Natural Health Product Raw Material: Policy statement

On this page

• Overview
• Raw materials and finished NHPs
• Product and Site Licence Requirements
• Additional guidance for importation of raw materials

Overview

A substance can be a raw material or finished Natural Health Product (NHP) depending on several factors, including its form, intended use and representation. Under this policy, products that are manufactured, sold or represented for use as NHPs must comply with regulatory requirements as outlined by the Natural Health Products Regulations (the Regulations). It is understood that a finished NHP may also be a raw material in certain instances for which different requirements exist. This document will provide clarity to help determine whether regulatory requirements are applicable.

Raw Materials and Finished NHPs

Raw materials

A raw material is any substance intended to be used in the manufacturing process to produce a finished NHP of different composition or form for the purpose of sale. Raw materials must comply with good manufacturing practices (GMP) requirements under Part 3 of the Regulations when used to manufacture an NHP. For more information, please refer to the Good manufacturing practices guide for natural health products (GUI-0158).

Raw material labelling should include information such as:

• material identity,
• supplier details,
• expiry date,
• lot numbers,
• storage requirements.

A raw material can have medicinal or non-medicinal properties.

A substance is considered a raw material when, within a practitioner–patient relationship, it is further prepared, combined, or modified by a practitioner to produce a patient-specific final product. Practitioners should follow relevant requirements and standards set by their provincial/territorial regulatory and/or professional bodies (such as labelling, record keeping, proper identification and documentation requirements for traceability purposes, etc.). For more information, please refer to the NHP Compounding Policy.

Please note that in addition to the above, other Acts and regulatory frameworks may apply to the raw material (for example, the Controlled Drugs and Substances Act, or the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)).

Finished NHPs

A finished NHP is a product that has undergone all stages of manufacturing which may or may not be packaged into its final container and labelled.

The Regulations prohibit the sale or importation for sale of products meeting the definition of an NHP, unless a product licence has been issued for the NHP.

In addition, unless they hold a valid site licence, in relation to NHPs, Canadian sites are prohibited from:

• manufacturing,
• packaging,
• labelling, and/or
• importing.

Note that, while distribution and storage of NHPs are not licensable activities, NHPs must be distributed and stored according to the requirements set out in Part 3 of the Regulations.

When a substance meets both the substance and function components of the NHP definition under section 1 of the Regulations, it is considered an NHP and licencing requirements apply.

• Substance component: Refers to the medicinal ingredients (MIs) in an NHP, which can include only substances listed on Schedule 1 to the Regulations and excludes substances under schedule 2 to the Regulations.
• Function component: Refers to those substances that are manufactured, sold or represented for therapeutic use. In this case, the Schedule 1 substance is in its final physical form (dosage form) and is sold as is, as an NHP.

For example, an NHP to be sold in different dosage forms (capsule versus powder) would require two separate product licences and natural product numbers (NPNs), and a site licence, as applicable, depending on the activity being carried out.

In the context of compounding, a finished NHP that requires further customization by a health care practitioner to address specific patient needs is considered a raw material. For more information on NHP Compounding, and how to differentiate between manufacturing of NHPs and the compounding of NHPs, refer to the NHP Compounding Policy.

Health Canada expects all NHPs, to meet established specifications for identity, purity, potency, and quantity, with finished product testing and quality oversight consistent with GMP. Practitioners who compound for individual patients are encouraged to source raw materials from reputable suppliers with traceable documentation and verify identity and quality prior to use.

Determining when a substance is a raw material or finished NHP

There are certain circumstances or attributes to a substance that may lead Health Canada to conclude that it is manufactured, sold or represented for use as a finished NHP or that it is considered a raw material. The table below is a non-exhaustive list of these criteria:

Health Canada does not look at a single criterion or feature in isolation to determine whether a substance is considered a finished NHP or raw material. It is the combination of criteria or features that is key in making this determination.

Product and Site Licence Requirements

The safety, efficacy and quality of NHPs and substances used in manufacturing is supported through product and site licensing requirements, and through the GMP requirements set out in Part 3 of the Regulations.

Product Licences

To sell an NHP in Canada, companies must obtain a product licence from Health Canada. The application process involves providing detailed information about the product, in accordance with section 5 of the Regulations, including its:

• ingredients,
• dosage form,
• recommended use,
• evidence supporting its safety, efficacy and quality.

For more information on how to apply for a product licence, please refer to the Natural Health Products Management of Applications Policy. For general inquiries related to NHP licence applications, please contact the NNHPD Client Support Unit at nnhpd-dpsnso@hc-sc.gc.ca.

Site Licences

Manufacturers, packagers, labellers and importers of NHPs must obtain a site licence from Health Canada and must comply with Part 3 of the Regulations. The application process involves providing information under section 28 of the Regulations about the site, including its location, proposed activity, operations and quality control measures.

For more information and to apply for a site licence, please refer to: Natural Health Product site licensing. For general inquiries related to site licence applications, please contact the Natural Health Products Licensing and Inspection Division at hpcd.nhp.sl-dcps.psn.le@hc-sc.gc.ca.

Importation of Raw Materials

• Importing a substance requiring further manufacturing does not require a site licence and product licence for importation and sale, as the substance would be considered a raw material.
• Importation of a substance or finished NHP by a health care practitioner, for use in compounding in the context of a practitioner-patient relationship, does not require a site licence and product licence for importation and sale. Refer to the compounding policy for further information.
• Importation of a substance requiring no further manufacturing or compounding, for the purpose of sale as an NHP requires a site licence and product licence for importation and sale.

Note: This includes the importation of a substance that is (re)packaged and/or (re)labelled to then be sold as an NHP. In this instance, as the substance is not further manufactured or compounded, a site licence and product licence is required for importation, packaging, labelling and sale.

Importation of Finished NHPs

• Importation of a finished NHP intended for further manufacturing requires a site licence and product licence for importation and sale. An NHP can also be considered "finished" in instances where it may only require re-packaging and re-labelling.
• Importation of a finished NHP by a third party (importer), which is further sold (distributed) to a health care practitioner or manufacturer, requires a site licence and product licence for importation and sale.

Please note, in instances where importation and distribution of substances/finished NHPs is intended for multiple uses, the highest regulatory requirements will be applied.

Additional guidance to support imported shipments

To facilitate Health Canada's decision-making on imported substances (raw material and finished NHPs), the following information should accompany each shipment (as applicable):

• Material/product identity,
• Supplier details (name, address),
• Lot number(s),
• Expiry date,
• Storage requirements,
• Intended use/claims associated with product,
• Product and site licence numbers.

To facilitate the importation of substances for the purpose of compounding in the context of practitioner-patient relationship (see the NHP Compounding Policy for more information), Health Canada recommends to clearly identify on the label that the substance is intended "for compounding NHPs". In addition to the above, complementary, traditional and alternative health care practitioners, should include the following information to accompany each shipment:

• the name of the practitioner,
• licence/registration number, address, and
• governing body.

Please note: Health Canada's Regulatory Operations and Enforcement Branch may request additional information to assist in making their admissibility decision.