REGULATORY
The biggest issue facing Nutraceutical companies selling in Canada, is complying with the stringent, often seen as over-the-top, Health Canada Regulations. Unlike the many countries throughout the world, Canada has very stringent regulations governing the sale of Natural Health Products. In fact, Canada is seen as a leader in the international community as it relates to regulations surrounding Natural Health Products. The main protocols that Health Canada has implemented to ensure products are safe for consumers are as follows:
NPN (Natural Products Number) Registrations
Before a Natural Health Product can be sold compliantly in Canada, it must receive a license from Health Canada in the form of an NPN#. The licensing process requires that the license application (known as a submission) must provide clinical research to Health Canada to support the efficacy, safety, quality and stability of ingredients in the product. The licensing process can be as fast as 30 days for monographed items (like Vitamin C) and can take as long as one year for more complex formulations. Products that are licensed by Health Canada must be labeled per Health Canada specifications and must have the NPN displayed on the front of the bottle.
Site Licensing
All facilities in Canada that import, store, label and ship Natural Health Products must be licensed by Health Canada with a Site License. The requirements of the site license put the onus on the Site Licensed facility to monitor the products it handles for regulatory compliance and safety protocols. Required Site License SOP’s include (but are not limited to) review of ingredient certificates of analysis, review of required lab testing for heavy metals and bacteria counts, maintenance of lot retention samples, recall procedures and recording of lot & batch codes and expiry date. All of this information must be recorded and maintained by the Site License facility. Stalco’s facilities are Site Licensed for the Importation storage, labeling and shipping of Natural Health Products. In addition to our Health Canada Site License, Stalco’s facilities are registered with the United States Food and Drug Administration.
Labeling
All products that Stalco ships are labeled in a compliant fashion per the destination country. In addition, prior to shipping internationally, Stalco ensures that all ingredients contained in the product are eligible for entry into the destination country. Currently 98% of Stalco’s shipments are to the US and Canada
The good news is that that we will manage all the regulatory requirements for you so you can focus on growing your business!
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