Product Formulation and Review
Ensure your NHP’s ingredients comply with Health Canada’s NHP regulations. Regulatory experts can assist in analyzing your formulation for compliance.
A Natural Product Number (NPN) is a unique eight-digit identifier assigned by Health Canada to licensed Natural Health Products (NHPs). This number acts as the product’s official stamp of approval, indicating that it has met Health Canada’s rigorous safety, efficacy, and quality standards. Consumers can easily find the NPN on product labels, which fosters trust and confidence in their NHP choices.
An NPN is critical for several reasons:
An NPN is essential for anyone involved in the manufacturing, packaging, labeling, distributing, importing, or selling of Natural Health Products (NHPs) in Canada. Specifically:
Obtaining an NPN involves a structured process:
Ensure your NHP’s ingredients comply with Health Canada’s NHP regulations. Regulatory experts can assist in analyzing your formulation for compliance.
Prepare a comprehensive document detailing your NHP’s ingredients, labeling, and supporting scientific evidence.
Gather and compile robust scientific evidence to support your NHP’s safety and efficacy claims.
Develop product labeling and marketing materials that meet NPN requirements and accurately represent your NHP.
Submit the PLA and supporting documents to Health Canada for evaluation. The review timeframe can vary.
If your application meets all requirements, Health Canada will issue your NPN. They may also request additional information, requiring revisions and resubmission.
Maintain your NPN by adhering to post-licensing requirements, such as reporting adverse reactions and keeping product information updated.
Navigate the complex regulatory landscape with confidence and ensure your product’s safety and market readiness with GRAS Experts.
We’ve been doing this for over 18 years, with over 2,000 happy clients!
No time to waste! We help you get to the market quickly without compromising quality.
Every ingredient is unique, and so is our approach. We tailor our services to your specific needs.
Safety is our top priority. We make sure your ingredients meet all the requirements.
Avoid costly delays, fines and potential product recalls with our expert guidance.
Regulations can change. We’ll keep you compliant for the long haul.
Products categorized as natural health products (NHPs) require an NPN to be sold in Canada. These include:
Products outside these categories may require other forms of regulatory approval, such as food additive submissions for conventional foods. If you’re unsure about whether your product falls into one of these categories, GRAS Experts can help your product and guide you through the process.
Health Canada typically takes 3 to 6 months to review an NPN application, but this depends on the complexity of the product and the quality of the submission. Clear documentation and accurate data can speed up the process. GRAS Experts ensure your application meets all requirements for faster approvals.
Yes, safety data from other regulatory agencies like the FDA or EFSA can support your NPN submission. However, Health Canada may require additional studies or documentation specific to Canadian standards, such as bilingual labeling or detailed safety assessments. GRAS Experts can help tailor international data to meet Canadian requirements.
The NPN application process can be difficult due to the need for extensive safety data, clear health claims, and bilingual labeling that meets Canadian standards. Missing or incomplete information often delays approvals. GRAS Experts can help ensure your submission is comprehensive, avoiding these common obstacles.
NPN approval in Canada and FDA GRAS compliance in the U.S. serve different regulatory purposes. FDA GRAS compliance focuses on food ingredients that are “Generally Recognized as Safe” for specific uses, based on scientific evidence or a history of safe use. In contrast, NPN approval applies to natural health products in Canada and requires additional evidence of safety, efficacy, and quality. While certification of GRAS ingredients can support an NPN application, Health Canada’s standards often demand more detailed evaluations for approval.
Once Health Canada grants an NPN, the product must continue to meet post-licensing requirements. This includes monitoring for any adverse reactions, maintaining accurate product records, and updating Health Canada if there are changes to the product formulation or labeling. Ongoing compliance ensures your product remains legally approved for sale in Canada. GRAS Experts can help in maintaining compliance and managing any updates needed for your NPN.
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