Health Canada Proposes Cost Recovery Fees for Natural Health Products

Health Canada Proposes Cost Recovery Fees for Natural Health Products

May 15, 2023 By

On May 12, 2023, Health Canada alerted industry of a new proposal to introduce cost recovery fees for Natural Health Product (NHP) regulatory activities in Canada. The proposal, open for consultation until July 26, 2023, will introduce fees to the NHP industry which will be similar to those in place for the human drug, veterinary drug, and medical device industries.


Health Canada is the agency responsible for helping people (in Canada) maintain and improve their health. In order to do so, the agency executes regulated activities for product categories, including NHPs, by way of published Acts and Regulations such as the Natural Health Product Regulations (NHPR). Launching a product in Canada under the NHPR carries a cost associated with regulatory activities such as the time it takes to evaluate a new product application.


Health Canada’s position is that other regulated categories such as drugs and medical devices, have cost recovery programs, or fees, in place in order to help recoup the cost of regulated activities. Without them, Health Canada would rely on taxpayers to fund their programs. According to Health Canada, this proposal aims to introduce cost recovery fees for NHPs so that taxpayers will no longer bear the brunt of the cost of NHP regulation in Canada.


These proposed fees will apply to all manufacturers, packagers, labelers, and importers of NHPs in Canada.

NHPs include:

  • Vitamins and minerals
  • Herbal remedies
  • Homeopathic medicines
  • Traditional medicines like Chinese and Ayurvedic (East Indian) medicines
  • Probiotics
  • Other products like amino acids and essential fatty acids

What Are the Proposed Fees?

The proposed fees below are as per Health Canada’s “Fees and Fee Policy” page.

Fee line/category

Proposed fee amount (2025) ($ CAD)

Existing performance standard (calendar days)

Proposed performance standard (calendar days)

Pre-market evaluation (EVAL)
Class I application or amendment $1,124 60 60 to review application/amendment
Class II application or amendment $2,761 90 120 to review application/amendment
Class III application or amendment $7,209 210 210 to review application/amendment
Class III novel application $58,332 210 (if treated as a Class III) 300 to review application
Class III novel safety and efficacy amendment $23,333 210 (if treated as a Class III) 210 to review amendment
Class III novel quality amendment $8,750 210 (if treated as a Class III) 210 to review amendment
NHP site licences (SL)
SL applications or amendments $4,784 30 to 90 180 to review application/amendment
Annual SL – manufacturing – sterile dosage form $40,071 30 to 90 (for renewals) 90 to review licence renewal application or confirm licence information
Annual SL – manufacturing – non-sterile dosage form $23,071
Annual SL – importation $20,035
Annual SL – packaging $7,650
Annual SL – labelling $6,921
NHP right to sell (RTS)
NHP RTS (per NPN or DIN-HM) $542 N/A 60 to update licensed NHP database

What Does This Mean for Industry?

Should Health Canada move forward with the proposal, it will place a significant monetary burden on all businesses involved with NHPs, especially entrepreneurs, despite mitigations proposed to lessen the impact on small businesses. Health Canada hopes to start charging these fees by April 1, 2025. If you are planning to launch new Natural Health Products in Canada, we suggest you file your product and/or site licence applications sooner rather than later to avoid the potential pending fees.

Open for Consultation

This proposal is open for consultation until August 10, 2023. We recommend anyone with a vested interest in Natural Health Products in Canada provide feedback and identify concerns about the fee proposals as soon as possible. You can do so here.

Additional Questions?

Contact dicentra today to learn more about these new fees and how they could impact your business.