Fees in Respect of Drugs and Medical Devices Regulations (SOR/2011-79)

Regulations are current to 2017-09-27 and last amended on 2013-12-19. Previous Versions

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 status from prescription drug to non-prescription drugSubmissions 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
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;
  • SOR/2013-122, s. 22.
 
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