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Natural Health Product Regulations in Canada: What You Need to Know

Oct 22, 2023
1 min read

Updated: Sep 9


Canada's Natural Health Products Regulations (NHPR) govern everything from vitamins to herbal remedies. If you manufacture, package, label, import, or distribute NHPs in Canada, here's the compliance picture you need to understand.

What Falls Under the NHP Regulations?

The regulations cover vitamins, minerals, herbal remedies, homeopathic medicines, probiotics, and traditional medicines sold as health products. If a product makes a health claim and fits this category, it's regulated as an NHP rather than a food, cosmetic, or drug.

Two Layers of Compliance

NHP compliance operates on two levels: the product itself must be licensed (earning an NPN), and the sites that manufacture, package, label, or import the product must hold a Site Licence. Missing either one means you can't legally sell.

Product Licensing

Every NHP needs a Natural Product Number (NPN) before sale, confirming Health Canada has reviewed it for safety, efficacy, and quality. See our dedicated NPN application guide for the full process.

Site Licensing

A Site Licence demonstrates that your facility follows Good Manufacturing Practices (GMP) — covering premises, equipment, personnel, sanitation, and quality control. Health Canada can inspect licensed sites, so documentation needs to reflect what actually happens on the floor, not a generic template.

Ongoing Obligations

Compliance doesn't end at licensing. You're required to maintain adverse reaction reporting procedures, keep distribution records, and update your license if the product formulation or claims change.

How TheMedNerds Helps

We support NHP companies through both product and site licensing, and build the GMP documentation Health Canada expects to see. Book a free consultation to review where your business stands.

 
 

At The MedNerds, we are committed to providing exceptional services to support your business. Our expertise in regulatory compliance and quality assurance will give you the confidence to navigate the complex landscape of the healthcare industry. Get in touch with us today to learn more about how we can help you.

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