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

Fees for Examination of a Submission — Drugs for Human Use Item Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Submission Class Description Fee ($) Fee ($) Fee ($) Fee ($) Fiscal Year Fiscal Year Fiscal Year Fiscal Year 2020-2021 2021-2022 2022-2023 2023-2024 1 New active substance Submissions in support of a drug, other than a disinfectant, that contains a medicinal ingredient not previously approved in a drug for sale in Canada and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph 1 400,288 437,884 475,481 513,077 2 Clinical or non-clinical data and chemistry and manufacturing data Submissions based on clinical or non-clinical data and chemistry and manufacturing data for a drug that does not include a new active substance 204,197 224,691 245,185 265,678 3 Clinical or non-clinical data only Submissions based only on clinical or non-clinical data for a drug that does not include a new active substance 90,864 95,987 101,110 106,232 4 Comparative studies Submissions based on comparative studies (e.g., clinical or non-clinical data, bioavailability data and data on the pharmacokinetics and pharmacodynamics of the drug) with or without chemistry and manufacturing data for a drug that does not include a new active substance 53,836 55,848 57,859 59,870 5 Chemistry and manufacturing data only Submissions based only on chemistry and manufacturing data for a drug that does not include a new active substance 27,587 30,670 33,752 36,835 6 Clinical or non-clinical data only, in support of safety updates to the labelling Submissions based only on clinical or non-clinical data, in support of safety updates to the labelling materials for a new drug that does not include a new active substance 19,442 19,442 19,442 19,442 7 Labelling only Submissions, other than those described in item 8, 11 or 12, of labelling material, that include data in support of the following: brand name assessment, standardized or published test methods, in vitro or in vivo photostability or applications for a drug identification number in support of changes to brand names of non-prescription drugs (but not including examination of other supporting clinical or non-clinical data, comparative data, or chemistry and manufacturing data) 3,816 4,328 4,841 5,353 8 Labelling only (generic drugs) Submissions in support of a change to the labelling to be consistent with the Canadian reference product that do not include any additional labelling updates requiring a labelling assessment 2,010 2,010 2,010 2,010 9 Administrative submission Submissions in support of a change in the manufacturer’s name or brand name, including the following: changes in ownership of the drug, request for an additional brand name or changes resulting from a licensing agreement being entered into by two manufacturers that do not require an assessment of labelling material or brand name (e.g., post-authorization label changes filed by licensees to remain identical to licensor’s drug and post-authorization chemistry and manufacturing updates for drugs listed in Schedule C or D of the Food and Drugs Act) 432 540 676 845 10 Disinfectant — full review Submissions, other than those described in item 11, that include data in support of a disinfectant 5,712 7,140 8,925 11,157 11 Labelling only (disinfectants) Submissions in support of changes to the labelling of disinfectants that do not require supporting data, submissions in support of safety updates for disinfectants that are new drugs or submissions in support of a change in the manufacturer’s name or brand name that requires a review of labelling material due to deviations from the previously authorized labelling or drug 2,507 2,507 2,507 2,507 12 Drug identification number application — labelling standards Applications, including those that pertain to changes to brand names for non-prescription drugs, that include an attestation of compliance with a labelling standard or Category IV Monograph for a drug and that do not include clinical or non-clinical data or chemistry and manufacturing data 1,616 1,616 1,616 1,616 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.

Fees for Examination of a Submission — Drugs for Veterinary Use Only Item Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Column 7 Column 8 Column 9 Type of Submission Component Fee ($) Fee ($) Fee ($) Fee ($) Fee ($) Fee ($) Fee ($) Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year 2020-2021 2021-2022 2022-2023 2023-2024 2024-2025 2025-2026 2026-2027 1 Application for drug identification number Information, other than that referred to in item 2, to support an application for a drug identification number, including the submission of labelling material for a second review, if required 918 1,148 1,436 1,714 1,959 2,204 2,448 2 Application for drug identification number Published references or other data 638 798 998 1,191 1,361 1,532 1,701 3 Application for drug identification number Documentation to support a change of manufacturer, a change to the name of a manufacturer or a change to the brand name of a drug 1 320 400 500 596 681 765 850 4 Notification — veterinary health product Information contained in a notification filed under subsection C.01.615(1) of the Food and Drug Regulations in respect of a veterinary health product 486 486 486 486 486 486 486 5 New drug submission Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in one animal species (in the case of an antiparasitic drug, several indications in one food animal species) 20,375 25,469 31,837 38,033 43,467 48,900 54,333 6 New drug submission Efficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species 12,342 15,428 19,286 23,039 26,331 29,622 32,913 7 New drug submission Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration and dosage form and two indications in one animal species 29,631 37,040 46,300 55,312 63,214 71,116 79,017 8 New drug submission Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species 40,125 50,157 62,697 74,899 85,599 96,299 106,998 9 New drug submission Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration 3,698 4,623 5,779 6,903 7,889 8,876 9,861 10 New drug submission Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength 612 765 957 1,143 1,306 1,469 1,632 11 New drug submission For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species 27,783 34,729 43,412 51,861 59,270 66,678 74,086 12 New drug submission For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species 37,040 46,300 57,875 69,140 79,017 88,893 98,770 13 New drug submission For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration 3,698 4,623 5,779 6,903 7,889 8,876 9,861 14 New drug submission For food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in an additional species 18,513 23,142 28,928 34,558 39,495 44,432 49,368 15 New drug submission Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug 6,171 7,715 9,644 11,520 13,166 14,811 16,456 16 New drug submission Chemistry and manufacturing data to support one strength of a single dosage form 6,171 7,715 9,644 11,520 13,166 14,811 16,456 17 New drug submission Chemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as item 16 3,086 3,858 4,823 5,760 6,584 7,407 8,229 18 New drug submission Documentation to support a change of manufacturer 2 320 400 500 596 681 765 850 19 Supplement to a new drug submission Efficacy data to support an additional indication in one animal species 16,053 20,067 25,084 29,965 34,246 38,527 42,807 20 Supplement to a new drug submission Efficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species 12,342 15,428 19,286 23,039 26,331 29,622 32,913 21 Supplement to a new drug submission Efficacy and safety data (in the intended species) to support an indication in another animal species 20,375 25,469 31,837 38,033 43,467 48,900 54,333 22 Supplement to a new drug submission Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration and dosage form and two indications in one animal species 29,631 37,040 46,300 55,312 63,214 71,116 79,017 23 Supplement to a new drug submission Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species 40,125 50,157 62,697 74,899 85,599 96,299 106,998 24 Supplement to a new drug submission Efficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species 9,869 12,336 15,421 18,422 21,053 23,685 26,316 25 Supplement to a new drug submission Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration 3,698 4,623 5,779 6,903 7,889 8,876 9,861 26 Supplement to a new drug submission Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength 612 765 957 1,143 1,306 1,469 1,632 27 Supplement to a new drug submission For food-producing animals, residue depletion studies to establish a new withdrawal period for a change in the dosage or route of administration of an approved dosage form in one species 3,698 4,623 5,779 6,903 7,889 8,876 9,861 28 Supplement to a new drug submission For food-producing animals, metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage and route of administration of an approved dosage form in an additional species 18,513 23,142 28,928 34,558 39,495 44,432 49,368 29 Supplement to a new drug submission For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, a maximum residue limit and a withdrawal period 9,257 11,571 14,464 17,279 19,748 22,216 24,684 30 Supplement to a new drug submission For the concurrent use of two drugs in a species of food-producing animals, residue depletion studies to determine if an extension to existing withdrawal periods is required 7,409 9,261 11,576 13,829 15,804 17,780 19,755 31 Supplement to a new drug submission Chemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process 6,171 7,715 9,644 11,520 13,166 14,811 16,456 32 Supplement to a new drug submission Chemistry and manufacturing data to support a change in formulation or dosage form 3,086 3,858 4,823 5,760 6,584 7,407 8,229 33 Supplement to a new drug submission Chemistry and manufacturing data to support a change in the packaging or sterilization process 2,462 3,078 3,848 4,595 5,250 5,906 6,562 34 Supplement to a new drug submission Chemistry and manufacturing data to support an extension of the expiry date 1,850 2,313 2,891 3,452 3,945 4,437 4,930 35 Supplement to a new drug submission Chemistry and manufacturing data to support the concurrent use of two drugs 1,850 2,313 2,891 3,452 3,945 4,437 4,930 36 Supplement to a new drug submission Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage form 612 765 957 1,143 1,306 1,469 1,632 37 Supplement to a new drug submission Documentation to support a change to the brand name of a drug 3 320 400 500 596 681 765 850 38 Abbreviated new drug submission or supplement to an abbreviated new drug submission Comparative (pharmacodynamic, clinical or bioavailability) data to support a single route of administration and dosage form 3,698 4,623 5,779 6,903 7,889 8,876 9,861 39 Abbreviated new drug submission or supplement to an abbreviated new drug submission For food-producing animals, residue depletion studies to confirm that the withdrawal periods for each species fall within the conditions of use for the Canadian reference product 3,698 4,623 5,779 6,903 7,889 8,876 9,861 40 Abbreviated new drug submission or supplement to an abbreviated new drug submission Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug 6,171 7,715 9,644 11,520 13,166 14,811 16,456 41 Abbreviated new drug submission or supplement to an abbreviated new drug submission Chemistry and manufacturing data to support a single dosage form 6,171 7,715 9,644 11,520 13,166 14,811 16,456 42 Abbreviated new drug submission or supplement to an abbreviated new drug submission 320 400 500 596 681 765 850 43 Preclinical submission Efficacy and safety data (in the intended species) and protocol to support the conduct of clinical studies relative to a single dosage form, route of administration and indication in one species 6,171 7,715 9,644 11,520 13,166 14,811 16,456 44 Preclinical submission Efficacy data and protocol to support the conduct of clinical studies relative to a single route of administration and indication with a dosage form for which a notice of compliance has been issued for use in the species to be treated 4,935 6,169 7,712 9,211 10,527 11,843 13,158 45 Preclinical submission For food-producing animals, toxicity, metabolism and residue depletion studies to establish a temporary acceptable daily intake, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species 18,513 23,142 28,928 34,558 39,495 44,432 49,368 46 Preclinical submission For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species 27,783 34,729 43,412 51,861 59,270 66,678 74,086 47 Preclinical submission For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species 37,040 46,300 57,875 69,140 79,017 88,893 98,770 48 Preclinical submission For food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism studies to establish a withdrawal period for a single dosage form, dosage and route of administration in an additional species 9,257 11,571 14,464 17,279 19,748 22,216 24,684 49 Preclinical submission Chemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient 6,171 7,715 9,644 11,520 13,166 14,811 16,456 50 Preclinical submission Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient 3,086 3,858 4,823 5,760 6,584 7,407 8,229 51 Sale of new drug for emergency treatment Information and material to support the sale of a new drug to be used in the emergency treatment of a non-food-producing animal 51 51 51 51 51 51 51 52 Sale of new drug for emergency treatment Information and material to support the sale of a new drug to be used in the emergency treatment of a food-producing animal 102 102 102 102 102 102 102 53 Experimental studies certificate Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal 980 980 980 980 980 980 980 54 Experimental studies certificate Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a non-food-producing animal 490 490 490 490 490 490 490 55 Experimental studies certificate Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal 2,958 2,958 2,958 2,958 2,958 2,958 2,958 56 Experimental studies certificate Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a food-producing animal 490 490 490 490 490 490 490 57 Notifiable change Information and material to support an application for a notifiable change 1,658 2,073 2,591 3,095 3,537 3,978 4,420 58 Protocol A protocol that is filed with the Minister and may support a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission or abbreviated new drug submission, a preclinical submission or information and material that is filed for the purpose of obtaining an experimental studies certificate 1,658 2,073 2,591 3,095 3,537 3,978 4,420 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.

Fees for Examination of an Application — Biocides Column 1 Column 2 Column 3 Item Class Description Fee ($) 1 Biocide full review — novel biocide An application for a market authorization or for a notice of acceptance in respect of a major change, other than an application based on a comparison referred to in item 7, if the biocide has a novel active ingredient, a novel combination of active ingredients, or a novel physical form, use, purpose or method of application 41,685 2 Biocide full review — tier I An application for a market authorization or for a notice of acceptance in respect of a major change, other than an application referred to in item 1, that contains 25 or fewer reports of tests and studies with respect to efficacy data 8,595 3 Biocide full review — tier II An application for a market authorization or for a notice of acceptance in respect of a major change, other than an application referred to in item 1, that contains 26 to 50 reports of tests and studies with respect to efficacy data 11,469 4 Biocide full review — tier III An application for a market authorization or for a notice of acceptance in respect of a major change, other than an application referred to in item 1, that contains at least 51 reports of tests and studies with respect to efficacy data 13,523 5 Biocide comparison — labelling only An application for a market authorization or for a notice of acceptance in respect of a major change that is based on a comparison and requires a review of labelling 2,748 6 Biocide comparison — administrative application An application for a market authorization or for a notice of acceptance in respect of a major change that is based on a comparison between the biocide and another biocide that is the subject of a market authorization in cases where only the brand name of the biocide, the name of the applicant or the name of the holder of the market authorization, or any combination thereof, differs from the corresponding information in respect of the other biocide 975 7 Biocide — use of foreign decisions An application for a market authorization that is based on a comparison between the biocide and a biocide that is authorized for sale by a foreign regulatory authority or an application for a notice of acceptance in respect of a major change to the biocide that is the subject of such a market authorization 3,100 8 Biocide monograph An application for a market authorization or for a notice of acceptance in respect of a major change that includes an attestation of compliance with a biocide monograph prepared by the Minister and requires supporting information for aspects of the biocide that are outside the parameters of the monograph 1,861 9 Biocide major change — monograph An application for a notice of acceptance in respect of a major change that includes an attestation of compliance with a biocide monograph prepared by the Minister and that does not require supporting information because the aspects of the biocide that are impacted by the change are within the parameters of the monograph 1,363 10 Biocide major change — quality and risks An application for a notice of acceptance in respect of a major change that does not include reports of tests and studies with respect to efficacy data 4,955 11 Biocide minor change The examination of a written description of a minor change 1,363

Fees for Examination of an Application for an Establishment Licence — Drugs for Human Use Item Column 1 Column 2 Column 3 Column 4 Column 5 Activity Fee ($) Fee ($) Fee ($) Fee ($) Fiscal Year Fiscal Year Fiscal Year Fiscal Year 2020-2021 2021-2022 2022-2023 2023-2024 1 Fabrication — sterile dosage form 41,626 41,730 41,834 41,937 2 Importation 27,359 29,033 30,707 32,380 3 Fabrication — non-sterile dosage form 27,000 28,364 29,727 31,091 4 Distribution 12,560 13,882 15,205 16,527 5 Wholesaling 4,937 6,171 7,715 9,644 6 Packaging/labelling 6,061 6,061 6,061 6,061 7 Testing 2,560 3,200 4,001 5,002

Fees for Examination of an Application for an Establishment Licence — Drugs for Veterinary Use Only Item Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Column 7 Column 8 Activity Fee ($) Fee ($) Fee ($) Fee ($) Fee ($) Fee ($) Fee ($) Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year 2020-2021 2021-2022 2022-2023 2023-2024 2024-2025 2025-2026 2026-2027 1 Fabrication — sterile dosage form 40,198 40,487 40,777 41,068 41,357 41,647 41,937 2 Importation 10,715 13,393 16,742 20,927 26,158 32,380 32,380 3 Fabrication — non-sterile dosage form 8,782 10,978 13,722 17,152 21,440 26,800 31,091 4 Distribution 4,835 6,043 7,555 9,443 11,803 14,754 16,527 5 Wholesaling 1,933 2,416 3,020 3,774 4,718 5,898 7,372 6 Packaging/labelling 6,061 6,061 6,061 6,061 6,061 6,061 6,061 7 Testing 1,315 1,644 2,055 2,569 3,210 4,013 5,002

Fee Reduction — Application for an Establishment Licence — Drugs Item Column 1 Column 2 Percentage of Fee Reduction Filing Period 1 25%July 1 to September 30 2 50%October 1 to December 31 3 75%January 1 to March 31

Fees for Right to Sell Drugs for Veterinary Use Only Item Column 1 Column 2 Column 3 Column 4 Fee ($) Fee ($) Fee ($) Fee ($) Fiscal Year Fiscal Year Fiscal Year Fiscal Year 2020-2021 2021-2022 2022-2023 2023-2024 1 312 367 422 477

Item Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Category Description Fee ($) Fee ($) Fee ($) Fee ($) Fiscal Year Fiscal Year Fiscal Year Fiscal Year 2020-2021 2021-2022 2022-2023 2023-2024 1 Applications for Class II licence Applications for Class II medical device licence other than those referred to in item 10 450 478 505 533 2 Applications for Class II licence amendment or applications to amend Class II authorization Applications for amendment of Class II medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class II medical device that is not a UPHN medical device, other than applications referred to in item 10 272 272 272 272 3 Applications for Class III licence Applications for Class III medical device licence other than those referred to in item 4 or 10 7,477 8,912 10,347 11,783 4 Applications for Class III licence (near patient) Applications for Class III medical device licence for a near patient in vitro diagnostic device 12,851 16,064 20,081 25,102 5 Applications for Class III licence amendment or applications to amend Class III authorization — changes in manufacturing Applications for amendment of Class III medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class III medical device that is not a UPHN medical device — changes in manufacturing process, facility or equipment or manufacturing quality control procedures 1,903 2,379 2,974 3,717 6 Applications for Class III licence amendment or applications to amend Class III authorization — significant changes not related to manufacturing Applications for amendment of Class III medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class III medical device that is not a UPHN medical device — significant changes other than those referred to in item 5 6,608 7,558 8,508 9,458 7 Applications for Class IV licence Applications for Class IV medical device licence other than those referred to in item 10 24,345 24,748 25,151 25,554 8 Applications for Class IV licence amendment or applications to amend Class IV authorization — changes in manufacturing Applications for amendment of Class IV medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class IV medical device that is not a UPHN medical device — changes referred to in paragraph 34(a) or 68.13(a) of the Medical Devices Regulations that relate to manufacturing 1,903 2,379 2,974 3,717 9 Applications for Class IV licence amendment or applications to amend Class IV authorization — significant changes not related to manufacturing Applications for amendment of Class IV medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for Class IV medical device that is not a UPHN medical device — any other changes referred to in paragraph 34(a) or (b) or 68.13(a) or (b) of the Medical Devices Regulations 8,057 9,983 11,752 13,521 10 Applications for Class II, III or Class IV licence, applications to amend such a licence or applications to amend Class II, III or Class IV authorization — private label medical device Applications for Class II, III or IV medical device licence, applications to amend Class II, III or IV licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class II, III or Class IV medical device that is not a UPHN medical device — private label medical device 147 147 147 147