Fees in Respect of Drugs and Medical Devices Order

Marginal note:Definitions

• 1 (1) The following definitions apply in this Order.

  entity

  entity has the meaning assigned by the definition organization in section 2 of the Criminal Code. (entité)

  fiscal year

  fiscal year means

  • (a) for the purposes of sections 16, 17, 25, 26, 49, 53, 57, 66, 67, 74 and 79, the fiscal year of a person that provides information under that section or of a person with which the person is affiliated; and

  • (b) for the purposes of any other section, the period beginning on April 1 in one year and ending on March 31 in the next year. (exercice)

  performance standard

  performance standard means the document entitled Performance Standards for the Fees in Respect of Drugs and Medical Devices Order, published by the Government of Canada on its website, dated September 11, 2023. (norme de rendement)

  small business

  small business means a person in respect of which either of the following criteria applies:

  • (a) the total of the number of employees of the person and of the persons with which the person is affiliated is fewer than 100; or

  • (b) the total of the gross revenue of the person and of the persons with which the person is affiliated is $30,000 or more but less than $5 million. (petite entreprise)

• Marginal note:Other words and expressions

  (2) Unless the context otherwise requires, other words and expressions used in this Order have the meanings assigned to them by the Food and Drug Regulations or the Medical Devices Regulations, as the case may be.

• Marginal note:Affiliation

  (3) For the purposes of this Order,

  • (a) one entity is affiliated with another entity if one of them is the subsidiary of the other or both are subsidiaries of the same entity or each of them is controlled by the same entity or individual;

  • (b) if two entities are affiliated with the same entity at the same time, they are deemed to be affiliated with each other; and

  • (c) an individual is affiliated with an entity if the individual controls the entity.

• Marginal note:Subsidiary entity

  (4) For the purposes of this Order, an entity is a subsidiary of another entity if it is controlled by that other entity.

• Marginal note:Control

  (5) For the purposes of this Order,

  • (a) a corporation is controlled by an entity or an individual if

    • (i) securities of the corporation to which are attached more than 50% of the votes that may be cast to elect directors of the corporation are held, directly or indirectly, whether through one or more subsidiaries or otherwise, other than by way of security only, by or for the benefit of that entity or individual, and

    • (ii) the votes attached to those securities are sufficient, if exercised, to elect a majority of the directors of the corporation; and

  • (b) an entity other than a corporation is controlled by an entity or individual if the entity or individual, directly or indirectly, whether through one or more subsidiaries or otherwise, holds an interest in the entity that is not a corporation that entitles them to receive more than 50% of the profits of that entity or more than 50% of its assets on dissolution.

• Marginal note:Deemed affiliation

  (6) For the purposes of this Order, if it may reasonably be considered that one of the main reasons for the separate existence of two or more corporations is so that one of them meets the applicable conditions for a remission of a fee fixed under this Order for which only small businesses are eligible, the two or more corporations are deemed to be affiliated with each other.