Currently, there is no cost to register your license application. However, Health Canada will soon be introducing a cost recovery for your application submissions. This will happen once the new Self-Care Framework is in place.
Amendments are not yet required for licensed Class 1 products.
At the present time for any Class 1 product that has a product license indicating “as authorized in the NNHPD monograph(s) to which the applicant attested”, amendments are not required to be filed with the NNHPD for specific changes that still meet the monograph to which you attested. However, under the updated Management of Product License Application guide, you will be required to file these changes, and more importantly, the review times will align with the review times for submissions. Meaning certain changes that previously had no pre-approval time, will now take 60, 90 or 210 calendar days! (With the timeline dependent on the change being made)
Linda Beach is the founder, sole owner, and Director of Canadian Natural Health Product Registry (CNHPR), operating under Medical Botany Research. Based on Canada’s west coast, Linda has been providing regulatory consulting and compliance expertise to Canadian and international companies since 2004, when Canada’s Natural Health Products Regulations first came into effect.
A Certified Herbalist with a degree in Botany and Medical Research, Linda also holds certifications in several natural and complementary healing modalities. This combination of scientific training and hands-on herbal expertise gives her a unique perspective on the products she helps bring to market — from vitamins and herbal remedies to nutraceuticals, cosmeceuticals, and sports supplements.
Over her two decades working directly with Health Canada, Linda has built strong working relationships with regulators that have translated into consistent success in securing Natural Product Numbers (NPNs) for her clients. Her advocacy work has had industry-wide impact — including playing a key role in Health Canada’s decision to reinstate hempseed oil to its approved ingredient database after it had been removed, restoring a path to market for products containing the ingredient.
Through CNHPR, Linda guides clients through every stage of the licensing process: developing a tailored regulatory strategy, compiling required documentation, and managing submissions from signing through to Health Canada approval.