Natural Health Product Raw Material Policy: Additional resources

Definitions

The definitions below are intended to supplement the provisions in the Food and Drugs Act (the Act) and its Regulations. In case of a discrepancy between this policy and the Act or the Natural Health Products Regulations (the Regulations), the definitions in the Act and the Regulations take precedence.

The definitions below relate to the context of the current Policy. Certain terms may have different meanings in other contexts.

Compounding: An activity performed by a health care practitioner in the context of a practitioner-patient relationship. The activity of preparing, combining, or modifying one or more medicinal ingredients to produce a final product customized to an exact specification tailored to a patient's need, and in a dosage form suitable to the patient.

Compounded product: A product prepared by a health care practitioner that is specifically tailored to an individual patient's needs.

Direction of use: Instructions for using a product safely and effectively. These directions are typically found on the product label, accompanying documentation and cover aspects such as time of administration (frequency and duration of use), or administration with respect to food or drink.

Distributor: As defined in section 1 of the Regulations, means a person who sells a natural health product to another person for the purpose of further sale by that other person.

Dosage form: The final physical form of the natural health product that may be used by the consumer without requiring any further manufacturing.

Finished natural health product: A product that has undergone all stages of manufacturing, including packaging into its final container and labelling.

Note: For the purpose of this policy, finished natural health product includes bulk product and is subject to the Regulations when intended for sale.
Bulk product: A product in dosage form not in its final packaging, usually in quantities larger than the largest commercially available package size.

Health care practitioner/complementary, traditional and alternative health care practitioner: A person providing health services within the boundaries of the province/territory in which they may be licensed. A health care practitioner is an individual who, if applicable, meets the provincial or territorial definition of the term, including but not limited to, pharmacists, Traditional Chinese Medicine practitioners, herbalists, naturopathic doctors, homeopaths and others.

Import: To bring a substance into Canada, for the purpose of sale, further manufacturing and compounding.

Note: Importation of a finished NHP into Canada is subject to the Regulations.

Manufacturing: To fabricate or process one or more substance(s) (raw material) to create a finished product of different form/composition, for the purpose of sale where no health care practitioner-patient relationship exists (see 'Compounding'). This includes activities such as mixing or combining two or more substances or altering the form/composition of one or more substance(s) through various production processes (mechanical or chemical).

Process: A series of mechanical/physical actions performed on a substance to manufacture a product of different composition/form. Mixing/grinding with other substances.
Fabricate: To manufacture a product from substances.

Manufacturer: A person who fabricates or processes a natural health product for the purpose of sale, but does not include a pharmacist or other health care practitioner who, at the request of a patient, compounds a natural health product for the purpose of sale to that patient.

Medicinal ingredient: A substance which is set out in Schedule 1 of the NHPR, is biologically active and is included in an NHP for the purposes of:

diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state or its symptoms in humans;
restoring or correcting organic functions in humans; or
modifying organic functions in humans

A medicinal ingredient is characterized by its physical form, its chemical attributes, its source, its preparation, as well as its dose and pharmacological action.

Natural health product: Defined in section 1 of the Regulations as follows: means a substance set out in Schedule 1 or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in:

the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
restoring or correcting organic functions in humans; or
modifying organic functions in humans.

However, a natural health product does not include a substance set out in Schedule 2, any combination of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or a traditional medicine that is or includes a substance set out in Schedule 2.

Non-medicinal ingredient: A non-medicinal ingredient is defined as any substance that is added to a product to confer suitable consistency or form to the medicinal ingredients (suitable as per dosage form and route of administration). Non-medicinal ingredients:

should not exhibit pharmacological effects;
should not have any effect contradictory to the product's recommended purpose;
should not exceed the minimum concentration required for the formulation;
should not adversely affect the bioavailability, pharmacological activity or safety of the medicinal ingredients; and
should be safe.

Natural Health Product licensable activities: Refers to manufacturing, packaging, labelling or importing of NHPs for which a site licence is required by the Regulations.

Patient-practitioner relationship: A relationship that can be demonstrated, via records, to exist between a patient and a health care practitioner in which a health service is provided.

Patient: An individual with specific needs receiving personalized care from a health care practitioner.

Repackaging: Subdividing or breaking up a manufacturer's original package of a health product for the purpose of dividing and assembling the health product in larger or smaller quantities for redistribution or sale by retail.

Sell: As defined in section 2 of the Act, includes:

offer for sale, expose for sale or have in possession for sale — or distribute to one or more persons, whether or not the distribution is made for consideration, and
lease, offer for lease, expose for lease or have in possession for lease.

Substance: An ingredient or mixture of ingredients to be used for the purposes of compounding or manufacturing an NHP.

Third Party: Any individual, organization or company outside of a patient- practitioner relationship.