Guidance document: Fees for reviewing applications for dealer’s licences for controlled drugs and substances (veterinary use only)
On this page
- About this guidance document
- Purpose
- Fees
- Fee remission
- Fee payments
- Credits for missed performance standards
- Overpayment
- Certified statement of revenue
About this guidance document
Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.
This guidance document is an administrative, not a legal, instrument. It clarifies how the Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations (regulations) apply and how to comply with the associated requirements.
As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help the department administer fees associated with providing regulatory oversight of activities related to dealer's licences (veterinary use). We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.
Purpose
This guidance document will help applicants and veterinary dealer licence holders meet the regulatory requirements of the regulations. Where there are discrepancies between this document and the regulations, the regulations take precedence.
This document gives details on the timing of fee payment, exemptions and credit for missed performance standards.
Fees
Fees for a dealer's licence apply to each site where the licensed activities are conducted.
Exemptions to the fees
The regulations do not apply to the following:
- a branch or agency of the Government of Canada
- provincial or territorial governments
- individuals and organizations conducting only scientific research
The associated fees for a dealer's licence also do not apply.
The applicant must indicate they are exempt on section 6 of their application for issuing or renewing their licence.
First-year fee amount
The fee for a dealer's licence or its renewal during the first calendar year (January to December) of operations is half of the full fee in a given year.
Annual adjustment of fees
The fee for a dealer's licence for veterinary use is adjusted annually by an amount equivalent to the change in the Consumer Price Index from the previous year. An annual adjustment is necessary to ensure that the fees are keeping pace with inflation.
Each fall, Health Canada publishes a notice of intent in the Canada Gazette that outlines the fee rates as of April 1 of the upcoming fiscal year.
Fee remission
Eligibility and amount
We may grant a fee remission if the fee payable is greater than 1.5% of a licensed dealer's actual gross revenue from licensable activities in the previous calendar year. Revenue from licensable activities includes revenue from selling, testing, packaging and labelling controlled drugs or narcotics.
If a fee remission is granted, the total amount of the fee payable will equal 1.5% of the annual gross revenue. For example, if the company's gross revenue from activities conducted under the licence is $10,000, 1.5% of that amount is $150. The fee payable would be $150.
Conditions for remission
To obtain a fee remission, the licence holder must submit a Certified Statement of Revenue form.
Licensed dealers in their first calendar year of conducting activities under a dealer's licence:
- submit the Certified Statement of Revenue form provided by the Cost Recovery Invoicing Unit by email to criu-ufrc@hc-sc.gc.ca within 30 days after the end of that calendar year
Licensed dealers who are not in their first calendar year of conducting activities under a dealer's licence:
- submit the Certified Statement of Revenue form, provided upon request by the Cost Recovery Invoicing Unit, by email to hc.cds-sdc.sc@canada.ca with their application to renew their licence
For more information about this process, email us at criu-ufrc@hc-sc.gc.ca.
Exceptions to remission
Applicants for a dealer's licence (veterinary use only) are not entitled to a fee remission if they also require:
- a drug establishment licence in order to conduct an activity referred to in their application
Request for additional information
We will ask for additional information if the statement of revenue that is provided is not sufficient to determine the dealer's actual gross revenue. This is outlined in the regulations.
Depending on the circumstances, we may ask for:
- tax returns
- financial statements
- employment records
- other official documents
In extraordinary cases, we may ask for audited sales records.
Health Canada will not grant a remission if:
- the information we asked for is not provided within 90 days of our request or
- the information that is provided cannot be used to determine the actual gross revenue
Fee payments
Fees are payable when you receive an invoice from us. We will send an invoice after a licence has been issued or renewed. Interest on overdue accounts will begin to accrue 30 days from the date of the invoice.
Deferred payment for first year of activities
Health Canada will defer fees for licences issued or renewed for licence holders who have not completed 1 full calendar year (January to December) of licensable activities.
When the deferral period is over, we will send an invoice, which will include the fee for the initial licence issuance plus any renewals processed during the deferral period. For example:
- If a new licence is issued in June 2022, the period from January to December 2023 is considered the first full calendar year of activities.
- The fee for all licences issued to that point (including the initial licence issuance and any renewed licences) will not be payable until we send an invoice after December 2023.
To receive a fee remission for the first calendar year of conducting activities, the licensed dealer must submit a Certified Statement of Revenue form in January following the end of their first full calendar year of activities. If we do not receive this Certified Statement of Revenue form by the end of January, we will send an invoice in February without applying a fee remission.
Credits for missed performance standards
If Health Canada does not issue or renew a licence within the established performance standard, we will reduce the amount payable by 25%.
The performance standard is:
- New applicants: 270 calendar days from when we receive a complete application
- Licence renewals: 90 calendar days
For more information on performance standards, consult:
Overpayment
Applicants or licence holders who make an overpayment on their account may submit a written request for a refund by emailing the Cost Recovery Invoicing Unit at criu-ufrc@hc-sc.gc.ca.
Certified statement of revenue
To apply for a fee remission, licence holders must submit a Certified Statement of Revenue form.
When to submit a Certified Statement of Revenue form
If you are eligible to pay a reduced fee (known as a "fee remission") for a controlled drugs and substances dealer's licence, you must complete and submit a Certified Statement of Revenue form to request a fee remission.
If you hold a dealer's licence (veterinary use only), you may be eligible for fee remission. This is based on a percentage of gross revenue generated from activities conducted under the licence during the last completed calendar year.
The fee payable may be reduced to 1.5% of the applicable revenue.
If the applicable revenue is greater than this percentage, you are not eligible for fee remission. You will need to pay the dealer's licence fee in full.
If you are applying for a new dealer's licence (veterinary use only), you do not need to pay the fee until you have completed your first calendar year (January 1 to December 31) of operations under a licence. The Certified Statement of Revenue form is not required before that period. We will send you a copy of the form when your deferred payment period ends.
How to complete a Certified Statement of Revenue form
Licence fee remission
- Your dealer's licence number is the number that represents your establishment licence. You can find this number on the licence.
- Last completed calendar year refers to the last full year (for instance, January 1 to December 31) of your company's operations under the licence. For example, if you submit an application anytime in 2022, your last completed calendar year is January 1, 2021, to December 31, 2021. (For applications related to the deferred payment period, Health Canada will pre-populate this information.)
- Actual gross revenue refers to the total revenues earned by your organization from the licensable activities that were conducted during the calendar year in which the dealer's licence was required.
Certification
- A senior official or designated person who is responsible for the company's finances must complete this section.
How to submit a Certified Statement of Revenue form
For new licence applications or for renewal applications during the payment deferral period, Health Canada will contact you when it is time to submit the Certified Statement of Revenue form (for instance, when the payment deferral period ends).
For renewal applications after the payment deferral period, you must submit a Certified Statement of Revenue form along with your dealer's licence renewal package.
We may ask you to provide additional information if we require further clarification.
Information included in the Certified Revenue Statement form
Licence fee remission
- Dealer's licence number:
- Actual gross revenue (in Canadian dollars): $
- Last completed calendar year: 20__/01/01 – 20__/12/31
Certification
I, the undersigned, being the person responsible for the applicant's financial affairs, certify the above information respecting the annual gross revenue generated from the activities conducted under the dealer's licence in the last completed calendar year to be true and correct.
- Company name:
- Date:
- Senior official's name:
- Senior official's title:
- Phone:
- Email:
- Senior official's signature:
Privacy notice
The personal information you provide to Health Canada is governed in accordance with the Privacy Act. We only collect the information we need to administer the Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations under the Financial Administration Act.
The information you provide will help you meet the requirements of a:
- veterinary-only use dealer's licence holders under section 4 (1) of the Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations
In limited and specific situations, your personal information may be disclosed without your consent in accordance with subsection 8(2) of the Privacy Act. This personal information collection is described in Info Source.
In addition to protecting your personal information, the Privacy Act gives you the right to request access to and correction of your personal information.
For more information about these rights or about our privacy practices, please contact:
Director, Privacy Management Division
Telephone: 613-946-3179
Email: privacy-vie.privee@hc-sc.gc.ca
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