Veterinary Drug Evaluation Fees Regulations (SOR/96-143)

Regulations are current to 2017-11-20

Veterinary Drug Evaluation Fees Regulations

SOR/96-143

FINANCIAL ADMINISTRATION ACT

Registration 1996-03-12

Regulations Prescribing the Fees to be Paid for a Veterinary Drug Submission Evaluation Service Provided by or on Behalf of Her Majesty in Right of Canada

P.C. 1996-295  1996-03-12

His Excellency the Governor General in Council, on the recommendation of the Minister of National Health and Welfare and the Treasury Board, pursuant to paragraph 19(1)(a)Footnote * of the Financial Administration Act, is pleased hereby to make the annexed Regulations prescribing the fees to be paid for a veterinary drug submission evaluation service provided by or on behalf of Her Majesty in right of Canada.

Short Title

 These Regulations may be cited as the Veterinary Drug Evaluation Fees Regulations.

Interpretation

 All words and expressions used in these Regulations have the meanings assigned to them by the Food and Drugs Act or the Food and Drug Regulations.

Application

 These Regulations apply only in respect of drugs for veterinary use.

 These Regulations do not apply in respect of a drug for veterinary use for which a submission, supplement or application referred to in any of sections 5 to 11 was filed on or before March 31, 1995.

New Drug Submission

 Every person who includes, in a new drug submission referred to in section C.08.002 of the Food and Drug Regulations, one or more components set out in column I of an item of Schedule I shall pay the applicable fee set out in column II of that item for the screening and examination of each component.

Supplement to a New Drug Submission

 Every person who includes, in a supplement to a new drug submission referred to in section C.08.003 of the Food and Drug Regulations, one or more components set out in column I of an item of Schedule II shall pay the applicable fee set out in column II of that item for the screening and examination of each component.

Abbreviated New Drug Submission and Supplement to an Abbreviated New Drug Submission

 Every person who includes, in an abbreviated new drug submission or a supplement to an abbreviated new drug submission referred to in section C.08.002 or C.08.003 of the Food and Drug Regulations, one or more components set out in column I of an item of Schedule III shall pay the applicable fee set out in column II of that item for the screening and examination of each component.

Drug Identification Number (Din)

 Every person who includes, in an application for a drug identification number referred to in section C.01.014.1 of the Food and Drug Regulations, one or more components set out in column I of an item of Schedule IV shall pay the applicable fee set out in column II of that item for the screening and examination of each component.

Preclinical New Drug Submission

 Every person who includes, in a preclinical new drug submission referred to in section C.08.005 of the Food and Drug Regulations, one or more components set out in column I of an item of Schedule V shall pay the applicable fee set out in column II of that item for the screening and examination of each component.

Experimental Studies Certificate

 Every person who includes, in an application for an experimental studies certificate referred to in section C.08.014 of the Food and Drug Regulations, one or more components set out in column I of an item of Schedule VI shall pay the applicable fee set out in column II of that item for the screening and examination of each component.

Emergency Drug Sale

 Every person who includes, in an application for a letter of authorization referred to in section C.08.010 of the Food and Drug Regulations, one or more components set out in column I of an item of Schedule VII shall pay the applicable fee set out in column II of that item for the screening and examination of each component.

Submission, Supplement or Application Filed on or After April 1, 1996

  •  (1) This section applies in respect of a submission, supplement or application referred to in any of sections 5 to 11 that is filed on or after April 1, 1996.

  • (2) Where the sum of the fees for components included in a submission, supplement or application is $10,000 or less, the fee for each component is payable at the time that the submission, supplement or application is filed.

  • (3) Where the sum of the fees for components included in a submission, supplement or application is more than $10,000, the fee for each component is payable as follows:

    • (a) 10% of the fee for the component at the time that the submission, supplement or application is filed;

    • (b) 40% of the fee for the component on receipt of a notice from the Minister or Director stating that the submission, supplement or application has been accepted for examination; and

    • (c) 50% of the fee for the component on receipt of a notice from the Minister or Director stating that the examination of the component has been completed.

Submission, Supplement or Application Filed Before April 1, 1996

  •  (1) This section applies in respect of a submission, supplement or application referred to in any of sections 5 to 11 where

    • (a) it was filed during the period beginning on April 1, 1995 and ending on March 31, 1996; and

    • (b) as of April 1, 1996, the screening of the submission, supplement or application has not begun.

  • (2) Where the sum of the fees for components included in a submission, supplement or application is $10,000 or less, the fee for each component is payable on receipt of a notice from the Minister or Director stating that the submission, supplement or application has been screened.

  • (3) Where the sum of the fees for components included in a submission, supplement or application is more than $10,000, the fee for each component is payable as follows:

    • (a) 10% of the fee for the component on receipt of a notice from the Minister or Director stating that the submission, supplement or application has been screened;

    • (b) 40% of the fee for the component on receipt of a notice from the Minister or Director stating that the submission, supplement or application has been accepted for examination; and

    • (c) 50% of the fee for the component on receipt of a notice from the Minister or Director stating that the examination of the component has been completed.

  •  (1) This section applies in respect of a submission, supplement or application referred to in any of sections 5 to 11 where

    • (a) it was filed during the period beginning on April 1, 1995 and ending on March 31, 1996; and

    • (b) as of April 1, 1996, the screening of the submission, supplement or application has begun but is not completed, or the submission, supplement or application has been screened and accepted for examination but one or more of the components included in it are not yet under examination.

  • (2) Notwithstanding sections 5 to 11, the fee payable for the examination of each component not yet under examination as of April 1, 1996 is 90% of the applicable fee set out in the relevant schedule.

  • (3) Where the sum of the fees for components that are included in a submission, supplement or application and that are not yet under examination is $10,000 or less, the fee for each such component is payable on the later of

    • (a) April 1, 1996, and

    • (b) the date of receipt of a notice from the Minister or Director stating that the submission, supplement or application has been screened and accepted for examination.

  • (4) Where the sum of the fees for components that are included in a submission, supplement or application and that are not yet under examination is more than $10,000, the fee for each such component is payable as follows:

    • (a) 50% of the fee for the component on the later of

      • (i) April 1, 1996, and

      • (ii) the date of receipt of a notice from the Minister or Director stating that the submission, supplement or application has been screened and accepted for examination; and

    • (b) 50% of the fee for the component on receipt of a notice from the Minister or Director stating that the examination of the component has been completed.

  •  (1) This section applies in respect of each component included in a submission, supplement or application referred to in any of sections 5 to 11 where

    • (a) the submission, supplement or application was filed during the period beginning on April 1, 1995 and ending on March 31, 1996; and

    • (b) as of April 1, 1996, the component is still under examination.

  • (2) Notwithstanding sections 5 to 11, the fee payable for the examination of each component that is included in a submission, supplement or application and that is still under examination is

    • (a) where 25% or more but less than 50% of the component remains to be examined, 15% of the applicable fee set out in the relevant schedule;

    • (b) where 50% or more but less than 75% of the component remains to be examined, 40% of the applicable fee set out in the relevant schedule; and

    • (c) where 75% or more of the component remains to be examined, 65% of the applicable fee set out in the relevant schedule.

  • (3) The fee for each component still under examination is payable as follows:

    • (a) 50% of that fee on receipt of a notice from the Minister or Director stating the percentage of the component that remains to be examined; and

    • (b) 50% of that fee on receipt of a notice from the Minister or Director stating that the examination of the component has been completed.

 
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