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Drugs and Health Products
Biologic Submission and Application Review
| Fee Category | Description | Fee as of April 1, 2012 | Fee as of April 1, 2013 |
|---|---|---|---|
| New Active Substance | Submissions in support of a drug , excluding a disinfectant, that contains a medicinal ingredient not previously approved in a drug in Canada and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate, or polymorph. | $309,550 | $315,741 |
| Clinical or Non-Clinical Data and Chemistry & Manufacturing | Submissions based on Clinical or Non-Clinical data and Chemistry & Manufacturing data for a drug that does not include a new active substance. | $156,785 | $159,921 |
| 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. | $73,175 | $74,639 |
| Comparative Studies | Submissions based on comparative studies (e.g. Clinical or non-clinical data, bioavailability, pharmacokinetic and pharmacodynamic data) with or without Chemistry & Manufacturing data for a drug that does not include a new active substance. | $44,228 | $45,113 |
| Chemistry & Manufacturing Data only | Submissions based only on Chemistry & Manufacturing data for a drug that does not include a new active substance. | $20,910 | $21,329 |
| Published Data only | Submissions based only on published clinical or non-clinical data for a drug that does not include a new active substance. | $17,340 | $17,687 |
| Labelling Only | Submissions of labelling material. (i.e. does not include supporting clinical or non-clinical or Chemistry and Manufacturing data.) | $2,816 | $2,873 |
| Administrative Submission | Submissions in support of a manufacturer or product name change. | $291 | $297 |
| Drug Identification Number Application - Labelling Standard | Applications attesting to compliance with a labelling standard or Category IV Monograph for a drug that does not include clinical or non-clinical data or chemistry and manufacturing data. | $1,561 | $1,593 |
