Natural Health Product (NHP) Regulations Canada
In Canada, Natural Health Products (NHPs) are products such as vitamins and minerals, probiotics and traditional medicines. Products must be safe to use over-the-counter to be classified as NHPs. These products must be assessed by Health Canada and a license must be granted before they can be sold along with the NPN health Canada number.
- Accurate Label Review
- Fast Turnaround
- 10 years of experience
Natural Health Supplements NPN Health Canada process
The Canadian Food Inspection Agency enforces these regulations. Failure to meet safety and quality standards, or failure to correctly label food and beverage products will mean that these products cannot be sold in the Canadian market and could lead to legal action. NPN health Canada license number is mandatory
NHP Product Classification
Natural and Non-prescription Health Products in Canada have 3 classes, class I, II and III. Class I products means that the product active ingredient is present in the Health Canada monograph and considered safe. Class II the product can have some ingredients safe present in the monograph but also some active not present, therefore class II requires more documentations. Class III means that the product have active ingredients that are not present in any Health Canada monograph therefore a more comprehensive study and information are necessary to prepare the applications for Health Canada safety evaluation and approval. Cosmereg can assist in the product classification free of charge to determine the product classification and provide the correct pathway.
NPN Health Canada Product Licensing
Health Canada required Natural Health Products to be assessed before they can be sold in Canada. The aim of the assessment is to determine if the product is safe, effective and of a high quality. Once this has been determined, the product is issued a license to be sold. Cosmereg can assist in the submission of licensing requests for Natural Health Products for the three classes I, II and III.
Health Claim Substantiation & Product Development
Health Canada requires evidence that Natural Health Products are ‘effective’ before licenses can be issued for their sale in Canada. Cosmereg can assist in health claim substantiation by conducting a review of both published and unpublished information, to ensure that we access any information that exists to support your claim. This step is performed after obtaining the product license from Health Canada.
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FAQ
According to the Natural Health Product Regulations (2004), ‘Natural Health Products’ (NHPs) are products that are safe to use without a prescription and fall into one of the following categories:
- Vitamins and Minerals
- Herbal Remedies
- Homeopathic Medicines
- Traditional Medicines (i.e. Chinese Herbal Medicine)
- Probiotics
- Other natural products such as essential fatty acids.
In order to be sold in Canada, all ‘Natural Health Products’ must have a license along with the NPN health Canada number. Manufacturers must provide a lot of information about each product to Health Canada for assessment. Once a product has been assessed and has been found to be high-quality, safe and effective, Health Canada issues a license, which is accompanied by an 8-digit ‘Natural Product Number’ (NPN) or, in the case of homeopathic medicine, a Homeopathic Medicine Number (DIN-HM). These numbers must appear on the label.
WE OFFER OTHER CANADA SERVICES
COSMEREG CAN ASSIST YOU WITH ALL OF CANADIAN’S COSMETIC REGULATIONS AND REQUIREMENTS, WHETHER YOU’RE MANUFACTURING IN CANADA OR IMPORTING PRODUCTS INTO CANADA.
ANY FOOD OR BEVERAGE PRODUCTS SOLD IN CANADA MUST MEET HEALTH CANADA’S STANDARDS FOR SAFETY AND NUTRITIONAL QUALITY.
ALL MEDICAL DEVICES ARE REVIEWED BY HEALTH CANADA BEFORE AUTHORIZATION FOR THEIR SALE IN CANADA IS GRANTED.