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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

ItemColumn 1Column 2Column 3
Submission ClassDescriptionFee ($)
1New active substanceSubmissions 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
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 substance.153,710
3Clinical or non-clinical data onlySubmissions based only on clinical or non-clinical data for a drug that does not include a new active substance.71,740
4Comparative studiesSubmissions 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
5Chemistry and manufacturing data onlySubmissions based only on chemistry and manufacturing data for a drug that does not include a new active substance.20,500
6Published data onlySubmissions based only on published clinical or non-clinical data for a drug that does not include a new active substance.17,000
7Switch from prescription to non-prescription statusSubmissions 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
8Labelling onlySubmissions of labelling material (i.e. does not include supporting clinical or non-clinical data or chemistry and manufacturing data).2,760
9Administrative submissionSubmissions in support of a manufacturer or product name change.285
10DisinfectantsSubmissions and applications that include data in support of a disinfectant.3,820
11Drug identification number application — labelling standardsApplications 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 data1,530
  • SOR/2013-121, s. 7

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