Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
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Regulations are current to 2025-11-27 and last amended on 2025-05-31. Previous Versions
SCHEDULE 2.1(Subsection 27.2(1))
Fees for Examination of an Application — Biocides
| Column 1 | Column 2 | Column 3 | |
|---|---|---|---|
| Item | Class | Description | Fee ($) |
| 1 | Biocide full review — novel biocide | An application for a market authorization or for a notice of acceptance in respect of a major change, other than an application based on a comparison referred to in item 7, if the biocide has a novel active ingredient, a novel combination of active ingredients, or a novel physical form, use, purpose or method of application | 41,685 |
| 2 | Biocide full review — tier I | An application for a market authorization or for a notice of acceptance in respect of a major change, other than an application referred to in item 1, that contains 25 or fewer reports of tests and studies with respect to efficacy data | 8,595 |
| 3 | Biocide full review — tier II | An application for a market authorization or for a notice of acceptance in respect of a major change, other than an application referred to in item 1, that contains 26 to 50 reports of tests and studies with respect to efficacy data | 11,469 |
| 4 | Biocide full review — tier III | An application for a market authorization or for a notice of acceptance in respect of a major change, other than an application referred to in item 1, that contains at least 51 reports of tests and studies with respect to efficacy data | 13,523 |
| 5 | Biocide comparison — labelling only | An application for a market authorization or for a notice of acceptance in respect of a major change that is based on a comparison and requires a review of labelling | 2,748 |
| 6 | Biocide comparison — administrative application | An application for a market authorization or for a notice of acceptance in respect of a major change that is based on a comparison between the biocide and another biocide that is the subject of a market authorization in cases where only the brand name of the biocide, the name of the applicant or the name of the holder of the market authorization, or any combination thereof, differs from the corresponding information in respect of the other biocide | 975 |
| 7 | Biocide — use of foreign decisions | An application for a market authorization that is based on a comparison between the biocide and a biocide that is authorized for sale by a foreign regulatory authority or an application for a notice of acceptance in respect of a major change to the biocide that is the subject of such a market authorization | 3,100 |
| 8 | Biocide monograph | An application for a market authorization or for a notice of acceptance in respect of a major change that includes an attestation of compliance with a biocide monograph prepared by the Minister and requires supporting information for aspects of the biocide that are outside the parameters of the monograph | 1,861 |
| 9 | Biocide major change — monograph | An application for a notice of acceptance in respect of a major change that includes an attestation of compliance with a biocide monograph prepared by the Minister and that does not require supporting information because the aspects of the biocide that are impacted by the change are within the parameters of the monograph | 1,363 |
| 10 | Biocide major change — quality and risks | An application for a notice of acceptance in respect of a major change that does not include reports of tests and studies with respect to efficacy data | 4,955 |
| 11 | Biocide minor change | The examination of a written description of a minor change | 1,363 |
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