By: Joanna Chudyk, SENIOR REGULATORY AFFAIRS SPECIALIST, email
On May 12, 2023, the Non-Prescription and Natural Health Product Directorate (NNHPD) initiated a consultation regarding proposed fees for Natural Health Products (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 April 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 new round of consultation will remain open for public feedback until April 25, 2024. This extension provides stakeholders with another opportunity to voice their opinions and shape the final decision-making process.
Dell Tech has provided professional, confidential consulting services to the specialty chemical
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