Small business mitigation for drugs and medical devices

• Small business status application form
• Fee forms or application forms
• Regulatory transaction (RT) templates
• Documentation confirming small business status

• The company must be classified as a small business with fewer than 100 employees OR between $30,000 and $5 million CAD in annual gross revenues.
• The company must apply for and receive small business status before submitting any drug or medical device application.
• Company size calculations include all employees and revenue from the entire business, regardless of geographic location.
• Both domestic and international companies are eligible for the small business fee reduction.

Who is eligible?

• Pharmaceutical companies (human drugs)
• Veterinary drug companies
• Medical device companies

Eligible expenses

• Pre-market Evaluation fees for human and veterinary drugs.
• Pre-market Evaluation fees for medical devices.
• Right to Sell fees.
• Establishment Licence fees.

Ineligible Costs and Activities

• Businesses that fail to obtain small business status before submitting their application or notification
• Companies that withdrew after receiving a Screening Deficiency Notice or after a Screening Acceptance Letter was issued
• Human drug companies seeking a free Veterinary drug pre-market evaluation (only the first human OR first veterinary submission is free, not both)
• Companies that previously withdrew or were rejected after a final review decision for Administrative or Labelling Standard submissions
• Businesses that do not meet the small business definition (100+ employees or outside $30,000–$5 million annual revenue range)

Eligible geographic areas

• Companies based in Canada (all provinces and territories).
• International companies (businesses located outside Canada).

• Step 1: Apply for small business status
  • You must apply for and receive small business status before submitting your drug or medical device submission, application, or notification.
  • Submit your application through Health Canada's small business status process for each unique identifier.
• Step 2: Indicate small business status on all fee forms
  • After receiving your small business status, you must indicate on each fee form, application form, or regulatory transaction (RT) template that you hold valid small business status.
  • This must be done for every submission to receive the fee reduction.
• Step 3: Request free Pre-market Evaluation if applicable
  • To receive a free Pre-market Evaluation submission, indicate on your fee form, application form, or RT template that it is your first submission, application, or notification with Health Canada.
  • You may qualify for a free first Pre-market Evaluation for both human drugs and medical devices.
• Step 4: Submit your application
  • Complete your drug or medical device submission, application, or notification with all required documentation.
  • Ensure all fee forms include your small business status indication and first submission notification if applicable.
  • Submit to Health Canada for review.

• Fee reductions apply to human drugs, veterinary drugs, and medical devices.
• You must obtain small business status before submitting your application; otherwise, you will be invoiced the full fee.
• You must indicate your small business status on each fee form, application form, or regulatory transaction template.
• Veterinary drug pre-market evaluation submissions include Emergency Drug Release applications, Experimental Studies Certificate applications, Veterinary Health Product notifications, and Protocol Reviews.