Contents
- Whereas, pursuant to section 30.62 of the Food and Drugs A…
- Part 1 General
- Part 2 Drugs
- Part 3 Medical Devices
- Coming into Force
- Schedule 1 (Section 9)
- Schedule 2 (Section 21)
- Schedule 2.1 (Subsection 27.2(1))
- Schedule 3 (Sections 33 to 39 and 41 to 47)
- Schedule 4 (Sections 33 to 39 and 41 to 47)
- Schedule 5 (Section 48)
- Schedule 6 Fees for Right to Sell Drugs for Human Use (Section 52)
- Schedule 7 (Section 56)
- Schedule 8 Fees for Examination of an Application for a Licence, an Amendment Application for a Licence or an Application to Amend an Authorization — Medical Device (Section 60)
- Related provisions
- Amendments not in force
Whereas, pursuant to section 30.62 of the Food and Drugs Act, 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) and 30.63(1) of the Food and Drugs Act, makes the annexed Fees in Respect of Drugs and Medical Devices Order.Ottawa, May 3, 2019notenote
Part 1 · General
Interpretation
1Definitions#
Purpose
2Purpose — fees#
Non-application
3Non-application#
Annual Adjustment of Fees
4Adjustment of fees#
Requests for Information — Remissions for Small Businesses
5Information on request#
Performance Standard and Remission
6Remission — performance standard#
Part 2 · Drugs
Division 1 — Fees for Examination of a Submission — Drugs for Human Use
Interpretation
Non-application
Fees and Remissions
9Fee for examination#
10Fee and timing of payment — preliminary examination#
11Fee and timing of payment — no preliminary examination#
12Fee — filing in previous fiscal year#
13Deferred payment — notice of compliance#
14Remission — urgent public health need#
14.1Remission — designated COVID-19 drug#
15Remission — General Council Decision#
16Remission — small business#
17Remission — first submission by small business#
18Fee or difference payable#
Division 2 — Fees for Examination of a Submission — Drugs for Veterinary Use Only
Interpretation
19Definition of submission#
Application
Fees and Remissions
21Fee for examination#
22Fee and timing of payment — preliminary examination#
23Fee and timing of payment — no preliminary examination#
24Fee — filing in previous fiscal year#
25Remission — small business#
26Remission — first submission by small business#
27Fee or difference payable#
Division 2.1 — Fees for Examination of an Application — Biocides
Definition
27.1Definition of application#
Fees and Remissions
27.2Fee for examination#
27.3Fee and timing of payment — Preliminary examination#
27.4Fee and timing of payment — No preliminary examination#
27.5Fee — filing in previous fiscal year#
27.6Remission — small business#
27.7Remission — first application by small business#
27.8Fee or difference payable#
Division 3 — Fees for Examination of an Application for an Establishment Licence — Drugs
Interpretation
Fees and Remission
29Fee for examination#
30Timing of payment#
31Reinstatement#
32Interpretation#
33Fee — licence authorizing sterile fabrication#
34Fee — licence authorizing importation#
35Fee — licence authorizing non-sterile fabrication#
36Fee — licence authorizing distribution#
37Fee — licence authorizing wholesaling#
38Fee — licence authorizing packaging/labelling#
39Fee — licence authorizing testing#
40Fee — application for licence — building outside Canada#
41Fee — amendment — licence authorizing sterile fabrication#
42Fee — amendment — licence authorizing importation#
43Fee — amendment — licence authorizing non-sterile fabrication#
44Fee — amendment — licence authorizing distribution#
45Fee — amendment — licence authorizing wholesaling#
46Fee — amendment — licence authorizing packaging/labelling#
47Fee — amendment — licence authorizing testing#
48Prorated fee#
49Remission — small business#
50Difference payable#
Division 4 — Fees for Right to Sell Drugs for Human Use
Non-application
Fees and Remission
52Annual fee#
53Remission — small business#
54Difference payable#
Division 5 — Fees for Right to Sell Drugs for Veterinary Use Only
Application
Fees and Remission
56Annual fee#
57Remission — small business#
58Difference payable#
Division 6 — Fees for Right to Sell Biocides
58.1Annual fee#
58.2Remission — small business#
58.3Difference payable#
Part 3 · Medical Devices
Division 1 — Fees for Examination of an Application for a Licence, an Amendment Application for a Licence or an Application to Amend an Authorization — Medical Device
Interpretation
59Definitions#
Fees and Remissions
60Fee for examination#
61Reinstatement#
62Fee and timing of payment — preliminary examination#
63Fee and timing of payment — no preliminary examination#
64Fee — filing in previous fiscal year#
65Remission — General Council Decision#
66Remission — small business#
67Remission — first application by small business#
68Fee or difference payable#
Division 2 — Fees for Examination of an Application for an Establishment Licence — Medical Devices
Interpretation
69Definition of establishment licence#
Application
70Applicable classes#
Fee and Remission
71Fee for examination#
72Timing of payment#
73Reinstatement#
74Remission — small business#
75Difference payable#
Division 3 — Fees for Right to Sell Licensed or Authorized Class II, III or IV Medical Devices
Interpretation
76Definitions#
77Annual fee#
79Remission — small business#
80Difference payable#
Coming into Force
*81Sor/96-143#
Schedule 1 · (Section 9)
Item | Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | Column 6Submission Class | Description | Fee ($) | Fee ($) | Fee ($) | Fee ($)Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year2020-2021 | 2021-2022 | 2022-2023 | 2023-20241 | 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 polymorph1 | 400,288 | 437,884 | 475,481 | 513,0772 | 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 | 265,6783 | 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 | 106,2324 | 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 | 59,8705 | 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 | 36,8356 | 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 | 19,4427 | 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 | 5,3538 | 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 | 2,0109 | 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 | 84510 | 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 | 11,15711 | 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 | 2,50712 | 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
Schedule 2 · (Section 21)
Item | Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | Column 6 | Column 7 | Column 8 | Column 9Type of Submission | Component | Fee ($) | Fee ($) | Fee ($) | Fee ($) | Fee ($) | Fee ($) | Fee ($)Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year2020-2021 | 2021-2022 | 2022-2023 | 2023-2024 | 2024-2025 | 2025-2026 | 2026-20271 | 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 | 2,4482 | Application for drug identification number | Published references or other data | 638 | 798 | 998 | 1,191 | 1,361 | 1,532 | 1,7013 | 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 drug1 | 320 | 400 | 500 | 596 | 681 | 765 | 8504 | 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 | 4865 | 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 | 54,3336 | 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 | 32,9137 | 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 | 79,0178 | 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 | 106,9989 | 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 | 9,86110 | New drug submission | Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength | 612 | 765 | 957 | 1,143 | 1,306 | 1,469 | 1,63211 | 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 | 74,08612 | 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 | 98,77013 | 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 | 9,86114 | 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 | 49,36815 | 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 | 16,45616 | 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 | 16,45617 | 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 | 8,22918 | New drug submission | Documentation to support a change of manufacturer2 | 320 | 400 | 500 | 596 | 681 | 765 | 85019 | 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 | 42,80720 | 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 | 32,91321 | 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 | 54,33322 | 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 | 79,01723 | 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 | 106,99824 | 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 | 26,31625 | 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 | 9,86126 | 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 | 1,63227 | 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 | 9,86128 | 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 | 49,36829 | 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 | 24,68430 | 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 | 19,75531 | 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 | 16,45632 | 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 | 8,22933 | 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 | 6,56234 | 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 | 4,93035 | 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 | 4,93036 | 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 | 1,63237 | Supplement to a new drug submission | Documentation to support a change to the brand name of a drug3 | 320 | 400 | 500 | 596 | 681 | 765 | 85038 | 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 | 9,86139 | 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 | 9,86140 | 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 | 16,45641 | 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 | 16,45642 | Abbreviated new drug submission or supplement to an abbreviated new drug submission | Documentation to support(a)a change of manufacturer, in the case of an abbreviated new drug submission; or(b)a change to the brand name of a drug, in the case of a supplement to an abbreviated new drug submission4 | 320 | 400 | 500 | 596 | 681 | 765 | 85043 | 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 | 16,45644 | 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 | 13,15845 | 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 | 49,36846 | 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 | 74,08647 | 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 | 98,77048 | 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 | 24,68449 | 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 | 16,45650 | 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 | 8,22951 | 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 | 5152 | 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 | 10253 | 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 | 98054 | 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 | 49055 | 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 | 2,95856 | 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 | 49057 | 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 | 4,42058 | 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
Schedule 2.1 · (Subsection 27.2(1))
| Column 1 | Column 2 | Column 3Item | 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 | 41,6852 | 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 | 8,5953 | 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 | 11,4694 | 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 | 13,5235 | 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 | 2,7486 | 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 | 9757 | 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 | 3,1008 | 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 | 1,8619 | 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 | 1,36310 | 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 | 4,95511 | Biocide minor change | The examination of a written description of a minor change | 1,363
Schedule 3 · (Sections 33 to 39 and 41 to 47)
Item | Column 1 | Column 2 | Column 3 | Column 4 | Column 5Activity | Fee ($) | Fee ($) | Fee ($) | Fee ($)Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year2020-2021 | 2021-2022 | 2022-2023 | 2023-20241 | Fabrication — sterile dosage form | 41,626 | 41,730 | 41,834 | 41,9372 | Importation | 27,359 | 29,033 | 30,707 | 32,3803 | Fabrication — non-sterile dosage form | 27,000 | 28,364 | 29,727 | 31,0914 | Distribution | 12,560 | 13,882 | 15,205 | 16,5275 | Wholesaling | 4,937 | 6,171 | 7,715 | 9,6446 | Packaging/labelling | 6,061 | 6,061 | 6,061 | 6,0617 | Testing | 2,560 | 3,200 | 4,001 | 5,002
Schedule 4 · (Sections 33 to 39 and 41 to 47)
Item | Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | Column 6 | Column 7 | Column 8Activity | Fee ($) | Fee ($) | Fee ($) | Fee ($) | Fee ($) | Fee ($) | Fee ($)Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year2020-2021 | 2021-2022 | 2022-2023 | 2023-2024 | 2024-2025 | 2025-2026 | 2026-20271 | Fabrication — sterile dosage form | 40,198 | 40,487 | 40,777 | 41,068 | 41,357 | 41,647 | 41,9372 | Importation | 10,715 | 13,393 | 16,742 | 20,927 | 26,158 | 32,380 | 32,3803 | Fabrication — non-sterile dosage form | 8,782 | 10,978 | 13,722 | 17,152 | 21,440 | 26,800 | 31,0914 | Distribution | 4,835 | 6,043 | 7,555 | 9,443 | 11,803 | 14,754 | 16,5275 | Wholesaling | 1,933 | 2,416 | 3,020 | 3,774 | 4,718 | 5,898 | 7,3726 | Packaging/labelling | 6,061 | 6,061 | 6,061 | 6,061 | 6,061 | 6,061 | 6,0617 | Testing | 1,315 | 1,644 | 2,055 | 2,569 | 3,210 | 4,013 | 5,002
Schedule 5 · (Section 48)
Item | Column 1 | Column 2Percentage of Fee Reduction | Filing Period1 | 25% | July 1 to September 302 | 50% | October 1 to December 313 | 75% | January 1 to March 31Note: The fee payable under subsection 30(1) of this Order is not reduced if an application is filed on or after April 1 and up to and including June 30.
Schedule 6 · Fees for Right to Sell Drugs for Human Use (Section 52)
1Definition of disinfectant#
Schedule 7 · (Section 56)
Item | Column 1 | Column 2 | Column 3 | Column 4Fee ($) | Fee ($) | Fee ($) | Fee ($)Fiscal Year | Fiscal Year | Fiscal Year | Fiscal Year2020-2021 | 2021-2022 | 2022-2023 | 2023-20241 | 312 | 367 | 422 | 477
Schedule 8 · Fees for Examination of an Application for a Licence, an Amendment Application for a Licence or an Application to Amend an Authorization — Medical Device (Section 60)
1Definition of private label medical device#
Amendments not in force
— SOR/2024-121, s. 8Items 10 and 11 of Schedule 1 to the Order are repealed. — SOR/2024-121, s. 9The portion of item 1 of Schedule 1 to the Order in column 2 is replaced by the following: | Column 2Item | Description1 | Submissions in support of a drug that contains a medicinal ingredient not previously approved in a drug for sale in Canada and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph1 — SOR/2024-121, s. 11Section 1 and the heading before it of Schedule 6 to the Order are repealed. — SOR/2024-121, s. 12Item 1 of Schedule 6 to the Order is repealed. — SOR/2024-121, s. 13The portion of item 3 of Schedule 6 to the Order in column 1 is replaced by the following: | Column 1Item | Description3 | Drug, other than a biocide and other than one referred to in item 2
Federal laws of Canada reproduced under the Reproduction of Federal Law Order (SI/97-5); not the official version. Source: Justice Laws Website.