Fees in Respect of Dealer’s Licences Regulations
Version of the schedule from 2013-06-07 to 2013-12-18:
SCHEDULE 1(Section 6)
Fees for Examination Services
| Item | Column 1 | Column 2 | Column 3 |
|---|---|---|---|
| Submission Class | Description | Fee ($) | |
| 1 | New active substance | Submissions in support of a drug, excluding 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. | 303,480 |
| 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. | 153,710 |
| 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. | 71,740 |
| 4 | Comparative studies | Submissions based on comparative studies (e.g. clinical or non-clinical data, bioavailability, pharmacokinetic and pharmacodynamic data) with or without chemistry and manufacturing data for a drug that does not include a new active substance. | 43,360 |
| 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. | 20,500 |
| 6 | Published data only | Submissions based only on published clinical or non-clinical data for a drug that does not include a new active substance. | 17,000 |
| 7 | Switch from prescription to non-prescription status | Submissions based only on data that support the modification or removal of a medicinal ingredient listed in Schedule F to the Food and Drug Regulations (i.e. identical claim for existing drug). | 41,280 |
| 8 | Labelling only | Submissions of labelling material (i.e. does not include supporting clinical or non-clinical data or chemistry and manufacturing data). | 2,760 |
| 9 | Administrative submission | Submissions in support of a manufacturer or product name change. | 285 |
| 10 | Disinfectants | Submissions and applications that include data in support of a disinfectant. | 3,820 |
| 11 | Drug identification number application — labelling standards | Applications that attest to 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 | 1,530 |
- SOR/2013-121, s. 7
- Date modified: