Fees in Respect of Drugs and Medical Devices Order

Marginal note:Remission — first submission by small business

26 Subject to section 27, remission is granted to the person referred to in subsection 21(2) of an amount equal to the fee that is payable under subsection 21(1) if the following conditions are met:

• (a) the person has not previously filed a submission in respect of a drug; and

• (b) the person provides with their submission, in a form established by the Minister,

  • (i) in the case where the person has completed their first fiscal year,

    • (A) a statement indicating that the person met the definition small business in subsection 1(1) in their last completed fiscal year, and

    • (B) the following information:

      • (I) a list of the persons with which the person was affiliated in the person’s last completed fiscal year,

      • (II) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person was affiliated in the person’s last completed fiscal year,

      • (III) the number of employees of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year, and

      • (IV) the gross revenue of the person in their last fiscal year and of the persons with which the person was affiliated in those persons’ last completed fiscal year, and

  • (ii) in the case where the person has not completed their first fiscal year,

    • (A) a statement indicating that the person anticipates meeting the definition small business in subsection 1(1) in their first fiscal year, and

    • (B) the following information:

      • (I) a list of the persons with which the person is affiliated in the person’s first fiscal year,

      • (II) the start and end dates of the person’s fiscal year and of the fiscal year of the persons with which the person is affiliated in the person’s first fiscal year,

      • (III) the number of employees of the person in their first fiscal year and of the persons with which the person is affiliated in those persons’ last completed fiscal year, and

      • (IV) the projected gross revenue of the person in their first fiscal year and the gross revenue of the persons with which the person is affiliated in those persons’ last completed fiscal year.