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Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)

Regulations are current to 2021-02-15 and last amended on 2020-04-01. Previous Versions

SCHEDULE 1(Section 9)

Fees for Examination of a Submission — Drugs for Human Use

ItemColumn 1Column 2Column 3Column 4Column 5Column 6
Submission ClassDescriptionFee ($)Fee ($)Fee ($)Fee ($)
Fiscal YearFiscal YearFiscal YearFiscal Year
2020-20212021-20222022-20232023-2024
1New active substanceSubmissions 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 polymorph400,288437,884475,481513,077
2Clinical or non-clinical data and chemistry and manufacturing dataSubmissions based on clinical or non-clinical data and chemistry and manufacturing data for a drug that does not include a new active substance204,197224,691245,185265,678
3Clinical or non-clinical data onlySubmissions based only on clinical or non-clinical data for a drug that does not include a new active substance90,86495,987101,110106,232
4Comparative studiesSubmissions 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 substance53,83655,84857,85959,870
5Chemistry and manufacturing data onlySubmissions based only on chemistry and manufacturing data for a drug that does not include a new active substance27,58730,67033,75236,835
6Clinical or non-clinical data only, in support of safety updates to the labellingSubmissions 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 substance19,44219,44219,44219,442
7Labelling onlySubmissions, 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)3,8164,3284,8415,353
8Labelling 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 assessment2,0102,0102,0102,010
9Administrative submissionSubmissions 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)432540676845
10Disinfectant — full reviewSubmissions, other than those described in item 11, that include data in support of a disinfectant5,7127,1408,92511,157
11Labelling 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 drug2,5072,5072,5072,507
12Drug identification number application — labelling standardsApplications, 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 data1,6161,6161,6161,616
 
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