All natural health products (NHPs) manufactured, distributed, imported or sold in Canada require a product license before marketing.
To date, Diversified Nutrition Lifestyle (DNL Labs) has obtained over 300 product licenses with a 98% success rate for application approval. To compare, the current approval rate for a submission to Health Canada is less than 46%, which means one out of every two submissions is refused for inadequacy of data or poor submission preparation.
DNL Labs can assist you to obtain a license for your product. We also can offer to you, one or more of the 200 plus DNL Lab licenses we currently hold, that you may use to develop, market and distribute a full and compliant line of NHP licensed products.
COSTS TO PREPARE A SUBMISSION FOR YOUR PRODUCT:
1.Non-Traditional multi-ingredient - max $3,500 CDN
2.Compendial Submission - $1,300 CDN
3.Other types of submissions will be quoted after analysis of the formula and the requirement.
4.See below for an explanation for the 7 types of submissions.
Understanding Product Licensing in Canada
Natural Health Products (NHPs) are defined as: Vitamins and Minerals; Herbal Remedies; Homeopathic Medicines; Traditional Medicines such as Traditional Chinese Medicines; Probiotics, and other ingredients like Amino Acids and Essential Fatty Acids.
To obtain a product license, individuals must submit a product license application to the Natural Health Products Directorate (NHPD). The application must provide detailed information on the product, including: medicinal ingredients, source potency, non-medicinal ingredients, and recommended use. The application must include sufficient clinical trial data to allow NHPD to evaluate the safety, quality and efficacy of the NHP when used according to the recommended conditions of use.
There are seven different types of applications for a product licence, each with its own submission requirements:
• Compendial (may have a traditional and/or non-traditional claim);
• Traditional Claim;
• Non-Traditional Claim;
• TPD Category IV/Labelling Standard;
• Homeopathic DIN; and
• Transitional DIN.
The most difficult license to obtain is a Non-Traditional involving multiple ingredients. Many consultants state they have submitted thousands of applications but generally, they are single ingredient (monographed) submissions and the consultant fails to provide their success rate (which is a true evaluation of the quality of the application). A Notice of Refusal issued by Health Canada will require a complete re-submission and a return to the end of the queue, which currently has a 10,000 submission backlog.
A Non-Traditional application for a multiple ingredient submission must contain for example the following sections:
1. Cover letter:
2. Product License Application including
• Animal Tissue Forms;
• Therapeutic Value Additive Forms;
• Master File Letters of Access;
• Copies of Original References;
3. Evidence Summary Report;
4. Safety Summary Report;
5. Quality Summary Report;
6. Raw Material Specifications;
7. Finished Product Specifications;
8. Label Text;
9. List of References;
Once a product license application is assessed and granted market authorization by Health Canada, the product label will bear an eight-digit product license number preceded by the distinct letters NPN (Natural Product Number), or, in the case of a homeopathic medicine, by the letters NPN-HM.
The product license number on the label assures consumers that the product has been reviewed and approved by Health Canada for safety and efficacy.