2011 Drug Establishment Fee Remission Applicants in Respect to Veterinary Use Only (Letter and Form)

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This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.

Important Notice for Fee Remission Applicants in Respect to Veterinary Use Only

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 for Veterinary use only. You must select one of the following two options:

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

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

1. A Fee Form
2. A copy of your certified statement of revenue

   The type of certified statement of revenue that will be accepted is a statement signed by the individual responsible for the applicant's financial affairs that sets out the actual gross revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form from the previous calendar year. The statement can be a copy of the applicant's general ledger or sales logs from the general ledger. Where an applicant has audited financial records, this can be supplied to Health Canada in support of a request for fee remission.

3. Payment must be included with your application.

If payment is not received with your application, you will be invoiced and have up to 30 days to pay before interest is accrued.

Applications for fee remissions that are submitted without certified statement of revenue will not be accepted.

As outlined in the Establishment Licensing Fees Regulations, subsection 11(1), "Subject to subsection 13(2), if the total of the fees payable under sections 3 to 10 of these Regulations and the fee payable under section 3 of the Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations is greater than an amount equal to 1.5% of the applicant's actual gross revenue from the sale, testing and packaging/labelling of drugs, as well as controlled drugs and narcotics not in dosage form, for the previous calendar year, remission is granted of the difference between those amounts if the applicant provides, with their application for the annual review of their licence, a statement signed by the individual responsible for the applicant's financial affairs that sets out the actual gross revenue".

or

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

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

Within 90 days after the end of your first full calendar year you must supply certified statement of revenue prepared in accordance with generally accepted accounting principles. The type of certified statement of revenue that will be accepted is a statement signed by the individual responsible for the applicant's financial affairs that sets out the actual gross revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form from the previous calendar year. The statement can be a copy of the applicant's general ledger or sales logs from the general ledger. Where an applicant has audited financial records, this can be supplied to Health Canada in support of a request for fee remission.

If you submit a certified statement of revenue after the 90 day period, the application for fee remission will not be accepted.

As outlined in the Establishment Licensing Fees Regulations, subsection 11(1), "Subject to subsection 13(2), if the total of the fees payable under sections 3 to 10 of these Regulations and the fee payable under section 3 of the Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations is greater than an amount equal to 1.5% of the applicant's actual gross revenue from the sale, testing and packaging/labelling of drugs, as well as controlled drugs and narcotics not in dosage form, for the previous calendar year, remission is granted of the difference between those amounts if the applicant provides, with their application for the annual review of their licence, a statement signed by the individual responsible for the applicant's financial affairs that sets out the actual gross revenue".

Please be advised that if the certified statement of revenue submitted as per option A or B (above) is not sufficient then the following subsection of the Establishment Licensing Fees Regulations, 13(1), would apply: "If the Minister determines that, on the basis of any information available to the Minister, the statement provided under subsection 11(1) is not adequate to determine the actual gross revenue referred to in that subsection, the Minister may require, for the purpose of determining the fee payable or the amount of the remission, the applicant to provide sales 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: Fax 613-957-6711
Email: dominika_boruk@hc-sc.gc.ca

Original signed by
Dominika Boruk
Manager, Establishment Licence Invoicing Unit

Fee Form for Veterinary Use Only

If you choose to apply for a fee remission for Drug Establishment Licensing Fees and/or Controlled Drugs and Narcotic Fees for veterinary use only 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 calendar 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 calendar 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 certified statement of revenue to substantiate the figure listed in number 8.

   The type of certified statement of revenue that will be accepted is a statement signed by the individual responsible for the applicant's financial affairs that sets out the actual gross revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form from the previous calendar year. The statement can be a copy of the applicant's general ledger or sales logs from the general ledger. Where an applicant has audited financial records, this can be supplied to Health Canada in support of a request for fee remission.

   Applications for fee remissions that are submitted without certified statement of revenue 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. Please send 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, 2nd Floor
    PL 2002D
    250 Lanark Avenue
    Ottawa, Ontario
    K1A 0K9
    or
    Fax to: 613-957-6711

    Applications for fee remissions 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 calendar 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 certified statement of revenue 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 calendar year, and fill in Questions 7 - 10 of this form.

    The type of certified statement of revenue that will be accepted is a statement signed by the individual responsible for the applicant's financial affairs that sets out the actual gross revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form. The statement can be a copy of the applicant's general ledger or sales logs from the general ledger. Where an applicant has audited financial records, this can be supplied to Health Canada in support of a request for fee remission.

    If you submit certified statement of revenue after the 90 day period, the application for fee remission will NOT be accepted.

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

16. Do not send any payment at this time. Payment is due upon the expiry of the 90 day period.
17. This application must be submitted with the application for or renewal of an establishment licence to:

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

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