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

Regulations are current to 2017-11-20 and last amended on 2013-12-19. 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 1General

Definition

Definition of Minister

 In these Regulations, Minister means the Minister of Health.

Purpose

Marginal note:Purpose — fees
  •  (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

 These Regulations do not apply in respect of

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

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

  • (c) a drug that is the subject of an extraordinary use new drug submission filed under section C.08.002.01 of the Food and Drug Regulations or of an abbreviated extraordinary use new drug submission filed under section C.08.002.1 of those Regulations; or

  • (d) a drug that is an active pharmaceutical ingredient as defined in subsection C.01A.001(1) of the Food and Drug Regulations.

  • SOR/2013-121, s. 1.

Annual Adjustment of Fees

Marginal note:Adjustment of fees

 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 2Drugs

DIVISION 1Fees for the Examination of a Drug Submission

Interpretation

Marginal note:Definitions
  •  (1) The following definitions apply in this Division.

    actual gross revenue

    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. (recettes brutes réelles)

    anticipated gross revenue

    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. (recettes brutes prévues)

    fee verification period

    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. (période de vérification du prix à payer)

  • 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.

Fees

Marginal note:Fee for examination

 Subject to sections 11 to 14, the fee for 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 or an application for a drug identification number under section C.01.014.1 of those Regulations is, in respect of the submission class set out in column 1 of Schedule 1 and described in column 2, the fee set out in column 3. The fee is payable by the person who files the submission or supplement or makes the application.

Timing of Payment

Marginal note:Timing of payment — $10,000 or less
  •  (1) If the fee referred to in section 6 is $10,000 or less, it is payable at the time that the submission or supplement is filed or the application is made.

  • Marginal note:Timing of payment — more than $10,000

    (2) If the fee referred to in section 6 is more than $10,000,

    • (a) 10% of the fee is payable on receipt of a notice from the Minister stating that the submission, supplement or application has been found to be incomplete following a preliminary examination;

    • (b) 75% of the fee is payable on receipt of a notice from the Minister stating that the submission, supplement or application has been found to be complete following a preliminary examination and has been accepted for further examination; and

    • (c) 25% of the fee is payable on receipt of a notice from the Minister stating that the examination of the submission, supplement or application has been completed.

Marginal note:Remission — not accepted for examination

 If the total amount of the fee has been paid at the time of filing in accordance with subsection 7(1) and the person referred to in section 6 receives a notice from the Minister stating that the submission, supplement or application has not been accepted for further examination, remission is granted of the amount paid less 10%, which the Minister must repay to that person.

Marginal note:Deferred payment
  •  (1) If the person referred to in section 6 has not completed their first full fiscal year on the day on which they file the submission or make the application and if a statement signed by the individual responsible for the person’s financial affairs specifying the commencement date of that fiscal year is provided with the submission or application, the payment of the fee in respect of the submission or application is deferred for a two-year period following the day the submission is filed or application is made, together with the payment of any fee that becomes payable in respect of a supplement filed during that period. At the end of the two-year period, the person must pay all of the applicable amounts payable.

  • Marginal note:Inaccurate statement

    (2) If the Minister determines, on the basis of any information available to the Minister, that a statement provided under subsection (1) is inaccurate, the payment cannot be deferred and is payable in accordance with section 7. The Minister must notify the person accordingly.

Marginal note:Deferred payment — notice of compliance
  •  (1) If the person referred to in section 6 submits an application for authorization under section C.07.003 of the Food and Drug Regulations at the same time that it files the submission or supplement or makes the application for a drug identification number, the payment of the fee is deferred until the issuance of a notice of compliance under section C.08.004 of those Regulations or the issuance of a document setting out the drug identification number assigned for the drug under section C.01.014.2 of those Regulations.

  • Marginal note:Later date

    (2) If the person is also entitled to a deferral under section 9, the payment of the fee is deferred until the later date.

  • SOR/2013-121, s. 2(F).

Remission

Marginal note:Remission — anticipated gross revenue
  •  (1) Subject to subsection (4) and subsection 13(2), remission is granted of the amount by which the fee payable under section 6 exceeds 10% of the actual gross revenue of a person referred to in that section if

    • (a) the person provides with their submission, supplement or application

      • (i) a statement signed by the individual responsible for the person’s financial affairs indicating the person’s anticipated gross revenue and certifying that the fee payable under section 6 is greater than an amount equal to 10% of that anticipated gross revenue,

      • (ii) information establishing that the fee payable under section 6 is greater than an amount equal to 10% of the person’s anticipated gross revenue, and

      • (iii) the amount of $500 for processing the remission; and

    • (b) on the basis of the information provided under paragraph (a) and any other information available to the Minister, the Minister determines that the fee payable under section 6 is likely to be greater than an amount equal to 10% of the person’s actual gross revenue.

  • Marginal note:Amounts payable

    (2) The fee is then payable as follows:

    • (a) an amount equal to 10% of the person’s anticipated gross revenue is payable in accordance with subsection 7(2); and

    • (b) the amount, if any, by which the lesser of the fee payable under section 6 and 10% of the person’s actual gross revenue exceeds the amount paid under paragraph (a) is payable 60 days after the day on which the fee verification period ends.

  • Marginal note:Sales records

    (3) Within 60 days after the end of the fee verification period, the person must provide the Minister with sales records in regard to the sales of the drug in Canada during the fee verification period, prepared in accordance with generally accepted accounting principles, and a document signed by the individual responsible for the person’s financial affairs certifying that the records were so prepared.

  • Marginal note:Omission

    (4) If, within 60 days after the end of the fee verification period, the person has not provided the Minister with the records referred to in subsection (3), the difference between the fee payable under section 6 and the amount already paid is immediately payable.

  • SOR/2013-121, s. 3(E).
 
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