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

Regulations are current to 2014-09-01 and last amended on 2013-12-19. Previous Versions

Fees

Marginal note:Fee for examination

 Subject to sections 11 to 14, the fee for the examination of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission referred to in section C.08.002, C.08.002.1 or C.08.003 of the Food and Drug Regulations or an application for a drug identification number under section C.01.014.1 of those Regulations is, in respect of the submission class set out in column 1 of Schedule 1 and described in column 2, the fee set out in column 3. The fee is payable by the person who files the submission or supplement or makes the application.

Timing of Payment

Marginal note:Timing of payment — $10,000 or less
  •  (1) If the fee referred to in section 6 is $10,000 or less, it is payable at the time that the submission or supplement is filed or the application is made.

  • Marginal note:Timing of payment — more than $10,000

    (2) If the fee referred to in section 6 is more than $10,000,

    • (a) 10% of the fee is payable on receipt of a notice from the Minister stating that the submission, supplement or application has been found to be incomplete following a preliminary examination;

    • (b) 75% of the fee is payable on receipt of a notice from the Minister stating that the submission, supplement or application has been found to be complete following a preliminary examination and has been accepted for further examination; and

    • (c) 25% of the fee is payable on receipt of a notice from the Minister stating that the examination of the submission, supplement or application has been completed.

Marginal note:Remission — not accepted for examination

 If the total amount of the fee has been paid at the time of filing in accordance with subsection 7(1) and the person referred to in section 6 receives a notice from the Minister stating that the submission, supplement or application has not been accepted for further examination, remission is granted of the amount paid less 10%, which the Minister must repay to that person.

Marginal note:Deferred payment
  •  (1) If the person referred to in section 6 has not completed their first full fiscal year on the day on which they file the submission or make the application and if a statement signed by the individual responsible for the person’s financial affairs specifying the commencement date of that fiscal year is provided with the submission or application, the payment of the fee in respect of the submission or application is deferred for a two-year period following the day the submission is filed or application is made, together with the payment of any fee that becomes payable in respect of a supplement filed during that period. At the end of the two-year period, the person must pay all of the applicable amounts payable.

  • Marginal note:Inaccurate statement

    (2) If the Minister determines, on the basis of any information available to the Minister, that a statement provided under subsection (1) is inaccurate, the payment cannot be deferred and is payable in accordance with section 7. The Minister must notify the person accordingly.