Natural Health Product Licensing
By law, each NHP sold in Canada must be licensed by Health Canada’s Natural Health Product Directorate (NHPD). For each NHP, manufacturers or distributors must submit a product license application demonstrating that the NHP is high quality in terms of content and purity and is efficacious and safe as per label claims. If approved by NHPD, the NHP is granted a natural product number (NPN) which must be displayed on the product label. This gives consumers confidence in the quality, efficacy and safety of the product.
Many companies are unaware of NHPD Natural Health Product Regulations. Companies with unlicensed NHPs face risk that their products will be refused entry to Canada or will be pulled from store shelves. Distributors and retailers of unlicensed products face the risk of loss of substantial sales.
Imperia offers unmatched ability to help your company obtain NHP licenses and achieve regulatory compliance for the Canadian market. See Top 10 Reasons to hire Imperia as your NHP Licensing Specialists for the Canadian market.
Companies with NHP product licenses (or exemption) acquire significant benefits. They:
- acquire and/or maintain the freedom to sell their NHPs in Canada,
- increase sales potential and competitive position, especially when unlicensed NHPs are removed from the market,
- elevate the marketability of their NHPs around the world,
- establish themselves as regulatory leaders in their domestic markets, and
- position themselves favorably for changes to US NHP regulations to be implemented over the next five years.
In summary, Imperia has the human resources, experience and expertise to provide the highest quality licensing services for its clients. For more information on how Imperia can help you with product licensing, please contact us.
Translation Services
Cosmetic Notification
Sections 10 and 30 of the Cosmetic Regulations of the Food and Drugs Act require that a Cosmetic Notification Form be submitted to Health Canada within 10 days of first sale of a cosmetic product sold in Canada.
Imperia assist clients with this process. Please contact us for further information.
Site Licensing
All companies located in Canada that manufacture, label, package or import natural health products must hold a site license approved by the Natural Health products Directorate (NHPD). Sites must have procedures in place for product manufacture, storage, handling and distribution of natural health products. They must also adhere to Good Manufacturing Practices (GMPs) to ensure product safety and quality as specified in the Natural Health Product Regulations. Specifically, companies must employ standard operating procedures (SOPs) which outline standards and practices in 12 key areas including product specifications, premises, use of equipment, qualification of personnel, sanitation, operations, quality assurance, product stability, records retention, sterile manufacturing, lot or batch samples and recall reporting.
Foreign sites and foreign distributors do not need a site license but they must adhere to GMP.
To apply for a site license, applicants must submit two forms to the NHPD: a site license application form and a quality assurance report which assesses the company’s compliance with GMP.
Imperia is able to assist NHP companies to obtain a site license and achieve regulatory compliance in 5 ways:
- Review and report on the status of the company’s GMP compliance in 12 key areas. Deficiencies will be identified and corrective action recommended.
- Assist the company to obtain or write Standard Operating Procedures, as required.
- Draft and file the Site License Application with NHPD on behalf of the client. The application contains two reports: the Site License Application Form and the Quality Assurance Report (or equivalent).
- Provide GMP training on-site and set up a staff training record system.
- Communicate with the NHPD during the entire “Assessment Process” and collaborate with the client in responding to any further NHPD requirements in a timely manner.
International Trade Certificates
Firms exporting NHPs from Canada are often asked by foreign customers or foreign governments to supply a certification containing information about a product's regulatory or marketing status. Often, foreign governments are seeking official assurance that products exported to their countries can be marketed in Canada or meet specific Canadian NHP regulations related to safety, efficacy and quality.
Imperia assists firms which apply to the Natural Health Product Directorate (NHPD) to obtain these certificates, known as international trade certificates,. This facilitates the customs process for Canadian NHPs in destination countries.
