Overview of the Natural Health Products Regulations Guidance Document

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About this Guidance Document

This guidance document provides an overview of the definition of a natural health product and of the activities governed by the Natural Health Products Regulations. It is intended to be a first point of reference: it will help readers determine whether a product and the activities related to it are governed by the Natural Health Products Regulations. It also refers to all other applicable policies, guidance documents and other sources of information - the reader will be able to use this document as a starting point.

The Natural Health Products Regulations contain requirements for manufacturing, packaging, labelling, storing, importing, distributing and selling natural health products. It is the sale of natural health products for the purposes of manufacturing, packaging, labelling etc. that is captured by these Regulations, not the sale of natural health products by retailers.

These Regulations are intended to ensure that all Canadians have ready access to natural health products that are safe, effective and of high quality, while respecting freedom of choice and philosophical and cultural diversity.

The Natural Health Products Regulations are administered by the Natural Health Products Directorate (NHPD), Health Products and Food Branch, Health Canada.

Boxes with the text of the Regulations appear in relevant locations throughout the document. A complete version of the Regulations is available on the Internet [see Natural Health Products Regulations].

The definitions of terms used in this and all other Natural Health Products Directorate guidance documents are provided in the Glossary (page 25).

All of the policies, guidance documents and other sources of information mentioned in this guidance document can be found on the Internet.

The information in this guidance document is based on the Natural Health Products Regulations, published in the Canada Gazette, Part II, on June 18, 2003. These Regulations come into force on January 1, 2004.

Table of Contents

• 1. Scope of the Natural Health Products Regulations
• 2. What is a Natural Health Product?
  • 2.1 Schedule 1: List of Included Substances
  • 2.2 Schedule 2: List of Excluded Substances
  • 2.3 Bulk Herbs
  • 2.4 Hybrid Products
• 3. Activities Covered by the Natural Health Products Regulations
• • 3.1 Manufacturing
  • 3.2 Packaging
  • 3.3 Labelling
  • 3.4 Importing for Sale in Canada
  • 3.5 Distribution
  • 3.6 Clinical Trials Involving Humans
  • 3.7 Adverse Reaction Reporting
• 4. Main Components of the Natural Health Products Regulations
  • 4.1 Product Licensing
  • 4.2 Site Licensing
  • 4.3 Good Manufacturing Practices
  • 4.4 Clinical Trials
  • 4.5 Labelling and Packaging
• 5. Transition Period
• 6. Roles and Responsibilities
• 7. Policies, Guidance Documents and Other Applicable Sources of Information
  • 7.1 Guidance Documents
  • 7.2 Policies
  • 7.3 Other Applicable Sources of Information
• 8. Contacting Health Canada
• Glossary

1. Scope of the Natural Health Products Regulations

The Natural Health Products Regulations apply only to natural health products for human use.

Section 7(d) of the Regulations says that NHPD must not approve products that may injure the health of consumers. In developing the Natural Health Products Regulations, Health Canada's intent was to cover products that consumers can select and use themselves, without the need to consult a health care provider and obtain a prescription. Accordingly, with the exception of homeopathic medicines, products with ingredients that are required to be sold pursuant to a prescription (listed in Schedule F to the Food and Drug Regulations) are not natural health products. In reviewing all other product applications for safety and efficacy, NHPD will keep this intent in mind.

When there are risks associated with the use of a natural health product (for example, use by a particular group of people, such as seniors), NHPD may ask applicants to take certain measures to manage the risk, including putting advisory information on the product label, or restricting the dosage, route of administration, source or preparation, or form in which the natural health product is presented. However, if the risk cannot be mitigated (i.e., NHPD considers the natural health product unsafe for use in humans according to the recommended conditions of use), NHPD will not authorize the sale of a natural health product under the Natural Health Products Regulations.

The Regulations set requirements for the manufacturing, packaging, labelling, importation for sale, and distribution of natural health products. It is the sale of natural health products for the purposes of manufacturing, packaging, labelling, distributing, importing, or use in clinical trials that is captured by these Regulations, not the sale of natural health products by retailers. Clinical trials conducted in Canada using natural health products are also subject to these Regulations.

The Natural Health Products Regulations are a set of new regulations under the Food and Drugs Act. The following provisions from Part A and Part C of the Food and Drug Regulations were incorporated to allow for proper administration (including compliance and enforcement) of the Natural Health Products Regulations:

• A.01.022 to A.01.026, A01.040 to A.01.044, A.01.045, A.01.050, and A.01.051 (general administration);
• A.01.061 to A.01.063 (pressurized containers);
• C.01.001(2), C.01.001(3), and C.01.001(4) (definitions);
• C.01.012 (release of medicinal ingredients);
• C.01.015(1), C.01.015(2)(d) to (f) (disintegration of tablets); and
• C.01.028(1), C.01.028(2)(b) and (c), C.01.029, C.01.031(1), C.01.031.2(1)(a) and (c) to and (g), C.01.031.2(2), and C.01.031(2(3)(a) and (c) (cautionary statements and child resistant packaging).

2. What is a Natural Health Product?

The natural health product definition has two components: function and substance.

The function component refers to the natural health product definition capturing those substances that are manufactured, sold or represented for use in:

1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
2. restoring or correcting organic functions in humans; or
3. modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

The substance component refers to the medicinal ingredient in a natural health product.
Schedule 1, page 6, outlines the medicinal ingredients that natural health products may contain.
Schedule 2, page 10, specifies those substances that are not permitted in a natural health product.

2.1 Schedule 1: List of Included Substances

Item 1

Acceptable Substances

A plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material

A plant is a member of the biological Kingdom Plantae, and is either the whole plant or parts thereof. A plant consists of complex multicellular eukaryotes that have a cell wall composed primarily of cellulose. A plant usually produces its own food by photosynthesis using chlorophylls a and b. Example of plants are Allium sativum and Cassia angustifolia. Examples of plant parts are bark, wood, leaves, stems, roots, flowers, fruits, seeds and berries, or parts thereof.

A plant material is material obtained from a plant, including pollens, nucleic materials, mitochondria, chlorophyll and exudates such as resin.

An alga is a member of one of the protist biological Kingdoms. It consists of unicellular, colonial or relatively simple multicellular eukaryotes, and has a cell wall containing cellulose or silica. Algae usually produce their own food by photosynthesis, and are mostly aquatic. Examples of algae are Chlorella pyrenoidosa and Laminaria digitata.

A bacterium is a member of one of the biological Kingdoms of the Domains Bacteria or Archaea. It consists of usually unicellular (sometimes aggregated, colonial or simple multicellular) prokaryotes whose cells lack nuclei or other internal compartmentalization, but have a cell wall external to the plasma membrane in most species. An example is Spirulina (cyanobacteria).

A fungus is a member of the biological Kingdom Fungi. A fungus consists mainly of complex multicellular eukaryotes that have a cell wall composed primarily of chitin. Fungi are heterotrophs that absorb nutrients from their surroundings by decomposing organic materials. Examples are Lentinus edodes (Shiitake mushroom) and Grifolia frondosa (Maitake mushroom).

An animal is a member of the biological Kingdom Animalia. An animal consists of complex multicellular eukaryotes whose cells have a membrane but no wall. Most members have muscles and nervous tissues. They are heterotrophs that mostly ingest food into a specialized cavity, where it is digested. Examples are Squalus acanthias (shark) and Gadus morhua (cod).

A non-human animal material is a body part or secretion obtained from an animal other than a human and used in the preparation of a natural health product. Examples are elk antler velvet, bovine colostrums, shark cartilage, and attenuation prepared from canine milk (Lac caninum).

To be acceptable as homeopathic medicines under the Natural Health Products Regulations, a non-human animal material must be listed in one of: the Homeopathic Pharmacopoeia of the United States, the Homöopathische Arzneimittel, the Pharmacopée française or the European Pharmacopeia.

Item 2

Acceptable Substances

An extract or isolate of a substance described in item 1, the primary molecular structure of which is identical to that which it had prior to its extraction or isolation

An extract is a substance prepared by treating a plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material with solvents to obtain the desired compounds. Examples are Echinacea angustifolia solid extract, Panax ginseng tincture and St. John's Wort fluid extract.

An isolate is a purified constituent of a defined molecular structure obtained from a plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material. Examples are glutathione and capsaicin.

Item 3

Acceptable Substances

Any of the following vitamins:

1. Biotin
2. Folate
3. Niacin
4. Pantothenic acid
5. Riboflavin
6. Thiamin
7. Vitamin A
8. Vitamin B6
9. Vitamin B12
10. Vitamin C
11. Vitamin D
12. Vitamin E

Vitamins are naturally occurring organic substances required by the body to maintain health. Dietary Reference Intakes (DRIs) are the standards for referencing upper levels of vitamins. More information on DRIs. In some cases, Health Canada's Therapeutic Products Directorate has established lower levels for vitamins; in other words, the amount of vitamin in a natural health product cannot be lower than this level.

Recognizing that the natural health product definition excludes substances that require a prescription, and that vitamin K is currently listed on Schedule F to the Food and Drug Regulations without specifying parameters, NHPD has removed vitamin K from Schedule 1 until the parameters for vitamin K have been determined.

Item 4

Acceptable Substances

An amino acid

An amino acid is a class of organic molecule that contains amino and carboxyl groups. Amino acids form the main constituents of proteins that are found in a plant or a plant material, an alga, a fungus, a bacterium or a non-human animal material. The following are acceptable amino acids. NHPD acknowledges that there are other amino acids not captured under this definition. These amino acids will be captured under the isolate category:

1. L-alanine
2. L-arginine
3. L-asparagine
4. L-aspartic acid
5. L-cysteine
6. L-glutamine
7. L-glutamic acid
8. L-glycine
9. L-histidine
10. L-isoleucine
11. L-leucine
12. L-lysine
13. L-methionine
14. L-phenylalanine
15. L-proline
16. L-serine
17. L-threonine
18. L-tyrosine
19. L-valine

Item 5

Acceptable Substances

An essential fatty acid

An essential fatty acid cannot be synthesized in the body; hence, it must be supplied through the diet or a supplement. Linoleic acid and alpha linolenic acid are essential fatty acids. All other fatty acids (such as oleic acid, conjugated linoleic acid, gamma-linoleic acid, arachidonic acid, eicosapentaenoic acid and docosahexaenoic acid) are considered extracts or isolates (see item 2, above). For more information, see the Evidence for Quality of Finished Natural Health Products Guidance Document.

Item 6

Acceptable Substances

A synthetic duplicate of a substance described in any of items 2 to 5

A synthetic duplicate is a substance that shares an identical chemical structure and pharmacological properties with its natural counterpart. Examples are vitamin E - DL alpha-tocopherol.

A semi-synthetic substance may also be acceptable as a natural health product provided it shares an identical chemical structure and pharmacological properties with its natural counterpart. A semi-synthetic substance is produced by a process that chemically changes a related starting material that has been extracted or isolated from a plant or a plant material, an alga, a fungus or a non-human animal material. An example is ginsenosides (the starting compound used is betulafolienetriol).

Item 7

Acceptable Substances

A mineral

A mineral is a naturally occurring solid, inorganic substance with a definite and predictable chemical composition and physical properties.

Item 8

Acceptable Substances

A probiotic

The Natural Health Products Regulations define a probiotic as a monoculture or mixed-culture of live micro-organisms that benefit the microbiota indigenous to humans. A probiotic is limited to non-pathogenic microorganisms. An example is Lactobacillus acidophilus.

2.2 Schedule 2: List of Excluded Substances

Item 1

Non Acceptable Substances

A substance set out in Schedule C to the Food and Drugs Act

Schedule C substances include radiopharmaceuticals and drugs other than radionuclides sold or represented for use in the preparation of radiopharmaceuticals. These substances are regulated by the Food and Drugs Act (see sections 12 and 30) and the Food and Drug Regulations.

Item 2

Non Acceptable Substances

A substance set out in Schedule D to the Food and Drugs Act (biologics), except for the following:

1. a drug that is prepared from any of the following micro-organisms, namely, an alga, a bacterium or a fungus; and
2. any substance set out in Schedule D, when it is prepared in accordance with the practices of homeopathic pharmacy.

These two categories of substances, (a) and (b), may contain Schedule D substances.

A biologic is a drug that is prepared using a biological starting or source material and using for example, either conventional manufacturing methods, recombinant DNA technology, and/or other novel approaches.

The following are Schedule D substances:

1. Allergenic substances used for the treatment or diagnosis of allergenic or immunological diseases
2. Anterior pituitary extracts
3. Aprotinin
4. Blood and blood derivatives
5. Cholecystokinin
6. Drugs obtained by recombinant DNA procedures
7. Drugs, other than antibiotics, prepared from micro-organisms
8. Glucagons
9. Gonadotrophins
10. Human plasma collected by plasmapheresis
11. Immunizing agents
12. Insulin
13. Interferon
14. Monoclonal antibodies, their conjugates and derivatives
15. Secretin
16. Sensitivity discs and sensitivity tablets
17. Snake venom
18. Urokinase

Item 3

Non Acceptable Substances

A substance regulated under the  Tobacco Act

Substances regulated by the Tobacco Act are not permissible as natural health products. Examples are chewing tobacco and smoking tobacco.

Item 4

Non Acceptable Substances

A substance set out in any of Schedules I to V to the Controlled Drugs and Substances Act

Substances set out in Schedules I to V to the Controlled Drugs and Substances Act are not acceptable as natural health products.

Only the following substances, which are set out in Schedule VI of the Controlled Drugs and Substances Act, are permissible as natural health products:

1. Benzyl methyl ketone
2. Ephedrine
3. Ergometrine
4. Ergotamine
5. Lysergic acid
6. Pseudoephedrine

These schedule VI substances are regulated by both the Controlled Drugs and Substances Act and the Natural Health Products Regulations.

Item 5

Non Acceptable Substances

A substance that is administered by puncturing the dermis

Substances administered by puncturing the dermis are not acceptable as natural health products. However, substances administered by means of insertion into cavities and canals of the body, such as suppositories, are permissible as natural health products.

Item 6

Non Acceptable Substances

An antibiotic prepared from an alga, a bacterium or a fungus or a synthetic duplicate of that antibiotic

An antibiotic prepared from an alga, a bacterium or a fungus or a synthetic duplicate of that antibiotic is regulated by the Food and Drugs Act and Food and Drug Regulations. Such an antibiotic is not acceptable as a natural health product.

2.3 Dosage Form and Bulk Herbs

While manufacturers may select different dosage forms for a specific natural health product, including bulk or loose, safety and proper labelling for consumers must not be compromised.

Manufacturers, packagers, labellers, distributors and importers who handle bulk or loose natural health products are subject to the requirements of the Natural Health Products Regulations.

A policy for bulk herbs will set out the labelling requirement for bulk herbs ready for use by the consumer. Further guidance on this issue will be forthcoming.

NHPD recognizes that in some cases, consumers may find it difficult to distinguish between foods and natural health products. To help product licence applicants, NHPD has developed a list of dosage forms which suggest that a product is a natural health product. Industry may use this list as a guide. NHPD uses this list for tracking to ensure consistency in its databases. It is updated regularly. See the Product Licensing Guidance Document for more information.

NHPD is also developing a list of herbs that will always be considered natural health products regardless of dosage form.

See Section 3 for information on raw ingredients.

2.4 Hybrid Products

Hybrid natural health products are products that contain, in addition to the natural health product, a drug, a food, a cosmetic or a medical device. A hybrid product may be subject to one or more of the Natural Health Products Regulations, Food and Drug Regulations, Cosmetics Regulations, or Medical Devices Regulations, depending on the ingredients, representation for use (primary purpose) and health claims of that product. However, drug-natural health product combinations are always regulated as drugs under the Food and Drugs Act and Food and Drug Regulations.

Recognizing the potential complexity and diversity of hybrid products, NHPD classifies them on a case-by-case basis. The NHPD is participating in a broader Health Canada initiative with respect to the classification of health products.

3. Activities Covered by the Natural Health Products Regulations

Each natural health product sold in Canada requires a product licence. A site licence is required in order to manufacture, package, label, and import for sale a natural health product.

Laboratories

A laboratory that solely tests a natural health product is not required to obtain a site licence.

For example, a manufacturer, packager, labeller or importer may contract a laboratory to perform testing on a natural health product. Manufacturers, packagers, labellers and importers are encouraged to contract laboratories that follow good laboratory practices.

If a laboratory conducts additional activities, namely manufacturing, packaging, labelling, importing or distributing, then a site licence is required.

3.1 Manufacturing

A manufacturer is 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 to sell to that patient.

In other words, the manufacturer definition does not include:

• health care practitioners who compound products at the request of patients (for example, pharmacists, Traditional Chinese Medicine practitioners, herbalists, naturopathic doctors); and
• complementary and alternative health care practitioners and traditional Aboriginal medicine practitioners.

A policy on the compounding of natural health products will be developed.

In addition, it was not the intent of the Natural Health Products Regulations for growers who handle or treat a product to preserve the integrity of the raw material to be included in the manufacturer definition.

The site licence provisions apply to manufacturers of natural health products. These provisions include requirements for product specifications, premises, equipment, personnel, sanitation, operations, quality assurance, product stability, record keeping, product sterility, ophthalmic use, lot or batch samples and recall reporting. See Part 3 of the Natural Health Products Regulations, the Good Manufacturing Practices Guidance Document and the Site Licence Guidance Document for manufacturing guidelines.

3.2 Packaging

The site licence provisions apply to companies packaging natural health products. See Part 3 and Part 5 of the Natural Health Products Regulations, the Product Licensing Guidance Document and the Good Manufacturing Practices Guidance Document for more information.

Packaging requirements for herbs sold in bulk or loose forms will be developed.

3.3 Labelling

The site licence provisions apply to companies labelling natural health products.

See Part 3 and Part 5 of the Natural Health Products Regulations, the Product Licensing Guidance Document and the Good Manufacturing Practices Guidance Document for packaging guidelines.

3.4 Importing for Sale in Canada

An importer is a person who imports a natural health product into Canada for the purpose of sale. The site licence provisions apply to importing. See Part 3 of the Natural Health Products Regulations, the Good Manufacturing Practices Guidance Document and and the Site Licence Guidance Document for guidelines on importing.

Direct Sellers

In the case of direct sellers who may receive imported products directly from a parent company located in or outside of Canada, the parent company representing the direct seller is required to obtain a site licence. If the parent company is located outside of Canada, it must have a site in Canada and it must obtain a site licence for this site. If the parent company is located in Canada, it must obtain a site licence for this site. The onus is on the direct seller's parent company to maintain all necessary documents to allow for complete recall of a product. Independent direct sellers are not considered distributors and, as a result, do not have to meet good manufacturing practices or obtain a site licence.

Foreign Sites

Canadian importers must be licensed and the onus is on them to provide evidence that imported products come from sites that meet Canadian good manufacturing practices under Part 3 of the Natural Health Products Regulations, or equivalent standards.

One of the following types of evidence is required from importers with respect to the foreign sites:

• a good manufacturing practices inspection report by a Health Canada inspector;
• the Quality Assurance Report and when applicable Supplementary Quality Assurance Report for homeopathic medicines signed and dated by a quality assurance person or third-party auditor who has the technical expertise and training relating to each activity being reviewed and to the requirements set out in Part 3; or
• an audit, inspection report or equivalent with a memorandum of understanding or mutual recognition agreement between a foreign regulatory agency and NHPD, when applicable;
• a licence from the accepted regulatory authority in a designated country or association of countries (see appendix 6 of the Site Licensing Guidance Document) which are recognized under the current Guidance Document on Drug Establishment Licences And Establishment Licensing Fees, and are therefore considered to meet standards equivalent to Canadian GMP requirements.
  

See the Site Licence Guidance Document and the Guidance Document on Drug Establishment Licences and Establishment Licensing Fees for information.

Note: Establishment licence holders who are also importers and have foreign sites that are not listed on their licence should submit evidence as defined above.

It is the responsibility of the importer to ensure that the reports submitted to NHPD are complete and that all requirements of the Good Manufacturing Practices are being met. Supplementary information may be requested.

Clinical Trials

For clinical trials (see section 3.6; page 15), to import means to import a natural health product into Canada for the purpose of sale in a clinical trial. The clinical trial sponsor must submit to NHPD information about the sponsor's representative in Canada who is responsible for the sale of the natural health product. For more information, see Part 4 of the Natural Health Products Regulations and the Clinical Trials Guidance Document.

3.5 Distribution

A distributor is a person who sells a natural health product to another person for the purpose of further sale by that other person. This definition includes wholesalers, whose name and address are usually not on a product label. This definition does not include independent direct sellers (see Importing for Sale in Canada, section 3.4.)

Good manufacturing practices apply equally to distributors and wholesalers whether or not the company name appears on the label; however, distributors and wholesalers do not need to obtain a site licence. See Part 3 of the Natural Health Products Regulations, and the Good Manufacturing Practices Guidance Document and the Site Licence Guidance Document for distribution guidelines.

3.6 Clinical Trials Involving Humans

A clinical trial is an investigation of a natural health product that involves human subjects and that is intended to discover or verify the product's clinical, pharmacological or pharmacodynamic effects, to identify any adverse events that are related to its use, to study its absorption, distribution, metabolism and excretion, and to ascertain its safety or efficacy. The clinical trial sponsor is responsible for applying for clinical trial approval from NHPD, and research ethics approval from an independent research ethics board.

The Natural Health Products Regulations set out obligations for the clinical trial sponsor, which include good clinical practices, product labelling, record keeping, information and samples submission, and adverse reaction reporting. The site licence provisions do not apply to clinical trials, and sponsors are not required to have a site licence to conduct a clinical trial. Health Canada inspects clinical trial sites for compliance with good clinical practices. A Clinical Trials Guidance Document will be developed.

For more information on the inspection and conduct of clinical trials, see Part 4 of the Natural Health Products Regulations.

3.7 Adverse Reaction Reporting

Health Canada's adverse reaction reporting system sets out the requirements for monitoring and reporting adverse reactions associated with the use of natural health products. This reporting system is an important part of the product review system, which is based on risk assessment and the corresponding management of risks.

Product licence holders are required to provide Health Canada with information about any serious adverse reactions and any serious unexpected adverse reaction to their products. For more information on reaction reporting, see Part 1 and Part 3 of the Natural Health Products Regulations, and the Adverse Reaction Reporting Guidance Document.

Clinical trial sponsors must also report to Health Canada any serious adverse reactions and any serious unexpected adverse reactions to the natural health product that have occurred inside Canada. For more information on reaction reporting for clinical trials, see Part 4 of the Natural Health Products Regulations, and the Clinical Trials Guidance Document.

4. Main Components of the Natural Health Products Regulations

The Natural Health Products Regulations set out requirements for manufacturing, packaging, labelling, storing, importation for sale, distributing and selling natural health products, as well as clinical trials involving humans.

It is the sale of natural health products for the purposes of manufacturing, packaging, labelling, distributing, importing, and use in clinical trials that is captured by these Regulations, not the sale of natural health products by retailers.

4.1 Product Licensing

Part 1 (Product Licences) of the Natural Health Products Regulations sets out requirements for product licensing and the responsibilities of the product licence holder. The Regulations require an individual to obtain a product licence prior to selling an NHP in Canada.

See the following guidance documents for more information:

• Product Licensing Guidance Document
• Evidence for Quality of Finished Natural Health Products
• Evidence for Safety and Efficacy of Finished Natural Health Products
  • List of Acceptable Non-medicinal Ingredients
• Compendium of Monographs
• Homeopathics Guidance Document
• The Adverse Reaction Reporting Guidance Document-For Health Care Providers and Consumers

4.2 Site Licensing

Part 2 (Site Licences) sets out the requirements for site licensing and the responsibilities of a site licence holder. A site licence is required for manufacturers, packagers, labellers and importers of natural health products.

See the Site Licence Guidance Document for more information.

4.3 Good Manufacturing Practices

Part 3 (Good Manufacturing Practices) sets out good manufacturing practices - measures designed to ensure an effective overall approach to product quality control and risk management. They do so by setting appropriate standards and practices for product testing, manufacturing, storage, handling and distribution. The Good Manufacturing Practices Guidance Document outlines the requirements in detail for the manufacturing, packaging, labelling, importing and distributing of natural health products.

See the Good Manufacturing Practices Guidance Document for more information.

4.4 Clinical Trials

Part 4 (Clinical Trials) of the Natural Health Products Regulations covers clinical trials of natural health products involving humans. The requirements for clinical trials are designed to protect the rights, safety and well-being of clinical trial participants and other persons involved in conducting and evaluating clinical trials. The site licence provisions of the Regulations do not apply to clinical trial sites, but the sponsor who conducts the clinical trial must meet all the requirements set out in Part 4.

See the Clinical Trials Guidance Document for more information.

4.5 Labelling and Packaging

Part 5 (Labelling and General) sets out the requirements for labelling and packaging natural health products.

See the Product Licensing Guidance Document for more information.

5. Transition Period

The Natural Health Products Regulations come into force on January 1, 2004.

Part 6 of the Natural Health Products Regulations sets out the transition period for the implementation of the Regulations. For information on the compliance and enforcement requirements for activities conducted during the transition period, please refer to the Compliance and Enforcement Guidance Document, the Transition Guidance Document and the Good Manufacturing Practices Guidance Document.

There is a two-year transition period for site licensing, from January 1, 2004 to December 31, 2005, for manufacturers, packagers, labellers and importers of natural health products conducting activities in Canada before the coming into force date of January 1, 2004. The Food and Drug Regulations continue to apply until manufacturers, importers, packagers and labellers obtain a natural health product site licence.

There is a six-year transition period for product licensing, from January 1, 2004 to December 31, 2009, for natural health products with drug identification numbers (DIN) issued under the Food and Drug Regulations. The applicable provisions of the Food and Drug Regulations continue to apply for products with a DIN until they are licensed under the Natural Health Products Regulations. From January 1, 2004, all new products that fit the natural health products definition must comply with the Natural Health Products Regulations immediately and must obtain a product licence prior to being sold in Canada.

All natural health products must comply with all the Regulations by January 1, 2010.

For detailed information on the transition provisions, see the Transition Guidance Document.

6. Roles and Responsibilities

It is the responsibility of product licence, site licence and clinical trial applicants to provide all the necessary information for their respective applications. NHPD assesses applications based on the data submitted, but may request more information to review the application.

Applicants may appeal a Health Canada decision not to issue a product or site licence, or the decision not to approve a clinical trial. An appeals mechanism will be developed.

Health Canada may at any time inspect a site, and suspend or cancel a product or site licence when there are reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a purchaser or consumer of a natural health product. Health Canada may suspend the authorization to sell or import a natural health product for the purposes of a clinical trial, in its entirety or at a clinical trial site at any time, if Health Canada has reasonable grounds to believe that such action is necessary. For more information, see the Product Licensing Guidance Document, the Site Licence Guidance Document and the Good Manufacturing Practices Guidance Document.

7. Policies, Guidance Documents and Other Applicable Sources of Information

All of the policies, guidance documents and other applicable sources of information mentioned in this guidance document can be found on the Internet.

7.1 Guidance Documents

General

• Transition Guidance Document - This guidance document explains the provisions of Part 6 of the Natural Health Products Regulations, specifically sections 108 to 115, the provisions that govern the transition periods associated with the Regulations.
• Compliance and Enforcement Policy for Natural Health Products - This guidance document explains the approach that NHPD will take to phasing in natural health products that are already on the market prior to January 1, 2004. It will provide uniformity in the identification and classification of non-compliant natural health products according to risk. The phase in approach will allow for a progressive reduction of non-compliant natural health products in a consistent manner using risk as the primary method of identifying products.
• Natural Health Products Compliance Guide - This guidance document is a reference document to aid in assessing the compliance status of a natural health product. It sets forth the criteria and risk determination process by which the risk posed by a particular product is assessed.

Pre-market Activities

The following guidance documents contain information related to pre-market activities:

• Product Licensing Guidance Document - This guidance document outlines the requirements for Applicants when submitting a product licence application to the Natural Health Products Directorate. It also outlines the way the NHPD will manage those submissions.
• Evidence for Safety and Efficacy of Finished Natural Health Products - This guidance document helps product licence applicants determine the appropriate evidence (amount and type of data) that is required to successfully complete the parts of the product licence application about recommended conditions of use of a natural health.
  • List of Acceptable Non-medicinal Ingredients - This section of the Evidence for Safety and Efficacy of Finished Natural Health Products Guidance Document lists non-medicinal ingredients acceptable in natural health products.
• Evidence for Quality of Finished Natural Health Products - This guidance document focuses on the quality requirements for finished natural health products to be sold in Canada. Manufacturers, packagers, labellers, importers and distributors must include evidence of the quality of their product on their application for a product licence, when applying to amend a product licence or when notifying Health Canada of changes to the product.
• Compendium of Monographs - NHPD developed the Compendium of Monographs as a tool for the timely and efficient evaluation of the safety and efficacy of many commonly used medicinal ingredients that comprise natural health products. NHPD's product licensing system allows applicants to reference a monograph listed in the Compendium in support of the safety and efficacy of the product as part of their product licence application.
• Evidence for Homeopathic Medicines - This document reviews the safety, efficacy and quality requirements for homeopathic medicines. Applicants completing an application for a homeopathic medicine should review this document to ensure they meet all the requirements.
• Site Licence Guidance Document - This guidance document is intended for manufacturers, packagers and labellers of natural health products in Canada and elsewhere, and for Canadian importers of natural health products.
• Good Manufacturing Practices Guidance Document - This guidance document is intended for manufacturers, packagers and labellers of natural health products in Canada and elsewhere, including Canadian importers and distributors of these products. It is meant to help them meet the good manufacturing practice requirements.
• Clinical Trials Guidance Document
• (under development)
• Labelling and Packaging part of the Product Licensing Guidance Document - This guidance document outlines the requirements for the labelling of all natural health products and explains how these requirements can be met.

Post-market Activities

The following guidance documents contain information related to post-market activities:

• Product Licensing Guidance Document - This guidance document outlines the requirements for Applicants when submitting a product licence application to the Natural Health Products Directorate. It also outlines the way NHPD will manage those submissions.
• Site Licence Guidance Document - This guidance document is intended for manufacturers, packagers and labellers of natural health products in Canada and elsewhere, and for Canadian importers of natural health products.
• Good Manufacturing Practices Guidance Document - This guidance document is intended for manufacturers, packagers and labellers of natural health products in Canada and elsewhere, including Canadian importers and distributors of these products. It is meant to help them meet the good manufacturing practice requirements.
• The Adverse Reaction Reporting Guidance Document - For Health Care Providers and Consumers - This guidance document outlines the information product licence holders must submit to Health Canada about adverse reactions to their natural health products.

7.2 Policies

• Appeals process (under development)
• Compounding of natural health products (under development)
• Direct sellers and foreign site manufacturers (under development)
• Bulk herbs (under development)

7.3 Other Applicable Sources of Information

• Frequently asked questions
• List of herbs that are always NHPs regardless of dosage form

8. Contacting Health Canada

More information is available:

Natural Health Products:
NHPD (General Inquiries)
Fax: 613-948-6810
E-mail : NHPD_DPSN@hc-sc.gc.ca

Drugs and Medical Devices: Therapeutic Products Directorate (General Inquiries)
Tel: 613-957-0368 or 613-957-0369
Fax: 613-946-3916
E-mail : sipdmail@hc-sc.gc.ca.

Food: Food Directorate (General Inquiries)
Tel: 613-957-1821
Fax: 613-957-1784
E-mail: food-aliment@hc-sc.gc.ca

Cosmetics: Cosmetics Programme (National Consumer Product Safety Office)
Tel: (613) 957-4467
Fax: (613) 952-3039
E-mail: CPS-SPC@hc-sc.gc.ca

Master Glossary

Acknowledgment letter. A letter issued to all applicants to confirm the receipt of their application. The acknowledgment letter includes the file number, transaction number and date or receipt of application and request for clarity to company information, if required.

Adaptogen. A substance which increases the body's general, non-specific resistance to a wide spectrum of physical, chemical and biological factors. An adaptogen by definition must:

• be innocuous.
• have a wide range of therapeutic activity.
• manifest its action only against a corresponding challenge (physical, chemical or biological) to the system.
• have a normalizing action irrespective of the direction of foregoing pathological changes.

Adverse Reaction. A noxious and unintended response to a natural health product that occurs at any dose used to test for the diagnosis, treatment or prevention of a disease or for modifying an organic function.

Alga. A member of one of the protist biological kingdoms, consisting of unicellular, colonial or relatively simple multicellular eukaryotes that have a cell wall containing cellulose or silica, that usually produce their own food by photosynthesis using various chlorophylls and accessory pigments (some may also be heterotrophic under appropriate conditions), that are mostly aquatic and that lack multicellular dependent embryos.

Amino acids. A class of organic molecules containing amino and carboxylic groups, forming the chief constituents of proteins found in a plant or a plant material, an alga, a bacterium, a fungus, or a non-human animal material.

Animal. A member of the biological kingdom Animalia, consisting of complex multicellular eukaryotes whose cells have a membrane but no wall, that have muscle and nervous tissue in most members, that are heterotrophs that mostly ingest food into a specialized cavity where it is digested, and that reproduce sexually by means of motile sperm and larger, nonmotile eggs (in some animals there is also asexual reproduction).

Annual Summary Report. A detailed record containing a concise and critical analysis of all adverse reactions that have occurred inside Canada and all adverse reactions for which a case report is required, with respect to a natural health product, at a dose used or tested for the diagnosis, treatment or prevention of a disease or for maintaining or promoting health or otherwise modifying organic functions in humans, that have occurred during the previous 12 months.

Assess. Steps taken by the site licence holder to ensure that the requirements in the Food and Drugs Act, the Natural Health Products Regulations and in-house standards are met. The steps could include, among others, monitoring and testing of raw and/or packaging materials, tracking of production, maintenance of records and testing of finished products.

Attenuation. Attenuations are prepared by dissolving one part of the soluble basic substance in a sufficient quantity of purified water or other appropriate menstruum, specified in the recognized monograph, to produce (x) parts by volume of liquid attenuation (e.g. 1X, 1CH).

Bacterium. A member of one of the biological kingdoms of the domains Bacteria or Archaea, consisting of usually unicellular (sometimes aggregated, colonial or simple multicellular) prokaryotes whose cells lack nuclei or other internal compartmentalization. Most species have a cell wall external to the plasma membrane, composed primarily of peptidoglycan (except in Archaea). Bacteria have diverse means of nutrition; the group consists mostly of chemoheterotrophs, but there are also chemoautotrophs, photoautotrophs and photoheterotrophs. They reproduce by binary fission.

Batch. A quantity of product in the processing stage, homogeneous within specified limits, produced according to a single manufacturing order and as attested by the signatories to the order.

Batch number. A distinctive combination of numbers and/or letters that specifically identifies a batch, and appears on documents such as the batch record, certificate of analysis.

Batch record. Production document that captures the quantity and lot number of all materials used, as well as production steps in the manufacturing of a single batch of a natural health product in dosage form.

Biomarker. A distinctive biological or biologically derived indicator (as a biochemical metabolite in the body) of a process, event or condition (as aging or exposure to a toxic substance).

Brand Name. A name in English or French, whether or not it includes the name of a manufacturer, corporation, partnership or individual (a) that is used to distinguish the natural health product; and (b) under which a natural health product is sold or advertised.

Bulk natural health product. Unpackaged dosage form, usually in quantities larger than the largest commercially available package size.

Bulk preparation. Unpackaged homeopathic preparation, usually in quantities larger than the largest commercially available package size.

Case Report. A detailed record of all relevant data associated with the use of the natural health product in a subject.

Certificate. A legally authenticated written declaration issued by a recognized institution to a person completing a course of study.

Certificate of Analysis. A document signed by a qualified analyst that includes the product name, ingredient listing, lot number of the product, test conducted, test method and results, conclusion of the test (satisfactory or unsatisfactory), name and position of the analyst, and date of issuance.

Certificate of Manufacture A document issued by a vendor to a distributor or importer that attests that a specific lot of product has been produced according to its master production document. Such certificates include a summary of the current batch documentation, with reference to respective dates of revision, manufacture and packaging, and are signed and dated by the vendor's authorized quality assurance person.

Chemical name. The name an ingredient is referred to in the International Union of Pure and Applied Chemistry nomenclature.

Child-resistant Package. A child-resistant package when tested in accordance with an acceptable method:

1. in the case of a test group comprising children, cannot be opened:
   1. by at least 85 per cent of those children prior to a demonstration to them of the proper means of opening the package, and
   2. by at least 80 per cent of those children after the demonstration, and
2. in the case of a test group comprising adults:
   1. can be opened by at least 90 per cent of those adults, and
   2. where the package is designed so that, once opened and reclosed, it continues to meet the requirements of subparagraph (i), can be so reclosed by at least 90 per cent of those adults; or
   3. complies with the requirements of one of the following standards, namely,
      1. Canadian Standards Association Standard CAN/CSA-Z76.1-M90, entitled Reclosable Child-Resistant Packages, published January 1990, as amended from time to time,
      2. European Standard EN 28317:1992, entitled Child-resistant packaging-Requirements and testing procedures for reclosable packages, as adopted by the European Committee for Standardization on October 30, 1992, recognized by the British Standards Institution, and effective February 15, 1993 and by the Association française de normalisation, and effective December 20, 1992, and which reiterates fully the international standard ISO 8317:1989, as amended from time to time, and
      3. Code of Federal Regulations (United States), Title 16, Section 1700.15, entitled Poison prevention packaging standards, as amended from time to time.

Clinical Trial. An investigation in respect of a natural health product that involves human subjects and that is intended to discover or verify its clinical, pharmacological or pharmacodynamic effects, to identify any adverse events that are related to its use, to study its absorption, distribution, metabolism and excretion, or to ascertain its safety or efficacy.

Clinical trial applicant. The sponsor of that clinical trial. A sponsor is an individual, corporate body, institution or organization that conducts a clinical trial, which includes the management and financing of that trial.

Comminution. The act of reducing to a fine powder or to small particles.

Common Name. For any medicinal or non-medicinal ingredient contained in a natural health product, the name by which it is commonly known and is designated in a scientific or technical reference

Conditions of Use. As defined in the Natural Health Products Regulations, 'conditions of use' or 'recommended conditions of use' for a product includes:

• health claim
• route of administration
• dose
• dosage form
• duration of use.

Constituent. A component part i.e. a single chemical isolated from a whole herb.

Container. The blister pack, bottle, cover, sachet, strip pack, tube, vessel, vial, wrapper or other similar article that covers the natural health product.

Critical process. A process that may cause significant variation in the quality of the finished product.

DIN (drug identification number). A numerical code assigned to each drug product marketed under or in accordance with the Food and Drugs Act and Food and Drug Regulations.

Diploma. A document issued by an educational institution, such as a university, college, or technical institute, vouching that the recipient has earned a degree or successfully completed a particular course of study.

Display Card. A display card is a material on which the information required by the above labelling guidelines can be displayed. It does not include the surface area of the bottom, of any seam or of any concave or convex surface near the top or the bottom of a container.

Distributor. 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 which may be used by the consumer without requiring any further manufacturing.

Dwelling house. Place of residence.

Education. The act or process of imparting or acquiring knowledge or skills; the learning of information by instruction, training, or study can be testified to by a degree, certificate or diploma.

Effectiveness. A measure of the accuracy or success of a diagnostic or therapeutic technique when carried out in an average clinical environment. The extent to which a treatment achieves its intended purpose.

Efficacy. The extent to which a specific intervention, procedure, regimen or service produces a beneficial result under ideal conditions.

Enzyme. A protein that acts as a catalyst, increasing the rate at which a specific biochemical reaction occurs. Enzymes may be derived from a plant or a plant material, an alga, a bacterium, a fungus, or a non-human animal material.

Essential fatty acid. Cannot be synthesized in the body and have to be supplied through the diet or a supplement. Current knowledge indicates that there are only two essential fatty acids: linoleic acid and a-linolenic acid.

Experience. Active participation in events or activities leading to the acquirement of knowledge or skills; the knowledge or skills retained from personally observing, encountering, or undergoing something.

Expiry date. Means the earlier of

1. the date, expressed at minimum as a year and month, up to and including which a natural health product maintains its purity and physical characteristics and its medicinal ingredients maintain their quantity per dosage unit and their potency, and
2. the date, expressed at minimum as a year and month, after which the manufacturer recommends that the natural health product should not be used.

Extract. A substance prepared by treating a plant or a plant material, an alga, a bacterium, a fungus, or non-human animal material with solvents to remove any constituents.

Filling. Transferring and enclosing a bulk product into its final container.

Finished product. A product that has undergone all stages of production, including packaging in its final container and labelling.

Flame Projection. The ability of the pressurized contents of an aerosol container to ignite and the length of that ignition, when tested in accordance with official method DO-30, Determination of Flame Projection, dated October 15, 1981.

Flashback. That part of the flame projection that extends from its point of ignition back to the aerosol container when tested in accordance with official method DO-30, Determination of Flame Projection, dated October 15, 1981; (retour de flamme).

Formulating. Preparing components and combining raw materials into a bulk natural health product.

Fungus. A member of the biological kingdom Fungi, consisting mostly of complex multicellular eukaryotes with a cell wall, usually composed primarily of chitin. Fungi are heterotrophs that absorb nutrients from their surroundings after decomposing organic material. They reproduce by unicellular spores produced sexually and/or asexually.

Good manufacturing practices. Measures to ensure an overall effective approach to product quality control and risk management. They apply to places, people, processes and products with respect to which activities are being conducted. Please refer to Part 3 of the Natural Health Products Regulations and the Good Manufacturing Practices for Natural Health Products Guidance document.

Hazard Analysis and Critical Control Points (HACCP). An internationally recognized system of food safety methods. It is a systematic approach to the identification, evaluation, and control of food safety hazards.

Health Canada inspection report. A written inspection report prepared by an inspector from Health Canada, using either the drug or natural health product good manufacturing practices as the basis for the site assessment.

Health Claim. This is a synonym of a "Recommended Use or Purpose" found within the definition for "Recommended conditions of use".

Homeopathic medicine. Medicines that are manufactured from or contain as medicinal ingredients only those substances or sources referenced in the Homeopathic Pharmacopoeia of the United States, the Homöopathische Arzneimittel, the Pharmacopée française or the European Pharmacopoeia, as amended from time to time, and that are prepared in accordance with these pharmacopoeias.

Immediate Container. Means the container that is in direct contact with a natural health product.

Import. To bring into Canada a natural health product for the purpose of sale.

Importer. A person who imports a natural health product into Canada for the purpose of sale.

Ingredient. A single substance that is a component part of any combination or mixture. For example, vitamin C is a common ingredient in a multi-vitamin product. (see also 'product')

Inner Label. The label on or affixed to an immediate container of a natural health product.

In-process control. Checks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the finished product conforms to its specifications. The control of the production environment or equipment may also be regarded as a part of in-process control.

In-process product. Any materials or mixture of materials that must, to become a product in dosage form, undergo further processing.

In-process testing. The examination or testing of any materials or mixture of materials during the manufacturing process.

Interaction. In pharmacology, the phenomenon that the combined effects of two causes differ from the sum of the effects separately (as in synergism and antagonism).

Interim Summary Report. A detailed record containing concise and critical analysis of all adverse reactions that have occurred inside Canada and all adverse reactions for which a case report is required, with respect to a natural health product, at a dose used or tested for the diagnosis, treatment or prevention of a disease or for maintaining or promoting health or otherwise modifying organic functions in humans, that have occurred since the date of the most recent annual summary report.

Irradiated Product. An irradiated product is processed with ionizing radiation in accordance with the Food and Drugs Act and Regulations. Irradiation can improve the quality, safety and variety of the product for the consumer.

ISO (International Organization for Standardization). A world wide organization of national standards bodies; ISO is a non-governmental organization that maintains a group of global standards.

Isolate. A purified constituent of a defined molecular structure obtained from a plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material.

Label (noun). Includes any legend, word or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic, device or package. Natural health products are included.

Label (verb). To affix the inner or outer label of the natural health product.

Licensee. A person who is issued a licence by the NHPD.

Lot. A quantity of any natural health product in dosage form, a raw material or a packaging material, homogeneous within specified limits, constituting all or part of a single batch and identified by a distinctive lot number which appears on the label of the finished product.

Lot number. Any combination of letters, figures or both, by which any natural health product can be traced in manufacture and identified in distribution.

Maceration. Processing method using unheated solvent (cold or room temperature water, alcohol, or other organic solvent) to extract medicinal properties from a raw material.

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 the patient, compounds a natural health product for the purpose of sale to that patient.

Manufacture. To fabricate or process a product for the purpose of sale.

Manufacturing order. Instructions that outline in detail the materials and procedures required to manufacture, prepare and preserve a single batch of a natural health product in dosage form.

Margin of Safety. The difference between the minimal therapeutic dose and the minimal toxic dose of a therapeutic substance.

Marker compound. A constituent that occurs naturally in the material and that is selected for special attention (e.g. for identification or standardization purposes) by a researcher or manufacturer. Marker compounds are not necessarily pharmacologically active.

Marketing authorization. A legal document issued by the Natural Health Products Directorate authorizing the sale of a natural health product in Canada.

Master formula. A document or set of documents specifying the raw materials with their quantities and the packaging materials, together with a detailed description of the procedures and precautions required to produce a specified quantity of a finished product.

Master production document. A document that includes specifications (raw material, packaging material, packaged dosage form), master formula, sampling procedures and critical processing related standard operating procedures, whether or not these procedures are specifically referenced in the master formula. It also includes a complete list of raw materials used in the manufacture of the product, designated by names or codes; the amount of each raw material required for the theoretical product formulation; manufacturing and process control instructions and in-process testing requirements (e.g. checks on materials, pre-treatments, sequence of adding materials, mixing time and temperatures); a statement of the principal equipment to be used; a statement of the theoretical weight or measure of the manufactured product and the acceptable limits beyond which an investigation is required; a description of the finished product containers, closures and packaging labels; any special precautions to be observed; and dates and times (if applicable) of commencement and completion of significant intermediate stages, such as blending or heating, and of completion of production.

Medicinal Ingredient. Any substance set out in Schedule 1 of the Natural Health Products Regulations that is intended to furnish pharmacological activity or other direct effect in:

1. the diagnosis, treatment, mitigation, or prevention of a disease, disorder or abnormal physical state or its symptoms in humans; or
2. restoring or correcting organic functions in humans; or
3. modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

Mineral. A naturally occurring, sold, inorganic substance with a definite and predictable chemical composition and physical properties.

Mother tincture. A relatively concentrated aqueous alcoholic extract from which subsequent attenuations are prepared. Synonyms: mother liquor, stock solution, starting solution.

Natural health product. 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:

1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
2. restoring or correcting organic functions in humans; or
3. modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

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.

NPN/DIN-HM. Natural Product Number is an eight (8) digit numerical code assigned to each natural health product approved to be marketed under the Natural Health Products Regulations. DIN-HM is an eight (8) digit numerical code assigned to each homeopathic medicine approved to be marketed under the Natural Health Products Regulations.

Notice of cancellation of licence. A notice issued when corrective action is not taken after suspension and licensee fails to prove that the situation did not exist.

Notice of suspension of licence. A notice that is issued to suspend a licence, when the licensee fails to take corrective action within 90 days of receiving the notice of intent to suspend.

Observation. A deviation or deficiency of good manufacturing practice noted by an inspector or assessor.

Organic. A labelling and advertising term that denotes a plant or a plant material, a fungus or a non-human animal material certified to have been produced in accordance with the production, processing, packaging, storage and distribution provisions of the National Standard of Canada for Organic Agriculture. Certification according to other organic standards is also acceptable. Products not within the scope of agricultural standards (e.g. aquatic non-human animal material, algae, cyanobacteria, ("blue-green algae")) must be certified to have been produced in accordance with an aquacultural or other applicable organic standard.

Outer Label. The label on or affixed to the outside of a package of a natural health product.

Package (noun). Includes anything in which any natural health product is wholly or partly contained, placed or packed.

Package (verb). To put a product in its immediate container.

Packaging material. Labels, printed packaging materials and those components in direct contact with the dosage form.

Packaging order. Instructions that outline in detail the materials and special procedures required to package and label a single lot of a product in dosage form.

Paradigm. A world view which underlies the theories and methodology in science in a particular period of history or within a particular culture.

Percolation. A method used for the extraction of dried substances that have been reduced to the proper degree of fineness.

Plant. A member of the biological kingdom Plantae, consisting of complex multicellular eukaryotes with a cell wall composed primarily of cellulose. They usually produce their own food by photosynthesis using chlorophylls a and b (secondarily lost in parasites), are mostly terrestrial and have multicellular reproductive structures producing dependent embryos.

Potency. The amount per dosage unit of the standardized component(s) which further characterizes the quantity of the ingredient. It is required only when a claim on the potency is to be on the label, or it is required for a specific product (i.e. when literature supports the product with that standardized component). In the Supplementary Good Manufacturing Practices for Homeopathic Medicines, potency refers to the degree of dilution of a homeopathic medicine.

Pre-market Authorization. The regulatory requirement to receive a product licence before placing it on the market.

Pressurized Container. A pressurized container is a disposable metal container designed to release pressurized contents by use of a manually operated valve that forms an integral part of the container.

Primary molecular structure. The chemical structure of a substance. For substances isolated from a plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material, its primary molecular structure must be unaltered from its original form. While minor modifications performed to stabilize or solubilize the molecular structure are acceptable, any structural alterations that may affect the pharmacological activity of the substance are not. For example, conjugation or esterification is acceptable.

Principal Display Panel. The principal display panel is that part of the inner or outer label applied to all or part of the principal display surface of the container that is displayed or visible under normal or customary conditions of sale or use.

Probiotic. A monoculture or mixed-culture of live micro-organisms that benefit the microbiota indigenous to humans.

Processing deficiency notice. A notice issued by the processing unit to request missing information or clarification.

Product. A substance or combination of substances manufactured or refined for sale. (see also 'ingredient')

Product licence applicant. An individual with legal ownership of and responsibility for the natural health product. The product licence applicant may be located in or outside of Canada. Applicants who are located outside of Canada must identify a Canadian representative.

Production. All operations involved in the preparation of a finished product, from receipt of materials, through processing and packaging, to completion of the finished product, including storage.

Proper name. In respect of an ingredient of a natural health product, one of the following:

1. if the ingredient is a vitamin, the name for that vitamin set out in item 3 of Schedule 1;
2. if the ingredient is a plant or a plant material, an alga, a bacterium, a fungus, a non-human animal material or a probiotic, the Latin nomenclature of its genus and, if any, its specific epithet; and
3. if the ingredient is other than one described in paragraphs (a) or (b), the chemical name of the ingredient.

Purity. The extent to which a raw material or a product in dosage form is free from undesirable or adulterating chemical, biological or physical entities as defined by specification.

Qualification. To make competent or eligible for an office, position, or task by having the proper or necessary skills, knowledge, credentials, accomplishments or qualities.

Quality assurance. All the planned and systematic activities applied within the quality system to provide adequate confidence that the predetermined standards for quality and safety will be met.

Quality assurance person. The person who is responsible for assuring the quality of the natural health product before it is made available for sale. This person should be qualified by education, training and/or experience relating to the specific activity (i.e manufacturing, packaging, labelling and importing).

Quality assurance report. A report prepared by either a quality assurance person or a third party auditor who meets the requirements with respect to education, training, and experience according to section 51(a) (ii) of the Natural Health Products Regulations. This report is based on the assessment against the good manufacturing practices regulations and requirements set out in the good manufacturing practices guidance document. It is considered a self-assessment document and evidence of good manufacturing practices compliance.

Quantity. The amount of medicinal ingredient(s) per dosage unit. It is always required for a product, as it is the amount of medicinal ingredient in the product.

Quarantine. Effective restriction of the availability of material or product for use (physically or by system), until released by the quality assurance person.

Raw material. Any substance, other than in-process product or packaging material, intended to be used in the manufacture of products, including those that appear in the master formula but that do not appear in the product such as solvents and processing aids.

Recognized building. In respect of the fabrication, packaging/labelling or testing of a natural health product, a building that a regulatory authority that is designated under subsection (1) in respect of that activity for that natural health product has recognized as meeting its good manufacturing practices standards in respect of that activity for that natural health product.

Recognized institution. A Canadian or international educational facility (e.g. a university, college or professional or post-secondary institute) generally approved of or having a secure reputation; credible, reputable, and authoritative.

Recommended conditions of use. With regard to a natural health product:

• its recommended use or purpose;
• its dosage form;
• its recommended route of administration;
• its recommended dose;
• its recommended duration of use, if any; and
• its risk information, including any cautions, warnings, contra-indications or known adverse reactions associated with its use.

Reconciliation. A comparison, making due allowance for normal variation, between the amount of product or materials theoretically produced or used and the amount actually produced or used.

Reprocessing. Subjecting all or part of a batch or lot of an in-process product or finished product to a previous step or alternate manufacturing process due to failure to meet predetermined specifications.

Returned product. Bulk or finished product sent back to the manufacturer, distributor or importer.

Risk Reduction Claim. A claim which describes the relationship between using a product and reducing risk of developing a chronic disease or abnormal physiological state, by significantly altering a major risk factor or factors recognized to be involved in its development.

Safener. An ingredient used in some herbal natural health products that mitigates or alters the effects of the primary medicinal ingredient to prevent adverse reactions. Safeners, since they are biologically active are subject to the same data requirements as for a medicinal ingredient.

Safety. The ability for a natural health product to produce a beneficial health outcome, outweighing the risk associated with using it, in humans, according to the recommended conditions of use.

Sampling. Collection of a number of units that comprises representative sample from a designated lot or batch of product.

Security package. A package having a security feature that provides reasonable assurance to consumers that the package has not been opened prior to purchase.

Self-care. Self-care involves the activities individuals undertake for the prevention, treatment and symptomatic relief of diseases, injuries or chronic conditions that individuals can recognize and manage on their own behalf, either independently or in cooperation with a health care provider.

Sell. Includes offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration.

Serious Adverse Reaction. A noxious and unintended response to a natural health product that occurs at any dose and that requires in-patient hospitalization or a prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life threatening or that results in death.

Serious Unexpected Adverse Reaction. A serious adverse reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the natural health product.

Site. A place of or for an activity specified under the Regulations.

Site licence applicant. An individual with legal responsibility for the site of manufacturing, packaging, labelling or importation of a natural health product to be sold in Canada.

Site licence number. A number issued by Health Canada's Natural Health Products Directorate based on the requirements set out in the Natural Health Products Regulations as proof of authorization to conduct specified activities at the listed locations.

Small package. An immediate container that is not large enough to accommodate an inner label that complies with the inner label requirements as described in this document.

Spent herb. means the botanical material remaining after the extraction process is complete.

Standardization. The application of product knowledge, good agricultural or wildcrafting practices, and good manufacturing practices to minimize inherent variations in the composition of natural substances in order to ensure consistent product quality from one batch to the next.

Standard operating procedures. An authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material but of a more general nature (e.g. equipment operation, maintenance and cleaning, cleaning of premises and environmental control, sampling and inspection). Certain standard operating procedures may be used to supplement product-specific master production documents.

Standards of Evidence. Clearly defined criteria used by regulators to evaluate the safety, quality and effectiveness of a claim regarding a health product or food. The criteria define the amount and type of data required to support the safety of a product and all health claims that are associated with it. Although Standards of Evidence may differ from one type of product to another, they are consistent within a similar category of products.

Sterile dosage form. A dosage form that is free from microbial contamination.

Sterile Product. It is a product that is free from viable microorganisms.

Structure-Function Claim. A claim which describes the effect of a product on a structure or physiological function in the human body, or a product's support of an anatomical, physiological, or mental function. This category includes claims of maintaining or promoting health.

Synthetic duplicates. A substance that shares an identical chemical structure and pharmacological properties with its natural counterpart.

Third-party auditor. An auditor who is independent of the company he or she is auditing and who is qualified by education, training, and experience to conduct a natural health product good manufacturing practices site audit.

Tonic. Medicinal preparations used to restore normal tone to tissues or to stimulate the appetite.

Traditional medicine. The sum total of the knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health, as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness. Traditional medicine has a long history (50 consecutive years) of use.

Training. To make proficient with specialized instruction and practice.

Treatment Claim. A claim which relates to the diagnosis, treatment, mitigation or prevention of a disease, disorder, or abnormal physical state or its symptoms in humans.

Trituration. Attenuations of solid substances are prepared by trituration of the crude substance with lactose, in the proportion of one part by weight of the crude substance and nine parts by weight of lactose to produce the appropriate trituration and subsequent trituration (e.g. 1X, 1C).

Vitamin. An organic substance needed in small amounts to maintain normal health.

Voucher Specimen. A representative specimen preserved to permit independent verification of identity and to allow further examination (e.g. pressed plants, non-human animal material in preserving fluids).