Fees in Respect of Dealer’s Licences Regulations
Version of the schedule from 2013-12-19 to 2020-03-31:
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 status from prescription drug to non-prescription drug | Submissions based only on data that support the amendment, or the removal, of the reference to the medicinal ingredient on the Prescription Drug List that is applicable to the drug in question. | 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
- SOR/2013-122, s. 22
- Date modified: