Regulatory Support for International Shipping Expansion
Stalco offers full regulatory support to help your business expand around the globe.
We cover everything from ensuring your products and ingredients are compliant in the countries you want to sell them in to making sure your labels match the requirements of each country you’re shipping to.
We can help you attain Health Canada licenses for any products you’re looking to sell within Canada and our internal regulatory team can help make sure all your products are compliant to pre-clear customs allowing same day shipping within North America.
NPN Registrations
Before a Natural Health product can be compliantly sold 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 and stability of ingredients in the product. The licensing process can be as fast as 30 days for monograph items (like Vitamin C) and as slow as a year for more complex formulations. Products that are licensed by Health Canada must be labeled per Health Canada specifications and display the NPN number on the front of the bottle.
In addition to a house brand assortment of licensed natural health products, Stalco has a database of already approved formulations covering all major categories in the Natural Products sector. Access to our licensed database allows our clients FAST access to a catalogue of licensed formulations for compliant sale in the Canadian market without having to go through a complex regulatory program on their own.
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.
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.
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