Natural Health Products in Canada and the Natural and Non-prescription Health Products Directorate

Did you know that 73% of Canadians regularly take natural health products such as vitamins and minerals, herbal products and homeopathic medicines in their daily lives?

The Natural Health Products Directorate (NHPD) has recently changed its name to the Natural and Non-Prescription Health Products Directorate (NNHPD) since they have expanded their oversight into non-prescription and disinfectant drugs.  On May 6, 2016, NNHPD will be relocating their offices.  It is important that all submissions and inquiries are directed to their new mailing and email addresses as this department will not be responsible for packages sent to its former address.

What are Natural Health Products?

According to the Natural Health Products Regulations, which became effective in Canada on January 1, 2004, a Natural Health Product (NHP) is defined as “vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines, probiotics and other products such as amino acids and essential fatty acids”.  This classification of consumer products must be safe to use as an over the counter product and cannot require a prescription to be sold.

Health Canada’s Role:

Through the NNHPD, Health Canada assures that all Canadians have access to a wide range of these products that are safe, effective and high quality.  This agency assesses all natural health products and establishes Product and Site licenses before these products can be marketed in Canada.  There are several applications and submissions that are required to meet the requirements.  In order to receive these licenses, specific labeling and packaging requirements must be met, proper safety and efficacy evidence is required and good manufacturing practices must be followed.  They will check that NHPs are properly manufactured, meaning without contamination or incorrect ingredients, along with post-market monitoring to make sure that the NHP Regulations are being continuously followed.

Lastly, Health Canada sets out requirements and regulations associated with the Clinical trials that are conducted on these products.  The purpose of testing using human subjects is to discover, or the more likely case, verify a product’s effects.  They might also be conducted to study any adverse events that could be related to its use in order to support the safety of the product and its quality.

It is important for companies to have a trusted consulting firm with extensive knowledge about Natural Health Products to properly receive licensing and approval from Health Canada.  Focal Point Research are experienced Natural Health Product Regulatory Consultants in Canada.  FPR can help you avoid any roadblocks while getting your Natural Health Products into the Canadian market.