We bring extensive experience and expertise to get your natural health product to market quickly, efficiently and compliantly. Do you need a license to sell vitamins and supplements? Yes. You need product licenses and activity licenses. Our roots originate in the Natural Health Products industry. Over the years, we have developed robust insights and processes for supporting clients with Product License Applications and Compliance with Health Canada regulations. We are often the firm of choice when issues arise between brand owners and the regulators often serving as a liaison between the company, their legal advisors and the regulator.
Services and Solutions
A very common question we are asked is: Do you need a license to sell vitamins and supplements? We take a holistic view by taking into consideration your product development goals and the current regulatory and compliance environment in going from concept to finished product or modifying a current formulation. Product development is a journey initially from concept to prototype and then from prototype to scale up. Our subject-matter-experts come from all walks of education and experience and that sum total expertise is offered to support your vision. Often a successful product launch takes the combined efforts of chemists, microbiologists, toxicologists, manufacturing formulators and chemists, process engineers, regulatory and quality control professionals.
Evidence Reports
Preparation of evidence reports based on scientific literature searches, review and analysis that support the product’s health claim(s).
Safety Summary Reports
Preparation of Safety Summary Reports based on scientific literature searches, review and analysis.
Scientific and Clinical Studies Articles Review
Scrutiny and submission of full-text articles of scientific and clinical studies supporting the product’s efficacy and safety.
Quality Summary Reports
Preparation of a Quality Summary report stating the final product specifications, including the identity, purity, potency and quantity of the medicinal ingredients, and describing the unit process operations and the in-process quality control points used during manufacture.
NPN E-submissions
E-submissions for pertinent official product registration forms (product license application, NPN numbers)
Combination Rationales
An essential component of the Product License Application (PLA) submission to explain why combining ingredients at their respective quantities is likely to be safe and efficacious within the context of the recommended conditions of use.
Product License Applications (PLA)
We provide Product License Application (PLA) submissions services for the four classes of Natural Health Products. Working with our team eliminates the question, “Do you need a license to sell vitamins and supplements?“ our team of experts guides you through the process of getting a license and what is required for you to succeed. Each class of product has different requirements in terms of the information to be submitted at the time of review.
Compendial
Licenses for products with a single ingredient that have well-known dosages and clinical indications.
Traditional
For formulations that contain botanical ingredients. These formulations are well described in traditional herbal literature and have dosages and clinical indications that have been traditionally described. This classification will require Quality and Safety reports to be filed.
Non-Traditional
Formulations that have multi-ingredient combinations that may or may not be supported by modern clinical trial evidence efficacy claims. This classification requires Quality, Safety and Efficacy reports to be prepared and filed.
Homeopathic
Homeopathic medicines are required to have a product number before being sold in Canada. The product number appears on the label of the product preceded by DIN-HM. We assist in the completion and submission of the Product License Application (PLA) for specific claim applications and non-specific claim applications. along with evidence of safety and efficacy for review by Natural Health Products Directorate (NHPD) prior to Health Canada approval.