Reduction of Fees
16 (1) In this section, fee verification period, in respect of a drug for which an application is made under this section, means the period beginning on the date that the drug is first sold in Canada and ending three years after that date.
(2) A person who files a submission, supplement or application referred to in any of sections 5 to 7 may apply to the Minister or Director, as the case may be, for a reduction in the fee payable for each component included in the submission, supplement or application.
(3) The Minister or Director shall grant an application made under subsection (2) where
(a) the Minister or Director has reasonable grounds to believe that, during the fee verification period, the applicant’s revenue from sales in Canada of the drug to which the submission, supplement or application relates will be less than 10 times the sum of the applicable fees calculated in accordance with sections 5 to 7, 14 and 15; and
(b) the applicant submits with the application a fee for processing the application in the amount of $1,000.
(4) Notwithstanding sections 5 to 7, 14 and 15, where the Minister or Director grants an application made under subsection (2), the fee payable for the components included in the submission, supplement or application is the lesser of
(a) the sum of the applicable fees calculated in accordance with sections 5 to 7, 14 and 15, and
(b) the greater of
(5) The fee calculated in accordance with subsection (4) is payable as follows:
(a) 10% of the applicant’s anticipated revenue from sales of the drug in Canada during the fee verification period is payable at the times and in the manner set out in sections 12 to 15, as applicable; and
(b) the balance, if any, is payable 60 days after the day on which the fee verification period ends.
Coming into Force
17 These Regulations come into force on April 1, 1996.
- Date modified: