General information about natural health products
What are natural health products?
Natural health products (NHP) are defined as traditional medicines, homeopathic medicines, vitamins and minerals, probiotics and other products like amino acids and essential fatty acids.
How is the sale of natural health products regulated?
In Canada, the sale of non-prescription natural health products is regulated by the Natural Health Products Regulations associated with the federal Food and Drugs Act. These regulations came into effect on January 1, 2004, after a series of consultations with stakeholders and the Canadian public to draft an appropriate regulatory framework for natural health products in Canada.
What is a NPN?
Since January 1, 2010, natural health products with a Drug Identification Number (DIN) were gradually given a Natural Product Number (NPN). The NPN on the label is an indication that the product has been examined by Health Canada with regard to safety, quality and health claims. In the case of homeopathic medicines, the label features a DIN-HM.
Are natural health products that now have an NPN still covered by the Public Prescription Drug Insurance Plan and in institutions?
Following recommendations drafted by INESSS, products that were already registered under a generic name that has had its DIN replaced by a NPN may remain on the lists of medications.
How does INESSS evaluate registration applications for these types of products?
INESSS will begin by evaluating the generic names of already registered natural health products for registration, including those presented in the form of various salts. The evaluation process for a natural health product that meets established requirements is the same as that for drugs with a DIN.
Do manufacturers have to provide a proof of bioequivalence when a new version of an already registered drug is submitted for inclusion on the lists of medications?
Manufacturers of natural health products do not have to provide a proof of bioequivalence, because Health Canada grants a product licence without this proof.