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

As of April 1, 2020, Health Canada adopted 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.

On this page

• Available fee reduction
• Small business definition
• Determine your affiliate status
• Qualify for a free Pre-market Evaluation submission
• Steps to receive a small business fee reduction

Available fee reduction

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

• their first ever Pre-market Evaluation submission / application / notification for free
• 50% reduction for all Pre-market Evaluation fees
• 25% reduction for all Right to Sell fees
• 25% reduction for all Establishment Licence fees

Small business definition

A small business is any business including all of its affiliates that has:

• fewer than 100 employees or
• between $30,000 and $5 million (CAD) in annual gross revenues

Calculations of business size include employee totals and annual gross revenue from the entire business. This includes all employees and revenue regardless of geographic location (domestic and international) 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:

• are controlled by the sponsor's company whereby the sponsor's / manufacturer’s company holds 50% or more of the affiliate's votes or shares
• control the sponsor's / manufacturer’s company whereby the affiliate holds 50% or more of the sponsor's / manufacturer’s company's votes or shares
• share a parent company with the sponsor / manufacturer whereby they are controlled by the same company that controls the sponsor's /manufacturer’s company

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 submission for both its first Drug and its first Medical Device Pre-market Evaluation submission. Pre-market Evaluation submissions are filed before a drug or medical device is authorized for sale in Canada. Once a Pre-market Evaluation submission is filed Health Canada reviews the product to assess its safety, efficacy and quality and determine if it will receive authorization.

Please note that veterinary drug Pre-market Evaluation submissions include but are not limited to:

• Emergency Drug Release (EDR) applications
• Experimental Studies Certificate (ESC) applications
• Veterinary Health Product (VHP) notifications
• Protocol Reviews

Examples:

• If your company previously submitted a Medical Device Pre-market Evaluation submission, it still qualifies to have its first Human drug or Veterinary drug Pre-market Evaluation submission free.
• If your company previously submitted a Human drug Pre-market Evaluation submission, it does not qualify to have its first Veterinary drug Pre-market Evaluation submission free.

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:

• Companies that previously withdrew before acceptance into review and a Screening Deficiency Notice / Letter was not issued qualify for a free Pre-market Evaluation submission.
• Companies that previously withdrew before acceptance into review and a Screening Deficiency Notice / Letter was issued do not qualify for a free Pre-market Evaluation submission.
• Companies that previously withdrew or received a rejection after a decision is made to issue a Screening Acceptance Letter do not qualify for a free Pre-market Evaluation submission (Administrative and Labeling Standard submissions only).
• Companies that previously withdrew or received a rejection after a final review decision was made for Administrative or Labelling Standard submissions do not 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 before submitting your drug or medical device submission / application / notification.

After receiving your small business status, you must indicate on each fee form / application form / regulatory transaction (RT) template that you hold valid small business status.

To receive a free Pre-market Evaluation submission you must also indicate on your fee form / application form / regulatory transaction (RT) template 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 sbo-bpe@hc-sc.gc.ca.