Small business mitigation for drugs and medical devices: Small business fee reduction measures

As of April 1, 2020, Health Canada will adopt measures for small business fee reductions for human and veterinary drugs and medical devices. To receive a fee reduction you must first apply for and receive small business status for each unique identifier. You will be invoiced the full fee if you do not apply for and receive small business status before submitting your submission / application / notification.

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Available fee reduction

As of April 1, 2020, qualifying small businesses will receive a:

Small business definition

A small business is any business that has:

Calculations of business size include employee totals and annual gross revenue from the entire business. This includes all of its affiliates, regardless of geographic location or product line.

Small business fee reduction is available to both domestic and international companies.

Determine your affiliate status

We define an affiliated company as those that:

For further clarification and official definitions, please review the Fees in Respect of Drugs and Medical Devices Order.

Qualify for a free Pre-market Evaluation submission

Your small business may qualify to receive a free Pre-market Evaluation submission for both its first Drug and its first Medical Device submission.

Veterinary drug Pre-market Evaluation submissions include but are not limited to:

Examples:

If you previously filed with Health Canada and withdrew or received a rejection, please review the following situations to see if you still qualify for a free Pre-market Evaluation submission:

Steps to receive a small business fee reduction

You must apply and be granted small business status first, before submitting your drug or medical device submission / application / notification.

After receiving your small business status you must indicate on each fee form that you hold valid small business status.

To receive a free Pre-market Evaluation submission you must also indicate on your fee form that it is your first submission / application / notification with Health Canada.

More information

If you have questions about our drugs and medical devices small business fee reduction measures, you can reach us at the Small Business Office at hc.sbo-bpe.sc@canada.ca.

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