Fees in Respect of Human Drugs and Medical Devices

New  Fees in Respect of Human Drugs and Medical Devices Regulations came into effect on April 1, 2011.

Please find links to the updated human drug and medical device fees below.

Drug Fees, Mitigation Measures, and Resources

• Pharmaceutical Submission and Application Review
• Biologic Submission and Application Review
• Drug Establishment Licence
• Drug Master Files
• Right to Sell Drugs

Medical Device Fees, Mitigation Measures, and Resources

• Medical Device Licence Application Review
• Medical Device Establishment Licence
• Right to Sell Licensed Class II, III or IV Medical Devices

For information regarding how updated fees have been developed for human drugs and medical devices, please refer to Health Canada's User Fees Proposal.

Notice of fees effective April 1, 2013 (New)

As per section 4 of the Fees in Respect of Drugs and Medical Devices Regulations, every fee outlined by the regulations is to be increased annually by 2%. For a listing of the updated fees as of April 1, 2013, please refer to the notice published in the  Canada Gazette, Part I.

Also effective April 1, 2013, user fees for Drug Master Files and Certificate of a Pharmaceutical Product, two non-regulatory user fees, will be updated by 2% as per the notice posted in the  Canada Gazette, Part I.