Natural and Non-prescription Health Products Directorate (NNHPD) under Health Canada is the regulatory authority for Natural Health Product (NHP) and non-prescription drugs. All Natural Health Products (herbal products, vitamins and alternate medicine etc.) are regulated under the Natural Health Products Regulations, which came into force on January 1, 2004. The regulation mandates that all Natural Health Products that have health claim(s) are required to have a product license and be manufactured in a GMP environment. This regulation has enabled Canada to reach the leading position in the word in terms of Natural Health product safety and quality.
A manufacture must obtain Good Manufacturing Practice (GMP) certification from NNHPD before it can manufacture a Natural Health product. NNHPD is responsible for assessing Canadian GMP, A foreign manufacturer must submit documentation to NNHPD for their assessment in order to have the ability to manufacture products for the Canadian market. A Canadian representative (Importer) is required for any foreign manufacturer to sell their products in Canada. Importers must also have GMP certification from NNHPD in term of warehousing, logistics (including tracing) and approving products for sale in Canada. A Canadian Importer is necessary for NNHPD to identify a responsible Canadian entity for products in the Canadian market. Cyctek Inc. has help more than 50 Canadian and international manufacturers to obtain Canadian GMP licenses and have their product imported in the Canadian market. A site license must be renewed every one to three years, the importer is responsible for the site license renewal.
In addition, any NHP must have a valid product license to sell in the Canadian market. The product license is a permanent license that does not require renewal. The product license lists the ingredient and its quantity in details and can be found on-line by the public. This feature allows a Canadian product license holder to share the product approval information to all of its trading partners. This feature was helpful for a license holder to obtain product approvals from other countries. Cyctek Inc. has the experience of successfully obtaining over 3000 product licenses since 2006. We had the ability to register complex products with their health claims. The number of ingredients in a complex product exceed 80; in addition, we were able to obtain approval on products that can be used by children and pregnant women. We are experts in herbal medicine, especially Traditional medicine. Our team is trained in herbal medicine and its functions and indications and helped many manufacturers file the native claims for their products.