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This guidance document provides information to help product licence applicants determine the evidence (type and amount of data) to be provided to support the safety (risk) and efficacy (benefit) of traditional medicines.

The Natural Health Products (NHP) Online System is a suite of secure web applications and tools that you can use to fill your NHP licence application.

The Electronic Product Licence Application (ePLA) form is for Natural Health Product Licence Applications and for post-licence changes. The ePLA is designed to be completed on the applicant's workstation where it can be saved and retrieved at any time.

The NHP MAP outlines the process applied by NNHPD to manage Product Licence Applications (PLA) for Natural Health Products (NHPs) submitted in accordance with the Natural Health Products Regulations (NHPR). The policy also outlines the responsibilities and expectations of NHP applicants throughout the application process.

The Licensed Natural Health Products Database contains information about natural health products that have been issued a product licence by Health Canada.

The Health Products and Food Branch (HPFB) commits to issue a product licensing decision within the service delivery standards outlined in: Service standards for the management of Product Licence Applications (PLA) for Natural Health Products (NHP).

Companies must hold a site licence to manufacture, package, label or import natural health products (NHPs) in Canada. When doing these activities, companies must follow good manufacturing practices requirements (NHP GMPs) in the Natural Health Product Regulations (NHPR). It is a company’s responsibility to comply with the applicable regulatory requirements. When we identify an issue, we take compliance and enforcement actions based on several factors such as the risk to your health.

The site licensing system requires that all manufacturers, packagers, labellers, and importers be licensed. Sites must have procedures in place for distribution records and product recalls and for the handling, storage and delivery of their products. They must also demonstrate that they meet good manufacturing practice requirements.

Site licence holder and foreign site reference number data extracts.

The licence holder is ultimately responsible for product quality. This guidance document describes the requirements for producing high quality NHPs; however, it allows for flexibility in how these requirements are met.