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

Regulations are current to 2013-04-29 and last amended on 2011-04-01. Previous Versions

Fees in Respect of Drugs and Medical Devices Regulations

SOR/2011-79

FINANCIAL ADMINISTRATION ACT

Registration 2011-03-25

Fees in Respect of Drugs and Medical Devices Regulations

P.C. 2011-441 2011-03-25

Whereas the requirements of section 4 of the User Fees ActFootnote a have been complied with in respect of the fees fixed in the annexed Regulations;

Therefore His Excellency the Governor General in Council, on the recommendation of the Treasury Board and the Minister of Health, pursuant to subsection 19(1)Footnote b and section 19.1Footnote b of the Financial Administration ActFootnote c and, considering that it is otherwise in the public interest, subsection 23(2.1)Footnote d of that Act, hereby makes the annexed Fees in Respect of Drugs and Medical Devices Regulations.

PART 1

GENERAL

Definition

Definition of “Minister”

1. In these Regulations, “Minister” means the Minister of Health.

Purpose

Marginal note:Purpose — fees

  • 2. (1) The purpose of these Regulations is to prescribe the fees for

    • (a) 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, an application in respect of an establishment licence under those Regulations or an application for a drug identification number under section C.01.014.1 of those Regulations;

    • (b) the examination of an application for, or the renewal of, a dealer’s licence under Part G of the Food and Drug Regulations or under the Narcotic Control Regulations;

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

    • (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.

  • Marginal note:Purpose — remission

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

Application

Marginal note:Non-application

3. These Regulations do not apply in respect of

  • (a) a drug that is proposed for veterinary use only; or

  • (b) a drug that is a natural health product.

Annual Adjustment of Fees

Marginal note:Adjustment of fees

4. Every fee set out in these Regulations is to be increased annually by 2%, rounded up to the nearest dollar, beginning on April 1, 2012.

PART 2

DRUGS

Division 1

Fees for the Examination of a Drug Submission

Interpretation

Marginal note:Definitions

  • 5. (1) The following definitions apply in this Division.

    “actual gross revenue”

    « recettes brutes réelles »

    “actual gross revenue” means the amount earned by the person referred to in section 6 during the fee verification period from the sales in Canada of the drug that is the subject of a submission, a supplement or an application referred to in that section.

    “anticipated gross revenue”

    « recettes brutes prévues »

    “anticipated gross revenue” means the amount that the person referred to in section 6 expects to earn during the fee verification period from the sales in Canada of the drug that is the subject of a submission, a supplement or an application referred to in that section.

    “fee verification period”

    « période de vérification du prix à payer »

    “fee verification period”, in respect of a drug that is the subject of a submission, a supplement or an application referred to in section 6, means the period beginning on the day on which the drug is first sold in Canada after a notice of compliance is issued in respect of the submission or supplement or after a drug identification number is assigned for the drug as a result of the application and ending three years after that day.

  • Marginal note:Words and expressions

    (2) Unless the context otherwise requires, all other words and expressions used in this Division have the meanings assigned to them by the Food and Drug Regulations.