Fees in Respect of Drugs and Medical Devices Order

Marginal note:Remission — performance standard

• 6 (1) If the Minister determines that the performance standard has not been met in relation to a fee that is payable under this Order, remission is granted to the person that must pay the fee

  • (a) of an amount equal to 25% of the fee; or

  • (b) of an amount equal to 25% of the amount that is payable, in the case where remission is granted of part of the fee under any other provision of this Order.

• Marginal note:Exceptions

  (2) Subsection (1) does not apply to a fee for the examination of

  • (a) an application or submission referred to in this Order in respect of which a joint or parallel review is conducted by the Minister and a foreign regulatory authority;

  • (b) an application for a licence that is filed under section 32 of the Medical Devices Regulations if

    • (i) the medical device to which the application relates includes a component that is a drug, and

    • (ii) the Minister has made a decision in respect of the application to issue or amend a medical device licence under section 36 of those Regulations, or to refuse to issue or amend such a licence under section 38 of those Regulations; or

  • (c) a new drug submission for a designated COVID-19 drug if subsection C.08.002(2.3) of the Food and Drug Regulations applies to that submission.