last completed fiscal year,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,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, andthe 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, andin the case where the person has not completed their first fiscal year,a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, andthe following information:a list of the persons with which the person is affiliated in the person’s first fiscal year,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,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, andthe 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 payableIf 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 ifthe 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; orthe 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.
Fees for Examination of an Application for an Establishment Licence — Medical DevicesInterpretation
Definition of establishment licenceIn this Division, establishment licence means a licence issued under section 46 of the Medical Devices Regulations.
Application
Applicable classesThis 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
Fee for examinationThe 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.Fee paid by person that files applicationThe fee is payable by the person that files the application.
Timing of paymentThe 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.
ReinstatementEvery 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.
Remission — small businessSubject 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,in the case where the person has completed their first fiscal year,a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, andthe following information:a list of the persons with which the person was affiliated in the person’s last completed fiscal year,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,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, andthe 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; andin the case where the person has not completed their first fiscal year,a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, andthe following information:a list of the persons with which the person is affiliated in the person’s first fiscal year,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,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, andthe 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 payableIf 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 ifthe 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; orthe 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.
Fees for Right to Sell Licensed or Authorized Class II, III or IV Medical DevicesInterpretation
DefinitionsThe following definitions apply in this Division.authorization means an authorization for a medical device issued under section 68.12 of the Medical Devices Regulations, if the deviceis a Class II, III or IV device; andis not a UPHN medical device. (autorisation)licence means a medical device licence issued under paragraph 36(1)(a) of the Medical Devices Regulations. (homologation)SOR/2023-21, s. 6SOR/2023-278, s. 4
Annual feeThe 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.Fee payable by holderThe 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.SOR/2023-21, s. 6SOR/2023-278, s. 6
Timing of paymentThe fee is payable on December 20.
Remission — small businessSubject 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,in the case where the person has completed their first fiscal year,a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, andthe following information:a list of the persons with which the person was affiliated in the person’s last completed fiscal year,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,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, andthe 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; andin the case where the person has not completed their first fiscal year,a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, andthe following information:a list of the persons with which the person is affiliated in the person’s first fiscal year,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,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, andthe 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.SOR/2023-21, s. 7
Difference payableIf 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 ifthe 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; orthe 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
SOR/96-143This 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.[Note: Regulations in force April 1, 2020.]
(Section 9)Fees for Examination of a Submission — Drugs for Human UseItemColumn 1Column 2Column 3Column 4Column 5Column 6Submission ClassDescriptionFee ($)Fee ($)Fee ($)Fee ($)Fiscal YearFiscal YearFiscal YearFiscal Year2020-20212021-20222022-20232023-20241New active substanceSubmissions in support of a drug, other than a disinfectant, that contains a medicinal ingredient not previously approved in a drug for sale in Canada and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph1400,288437,884475,481513,0772Clinical or non-clinical data and chemistry and manufacturing dataSubmissions based on clinical or non-clinical data and chemistry and manufacturing data for a drug that does not include a new active substance204,197224,691245,185265,6783Clinical or non-clinical data onlySubmissions based only on clinical or non-clinical data for a drug that does not include a new active substance90,86495,987101,110106,2324Comparative studiesSubmissions based on comparative studies (e.g., clinical or non-clinical data, bioavailability data and data on the pharmacokinetics and pharmacodynamics of the drug) with or without chemistry and manufacturing data for a drug that does not include a new active substance53,83655,84857,85959,8705Chemistry and manufacturing data onlySubmissions based only on chemistry and manufacturing data for a drug that does not include a new active substance27,58730,67033,75236,8356Clinical or non-clinical data only, in support of safety updates to the labellingSubmissions based only on clinical or non-clinical data, in support of safety updates to the labelling materials for a new drug that does not include a new active substance19,44219,44219,44219,4427Labelling onlySubmissions, other than those described in item 8, 11 or 12, of labelling material, that include data in support of the following: brand name assessment, standardized or published test methods, in vitro or in vivo photostability or applications for a drug identification number in support of changes to brand names of non-prescription drugs (but not including examination of other supporting clinical or non-clinical data, comparative data, or chemistry and manufacturing data)3,8164,3284,8415,3538Labelling only (generic drugs)Submissions in support of a change to the labelling to be consistent with the Canadian reference product that do not include any additional labelling updates requiring a labelling assessment2,0102,0102,0102,0109Administrative submissionSubmissions in support of a change in the manufacturer’s name or brand name, including the following: changes in ownership of the drug, request for an additional brand name or changes resulting from a licensing agreement being entered into by two manufacturers that do not require an assessment of labelling material or brand name (e.g., post-authorization label changes filed by licensees to remain identical to licensor’s drug and post-authorization chemistry and manufacturing updates for drugs listed in Schedule C or D of the Food and Drugs Act)43254067684510Disinfectant — full reviewSubmissions, other than those described in item 11, that include data in support of a disinfectant5,7127,1408,92511,15711Labelling only (disinfectants)Submissions in support of changes to the labelling of disinfectants that do not require supporting data, submissions in support of safety updates for disinfectants that are new drugs or submissions in support of a change in the manufacturer’s name or brand name that requires a review of labelling material due to deviations from the previously authorized labelling or drug2,5072,5072,5072,50712Drug identification number application — labelling standardsApplications, including those that pertain to changes to brand names for non-prescription drugs, that include an attestation of compliance with a labelling standard or Category IV Monograph for a drug and that do not include clinical or non-clinical data or chemistry and manufacturing data1,6161,6161,6161,616
A 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.SOR/2021-47, s. 4SOR/2021-47, s. 5(Section 21)Fees for Examination of a Submission — Drugs for Veterinary Use OnlyItemColumn 1Column 2Column 3Column 4Column 5Column 6Column 7Column 8Column 9Type of SubmissionComponentFee ($)Fee ($)Fee ($)Fee ($)Fee ($)Fee ($)Fee ($)Fiscal YearFiscal YearFiscal YearFiscal YearFiscal YearFiscal YearFiscal Year2020-20212021-20222022-20232023-20242024-20252025-20262026-20271Application for drug identification numberInformation, other than that referred to in item 2, to support an application for a drug identification number, including the submission of labelling material for a second review, if required9181,1481,4361,7141,9592,2042,4482Application for drug identification numberPublished references or other data6387989981,1911,3611,5321,7013Application for drug identification numberDocumentation to support a change of manufacturer, a change to the name of a manufacturer or a change to the brand name of a drug13204005005966817658504Notification — veterinary health productInformation contained in a notification filed under subsection C.01.615(1) of the Food and Drug Regulations in respect of a veterinary health product4864864864864864864865New drug submissionEfficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in one animal species (in the case of an antiparasitic drug, several indications in one food animal species)20,37525,46931,83738,03343,46748,90054,3336New drug submissionEfficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species12,34215,42819,28623,03926,33129,62232,9137New drug submissionEfficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration and dosage form and two indications in one animal species29,63137,04046,30055,31263,21471,11679,0178New drug submissionEfficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species40,12550,15762,69774,89985,59996,299106,9989New drug submissionComparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration3,6984,6235,7796,9037,8898,8769,86110New drug submissionComparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength6127659571,1431,3061,4691,63211New drug submissionFor food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species27,78334,72943,41251,86159,27066,67874,08612New drug submissionFor food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species37,04046,30057,87569,14079,01788,89398,77013New drug submissionFor food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration3,6984,6235,7796,9037,8898,8769,86114New drug submissionFor food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in an additional species18,51323,14228,92834,55839,49544,43249,36815New drug submissionChemistry and manufacturing data for a non-compendial medicinal ingredient of a drug6,1717,7159,64411,52013,16614,81116,45616New drug submissionChemistry and manufacturing data to support one strength of a single dosage form6,1717,7159,64411,52013,16614,81116,45617New drug submissionChemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as item 163,0863,8584,8235,7606,5847,4078,22918New drug submissionDocumentation to support a change of manufacturer232040050059668176585019Supplement to a new drug submissionEfficacy data to support an additional indication in one animal species16,05320,06725,08429,96534,24638,52742,80720Supplement to a new drug submissionEfficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species12,34215,42819,28623,03926,33129,62232,91321Supplement to a new drug submissionEfficacy and safety data (in the intended species) to support an indication in another animal species20,37525,46931,83738,03343,46748,90054,33322Supplement to a new drug submissionEfficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration and dosage form and two indications in one animal species29,63137,04046,30055,31263,21471,11679,01723Supplement to a new drug submissionEfficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species40,12550,15762,69774,89985,59996,299106,99824Supplement to a new drug submissionEfficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species9,86912,33615,42118,42221,05323,68526,31625Supplement to a new drug submissionComparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration3,6984,6235,7796,9037,8898,8769,86126Supplement to a new drug submissionComparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength6127659571,1431,3061,4691,63227Supplement to a new drug submissionFor food-producing animals, residue depletion studies to establish a new withdrawal period for a change in the dosage or route of administration of an approved dosage form in one species3,6984,6235,7796,9037,8898,8769,86128Supplement to a new drug submissionFor food-producing animals, metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage and route of administration of an approved dosage form in an additional species18,51323,14228,92834,55839,49544,43249,36829Supplement to a new drug submissionFor food-producing animals, toxicity studies to support a change of an established acceptable daily intake, a maximum residue limit and a withdrawal period9,25711,57114,46417,27919,74822,21624,68430Supplement to a new drug submissionFor the concurrent use of two drugs in a species of food-producing animals, residue depletion studies to determine if an extension to existing withdrawal periods is required7,4099,26111,57613,82915,80417,78019,75531Supplement to a new drug submissionChemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process6,1717,7159,64411,52013,16614,81116,45632Supplement to a new drug submissionChemistry and manufacturing data to support a change in formulation or dosage form3,0863,8584,8235,7606,5847,4078,22933Supplement to a new drug submissionChemistry and manufacturing data to support a change in the packaging or sterilization process2,4623,0783,8484,5955,2505,9066,56234Supplement to a new drug submissionChemistry and manufacturing data to support an extension of the expiry date1,8502,3132,8913,4523,9454,4374,93035Supplement to a new drug submissionChemistry and manufacturing data to support the concurrent use of two drugs1,8502,3132,8913,4523,9454,4374,93036Supplement to a new drug submissionChemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage form6127659571,1431,3061,4691,63237Supplement to a new drug submissionDocumentation to support a change to the brand name of a drug332040050059668176585038Abbreviated new drug submission or supplement to an abbreviated new drug submissionComparative (pharmacodynamic, clinical or bioavailability) data to support a single route of administration and dosage form3,6984,6235,7796,9037,8898,8769,86139Abbreviated new drug submission or supplement to an abbreviated new drug submissionFor food-producing animals, residue depletion studies to confirm that the withdrawal periods for each species fall within the conditions of use for the Canadian reference product3,6984,6235,7796,9037,8898,8769,86140Abbreviated new drug submission or supplement to an abbreviated new drug submissionChemistry and manufacturing data for a non-compendial medicinal ingredient of a drug6,1717,7159,64411,52013,16614,81116,45641Abbreviated new drug submission or supplement to an abbreviated new drug submissionChemistry and manufacturing data to support a single dosage form6,1717,7159,64411,52013,16614,81116,45642Abbreviated new drug submission or supplement to an abbreviated new drug submissionDocumentation to supporta change of manufacturer, in the case of an abbreviated new drug submission; ora change to the brand name of a drug, in the case of a supplement to an abbreviated new drug submission432040050059668176585043Preclinical submissionEfficacy and safety data (in the intended species) and protocol to support the conduct of clinical studies relative to a single dosage form, route of administration and indication in one species6,1717,7159,64411,52013,16614,81116,45644Preclinical submissionEfficacy data and protocol to support the conduct of clinical studies relative to a single route of administration and indication with a dosage form for which a notice of compliance has been issued for use in the species to be treated4,9356,1697,7129,21110,52711,84313,15845Preclinical submissionFor food-producing animals, toxicity, metabolism and residue depletion studies to establish a temporary acceptable daily intake, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species18,51323,14228,92834,55839,49544,43249,36846Preclinical submissionFor food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species27,78334,72943,41251,86159,27066,67874,08647Preclinical submissionFor food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species37,04046,30057,87569,14079,01788,89398,77048Preclinical submissionFor food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism studies to establish a withdrawal period for a single dosage form, dosage and route of administration in an additional species9,25711,57114,46417,27919,74822,21624,68449Preclinical submissionChemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient6,1717,7159,64411,52013,16614,81116,45650Preclinical submissionChemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient3,0863,8584,8235,7606,5847,4078,22951Sale of new drug for emergency treatmentInformation and material to support the sale of a new drug to be used in the emergency treatment of a non-food-producing animal5151515151515152Sale of new drug for emergency treatmentInformation and material to support the sale of a new drug to be used in the emergency treatment of a food-producing animal10210210210210210210253Experimental studies certificateInformation and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal98098098098098098098054Experimental studies certificateInformation and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a non-food-producing animal49049049049049049049055Experimental studies certificateInformation and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal2,9582,9582,9582,9582,9582,9582,95856Experimental studies certificateInformation and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a food-producing animal49049049049049049049057Notifiable changeInformation and material to support an application for a notifiable change1,6582,0732,5913,0953,5373,9784,42058ProtocolA protocol that is filed with the Minister and may support a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission or abbreviated new drug submission, a preclinical submission or information and material that is filed for the purpose of obtaining an experimental studies certificate1,6582,0732,5913,0953,5373,9784,420
This 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.This item applies only to a new drug submission that does not include any of the components set out in items 5 to 17.This 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.This 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.(Subsection 27.2(1))Fees for Examination of an Application — BiocidesColumn 1Column 2Column 3ItemClassDescriptionFee ($)1Biocide full review — novel biocideAn 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 application41,6852Biocide full review — tier IAn 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 data8,5953Biocide full review — tier IIAn 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 data11,4694Biocide full review — tier IIIAn 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 data13,5235Biocide comparison — labelling onlyAn 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 labelling2,7486Biocide comparison — administrative applicationAn 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 biocide9757Biocide — use of foreign decisionsAn 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 authorization3,1008Biocide monographAn 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 monograph1,8619Biocide major change — monographAn 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 monograph1,36310Biocide major change — quality and risksAn 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 data4,95511Biocide minor changeThe examination of a written description of a minor change1,363
SOR/2024-121, s. 10(Sections 33 to 39 and 41 to 47)Fees for Examination of an Application for an Establishment Licence — Drugs for Human UseItemColumn 1Column 2Column 3Column 4Column 5ActivityFee ($)Fee ($)Fee ($)Fee ($)Fiscal YearFiscal YearFiscal YearFiscal Year2020-20212021-20222022-20232023-20241Fabrication — sterile dosage form41,62641,73041,83441,9372Importation27,35929,03330,70732,3803Fabrication — non-sterile dosage form27,00028,36429,72731,0914Distribution12,56013,88215,20516,5275Wholesaling4,9376,1717,7159,6446Packaging/labelling6,0616,0616,0616,0617Testing2,5603,2004,0015,002
(Sections 33 to 39 and 41 to 47)Fees for Examination of an Application for an Establishment Licence — Drugs for Veterinary Use OnlyItemColumn 1Column 2Column 3Column 4Column 5Column 6Column 7Column 8ActivityFee ($)Fee ($)Fee ($)Fee ($)Fee ($)Fee ($)Fee ($)Fiscal YearFiscal YearFiscal YearFiscal YearFiscal YearFiscal YearFiscal Year2020-20212021-20222022-20232023-20242024-20252025-20262026-20271Fabrication — sterile dosage form40,19840,48740,77741,06841,35741,64741,9372Importation10,71513,39316,74220,92726,15832,38032,3803Fabrication — non-sterile dosage form8,78210,97813,72217,15221,44026,80031,0914Distribution4,8356,0437,5559,44311,80314,75416,5275Wholesaling1,9332,4163,0203,7744,7185,8987,3726Packaging/labelling6,0616,0616,0616,0616,0616,0616,0617Testing1,3151,6442,0552,5693,2104,0135,002
(Section 48)Fee Reduction — Application for an Establishment Licence — DrugsItemColumn 1Column 2Percentage of Fee ReductionFiling Period125%July 1 to September 30250%October 1 to December 31375%January 1 to March 31
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.(Section 52)Fees for Right to Sell Drugs for Human UseInterpretation
Definition of disinfectantIn this Schedule, disinfectant has the meaning assigned by the definition antimicrobial agent in subsection C.01A.001(1) of the Food and Drug Regulations.ItemColumn 1Column 2Column 3Column 4Column 5Type of DrugFee ($)Fee ($)Fee ($)Fee ($)Fiscal YearFiscal YearFiscal YearFiscal Year2020-20212021-20222022-20232023-20241Disinfectant1,2851,3441,4031,4622Non-prescription drug1,6232,0222,4212,8203Drug other than one referred to in item 1 or 21,8362,7544,0804,679
(Section 56)Fees for Right to Sell Drugs for Veterinary Use OnlyItemColumn 1Column 2Column 3Column 4Fee ($)Fee ($)Fee ($)Fee ($)Fiscal YearFiscal YearFiscal YearFiscal Year2020-20212021-20222022-20232023-20241312367422477
(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 DeviceInterpretation
Definition of private label medical deviceIn this Schedule, private label medical device means a medical device that is identical in every respect to a medical device in respect of which a licence has been issued, except that the device is labelled with the name and address of another manufacturer and the name and identifier of the device that the other manufacturer is proposing to sell under its own name or under a trademark, design, trade-name or other name or mark owned or controlled by it.
ItemColumn 1Column 2Column 3Column 4Column 5Column 6CategoryDescriptionFee ($)Fee ($)Fee ($)Fee ($)Fiscal YearFiscal YearFiscal YearFiscal Year2020-20212021-20222022-20232023-20241Applications for Class II licenceApplications for Class II medical device licence other than those referred to in item 104504785055332Applications for Class II licence amendment or applications to amend Class II authorizationApplications 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 102722722722723Applications for Class III licenceApplications for Class III medical device licence other than those referred to in item 4 or 107,4778,91210,34711,7834Applications for Class III licence (near patient)Applications for Class III medical device licence for a near patient in vitro diagnostic device12,85116,06420,08125,1025Applications for Class III licence amendment or applications to amend Class III authorization — changes in manufacturingApplications 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 procedures1,9032,3792,9743,7176Applications for Class III licence amendment or applications to amend Class III authorization — significant changes not related to manufacturingApplications 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 56,6087,5588,5089,4587Applications for Class IV licenceApplications for Class IV medical device licence other than those referred to in item 1024,34524,74825,15125,5548Applications for Class IV licence amendment or applications to amend Class IV authorization — changes in manufacturingApplications 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 manufacturing1,9032,3792,9743,7179Applications for Class IV licence amendment or applications to amend Class IV authorization — significant changes not related to manufacturingApplications 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 Regulations8,0579,98311,75213,52110Applications 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 deviceApplications 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 device147147147147
SOR/2023-21, s. 8SOR/2023-21, s. 9SOR/2023-278, s. 5SOR/2023-278, s. 6RELATED PROVISIONS — SOR/2024-121, s. 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.
AMENDMENTS NOT IN FORCE — SOR/2024-121, s. 8
Items 10 and 11 of Schedule 1 to the Order are repealed.
 — SOR/2024-121, s. 9
The portion of item 1 of Schedule 1 to the Order in column 2 is replaced by the following:Column 2ItemDescription1Submissions 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. 11
Section 1 and the heading before it of Schedule 6 to the Order are repealed.
 — SOR/2024-121, s. 12
Item 1 of Schedule 6 to the Order is repealed.
 — SOR/2024-121, s. 13
The portion of item 3 of Schedule 6 to the Order in column 1 is replaced by the following:Column 1ItemDescription3Drug, other than a biocide and other than one referred to in item 2
SOR/2024-1212025-05-31SOR/2024-2472024-12-18SOR/2023-2782024-01-03SOR/2023-212023-02-22SOR/2021-472021-03-19