Natural Health Products Compliance

Natural Health Products (NHPs) Compliance
& Quality Solutions

NHPs are naturally occurring substances that are used to restore or maintain good health. NHPs include:

NHPs are naturally occurring substances that are used to restore or maintain good health.
NHPs include vitamins and minerals, herbal medicines, amino acids, etc.
Some consumer products like certain kinds of toothpaste, shampoos, facial products, and mouthwashes are also classified as NHPs in Canada.
All natural health products must be licensed as per natural health products regulations before they can be legally sold in Canada.
A site license is also required for Canadian companies who are involved in manufacturing, packaging, labeling, or importing natural health products.
Licenses are regulated and issued by the Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada.
On approval of NHP by Health Canada, an NPN (Natural Product Number) or DIN-HM (Drug Identification Number-Homeopathic Medicine Number) consisting of an eight-digit identifier is issued.
To get product and site licenses, the following requirements must be met

NHP license applications, amendment applications, and master file application
Notifications and responding to government RFIs (requests for information)
Finished product specifications, safety and efficacy summary reports, and ingredient issue forms
Designing standard operating procedures
Training programs for entry, mid-level, and senior management
Site and QMS Audit services (a must before regulatory inspections)
Preparing and reviewing compliant labels