Regulatory Compliance

Making sense of regulations.
As required by the Natural Health Product Regulations, a product license (NPN, Din-HM) is required before a natural health products can be legally sold in Canada. Obtaining a license requires submitting to Health Canada detailed information on the product, including: medicinal ingredients, potency, non-medicinal ingredients, recommended use, and evidence to support the safety, efficacy, and quality of the products. GFR can assist clients in the preparation of product license application by providing information regarding ingredients, manufacturing process and other technical information related to the formulation and quality aspects of the product. We can also work with you to make sure that your label meets the Canadian labeling requirements and matches the formula. For products that fall under food category, we can assist you in meeting and developing nutritional labeling requirements.

Our support is not limited to compliance to Canadian regulations. We can help client register their products overseas by facilitating application for international trade certificate (ITC’s, NPN products only), free sale certificate, GMP certificate; or by preparing other technical information such as certificate of Analysis, stability testing, and Finished Product specifications. We have experience working with clients in Asia, Middle East and Europe.