Health Canada Proposes Fees For Natural Health Products

Earlier this year, Health Canada published a proposal relating to a cost-recovery regime for natural health products (NHPs).  Health Canada proposes to start charging fees for NHP regulatory activities on April 1, 2025.

Pursuant to the Natural Health Product Regulations, NHPs must have a product licence to be legally sold in Canada, and Canadian sites that manufacture, package, label, and import NHPs must have a site licence.  Currently, there are no fees associated with NHP product or site licences.

Health Canada’s proposal outlines three categories of fees:

• Pre-market Evaluation: A fee is proposed for all new NHP applications or applications to amend existing products, which ranges from $1,124 to $58,332, depending on the type of application.
• Site Licence: This category includes a proposed fee of $4,784 for new site licence applications or amendments, and an annual site licence fee for each facility that manufactures, imports, labels and/or packages NHPs.  The proposed annual fees range from $6,921 to $40,071 depending on the type of activity conducted.
• Right to Sell: Health Canada proposes to charge an annual fee of $542 per Natural Product Number.

Health Canada is proposing a fee reduction for small businesses, which is defined as a company, including its affiliates, that has fewer than 100 employees, or between $30,000 and $5 million in annual revenue.  According to the proposal, small businesses would be eligible for the following fee reductions:

• 100% for pre-market evaluation fees for the business's first-ever NHP submission;
• 50% for pre-market evaluation fees for all subsequent NHP submissions; and
• 25% for site licence fees and the annual right to sell fee.

For more information on Health Canada’s proposal and the specific fees, please see here.

Summary By: Michelle Noonan