Fees in respect of drugs and medical devices

The Fees in Respect of Drugs and Medical Devices Order came into effect on April 1, 2020. They were revised in March 2021 to reflect a new remission provision for COVID-19 drugs that transition to the Food and Drug Regulations and in February 2022 to exclude rolling submissions for COVID-19 drugs from penalties for missed standards. They were also amended in February 2023 to reflect changes to the fee categories to include amendments to COVID-19 medical device authorizations.

Please find links to the updated human and veterinary drug and medical device fees as well as the relevant guidance documents below.

Notice of fees effective April 1, 2024 (New)

As per section 4.1 of the Fees in Respect of Drugs and Medical Devices Order, every fee outlined by the Order is to be increased annually by the Consumer Price Index (CPI). Most fees under the Order are also currently being rolled out over 4 to 7 years. The notice of updated fees as of April 1, 2024 is published in the Canada Gazette, Part I. Fees as of April 1, 2024 can be accessed through the fee webpages linked in the above section.

Also effective April 1, 2024, user fees for Drug Master Files, Certificate of Pharmaceutical Product, Certificate of Supplemental Protection and Human Drug Dealer's Licence will be updated by 2%. Veterinary Drug Dealer's Licence fees will be updated by CPI. Fees as of April 1, 2024, have been posted in the Canada Gazette, Part I and on Health Canada's fee webpages.

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