NPN Application for Your Products

All natural health products (NHPs) sold in Canada require a product license before being legally sold.

Filing a Product License Application in Canada for a natural health product (NHP) can be a complex, time-consuming process.

To secure a license, applicants must provide detailed information about the product to Health Canada, including medicinal ingredients, source, dose, potency, non-medicinal ingredients, and recommended use.

Orchard Vale Naturals can assist your licensing efforts using in-house product expert and a decade of regulatory experience to speed the process and maximize success. Our clients can also tap into Orchard Vale Naturals’ own portfolio of 200+ licenses.

Our highly qualified team is experienced in the preparation of all submission types, including traditional, non-traditional, homeopathic, combination, and compendial, and in all submission categories, including plant or animal materials, extracts, isolates, synthetics, probiotics, and enzymes.

We offer the following services:

• Class I and Class II NPN applications preparation and submission in ePLA format
• Initial Product Classification (to verify product qualifies as an NHP)
• Preparation of Safety & Efficacy Summary Reports
• Preparation of Finished Product Specifications & Quality Summary Reports
• Preparation of compliant draft labels
• Preparation of submissions in ePLA format to Health Canada
• Filing Notifications and Amendments
• Responding to government Clarification Requests (CRs)
• Responding to government Information Request Notices (IRNs)