Salix Sciences

By Sharan Sidhu, 21 JAN 2025.

I still remember the first time I heard about the concept of cost recovery for Natural Health Products (NHPs) in Canada. It was during a regulatory session at the CHFA conference and trade show in 2013. At the time, the idea seemed like a distant possibility, one that many of us hoped would remain theoretical. Fast forward over a decade, and that once-bleak concept is on the verge of becoming a reality unless political intervention or lobbying efforts, like the “Save Our Supplements” campaign, can turn the tide.

So, what is cost recovery, and why is it being proposed? In essence, it’s a proposed mechanism to recoup a portion of the costs associated with regulatory activities while supporting improvements to the program itself. Now in another iteration, Health Canada’s proposed cost recovery framework for NHPs has been further refined. Here’s an overview of what the framework entails:

The Proposed NHP Fee Structure

The cost recovery program introduces fees under three main categories:

1. Pre-Market Evaluation (EVAL): A fee will be charged for submitting new NHP applications or amendments to existing products.

2. Site Licences (SL): Fees will apply to assess new site licence applications or amendments, and annual site licence fees will apply based on activities.

3. Right to Sell (RTS): An annual fee will grant companies the exclusive right to sell their NHPs in Canada.

Support for Small Businesses

The concept of cost recovery is more significant for small businesses, especially given the current economic climate and rising operational costs. Health Canada has introduced a small business discount program for businesses with fewer than 100 employees or with an annual revenue between $30,000 and $5 million CAD. This initiative offers a 100% discount on pre-market evaluation fees for a business’s first-ever NHP submission, a 50% discount on pre-market evaluation fees for all subsequent product submissions, and a 25% discount on site licensing fees and the annual right-to-sell fee. These measures are designed to ease the financial burden on small businesses and support their continued success in the industry.

Looking Ahead

As the proposed cost recovery program inches closer to implementation, it’s clear that the landscape for Natural Health Products in Canada is shifting. Whether this framework will strike the right balance between ensuring regulatory sustainability and supporting industry growth remains to be seen.

In the meantime, if your organization is seeking a risk-free assessment of market entry, including product category, fees, and timelines, Salix Sciences is offering a complimentary evaluation. Learn more at (https://www.linkedin.com/feed/update/urn:li:activity:7284977561762254849/)

The Fee Summaries

Table 1: FEE SCHEDULE FOR PRE-MARKET EVALUATION OF NHPS WITHOUT SMALL BUSINESS DISCOUNT

		YEAR & DATE
		Year 1	Year 2	Year 3	Year 4	Year 5	Year 6	Year 7
	Application / Amendment Class	01 DEC 2025 – 31 MAR 2027	01 APR 2027 – 31 MAR 2028	01 APR 2028 – 31 MAR 2029	01 APR 2029 – 31 MAR 2030	01 APR 2030 – 31 MAR 2031	01 APR 2030 – 31 MAR 2032	01 APR 2032 – 31 MAR 2033
Pre-market evaluation	Class I	$128	$157	$177	$196	$236	$265	$294
	Class II	$513	$631	$710	$788	$946	$1,064	$1,182
	Class III	$1,799	$2,214	$2,491	$2,768	$3,321	$3,736	$4,151
Right to sell	NHP RTS	$154	$189	$213	$237	$254	$285	$317

Table 2: FEE SCHEDULE FOR PRE-MARKET EVALUATION OF NHPS WITH THE SMALL BUSINESS DISCOUNT

		YEAR & DATE
		Year 1	Year 2	Year 3	Year 4	Year 5	Year 6	Year 7
	Application / Amendment Class	01 DEC 2025 – 31 MAR 2027	01 APR 2027 – 31 MAR 2028	01 APR 2028 – 31 MAR 2029	01 APR 2029 – 31 MAR 2030	01 APR 2030 – 31 MAR 2031	01 APR 2030 – 31 MAR 2032	01 APR 2032 – 31 MAR 2033
Pre-market evaluation	Class I	$64	$79	$89	$98	$118	$133	$147
	Class II	$257	$316	$355	$394	$473	$532	$591
	Class III	$900	$1,107	$1,246	$1,384	$1,661	$1,868	$2,076
Right to sell	NHP RTS	$116	$142	$160	$178	$191	$214	$238

Table 3: FEE SCHEDULE FOR SITE LICENSING WITHOUT THE SMALL BUSINESS DISCOUNT

		YEAR & DATE
		Year 1	Year 2	Year 3	Year 4	Year 5	Year 6	Year 7
	Fee Category	01 DEC 2025 – 31 MAR 2027	01 APR 2027 – 31 MAR 2028	01 APR 2028 – 31 MAR 2029	01 APR 2029 – 31 MAR 2030	01 APR 2030 – 31 MAR 2031	01 APR 2030 – 31 MAR 2032	01 APR 2032 – 31 MAR 2033
Site Licensing	Application / Amendments	$1,147	$1,412	$1,588	$1,765	$1,882	$2,117	$2,353
Annual Fees	Manufacturing	$4,661	$5,737	$6,454	$7,171	$7,649	$8,605	$9,561
	Importation	$3,995	$4,917	$5,531	$6,146	$6,555	$7,375	$8,194
	Packaging & Labelling	$1,448	$1,782	$2,005	$2,227	$2,376	$2,673	$2,970

Table 4: FEE SCHEDULE FOR SITE LICENSING WITH THE SMALL BUSINESS DISCOUNT

		YEAR & DATE
		Year 1	Year 2	Year 3	Year 4	Year 5	Year 6	Year 7
	Fee Category	01 DEC 2025 – 31 MAR 2027	01 APR 2027 – 31 MAR 2028	01 APR 2028 – 31 MAR 2029	01 APR 2029 – 31 MAR 2030	01 APR 2030 – 31 MAR 2031	01 APR 2030 – 31 MAR 2032	01 APR 2032 – 31 MAR 2033
Site Licensing	Application/ Amendments	$860	$1,059	$1,191	$1,324	$1,412	$1,588	$1,765
Annual Fees	Manufacturing	$3,496	$4,303	$4,841	$5,378	$5,737	$6,454	$7,171
	Importation	$2,996	$3,688	$4,148	$4,610	$4,916	$5,531	$6,146
	Packaging & Labelling	$1,086	$1,337	$1,504	$1,670	$1,782	$2,005	$2,228

The industry’s collective voice will be crucial in shaping the final outcome. Campaigns like “Save Our Supplements” are a testament to the power of advocacy and the importance of standing up for the future of natural health products in Canada.