Drug Evaluation Fees Regulations
SOR/95-424
Registration 1995-08-30
Regulations Prescribing the Fees to be Paid for a Drug Submission Evaluation Service Provided by or on Behalf of Her Majesty in Right of Canada
P.C. 1995-1444 1995-08-30
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 drug submission evaluation service provided by or on behalf of Her Majesty in right of Canada.
Return to footnote *S.C. 1991, c. 24, s. 6
Short Title
1 These Regulations may be cited as the Drug Evaluation Fees Regulations.
Interpretation
2 (1) In these Regulations, class monograph means a document prepared by the Department that
(a) lists the types and strengths of medicinal ingredients that may be contained in drugs of a specified class; and
(b) sets out labelling and other requirements that apply to those drugs.
(2) All other 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
3 (1) These Regulations do not apply in respect of drugs proposed for veterinary use only.
(2) These Regulations do not apply in respect of a submission, supplement or application referred to in any of sections 4 to 8 that was filed
(a) before October 1, 1994; or
(b) during the period beginning on October 1, 1994 and ending on August 31, 1995, where, as of September 1, 1995, the submission, supplement or application has been screened and all submission components included in it are under examination.
New Drug Submission
4 The fee payable for the screening and examination by the Minister of a new drug submission referred to in section C.08.002 of the Food and Drug Regulations is
(a) if the submission includes only one submission component set out in column I of an item of Part I of the schedule, the fee set out in column II of that item; or
(b) if the submission includes more than one submission component referred to in paragraph (a), a fee that is equal to the sum of the applicable fees for those components.
Supplement to a New Drug Submission
5 The fee payable for the screening and examination by the Minister of a supplement to a new drug submission referred to in section C.08.003 of the Food and Drug Regulations is
(a) if the supplement includes only one submission component set out in column I of an item of Part II of the schedule, the fee set out in column II of that item; or
(b) if the supplement includes more than one submission component referred to in paragraph (a), a fee that is equal to the sum of the applicable fees for those components.
Abbreviated New Drug Submission and Supplement to an Abbreviated New Drug Submission
6 The fee payable for the screening and examination by the Minister of an abbreviated new drug submission or a supplement to an abbreviated new drug submission referred to in sections C.08.002 and C.08.003 of the Food and Drug Regulations is
(a) if the submission or supplement includes only one submission component set out in column I of an item of Part III of the schedule, the fee set out in column II of that item; or
(b) if the submission or supplement includes more than one submission component referred to in paragraph (a), a fee that is equal to the sum of the applicable fees for those components.
Drug Identification Number (Din)
7 The fee payable for the screening and examination by the Director of an application for a drug identification number referred to in section C.01.014.1 of the Food and Drug Regulations is
(a) if the application includes only one submission component set out in column I of an item of Part IV of the schedule, the fee set out in column II of that item; or
(b) if the application includes more than one submission component referred to in paragraph (a), a fee that is equal to the sum of the applicable fees for those components.
Numbered Certificate of Registration (Gp)
8 The fee payable for the screening and examination by the Director of an application for a numbered certificate of registration (GP) referred to in section C.10.003 of the Food and Drug Regulations is
(a) if the application includes only one submission component set out in column I of an item of Part IV of the schedule, the fee set out in column II of that item; or
(b) if the application includes more than one submission component referred to in paragraph (a), a fee that is equal to the sum of the applicable fees for those components.
Submission, Supplement or Application Filed on or After September 1, 1996
9 (1) This section applies in respect of a submission, supplement or application referred to in any of sections 4 to 8 that is filed on or after September 1, 1996.
(2) Where the fee for a submission, supplement or application referred to in subsection (1) is $10,000 or less, the fee is payable at the time that the submission, supplement or application is filed.
(3) Where the fee for a submission, supplement or application referred to in subsection (1) is more than $10,000, the fee is payable as follows:
(a) 10 per cent on receipt of a notice from the Minister or Director stating that the submission, supplement or application has been screened;
(b) 65 per cent on receipt of a notice from the Minister or Director stating that the submission, supplement or application has been accepted for examination; and
(c) 25 per cent on receipt of a notice from the Minister or Director stating that the examination has been completed.
Submission, Supplement or Application Filed Before September 1, 1996
10 (1) This section applies in respect of a submission, supplement or application referred to in any of sections 4 to 8 that
(a) is filed during the period beginning on September 1, 1995 and ending on August 31, 1996; or
(b) was filed during the period beginning on October 1, 1994 and ending on August 31, 1995 where, as of September 1, 1995, screening of the submission, supplement or application has not begun.
(2) Subject to subsection (3), the fee for a submission, supplement or application referred to in paragraph (1)(a) or (b) is payable as follows:
(a) 10 per cent on receipt of a notice from the Minister or Director stating that the submission, supplement or application has been screened;
(b) 15 per cent on receipt of a notice from the Minister or Director stating that the submission, supplement or application has been accepted for examination; and
(c) 75 per cent on receipt of a notice from the Minister or Director stating that the examination has been completed.
(3) Where the fee for a submission, supplement or application referred to in paragraph (1)(a) is $10,000 or less, the fee is payable at the time that the submission, supplement or application is filed.
11 (1) This section applies in respect of a submission, supplement or application referred to in any of sections 4 to 8 where
(a) it was filed during the period beginning on October 1, 1994 and ending on August 31, 1995; and
(b) as of September 1, 1995 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 submission components included in it are not yet under examination.
(2) Notwithstanding sections 4 to 8, the fee payable for the screening and examination by the Minister or Director of a submission, supplement or application referred to in subsection (1) is 90 per cent of the sum of the applicable fees, as set out in the schedule, for the submission components included in it that are not yet under examination as of September 1, 1995.
(3) The fee for a submission, supplement or application referred to in subsection (1) is payable as follows:
(a) 25 per cent on receipt of a notice from the Minister or Director stating that the submission components that were not yet under examination as of September 1, 1995 are now under examination; and
(b) 75 per cent on receipt of a notice from the Minister or Director stating that the examination has been completed.
Reduction of Fees
12 (1) In this section, fee verification period, in respect of a drug for which application is made under this section, means the period beginning on the date that the drug is first sold in Canada and ending three years after that date.
(2) A person who files a submission, supplement or application referred to in any of sections 4 to 8 may apply to the Minister or Director, as the case may be, for a reduction in the fee payable under these Regulations.
(3) The Minister or Director shall grant an application made under subsection (2) where
(a) the Minister or Director has reasonable grounds to believe that, during the fee verification period, the applicant’s revenue from sales in Canada of the drug in respect of which the submission, supplement or application relates will be less than 10 times the applicable fee calculated in accordance with sections 4 to 8 and 11; and
(b) the applicant submits with the application a fee for processing the application in the amount of $1,000.
(4) Notwithstanding sections 4 to 8 and 11, where the Minister or Director grants an application made under subsection (2), the fee payable in respect of the submission, supplement or application is the lesser of
(a) the applicable fee calculated in accordance with sections 4 to 8 and 11; and
(b) the greater of
(i) 10 per cent of the applicant’s anticipated revenue from sales of the drug in Canada during the fee verification period, and
(ii) 10 per cent of the applicant’s actual revenue from sales of the drug in Canada during the fee verification period, as verified by audited sales records for the drug.
(5) The fee calculated in accordance with subsection (4) is payable as follows:
(a) an amount equal to 10 per cent of the applicant’s anticipated revenue from sales of the drug in Canada during the fee verification period is payable at the times and in the manner set out in sections 9 to 11, as applicable; and
(b) the balance, if any, is payable 60 days after the day on which the fee verification period ends.
Coming into Force
13 These Regulations come into force on September 1, 1995.
SCHEDULE(Sections 4 to 8 and 11)Fees Payable for Drug Evaluation Service
PART INew Drug Submission
| Column I | Column II | |
|---|---|---|
| Item | Submission Component | Fee |
| 1 | Preclinical and clinical data to support a single route of administration, dosage form and condition of use | $117,000 |
| 2 | Clinical data without preclinical data, or clinical data with supplementary or confirmatory preclinical data, to support a single or additionalFootnote for 1 route of administration, dosage form or condition of use | 52,900 |
| 3 | Comparative (bioavailability, pharmacodynamic or clinical) data to support a single or additional1 route of administration or dosage form | 17,200 |
| 4 | Comparative (bioavailability, pharmacodynamic or clinical) data required to support each additional strengthFootnote for 2 | 2,700 |
| 5 | Published clinical references or other published dataFootnote for 3 | 2,200 |
| 6 | Chemistry and manufacturing data for the medicinal ingredient of a drugFootnote for 4 | 11,500 |
| 7 | Chemistry and manufacturing data to support a single dosage form | 15,300 |
| 8 | Documentation to support a change of manufacturerFootnote for 5 | 250 |
Return to footnote 1This is in addition to the route of administration, dosage form and condition of use referred to in item 1.
Return to footnote 2One study to support strengths may be included with a new drug submission, under item 1 or 2, without payment of the fee set out in item 4.
Return to footnote 3This item applies only where a new drug submission does not require the filing of a submission component set out in any of items 1 to 4.
Return to footnote 4A medicinal ingredient that has been evaluated in another submission to which reference is made is not required to be evaluated.
Return to footnote 5This item applies only where a new drug submission does not include any of the submission components set out in items 1 to 7.
PART IISupplement to a New Drug Submission
| Column I | Column II | |
|---|---|---|
| Item | Submission Component | Fee |
| 1 | Clinical data without preclinical data, or clinical data with supplementary or confirmatory preclinical data, to support an additionalFootnote for 1 route of administration, dosage form or condition of use | $52,900 |
| 2 | Information and material to support | 52,900 |
| (a) the removal of a drug from Schedule F to the Food and Drug Regulations, and | ||
| (b) a new condition of use | ||
| 3 | Information and material to support the removal of a drug from Schedule F to the Food and Drug Regulations (same condition of use) | 17,200 |
| 4 | Comparative (bioavailability, pharmacodynamic or clinical) data to support a single or additional1 route of administration or dosage form | 17,200 |
| 5 | Comparative (bioavailability, pharmacodynamic or clinical) data required to support each additional strengthFootnote for 2 | 2,700 |
| 6 | Published clinical references or other published dataFootnote for 3 | 2,200 |
| 7 | Chemistry and manufacturing data for the medicinal ingredient of a drugFootnote for 4 | 11,500 |
| 8 | Chemistry and manufacturing data to support a single dosage form | 15,300 |
| 9 | Documentation to support a change to the name of a manufacturer or the brand name of a drugFootnote for 5 | 250 |
Return to footnote 1This is in addition to the routes of administration, dosage forms and conditions of use for which a notice of compliance has already been issued.
Return to footnote 2One study to support strengths may be included with a supplement to a new drug submission, under item 1 or 2, without payment of the fee set out in item 5.
Return to footnote 3This item applies only where a supplement to a new drug submission does not require the filing of a submission component set out in any of items 1 to 5.
Return to footnote 4A medicinal ingredient that has been evaluated in another submission to which reference is made is not required to be evaluated.
Return to footnote 5This item applies only where a supplement to a new drug submission does not include any of the submission components set out in items 1 to 8.
PART IIIAbbreviated New Drug Submission and Supplement to an Abbreviated New Drug Submission
| Column I | Column II | |
|---|---|---|
| Item | Submission Component | Fee |
| 1 | Comparative (bioavailability, pharmacodynamic or clinical) data to support a single route of administration and dosage form | $17,200 |
| 2 | Information and material to support the removal of a drug from Schedule F to the Food and Drug Regulations | 17,200 |
| 3 | Comparative (bioavailability, pharmacodynamic or clinical) data required to support each additional strength | 2,700 |
| 4 | Published clinical references or other published dataFootnote for 1 | 2,200 |
| 5 | Chemistry and manufacturing data for the medicinal ingredient of a drugFootnote for 2 | 11,500 |
| 6 | Chemistry and manufacturing data to support a single dosage form | 15,300 |
| 7 | Documentation to supportFootnote for 3 (a) a change of manufacturer, in the case of an abbreviated new drug submission; or (b) a change to the name of a manufacturer or the brand name of a drug, in the case of a supplement to an abbreviated new drug submission | 250 |
Return to footnote 1This item applies only where an abbreviated new drug submission or a supplement to an abbreviated new drug submission does not require the filing of a submission component set out in any of items 1 to 3.
Return to footnote 2A medicinal ingredient that has been evaluated in another submission to which reference is made is not required to be evaluated.
Return to footnote 3This item applies only where an abbreviated new drug submission or a supplement to an abbreviated new drug submission does not include any of the submission components set out in items 1 to 6.
PART IVDIN and GP
| Column I | Column II | |
|---|---|---|
| Item | Submission Component | Fee |
| 1 | Clinical data without preclinical data, or clinical data with supplementary or confirmatory preclinical data, to support a single route of administration, dosage form or condition of use | $52,900 |
| 2 | Comparative (bioavailability, pharmacodynamic or clinical) data to support a single route of administration or dosage form | 17,200 |
| 3 | Published references to support a traditional herbal medicine | 720 |
| 4 | Published clinical references or other published dataFootnote for 1 | 2,200 |
| 5 | Information establishing that a drug meets the requirements of a class monograph | 310 |
| 6 | Chemistry and manufacturing data | 1,500 |
| 7 | Information to support an application for a DIN or GP numberFootnote for 2 | 720 |
| 8 | Documentation to support a change of manufacturer, a change to the name of a manufacturer or a change to the brand name of a drugFootnote for 3 | 250 |
Return to footnote 1This item applies only where an application for a DIN does not require the filing of a submission component set out in item 1 or 2.
Return to footnote 2This item applies only where an application for a DIN or GP number does not require the filing of a submission component set out in any of items 1 to 5.
Return to footnote 3This item applies only where an application for a DIN or GP number does not include any of the submission components set out in items 1 to 7.
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