The implementation date for cost recovery on Natural Health Products (NHPs) is fast approaching. Starting December 1, 2025, registration fees will apply. To avoid these new costs, we strongly recommend submitting your product applications as soon as possible.
On May 12, 2023, the Non-Prescription and Natural Health Product Directorate (NNHPD) initiated a consultation regarding proposed fees for NHPs. This consultation garnered a substantial response, with over 4696 comments from individuals all across industry, predominantly expressing dissatisfaction with the new fees and timelines for implementation. In response, the NNHPD has unveiled a revised proposal on March 27, 2024. Below is an overview of the key revisions proposed:
- Phased Implementation: Rather than enforcing the fees by December 2025 as initially intended, a more gradual approach is proposed, spanning a seven-year period with gradual annual increases until 2033.
- Elimination of “Class III – Novel”: The proposed creation of a new NHP class, termed “Class III – Novel,” has been removed.
- Streamlined Fee Categories: The number of annual site licensing fee categories is being trimmed down from five to three, streamlining the fee structure.
Despite vocal concerns from industry stakeholders regarding the adverse effects these fees may inflict on small businesses, no adjustments have been made to the initial proposal regarding fee relief for companies with fewer than 100 employees and an annual revenue falling between $30,000 to $5 million CAD:
- A 100% discount on pre-market evaluation fees for the business’s inaugural NHP submission.
- Subsequent product submissions will include a 50% discount on pre-market evaluation fees.
- A 25% discount on site licensing fees and the annual right to sell fee.
It is clear NNHPD did take the feedback from industry and lowered the fees significantly to address the initial concerns. For instance, Site License (SL) renewals which initially cost up to $40,000, have now been lowered to $9,561 at the culmination of the seven-year period, applicable to both sterile and non-sterile settings. Additionally, the annual Right to Sell (RTS) fee has been reduced from $542 to $317, with a further reduction for small businesses, bringing their fee down to $238. For a comprehensive breakdown of the newly proposed fees, industry is encouraged to continue to provide feedback and review the new consultation published here “Revisions to Proposed Fees for Natural Health Products.”
The consultation on cost recovery for Natural Health Products (NHPs) closed to public feedback on April 25, 2024, and the industry is still awaiting an update from the NNHPD. If you want to avoid paying application fees, be sure to submit your product application before December 2025 to ensure you’re not subject to cost recovery.
Contact Dell Tech today for assistance on NHP licence applications, quality assurance, and more.
DELL TECH HAS PROVIDED PROFESSIONAL, CONFIDENTIAL CONSULTING SERVICES TO THE SPECIALTY CHEMICAL INDUSTRY IN CANADA, THE USA, EUROPE AND ASIA FOR THE LAST 40 YEARS.
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