Site Licensing for Natural Health Products

A site license allows the holder the authority to package, manufacture, label, and import NHPs in Canada.  All these activities must be carried out according to the good manufacturing practices outlined in the Natural Health Product Regulations.

This system requires that all manufacturers, packagers, importers, and labelers be licensed.  The sites must have procedures in place for product recalls, distribution records, and the storage, handling, and delivery of all their products. 

Canadian companies that are engaged in manufacturing, packaging, labeling, or importing of natural health products for sale are required to hold a valid site license that is issued by the Natural and Non-Prescription Health Products Directorate (NNHPD).  These licenses are only used for activities within Canada.

The NNHPD will issue a site license for; manufacturing, labeling, packaging, and importing activities related to Natural Health Products. 

SOPs and supporting documentation such as quality assurance reports), GMP compliant quality systems, GMP audit records, NHP site license amendments and NHP site license annexations for foreign sites.

Foreign NHP manufacturing sites must be annexed to an importer’s valid site license, and attest to following Good Manufacturing Practices (GMP).

Good manufacturing practices (GMP) are part of quality assurance and ensure that natural health products are consistently produced, controlled and meet the quality standards for their intended use.

Natural Health Products (NHPs) are substances that fall under Schedule 1 of the Natural Health Products Regulations. NHPs can include traditional products, such as Traditional Chinese Medicine, Ayurvedic medicine, and Homeopathics (HM-DIN). 

• NHPs must meet the requirements of the Food and Drugs Act, including licensing, labeling and GMP
• Obtaining a Natural Product Number (NPN) is a must for commercial importers of NHPs
• The NPN license holder must have a business location in Canada
• A Health Canada authorized importer should ensure quality assurance activities with the potency, identity, and purity of the health product
• Key activities performed by the importer include product release, stability data reporting, and if required, adverse event reporting

It is advisable to keep your import record for six years following the date of import as they can be audited by customs at any point during this time. Since you will be acting as the ‘Importer of Record’, you will be liable for the accuracy and completeness of the import declaration. Also, you will be responsible for the payment of applicable taxes and duties in Canada.

• Tax and duty must be paid upon importation into Canada
• The tariff, value, and origin of commodities being imported determine the rate of duty
• At the port of entry, certain import documentation needs to be presented to the border services.
• The import is subject to inspection, customs review, and audit prior to or after the importation.

The Government of Canada may levy extra fees for these services.

1. Site licensing compliance with NHP Regulations
2. Ensure you have quality assurance experts
3. Ensure your manufacturing units comply with GMP and NHP Regulations
4. Ensure your product labeling and packaging is compliant with NHP Regulations
5. Confirm whether you collect evidence that your product meets its shelf-life expiry
6. Are all sections of your GMPs covered by yourself and an importer of record
7. Be ready to provide written product release specifications according to NHP guidelines
8. Arrange for adding your building and supplements to the Canadian importer’s site license

An importer of record is required if you wish to manufacture, package or label NHPs outside of Canada.

Quality IMPORT Solutions can act as your importer of record! Any business that holds a valid site license issued by the NNHPD can act as an importer of record, so long as any domestic warehouse/storage facility is annexed to the importer’s site license as well as any foreign manufacturing sites.

We will serve as your formal Quality Assurance (QA) personnel or informal advisor on all matters associated with QA. So, leverage our expertise and take a proactive and anticipatory approach towards quality and regulatory requirements not only to prevent your site license from being revoked, but for the health and safety of consumers.

1. Improve Product Quality
2. High Company Standard
3. Improve Collaboration
4. Examine & Restructure Company Processes
5. Maintain A Better Work Culture
6. Reduce Waste and Save Money