Small business mitigation for drugs and medical devices: After you apply for small business status

On this page

• Receiving status confirmation
• Using your small business status
• Expiry of small business status
• Renewing your small business status
• Finishing your first fiscal year
• Additional assessment
• Fixing an application mistake

Receiving status confirmation

You’ll receive confirmation or rejection of your small business status immediately after submitting an application through the Drug and Medical Device Small Business Application portal. You’ll then be able to print your application results and a summary of your submitted information. You’ll also receive an electronic copy at the email address you provided.

Using your small business status

To receive small business fee reduction, you must wait at least 48 hours from when you receive small business status to when you submit a submission / application / notification.

You’ll need to indicate that you have a valid small business status on each fee form, application form or regulatory transaction (RT) template.

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

Your small business status must be valid at the time you submit your submission / application / notification.

Expiry of small business status

Your small business status is valid for 12 months following receipt of status. We will send you a reminder that your status is about to expire when you are nearing the end of your 12 months.

Renewing your small business status

If your company still qualifies under the small business definition, you’ll be able to renew your small business status up to 3 months before your status expires.

To renew your small business status, follow the same process you used when you first applied. You’ll be able to reuse your secure web portal account and activation code.

You will be invoiced the full fee if you do not renew your expired small business status before filing a submission / application / notification.

No longer qualifying for small business status

If your company no longer qualifies for small business status at the time of renewal, no action is required. Your small business status will automatically expire on completion of the 12-month period.

Finishing your first fiscal year

Companies that have not yet completed their first fiscal year will use a projection for their annual gross revenue and current employee total on their small business application.

After completing your first fiscal year, Health Canada will follow up with you and will request additional information to verify your small business status. This may include (but is not limited to) asking for:

• confirmation of your final annual gross revenue and employee total
• records that identify the number of persons employed for the previous fiscal year
• financial statements
• tax returns
• corporate and/or management organization charts
• other official documents issued or certified by a business registration authority

If Health Canada finds that your company did not meet the small business definition, it will notify your company and issue an additional invoice(s) for the difference between the full fee payable and the original invoice(s).

Additional assessment

At any point in time, Health Canada may request further information to verify your small business status. You are required to provide the additional information and documentation within 60 calendar days of the request.

Requested documentation may include (but is not limited to):

• records that identify the number of persons employed for the previous fiscal year
• financial statements
• tax returns
• corporate and/or management organization charts
• other official documents issued or certified by a business registration authority

Health Canada will notify you of the results following assessment. If Health Canada finds your company ineligible, it will issue an additional invoice(s) for the difference between the full fee payable and the original invoice(s).

Fixing an application mistake

If you have noticed a mistake in your application after submitting and receiving status, please contact the Small Business Office at sbo-bpe@hc-sc.gc.ca.

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.