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.
The proposed fees below are as per Health Canada’s “Fees and Fee Policy” page.
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|
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.
This proposal is open for consultation until July 26, 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.
Contact dicentra today to learn more about these new fees and how they could impact your business.