Fees in Respect of Drugs and Medical Devices Order

Marginal note:Purpose — fees

• 2 (1) The purpose of this Order is to fix the fees for the following:

  • (a) in respect of drugs for human use and drugs for veterinary use only, 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, as the case may be, an application in respect of an establishment licence filed under those Regulations or an application for a drug identification number filed under section C.01.014.1 of those Regulations;

  • (b) in respect of drugs for veterinary use only, the examination of a notification for a veterinary health product filed under subsection C.01.615(1) of the Food and Drug Regulations, a preclinical submission filed under subsection C.08.005(1) of those Regulations, information filed under section C.08.010 of those Regulations for the purpose of obtaining a letter of authorization, information and material filed under section C.08.014 of those Regulations for the purpose of obtaining an experimental studies certificate, information and material filed with the Minister in respect of a notifiable change or a protocol filed with the Minister;

  • (b.1) in respect of biocides, the examination of an application for a market authorization submitted under section 10 of the Biocides Regulations, an application for a notice of acceptance in respect of a major change submitted under subsection 15(2) of those Regulations, the examination of a written description of a minor change provided to the Minister under subsection 17(1) of those Regulations, other than a change to contact information referred to in paragraph (a) of the definition of minor change in subsection 1(1) of those Regulations or a change referred to in paragraph (f) of that definition, or the examination of an application for a market authorization for a biocide that is based on a comparison to a biocide that is authorized for sale by a foreign regulatory authority submitted under section 26 of those Regulations;

  • (b.2) the right to sell a biocide under the Biocides Regulations;

  • (c) the right to sell a drug under the Food and Drug Regulations;

  • (d) the examination of an application in respect of a medical device licence, the right to sell a medical device or the examination of an application in respect of an establishment licence under the Medical Devices Regulations; and

  • (e) the examination of an application to amend an authorization in respect of a Class II, III or IV medical device that is not a UPHN medical device or the right to sell such a device under the Medical Devices Regulations.

• Marginal note:Purpose — remission

  (2) The purpose of this Order is also to remit, in whole or in part, certain of those fees.