Health Canada

This labelling standard describes the requirements necessary to receive marketing authorization (a Drug Identification Number (DIN) or a Natural Product Number (NPN)) for topical anaesthetic, analgesic, and antipruritic products for the temporary relief of pain and itching.

All natural health products sold in Canada are subject to the Natural Health Products Regulations, which came into force on January 1, 2004. The Regulations help give Canadians access to a wide range of natural health products that are safe, effective and of high quality.

In Canada, natural health products (NHP's) fall under the Natural Health Products Regulations of the Food and Drugs Act. These Regulations came into effect on January 1, 2004. Several guidance documents have been created to provide industry with clear guidelines on how to comply with the...

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...

Fact sheets from the Natural Health Products Directorate of Health Canada

Protecting and promoting the health and safety of Canadians, their families and communities is of paramount importance to the Government of Canada. The Government is committed to ensuring that regulation of natural health products balances the protection of consumers' health and safety with the...

Protecting and promoting the health and safety of Canadians, their families and communities is of paramount importance to the Government of Canada. The Government is committed to ensuring that regulation of natural health products balances the protection of consumers' health and safety with the...

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.

This guide is intended to explain the new approach to submission of Finished Product Specifications for Product Licence Applications.

The purpose of this document is to assist stakeholders with the interpretation of legislation and regulatory requirements about distributing samples of prescription drugs, non-prescription drugs and natural health products.

The Food and Drugs Act (Act) and its regulations establish the framework to protect the safety of health products available to Canadians and to prevent deception in relation to these products. This framework includes a set of prohibitions and penalties, provides for the oversight and for the...

The purpose of this Policy is to further describe to regulated parties the compliance approach outlined in the Inspectorate's Compliance and Enforcement Policy (POL-0001) as it relates to NHPs to support a transparent, consistent and predictable compliance and enforcement approach.

This guidance document provides information to help sponsors determine what evidence should be submitted to Health Canada when applying to switch a medicinal ingredient from prescription to non-prescription status.

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.

This guidance document provides information to help product licence applicants determine the evidence (type and amount of data) to provide as part of a product licence application to support the safety (risk) and efficacy (benefit) of natural health products (NHPs) that make modern health claims.

This guidance provides information relating to the interpretation and enforcement of section 3 and Schedule A to the Food and Drugs Act (FDA), as well as sections A.01.067 and A.01.068 of the Food and Drug Regulations (FDR) and sections 103.2 and 103.3 of the Natural Health Products Regulations...

In Canada, natural health products and foods are regulated under the Food and Drugs Act (FDA) and its associated regulations. Products that meet the definition of a "natural health product" (NHP) as set out in the Natural Health Products Regulations (NHPR) are subject to the FDA as it applies to...

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...

As per the Natural Health Products Regulations, product and site licences are required before a natural health product can be marketed in Canada. This section explains what applications and submissions are required to meet the requirements of the Natural Health Products Regulations.

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.