Authority to Sell Veterinary Drugs Fees
Pursuant to Section C.01.014.5 of Food and Drug Regulations, every year Health Canada sends an Annual Drug Notification Form (ADNF) to the manufacturer of drugs that are approved for sale in Canada. The ADNF contains a list of those products that, according to Health Canada records, have been issued DINs and have not been discontinued by the manufacturer.
The completed ADNF with any requests for fee reduction should be submitted to Health Canada by mid-August. This allows sufficient time for fee reduction to be validated, updated, and reflected on the invoice which is issued October 1 for payment within 30 days.
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Fees are charged for the Authority to Sell Veterinary Drug in the upcoming year beginning October 1 and ending September 30 of the following year.
For all marketed products, which have been issued a DIN under subsection C.01.014.2(1) of the Food and Drug Regulations, the manufacturer must indicate on the ADNF if the product has not been sold on the Canadian market for a period of 12 consecutive months. This product is considered dormant.
Who is Eligible for a Fee Reduction?
A veterinary product qualifies for a reduced fee of $50.00 ($CDN) if its wholesale sales were less than $20,000 ($CDN) during the manufacturer’s previous fiscal year that was completed in the 12-month period before October 1st of the invoicing year. Since fees are charged at the beginning of the invoicing year, fee reductions are granted based on sales data of the manufacturer’s PREVIOUS fiscal year. Products for which the DIN has been discontinued are not eligible for a fee reduction as no fee is charged for cancelled DINs.
In order to be granted a fee reduction the manufacturer must provide, a completed Authority to Sell Veterinary Drugs Fee Reduction Request and Attestation Form, with their completed Annual Drug Notification Form. The form must be signed by an authorized officer of the manufacturer. Note that fee reductions will NOT be processed without this form.
It should be noted that a fee reduction will automatically be applied to all dormant DINs as these products have not been sold on the Canadian market for a period of 12 consecutive months. Manufacturers are not required to complete the Authority to Sell Veterinary Drugs Fee Reduction Request and Attestation Form for these products. These products will all be invoiced the reduced fee of $50.00 as part of the regular annual fees in October.
Manufacturers outside Canada must determine their eligibility by using their annual wholesale sales of the drug in Canada. Therefore, if the manufacturer sells the drug through more than one importer, in Canada, the reduction is based on the actual gross revenue that the manufacturer receives from the sales of all importers of the drug in Canada.
If any manufacturer does not return their ADNF, full fees will be charged for all of their marketed notified DINs in Canada. Also, any fee reduction request will not be accepted after invoices have been sent out.
Who is Responsible for Payment?
The manufacturer on record as holding the DIN when the invoice is issued is responsible for payment. The invoice and any subsequent monthly statements are prepared in the name of the manufacturer and are sent to the regulatory affairs section of the manufacturer or address identified as the billing address for the manufacturer on the returned ADNF.
If a new DIN has been assigned to a product in order to replace an existing notified product, but the previous DIN has not been discontinued by its manufacturer, the manufacturer of each DIN is held responsible for payment of an annual fee, whether or not the previous DIN is still available on the Canadian market. For example, where the ownership of a product has been transferred to another manufacturer and the new manufacturer has received a new DIN, an annual fee will be applied to both the old DIN and the new DIN if both are on Therapeutic Product Directorate’s records as being marketed.
When to Pay Fees?
Invoices for the annual fee for the authority to sell veterinary drug are sent on October 1 each year and must be paid within 30 days.
Do not send payment with the completed ADNF in August.
Where to Submit Annual Drug Notification Form?
Annual Drug Notification Form and Fee Reduction requests should be sent to the address/fax number/e-mail below:
By E-Mail: email@example.com
Resource Management and Operations Directorate
Office of Submissions and Intellectual Property
Finance Building, Address Locator 0201A1
101 Tunney’s Pasture Driveway
Ottawa, ON K1A 0K9
By Fax: (613) 954-3067
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