Drug Establishment Licence: Fee Reduction Request

(September 11, 2009)

Contact Information: Establishment Licence Invoicing Unit

Important Notice for Fee Reduction Applicants

This is to clarify the requirements if you choose to apply for a fee reduction for Drug Establishment Licensing Fees and/or Controlled Drugs and Narcotic Fees. You must select one of the following two options:

Option A. Your company has been in business for a full fiscal year

You will need to submit the following two documents with your application for an establishment licence:

1. A Fee Reduction Application form.
   
   As outlined in the Establishment Licensing Fees Regulations, subsection 12(2), "An application for a fee reduction shall be submitted together with an application for an establishment licence".
   
   Applications for fee reductions that are not included with the establishment licence application will not be accepted.
   
   
2. A copy of your financial records.
   
   The type of financial records that will be accepted is a statement similar to what you file for income tax purposes showing the detail of the total Canadian revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form.
   
   Applications for fee reductions that are submitted without financial records will not be accepted.
   
   As outlined in the Establishment Licensing Fees Regulations, subsection 13(1), "The Minister of Health shall grant an application for a fee reduction if the total fee payable pursuant to subsection 12(1) is more than 1.5 per cent of the applicant's gross revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form, for the applicant's previous fiscal year, based on financial records provided by the applicant and prepared in accordance with generally accepted accounting principles".

or

Option B. Your company has been in business for less than a full fiscal year

You will need to submit a Fee Reduction Application form with your application for an establishment licence:

As outlined in the Establishment Licensing Fees Regulations, subsection 12(2), "An application for a fee reduction shall be submitted together with an application for an establishment licence".

Applications for fee reductions that are not included with the establishment licence application will not be accepted.

Within 90 days after the end of your first full fiscal year you must supply financial records prepared in accordance with generally accepted accounting principles.. The type of financial records that will be accepted is a statement similar to what you file for income tax purposes, showing the detail of the total Canadian revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form.

If you submit financial records after the 90 day period, the application for fee reduction will not be accepted.

As outlined in the Establishment Licensing Fees Regulations, subsection 13(1), "The Minister of Health shall grant an application for a fee reduction if the total fee payable pursuant to subsection 12(1) is more than 1.5 per cent of the applicant's gross revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form, for the applicant's previous fiscal year, based on financial records provided by the applicant and prepared in accordance with generally accepted accounting principles".

Please be advised, if the financial records submitted as per option A or B (above) are not sufficient then the following subsection of the Establishment Licensing Fees Regulations, 15(1), would apply; "If the Minister of Health determines that, on the basis of any information available to that Minister, the financial records provided in accordance with subsection 13(1) or 14(2) might not be adequate for the purpose of determining the gross revenue, the Minister may require the applicant to submit financial records that have been audited by a qualified independent auditor".

If you have any questions regarding these requirements please contact:

Dominika Boruk
telephone: 613-946-5141
fax: 613-957-6711
email: dominika_boruk@hc-sc.gc.ca

Original signed by
Dominika Boruk
Acting Manager, Establishment Licence Invoicing Unit

Fee Reduction Application

If you choose to apply for a fee reduction for Drug Establishment Licensing Fees and/or Controlled Drugs and Narcotic Fees you must complete the following (please print):

1. State your licence number (if known):

2. State your company name:

3. Name of authorized official:

4. Title of authorized official:

5. Phone and fax numbers of authorized official:

6. Has your company been in business for a full fiscal year?

If yes, go to question 7.

If no, go to question 13.

7. What is the start and end date of the last complete fiscal year of your company?

8. What is the total Canadian revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form from your last complete fiscal year?

9. Submit financial records to substantiate the figure listed in number 8.

Financial records, prepared in accordance with generally accepted accounting principles (Subsection 13(1) of the Establishment Licensing Fees Regulations), must be submitted with the application for fee reduction. The type of financial records that will be accepted is a statement similar to what you file for income tax purposes showing the detail of the total Canadian revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form.

Applications for fee reductions that are submitted without financial records will not be accepted.

If the Minister of Health determines that the financial records you have submitted are not adequate, the Minister may require the applicant to submit financial records that have been audited by a qualified independent auditor.

10. Sign the following attestation: I certify that the information given on this form and in any documents attached is correct, complete, and fully discloses the total Canadian revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form.

11. Do Not Send Any Payment at this Time

12. This application must be submitted with the application for or renewal of an establishment licence to:

Establishment Licence Invoicing Unit
Graham Spry Building, 2^nd Floor
PL 2002D
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9
or
Fax to : (613) 957-6711

Applications for fee reductions that are not included with the establishment licence application will not be accepted.

For Companies Who Have Been in Business for a Full Fiscal Year You May Stop Here.

13. What is the proposed start and end date of the fiscal year of your company?

14. Sign the following attestation: I certify that the information given on this form is correct and complete.

15. Within 90 days after the end of your first full fiscal year you must supply financial records prepared in accordance with generally accepted accounting principles to substantiate the total Canadian revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form from your last complete fiscal year, and fill in Questions 7 - 10 of this form.

The type of financial records that will be accepted is a statement similar to what you file for income tax purposes, showing the detail of the total Canadian revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form.

If you submit financial records after the 90 day period, the application for fee reduction will not be accepted.

If the Minister of Health determines that the financial records you will have submitted are not adequate, the Minister may require the applicant to submit financial records that have been audited by a qualified independent auditor.

16. Do Not Send Any Payment at this Time

17. This application must be submitted with the application for or renewal of an establishment licence to:
Establishment Licence Invoicing Unit
Graham Spry Building, 2^nd Floor
PL 2002D
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9
or
Fax to : (613) 957-6711

Applications for fee reductions that are not included with the establishment licence application will not be accepted.