Health Canada has issued an important clarification regarding the proposed cost recovery framework for Natural Health Products (NHPs).
Although a revised fee proposal was published on March 27, 2024 — including a planned seven-year phase-in period and a target implementation date of December 1, 2025 — the fees have not been published in the Canada Gazette, Part II.
Under Canadian federal law, regulatory fees cannot be implemented unless formally published in Canada Gazette, Part II.
As of today:
No NPN application fee is in force
No NHP cost recovery will begin on December 1, 2025
NPN applications remain free
There is currently no government fee required to apply for an NPN.
In May 2023, Health Canada initiated public consultations on a proposed NHP cost recovery framework, including the introduction of an NPN application fee.
Following stakeholder feedback, a revised proposal was released in March 2024. The revised framework included phased implementation over seven years and confirmed that any official fees would require publication in Canada Gazette, Part II before coming into force.
Since this publication has not occurred, no new fees can legally be applied.
In September 2025, Health Canada and the Public Health Agency of Canada released their Red Tape Review report, outlining significant regulatory reforms.
Key initiatives include:
A simplified registration pathway for certain NHPs and Non-Prescription Drugs (NPDs)
Risk-based vigilance requirements
More flexible labelling regulations
Streamlined approval processes for NPDs
Health Canada has confirmed that implementing these reforms is its immediate priority. The NPN application fee proposal will only be reconsidered after these regulatory adjustments are completed.
These reforms will directly influence the future costing structure of the NHP program.
No NPN application fee will be charged in 2025
No NHP cost recovery framework is currently in force
A revised fee proposal is expected only after regulatory modernization is finalized
Stakeholder engagement will continue
Regulatory changes may ultimately result in more efficient submissions and reduced administrative burdens.
With no government application fees currently in place, this presents a strategic opportunity for companies planning to enter the Canadian NHP market.
Early application may help mitigate future regulatory and financial uncertainty.
We continue to monitor all updates from the Natural and Non-Prescription Health Products Directorate (NNHPD) and will provide timely guidance to support our clients’ regulatory planning and commercialization strategies.
For questions regarding NPN applications, site licences, or compliance planning, please contact our team.
Staying proactive is essential in an evolving regulatory environment.