osstg-gtnps-eng.pdf

Natural Health Products

Standard Terminology

Guide

Natural Health Products Online System Standard Terminology Guide

October 2013 - Version 3.0

Également offert en français sous le titre : Guide sur la terminologie normalisée du Système

Produits de santé naturels en ligne

Her Majesty the Queen in Right of Canada, represented by the Minister of Health, 2013.

About This Guide

The objective of this document is to provide guidance on the standards and

terminologies to facilitate the exchange and practical use of natural health product

information by the Natural Health Products (NHP) Online System.

Contact the Natural Health Products Directorate

Natural Health Products Directorate

Health Canada

2936 Baseline Road, Tower A

Ottawa, Ontario

K1A 0K9

http://www.healthcanada.gc.ca/nhp

Telephone: 1-888-774-5555

Fax: (613) 948-6810

Email: [email protected]

Table of Contents

About this Guide

1. Introduction

1.1 Development and terminologies

1.2 Using the Terminologies

1.3 Adding, Deleting, Changing Terms in the Terminologies

2. Ingredients Naming Standard Terminology

2.1 Approved Names

2.2 Proper Names

2.3 Common Names

2.3.1 Organism substances

2.4 Taxonomical Synonyms

2.5 Authorized References

2.6 The Scope of the Terminology

2.7 Types of Ingredients/Organisms

2.8 Obtaining the Terminology

2.8.1 Guidelines for chemical substances information

2.8.2 Guidelines for herbal component information

2.9 Chemical Substances and Herbal Components

2.10 Protein Substances

2.10.1 Guidelines for herbal naming

2.10.1.1 Approved herbal name

2.10.1.2 Herbal substance names

2.10.1.3 Custom herbal substances

2.10.2 Biological substances

2.10.2.1 Approved biological name

2.10.2.2 Biological substances

2.10.2.3 Custom biological substances

2.10.3 Organism group

2.10.4 Traditional chinese medicines

2.11 Live Microorganisms

2.12 Homeopathic substances

2.12.1 Guidelines for homeopathic substance information

3. Organism Parts Standard Terminology

4. Organism Substance Preparation Terminology

4.1 Approved Organism Substance Preparation Name

4.2 Potency

4.3 Extraction Ratio

4.4 Solvents

5. Organism Types Standard Terminology

6. Ingredient Roles

6.1 Medicinal Ingredients

6.2 Non-medicinal Ingredients

6.3 Components

6.4 Non-Natural Health Products

6.5 Homeopathic

7. Ingredient Rules

7.1 Toxicity Restrictions

7.2 Non-medicinal Restrictions

7.3 Non-medicinal Purposes

7.4 Medicinal Restrictions

7.5 Non-NHP Restrictions

7.6 Sub-ingredients

7.7 Source ingredients and source materials

8. International Conference on Harmonization M5 Controlled

Vocabularies

8.1 Dosage Form Standard Terminology

8.2 Routes of administration Standard Terminology

8.3 Units Standard Terminology

9. Non-medicinal Ingredient Purposes Standard Terminology

10. Test methods

11. Appendices

11.1 Organism substance preparation information required in

electronic product licence application form

11.2 Some authoritative references

11.2.1 Organism scientific names

11.2.2 Organism substances

11.2.3 Chemicals

11.2.4 Proteins

11.2.5 Chemical constituents and herbal components

11.2.6 Non-medicinal ingredients

11.2.7 Additional references2

1. Introduction

The Natural Health Products Directorate (NHPD) and the natural health products

industry engage in an intense information exchange during the Natural Health

Product (NHP) licensing phase. One of the objectives of the NHP Online System is to

capture and validate licence applications and to securely submit them electronically

along with appropriate attachments. Applying standard terminology to NHP licence

applications will provide the ability to exchange product information between the

NHPD and industry in a structured and efficient way. Therefore, standard

terminology is one of the essential elements in this information exchange.

Consistency in naming also assists in the retrieval of information from the NHP

Online System and provides the ability of health professionals and the public to

compare similar goods.

1.1. Development and Terminologies

Currently, no single internationally agreed upon list or primary reference

comprehensively covers all substances or terms used, or likely to be used, with

regards to natural health products in Canada. Consequently, the NHPD has been

confronted with the challenge of adapting two major standards in order to meet the

NHPD requirements for use by the NHP Online System:

1) Initially, naming conventions for ingredients were adapted from the

Approved Terminology for Medicines, of the Australian Therapeutic Goods

Administration (TGA). Further refinements and modifications to the

terminology are described in this document.

2) Terminologies for dosage forms, routes of administration, and units and

measurements have been adapted from the International Conference on

Harmonization (ICH) controlled lists.

1.2. Obtaining and Using the Terminologies

Currently, tools such as the Natural Health Products Ingredients Database (NHPID)

and the electronic product license application (e-PLA) have incorporated this

standard terminology. Most of the terminology used by the NHP Online System can

be accessed on the internet through the main page of the NHP Ingredients

Database Web Application.

The terminology described below is in the context of the presentation of information

in the NHP Ingredients Database Web application. Information on how to search the

NHP Ingredients Database using the online Web application is available in the

Natural Health Products Ingredients Database Web Application Guide.

Wherever applicable, only approved terms should be used. NHPD encourages the

use of the standard terminology in reports, emails, and other documents.

Ingredients can be entered into the electronic Product Licence Application

Form either

by choosing an ingredient name found in the NHP Ingredients Database,

by constructing a customized medicinal ingredient name by selecting an

organism, an organism part, and a preparation type; for example:

Echinacea angustifolia (organism), flower (organism part), extract dry

(preparation type). The standard terminology for organism name, the

organism part, and the preparation type is in the NHP Ingredients

Database.

Thus, the names of substances derived from organisms can be defined organism

substance names, which are in the NHP Ingredients Database, or custom organism

substance names, which are constructed in the e-PLA form.

1.3. Adding, Deleting, Changing Terms in the Terminologies

For adding new terms, deleting existing terms, or changing any data associated

with a term, the requestor should complete a Natural Health Products Ingredients

Database Issue Form (Instructions for the form are in the Natural Health Products

Ingredients Database Issue Form Guide.) The change request process is

summarized below.

1) The requestor collects necessary information about the issue and any

appropriate references.

2) The requester prepares an NHP Ingredients Database Issue Form and then

sends the completed form and reference documents to NHP Ingredients

Database Support at ingredient_[email protected] by email, or by mail to:

Online Solution Support

Bureau of Licensing Services and Systems

Qualicum Tower A

2936 Baseline Road

Ottawa, Ontario

K1A 0K9

3) The change request is viewed by a Terminology Specialist at the NHPD.

4) The original requester is informed of the decision made at the NHPD or is

asked for further clarification if required.

The time required for reviewing a request may vary depending on the quality

and/or the complexity of the request.

2. Substance Names in Standard

Terminology

Consistency in naming assists the retrieval of information from the NHP Ingredients

Database and allows efficient handling of acceptable ingredient information

including evidence to support safety and efficacy, and quality testing requirements.

NHPID names should be used when submitting applications for product licensing to

the NHPD as well as in product information, consumer information and other

promotional literature, wherever use of the terminology is applicable.

To understand conventions used in assigning approved names to the ingredients,

and abbreviations presented in the NHP Ingredients Database, users are

encouraged to review the Therapeutic Goods Administration (TGA)- Approved

Terminology for Medicines.

For names in the English language, both American and British spellings may be

used.

In some cases, names in the NHP Ingredients Database appear in a word order that

differs from that of normal language, such as “Angelica Root Dry”. On the product

label, the words in the name can appear in the order appropriate for normal

language. For example, on a product label either “Dry Angelica Root” or “Angelica

Root Dry” would be acceptable. In addition, on the label, “dried” can be substituted

for “dry”, and the plant part may be changed from singular to plural. For example

“Dried Angelica Roots” could appear on the label.

2.1. NHPID Names

An NHPID name is a unique identifier of a substance. Each substance has only one

NHPID name, which has been designated by NHPD as the name that should be used

as the primary identifier of the substance, wherever it is applicable.

Selecting NHPID names is based on the following rules.

It must be unique globally

It must be the primary name used in the reference cited

Avoid long names such as chemical International Union of Pure and Applied

Chemistry (IUPAC) names

Avoid uncommon synonyms

Trade names, product IDs, registry numbers, and other terminology IDs

(such as Flavour & Extract Manufacturers Association (FEMA)) cannot be

used as approved names; and

Although CAS Registry numbers appear in some entries in the NHP

Ingredients Database, these numbers cannot be used as substance names.

For homeopathic ingredients, the NHPID name will consist of the pharmacopoeia

name (abbreviated as EHP, HPUS etc.), an underscore, and a proper name of the

ingredient in the NHPID. For example: HPUS_Tormentilla

A preparation that can reasonably be specified by listing its individual ingredients

separately, usually will not be included in the standard terminology for ingredients,

and therefore will not have an NHPID name.

2.2. Proper Names

The Natural Health Products Regulations sets out rules for ingredient proper names.

The proper names are as follows.

For vitamins, use Biotin, Folate, Niacin, Pantothenic acid, Vitamin A,

Thiamine, Riboflavin, Vitamin B 6, Vitamin B 12, and Vitamins C, D and E.

Forchemical substances (except vitamins) and protein substances, use any

unambiguous chemical name provided by an authoritative reference such as

the Merck Index, the United States Pharmacopeia Dictionary, etc.

For an organism, a plant material, or a non-human animal material, use the

scientific Latin names of the organism, that is “its genus, and its specific

epithet” (For example, for Black currant seed oil, the proper name is the

scientific name of the plant species, Ribes nigrum.)

For homeopathic ingredients, the proper names are as provided in the

pharmacopoeia.

For some defined organism substances, the proper name is not the Latin binomial.

When a substance comes from a group of organisms, then its proper name is

usually the name of the substance. (For example, Shark cartilage is a proper

name). When an organism substance is produced by an organism, but is normally

outside the organism, as in the case of Honey, then the proper name can be the

name of the substance. (Thus, Honey is a proper name).

2.3. Common Names

The Product Licensing guidance document states that the common name of an

ingredient is “the name by which it is commonly known and is designated in a

scientific or technical reference”. However, in practice, especially for chemicals,

determining an unambiguous common name is not always straightforward.

According to the terminology presented here, ingredient common names are

mapped based on the following rules:

A common name must be supported by at least one authorized reference.

For homeopathic ingredients, the common names are as provided in the

pharmacopoeia.

2.3.1 Organism Substances

When a medicinal ingredient has a custom organism substance name that is

constructed in the electronic Product Licence Application Form (by choosing an

organism, organism part, and preparation method), the name that appears in the

Common Name field is a common name of the organism. The organism part

appears in the Source Material field for the ingredient. Using the common name of

the organism, the organism part, and the preparation method, a common name for

the organism substance can be assembled. (e.g. Carrot seed extract)

When a defined organism substance is chosen as a medicinal ingredient in the

electronic Product Licence Application Form, the proper name is normally the

scientific name of the organism, but the name in the Common Name field is a name

of the defined organism substance, rather than a common name of the organism.

For example, ingredient Saskatoon berry extract has “Saskatoon berry extract” in

the Common Name field and “Amelanchier alnifolia” as its proper name.

2.4. Taxonomical Synonyms and Subordinate Taxa

Taxonomical synonyms are scientific names other than the NHPID names for

organisms. For a particular scientific name, the subordinate taxa are scientific

subdivisions. For example, for the species Chamerion angustifolium, a name of a

subordinate taxon is Epilobium angustifolium subsp. circumvagum, which is a

synonym of Chamerion angustifolium subsp. circumvagum. Each name must be

supported by at least one authorized reference.

2.5. Authorized References

Generally, ingredients included in the terminology set must be supported by at least

one authoritative reference. Addition of a new name to the NHP Ingredients

Database may be proposed using the NHP Ingredients Database Issue Form, in

which the authoritative reference for the name should be included.

It is important to note that the citation of an authority or reference for a name in

the terminology does NOT imply that the standard specified by that authority is

applicable to the substance used in a particular natural health product. For some

substances, a particular standard is indicated in the NHP Ingredients Database. If

no standard is specified for a substance, then the quality of the substance should

comply with the requirements as defined in the Evidence for Quality in Finished

Natural Health Product guide.

Conflicts may occur amongst certain authorized references with regards to the

scientific names of organisms. The primary binomial name of a species may vary

from one reference to another, or may even be put into different taxonomy nodes.

In order to help the NHPD data managers capture taxonomy data and to help users

search the NHP Ingredients Database, the NHPD gives precedence to some

references when adding organism names. For example, the scientific names of

plants in the United States Department of Agriculture (USDA) Germplasm

Resources Information Network (GRIN) Database are used, if the plant is included

in that database.

2.6. The Scope of the Terminology

The ingredient naming standard terminology captures ingredient names and other

NHPD-approved ingredient related information. The terminology captures the

following data elements:

NHPID name. The official name for a substance or organism. Usually, it

should be used as the primary identifier for a substance or organism.

Proper name. A proper name is an unambiguous name as defined in the

Natural Health Products Regulations.

Common name. A common name is a secondary identifier for a substance

or organism.

Taxon (taxonomical synonym, or other scientific name for an organism).

CAS registry number. Chemical Abstracts Service registry number for a

substance.

Ingredient role. Medicinal, Non-medicinal role, Non-NHP, Homeopathic

and Component.

Schedule 1 classification. Medicinal ingredient classification defined by

Schedule 1 of the Natural Health Products Regulations.

Ingredient category. See Section 2.7 below.

2.7. Types of Substances and Organisms

Substances can be thought of as falling into three major groupings:

Chemical, which includes Chemical Substances, Protein Substances, Herbal

Components

Herbal, which includes materials derived from plants, fungi, algae, and blue-

green algae

Biological (but not herbal), which covers substances of biological origin other

than those derived from herbal sources

An ingredient has a name in one of following categories.

Chemical (Category: Approved Chemical Name (ACN)). A chemical

substance can be a substance that can be obtained from a plant or a plant

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

or a substance that can be synthesized; or a substance that can be

obtained from the non-organism part of the environment (for example by

mining).

Protein (Category: Approved Protein Name (APN)). A protein is a

macromolecule composed of a chain of amino acids linked by peptide

bonds. An enzyme is a protein that catalyzes a biochemical reaction.

Herbal name (Category: Approved Herbal Name (AHN)). An organism

that is considered an herbal organism (a plant, alga, fungus or blue-green

alga).

Defined Organism substance (Category: Approved Herbal Substance

Name (AHS)). A substance from an herbal organism (which has an AHN).

Defined Organism Substance (Category: Approved Food Name (AFN)). A

food substance derived from an herbal organism (AHN).

Defined Organism Substance (Category: Approved Biological Name

(ABN)). An organism that is a non-human animal, bacterium (but not a

blue-green alga) or a probiotic.

Defined Organism Substance (Category: Approved Biological Substance

Name (ABS)). A substance from a non-human animal or bacterium (but

not from a blue-green alga).

Homeopathic Substance (Category: Homeopathic Substance Name

(HMN)). A substance as defined in a homeopathic pharmacopoeia.

Some defined organism substances are organisms and other defined organism

substances are derived from organisms. In the NHP Ingredients Database,

organisms can be identified by family, genus, species, subspecies, varieties, strains,

and forms. In addition, some groups of organisms are included in the database, for

example sharks.

The terminology also captures Herbal Components. Herbal Components are

chemical compounds that can be found in an herbal organism or herbal

substance as an active/marker constituent. Although Chemical Substances

isolated from plant materials may be used as ingredients, Herbal

Components cannot have medicinal or non-medicinal ingredient roles.Herbal

Component (Category: Herbal Component Name (HCN)). Chemical

compounds found in an herb (which has an AHN) or an herbal substance

(which has an AHS) as an active or marker constituent.

Aggregated categories are also used for convenience, such as with the ingredient

search tools. The categories above are further aggregated as chemical (ACN),

protein (APN), organism (AHN and ABN), and organism substance (AHS and AFN,

and ABS).

2.8. Chemical Substances and Herbal Components

A chemical substance in some cases is a purified constituent of a defined molecular

structure, which may be isolated from a plant or a plant material, an alga, a

bacterium, a fungus or a non-human animal material; may be chemically

synthesized; and may have a medicinal, non-medicinal, or non-NHP role.

Inherently, herbal components are chemicals as well. However, since herbal

components are not isolated for medicinal or non-medicinal use, they have been

assigned an individual category.

The data for chemical substances is organized and displayed by category,

synonyms, CAS registry numbers, reference (for NHPID name), etc. The NHPID

name together with the reference will define the molecular species in the case of a

single substance; the composition of the substance in the case of a mixture; or the

characteristics of a variable material. However, when specifications for a substance

are provided in the reference for the NHPID name (such as the United States

Pharmacopeia), these are not usually the specifications required for the substance

when used as an ingredient. Chemical structures are only available for selected

chemical substances in the NHPID.

2.8.1 Guidelines for Chemical Substances Information

Table 1 provides an explanation of how chemical substance information is organized

and displayed in the NHP Ingredients Database

Table 1 - The required data members for chemical substances

Chemical Substance

Information

Description

NHPID Name

The NHPID (Natural Health Products Ingredients

Database) name is a well-characterized chemical

substance name.

Category

The category that the ingredient name belongs to

-- in this case, Approved Chemical Name

Structure

Chemical structure of substance

Schedule 1

Category of substances according to the Natural

Health Products Regulations’ Schedule 1 (for

example, plants, non-human animals, vitamins,

probiotics, etc). Provided only for medicinal

ingredients.

Proper Names

Unambiguous name(s) as per the Natural Health

Products Regulations.

Common Names

Common name(s) are other valid names.

Selecting their hyperlink will display the reference

for the name (e.g. Joint FAO/WHO Expert

Committee on Food Additives (JECFA), Merck

Index (MI), United States Pharmacopoeia (USP),

British Pharmacopoeia (BP), European

Chemical Substance

Information

Description

Pharmacopoeia (EP)).

Chemical Abstracts

Services (CAS) Registry

Number

The CAS Registry Number is assigned by the

Chemical Abstracts Service to identify a specific

chemical substance. Selecting the CAS number

will display its reference.

Other Registry Numbers

A chemical name may have more than one

registry number. For these other registry

numbers, selecting their hyperlink will display the

reference for that number.

Reference

A name reference code is included for each

chemical substance to indicate the reference for

the NHPID name. Selecting the reference code

hyperlink will display the reference information.

The citation of a reference for a name in the

terminology does NOT imply that the standard

specified by that reference is applicable to the

substance used in a particular natural health

product.

2.8.2 Guidelines for Herbal Component Information

Herbal components (HCN) are chemical compounds or groups of chemical

compounds that are components of plant and plant materials. Herbal components

themselves cannot be medicinal or non-medicinal ingredients and their role can

only be defined as a Component (see Section 6.0 - Ingredients Roles). An herbal

component may be used as a marker or/and active constituent of a standardized

herbal ingredient or in claims which concern the strength or concentration of the

component in an herbal ingredient.

Since all herbal components are chemicals in nature, naming herbal components

follows the convention of naming general chemicals. Furthermore, herbal

components belong to one of the five following chemical classes: carbohydrates and

lipids, nitrogen-containing compounds, alkaloids, phenolics, and terpenoids. Each

class is further divided into several subclasses.

An herbal component can be contained in various herbal substances and the

relative quantities may vary. In order to supply information on the herbal

components, the NHP Ingredients Database sometimes provides the lower and/or

upper amounts of the components in the parts of the source organisms (see

Section 7.6 - Sub-ingredients).

Table 2 provides an explanation of how herbal component information is organized

and displayed in the NHP Ingredients Database.

Table 2 - Required data members for herbal components

Herbal Component

Information

Description

NHPID Name

The NHPID (Natural Health Products Ingredients

Database) name is a well-characterized name for a

component of an herbal ingredient.

Category

The category that the ingredient name belongs to -

- in this case Herbal Component Name.

Proper Names

Unambiguous name(s) as per the Natural Health

Products Regulations.

Common Names

Common names are other valid names. Selecting

the hyperlink will display the reference for the

name.

Single or Group

Belonging to a single chemical or a group of

chemicals.

Chemical Class

One of five chemical classes: carbohydrates and

lipids, nitrogen-containing compounds, alkaloids,

phenolics, and terpenoids.

Chemical Subclass

One of the subordinate chemical groups of chemical

classes.

Chemical Abstracts

Service (CAS) Registry

Number

The CAS Registry Number is assigned by the

Chemical Abstracts Service to identify a specific

chemical substance. Selecting the CAS number will

display its reference.

Other Registry

Numbers

A chemical name may have more than one registry

number. For these other registry numbers,

selecting the hyperlink will display the reference for

that number.

Reference

A name reference code is included to indicate the

reference for the NHPID name. Selecting the

reference code hyperlink will display the reference

information. The citation of a reference for a name

in the terminology does NOT imply that the

standard specified by that reference is applicable to

the substance used in a particular natural health

Herbal Component

Information

Description

product.

2.9 Protein Substances

Proteins consist of amino acids which are a class of organic molecules that contain

amino and carboxyl groups. Proteins can be found in parts of plants, algae, fungi,

bacterium or non-human animal material. Enzymes primarily act as a catalyst

increasing the rate at which a specific biochemical reaction occurs. Enzymes are

considered to be protein molecules and are mainly of three types: metabolic

enzymes, digestive enzymes and food enzymes. An approved protein name (APN) is

an NHPD-approved name for the protein, and the name is supported by an

authoritative reference.

2.9.1 Guidelines for Protein Substances Information

Table 3 provides an explanation of how protein information is organized and

displayed in the NHP Ingredients Database.

Table 3 - The required data members for protein substances

Protein Substance

Information

Description

NHPID Name

The NHPID (Natural Health Products Ingredients

Database) name is a well-characterized name for

protein substances.

Category

The category that the ingredient name belongs to -

- in this case Approved Protein Name.

Proper names

Unambiguous name(s) as per the Natural Health

Products Regulations.

Common names

Common names are other valid names. Selecting

their hyperlink will display the reference for the

name (e.g. Merck Index (MI ), United States

Pharmacopoeia (USP), British Pharmacopoeia (BP),

European Pharmacopoeia (EP), Food Chemicals

Codex (FCC ).

Chemical Abstracts

Registry (CAS) Number

The CAS Registry Number is assigned by the

Chemical Abstracts Service to identify a specific

chemical substance. Selecting the CAS number will

Protein Substance

Information

Description

display its reference.

Other Registry

Numbers

A protein name may have more than one registry

number. For these other registry numbers,

selecting the hyperlink will display the reference for

that number.

Reference

A name reference code is included for each protein

to indicate the reference for the NHPID name.

Selecting the reference code hyperlink will display

the reference information. The citation of a

reference for a name in the terminology does NOT

imply that the standard specified by that reference

is applicable to the substance used in a particular

natural health product.

2.10 Organisms and Defined Organism Substances

The naming standard for ingredients from organisms (i.e. a plant or a plant

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

extract of the preceding or a probiotic) defines three types of names for organism

substances: approved scientific names for an organism (i.e. Latin binomials),

approved names found in authoritative references, and approved names assembled

from organism names, organism part names, and preparation methods found in an

authoritative reference.

Organism substances can belong to either herbal substances (Approved Herbal

Name, Approved Herbal Substance, Approved Food Name) or biological substances

(Approved Biological Name, Approved Biological Substance). Herbal substances are

preparations of plants, and other organisms that are treated as plants in the

International Code of Botanical Nomenclature, such as fungi and blue-green algae.

Biological substances are substances of biological origin that are not antibiotics;

biological substances are derived from non-human animals and bacteria (other than

blue-green algae).

In the NHP Ingredients Database, an organism that has been included in the

database has a page with the main heading “Organism” that includes information

on the organism’s family and usually information on taxonomical synonyms and

subordinate taxa. Those organisms which have medicinal roles have a second web

page which also has “Organism” as the main heading; this page indicates that the

organism has a medicinal role. An organism with a medicinal role can be chosen as

a medicinal ingredient in the electronic Product Licence Application Form. Although

the Organism –medicinal role page lists the parts as either Whole or Whole plant,

and the preparation as Dry or Fresh, in the electronic Product Licence Application

Form a wide range of parts and preparations can be selected to create a custom

medicinal ingredient name.

2.10.1 Guidelines for Herbal Naming

2.10.1.1 Approved Herbal Name

An Approved Herbal Name (AHN) is an NHPD-approved name for a plant or fungus

or blue-green alga. It must be a scientific name (usually a binomial Latin name)

supported by an authoritative reference. (For some authoritative references, see

the Appendix, section 11.2).

An AHN consists of a genus name, species descriptor, and any subordinate

taxonomical names such as subspecies, variety, and form when applicable. Please

note that there may be more than one binomial name (synonyms, spelling variants)

for one species. Only those with authoritative references are included in the NHP

Ingredients Database (approved herbal name and taxonomical synonyms). Some

example AHNs are as follows:

Coffea arabica

Triticum aestivum subsp. spelta

Coix lacryma-jobi var. ma-yuen

Cucumis melo subsp. melo var. cantalupensis

2.10.1.2 Herbal Substance Names

There are two categories of names for substances derived from organisms with an

AHN: Approved Herbal Substances Names (AHS) and Approved Food Names (AFN).

AHS and AFN are NHPD-approved ingredient names.

Usually, an AHS or AFN must be in English, French, or Latin. If an AHS or AFN

originates from another language, it is usually translated to English or French,

either by meaning or pronunciation. An AHS or AFN must be supported by at least

one authoritative reference and there must be at least one source organism name

(AHN) or organism group name. Information for organism parts and preparation

methods for AHS and AFN is also included. An organism part is represented by an

approved organism part name (see Section 3.0 - Organism Parts Standard

Terminology) and a preparation is represented by an approved organism

preparation name (see Section 4.0 - Organism Substance Preparation

Terminology).

For some AFN, the preparation method is indicated in the name; examples are

apple cider vinegar and Pyrus Communis (Pear) Fruit Juice. Typical preparations

for AFN are: dry, fresh, powder, juice dry, juice fresh, and juice concentrate.

AFNs refer only to edible substances fit for human consumption as foods. Even

though an inedible substance otherwise complies with the description of a food

substance in the category AHS, that inedible substance may not be named as an

AFN.

Some examples of AHS and AFN are shown in Table 4.

Table 4 - AHS and AFN examples

Name

AHS/AFN

Parent AHN

Organism

Parts

Organism

Preparations

Ambrette

Essential Oil

AHS

Abelmoschus

moschatus

Seed

Oil Essential

Amaranth Sprout

Powder

AHS

Amaranthus

cruentus

Sprout

Powdered

Radix Isatidis

AHS

Isatis tinctoria

Root

Dry

Rice

AFN

Oryza sativa

Seed

Dry, Fresh,

Powdered

2.10.1.3 Custom Herbal Substances

Custom Herbal Substances are herbal medicinal which are not part of the NHP

Ingredients Database, but can be identified in the electronic Product Licence

Application. Naming a Custom Herbal Substance must follow the rules outlined

below.

An herbal substance consists of three parts: AHN, the organism part name, and the

organism preparation method, where organism part name is an NHPD- approved

organism part name (see Section 3.0 - Organism Parts Standard Terminology) and

organism preparation method is an NHPD-approved organism part preparation

name (see Section 4.0 - Organism Substance Preparation Terminology). The

following illustrates the composition of a custom herbal substance:

"Thymus serpyllum" + "herb" + "dry" = “Thymus serpyllum herb dry"

2.10.2 Biological Substances

2.10.2.1 Approved Biological Name

Approved Biological Names (ABN) are the scientific names (usually binomial Latin

names) of organisms other than herbal organisms (non-human animals and

bacteria that are not blue-green algae). Like an AHN, an ABN can consist of three

parts: genus name, species epithet, and any subordinate taxonomical names.

Trinomial Latin names are also acceptable. An NHPD-approved biological name

must be supported by at least one authoritative reference (see the Appendix).

Some examples are:

Bos Taurus

Gekko gecko

Bufo bufo

Clupea harengus subsp. harengus

2.10.2.2 Biological Substances

Biological Substances have Approved Biological Substances (ABS) names and are

derived from organisms with Approved Biological Names (ABN). Like an AHS, an

ABS is a substance name usually in English, French, or Latin that is supported by at

least one authoritative reference (see Appendix). An ABS can be used as an NHPD-

approved ingredient name. Some ABS examples are as follows:

Royal jelly

Batryticatus Bombyx

Cornu Cervi Pantotrichum

Fish oil

2.10.2.3 Custom Biological Substances

Like Custom Herbal Substances, Custom Biological Substances are biological

substances that are not part of the NHP Ingredients Database. In the electronic

Product Licence Application Form, naming a Custom Biological Substance is similar

to naming a Custom Herbal Substance, i.e. approved organism name + organism

part name + organism preparation name.

2.10.3 Organism Group

The source materials of some ingredients, especially organism substances, are

groups of organisms. An approved group name should be created to deal with such

situations. An organism group consists of an approved organism group name, and

usually an included member list, and a possible excluded member list. If there is

not a member list for the group, then the membership of the group must be clear,

either from the group name or because there is a definition of the group in the NHP

Ingredients Database. The members can be a family name, genus name, species,

or any subordinate taxonomical names. The name of each member must be

supported by an authoritative reference. The following table (Table 5 - Organism

group examples) provides an example of an organism group for cottonseed oil.

Table 5 - Organism group examples

Group

Name

Included List

Excluded List

Cotton

group*

Gossypium [genus]

* The group can be the source of several related substances including cotton.

2.10.4 Traditional Chinese Medicines

In the NHP Ingredients Database, most medicinal ingredients used in traditional

Chinese medicine have the names that appear in the Chinese pharmacopoeia and

Materia Medica. When determining names, precedence is given to the

Pharmacopoeia of the People’s Republic of China, followed by the Chinese Herbal

Medicine, Materia Medica (Bensky et al. 2004).

2.11 Live Microorganisms

The medicinal ingredient in a natural health product can be a probiotic (Schedule 1

to the Natural Health Product Regulations). NHPD has adopted the internationally

accepted Food and Agriculture Organization (FAO)/World Health Organization

(WHO) (2006) definition of a probiotic: “"live microorganisms which when

administered in adequate amounts confer a health benefit to the host.” This

includes probiotics that might confer a health benefit in humans by benefiting the

microbiota indigenous to humans as in the Natural Health Products Regulations.

Many health effects of live microorganisms depend on the specific strain, and strain

is important for surveillance and epidemiology studies (Probiotics in Food, FAO Food

and Nutrition Paper 85). The rules for naming Organisms in section 2.10, above,

apply to live microorganisms. In addition, the strain must be specified, which is in

accordance with proposed nomenclature for bacteria used as active ingredients in

ICH M5 (Data Elements and Standards for Drug Dictionaries). For some live

microorganisms, the NHP Ingredients Database contains a specified strain, for

example Lactobacillus plantarum DSM 9843. For other microorganisms, the species

name is included in the NHP Ingredients Database, and the applicant indicates the

strain in the electronic Product Licence Application Form.

2.12 Homeopathic Substances

Homeopathic substances are substances as defined in one of the five

pharmacopoeias acceptable to NHPD: the Homeopathic Pharmacopoeia of the

United States (HPUS), the Encyclopedia of Homeopathic Pharmacopoeia (EHP), the

German Homeopathic Pharmacopoeia (HAB), the French Pharmacopoeia

(Pharmacopée française or PhF), and the European Pharmacopoeia (PhEur).

2.12.1 Guidelines for Homeopathic Substance Information

Table 6 provides an explanation of how homeopathic substance information is

organized in the NHP Ingredients Database.

Table 6 – The required data members for homeopathic substances

Homeopathic Substance

Information

Description

NHPID Name

NHPID names consist of the pharmacopoeia, an

underscore, and a proper name of the ingredient

Category

The category that the ingredient name belongs to – in

this case Homeopathic Name.

Proper name

As provided in the pharmacopoeia

Common name

As provided in the pharmacopoeia

Reference

Pharmacopoeia applicable to the ingredient.

3. Organism Parts Standard Terminology

Organism parts are used for three purposes:

1. as a part of the ingredient name,

2. to identify the raw materials (source materials) of a Custom Defined

Organism Substance, and

3. to identify the source of a substance, such as an isolate, when the source

material is a part of an organism.

The organism part standard terminology is developed at the NHPD based on the

Australian TGA Terminology for Naming Medicines. The full list of organism parts is

searchable through the NHP Ingredients Database using the Controlled Vocabulary

Search. Only the approved names of the list are acceptable wherever the

terminology is applicable. If additions of new parts or changes to existing part

names are required, a request for change should be sent to the NHPD via the NHP

Ingredients Database Issue Form (see section 1.3 above).

Please note that an Approved Organism Part Name may mean either a single

organism part (such as a leaf or seed) or a combination of organism parts when

they are difficult or impossible to separate, or they can provide the same medicinal

activity profiles (such as “root and root nodule” and “whole plant”). Unapproved

combination organism part names are not acceptable.

4. Organism Substance Preparation

Terminology

The organism substance preparations standard terminology captures preparation

names and other related data on preparing or processing Defined Organism

Substances and Custom Organism Substances from raw materials. In all, the

following data may be captured:

Approved organism substance preparation name (method of preparation)

Potency

Extraction ratio

Quantity Crude Equivalent (QCE)

Whether the source material for an extract is dry or fresh

Solvents

4.1. Approved Organism Substance Preparation Name

For each organism substance, a method of preparation must be chosen from the

approved organism substance preparation names. Examples of approved

preparation names are: Decoction, Decoction concentrate, Decoction standardized,

and Decoction concentrate standardized. A full list of the acceptable methods of

preparation along with their definitions can be found using the Controlled

Vocabulary Search of the NHP Ingredients Database with the category set to

Organism Part Preparation Types.

In the electronic Product Licence Application form, the requirements for other data

depend on the preparation names. For example, only standardised preparations

require potency. Please refer to Appendix (section 11.1) for the information

requirements associated with each organism substance preparation.

4.2. Potency

A potency is required only for standardised preparations. It captures the

concentration of an active or marker constituent of an ingredient. In the electronic

Product Licence Application, potency consists of the name of the active or marker

constituent and the amount of the constituent in the ingredient. In the NHPID, the

active marker constituent is indicated as a sub-ingredient of the ingredient.

4.3. Extraction Ratio

Extraction ratios usually do not appear in the NHPID. However, in the Product

Licence Application Form, extraction ratios are required for medicinal ingredients

that are extracts, tinctures, or similar preparations.

The extract rato captures how the preparation is concentrated or diluted in

comparison with the raw (crude) material used. It is always expressed as 1:X, X:1,

or 1:1. The first quantity is the amount of raw materials (in weight) and the second

the amount of final preparation (in weight or volume). No units are required. It

always means Kg:Kg, or Kg:L, or g:g ,or g:ml, or mg:mg, or mg:microliter.

1:X is used for diluted preparations, and X:1 for concentrated ones. The extract

ratio 1:1 is for liquid extraction preparations only.

4.4. Solvents

This refers to solvents remaining in final preparations. It is required only when the

final preparation contains solvents. The solvent term captures a solvent name and

its strength (percentage). Only approved solvent names are allowed and these can

be found using the NHP Ingredients Database.

5. Organism Types Standard Terminology

Organism types are NHPD-authorized terms for organism group types, such as

“Plant”, “Fungi”, “Algae”, and different animal types. Please refer to the Controlled

Vocabulary Search of the NHP Ingredients Database for all NHPD-authorized

organism types.

6. Ingredient Roles

Ingredients approved and named in the terminology by the NHPD under the Natural

Health Products Regulations are subsequently assigned a role(s) and any applicable

restrictions. Presently, ingredients can be assigned one or more of the following

roles: medicinal, non-medicinal, non-NHP, component or homeopathic role.

6.1. Medicinal Ingredients

A medicinal ingredient (MI) is any substance that contributes to the

pharmacological activity of the product. These substances include plants, plant

materials, algae, bacteria, fungi, non-human animal materials, extracts, isolates,

vitamins, amino acids, essential fatty acids, synthetic duplicates, minerals and

probiotics, as described in Schedule 1 of the Natural Health Product Regulations. In

addition, based on the definition of “natural health product” in the Natural Health

Product Regulations (Section 1(1)), some ingredients used in traditional medicines

that are not included in Schedule 1 can have a medicinal role in natural health

products, for example Crinis Carbonisatis (charred human hair). A natural health

product ingredient must not require a prescription under the Food and Drug

Regulations, when it is sold other than in accordance with section C.01.043 of those

Regulations (i.e. no substances on The Prescription Drug List unless it is in

homeopathic medicine), as per Section 2(2) of the Natural Health Product

Regulations.

Homeopathic substances are never given a medicinal role. They are assigned a

homeopathic role, meaning they are considered medicinal in homeopathic

applications only.

6.2. Non-medicinal Ingredients

A non-medicinal ingredient (NMI) is any substance such as a binder, colouring

agent or flavour added to an NHP that is necessary for the formulation of dosage

forms. Non-medicinal ingredients should not exhibit any pharmacological effects of

their own, and, where applicable, should not exceed the maximum concentration

allowed.

As per section 5 of the Natural Health Product Regulations, the proper name and

common name of all medicinal ingredients as well as the common name and

purpose of all non-medicinal ingredients must be provided on the Product Licence

Application form. The NHP Ingredients Database includes many substances with

non-medicinal ingredient roles. Where appropriate, certain limitations regarding

quantity, dosage form, and route of administration are listed. For a non-medicinal

ingredient listed in a Product Licence Application Form, if the quantity of this

ingredient is not included in the form, then the amount used in the product must

not exceed any limits in the NHP Ingredients Database. Whether or not there are

limits indicated in the NHP Ingredients Database, the amount of a non-medicinal

ingredient used in a product must not exceed levels appropriate for good

manufacturing practice (GMP).

A full list of substances with non-medicinal purposes can be found using the NHP

Ingredients Database. Substances with a non-medicinal ingredient role in the NHP

Ingredients Database have been evaluated for the validity of the substance names

and for evidence supporting their non-medicinal ingredient purposes. However,

inclusion of a non-medicinal ingredient role and purpose for a substance in the

database does not imply that the substance has actually been used as a non-

medicinal ingredient. Also, a non-medicinal ingredient role for a substance in the

database does not indicate that the safety of this non-medicinal use has been

evaluated and approved by Health Canada. For any non-medicinal ingredient, the

NHPD may require a safety assessment as per Section 7d of the Natural Health

Product Regulations. If there is a particular safety concern with a non-medicinal

ingredient, the NHPD may request additional information. If there is a particular

safety concern with a non-medicinal ingredient, the NHPD may request additional

information. For a generic (non-proprietary) non-medicinal ingredient not contained

in the NHP Ingredients Database or used outside of the stated limitations, the

applicant can request an addition to the database by submitting an NHP Ingredients

Database Issue Form to Online Solutions Support, as described in section 1.3

above. The applicant should provide evidence supporting the non-medicinal use of

the ingredient..

6.3. Components

An ingredient which is assigned a component role is a substance which can be

present naturally in plant material and which has neither a medicinal nor a non-

medicinal role. Components can be listed on the Product Licence Application form

as marker or active constituents in the potency section for standardized extracts.

6.4. Non-Natural Health Product

A non-NHP (non-natural health product) is any substance which cannot be

considered to be a medicinal ingredient in an NHP under some condition of use. It

may not belong to one of the items in Schedule 1 of the Natural Health Product

Regulations (for example, a synthetic drug is not included in Schedule 1) or it may

be listed in Schedule 2 of the Natural Health Product Regulations. (For example,

marijuana, being a restricted substance, is not allowed as a natural health product.)

Some ingredients have either a medicinal role or a non-NHP role depending on the

condition of use. For example, Vitamin A below 10 000 IU/day is considered

medicinal, but above this threshold is treated as a prescription drug, which makes it

a non-NHP.

6.5 Homeopathic

An ingredient which is assigned a homeopathic role is a substance defined in a homeopathic

pharmacopoeia and which has a medicinal role in homeopathic applications. Only homeopathic

substances can have a homeopathic role, and they cannot have any other role.

7. Ingredient Rules

One of the objectives of the NHP Ingredients Database is to interface with other

parts of the NHP Online System in order to be able to automatically and completely

validate natural health product licence applications by providing a repository of

acceptable medicinal and non-medicinal ingredients and associated validation rules.

Applications are validated against a set of rules which derive from legislation,

regulations, monographs and other sources, such as approved controlled

vocabulary lists. Applications will be matched against rules to determine which rules

apply and then be accepted or rejected according to these rules.

There are a number of different rule types necessary for application entry and

validation. Some of them are required solely for validation, while others are needed

simply to assist the various users or determine screen flow.

The rules described in this section are toxicity restrictions, medicinal rules, non-

medicinal rules, non-NHP rules and sub-ingredient rules.

7.1. Toxicity Restrictions

Toxicity restrictions are restrictions which are inherent as part of an ingredient (i.e.

safety limits). One of the restrictions for ingredients in oral products is given in

terms of the acceptable daily intake (ADI). ADI is an estimate of the amount of a

substance, expressed on a body-weight basis that can be ingested daily without

appreciable risk. The safety limit or ADI is listed in units of mg per kg of body

weight per day.

7.2. Non-medicinal Restrictions

Some natural health product ingredients have non-medicinal limitations which are

listed based on the quantity, route of administration and dosage form. However, an

additional factor to take into consideration for non-medicinal restrictions is the fact

that, in natural health product licence applications, some ingredients can be both

medicinal and non-medicinal. For such ingredients that appear in monographs, it is

important to capture both the medicinal and non-medicinal levels for various

product types (such as antacids, sunburn protectants, etc). In NHPD and

Therapeutic Products Directorate (TPD) Category IV (CAT IV) monographs for

various product types, the medicinal ingredients are given an allowable range. For

those ingredients that are both medicinal and non-medicinal, the medicinal lower

limit translates into an upper non-medicinal restriction. For example, the NHPD

Diaper Rash monograph has a medicinal dose range of 10 to 98% for Corn starch

(NHPID name of Starch – Maize), but Corn starch can be a non-medicinal ingredient

with many purposes. Any product attesting to the Diaper Rash monograph and

containing Corn starch must list Corn starch as a medicinal ingredient if the dose is

10% or greater even though the presence of Corn starch is really for non-medicinal

purposes. The non-medicinal restriction description can be provided in terms of

daily acceptable intake, single dose, percentage of preparation, etc.

7.3. Non-medicinal Purposes

Acceptable non-medicinal ingredient (NMI) purposes and their descriptions can be

found using the Controlled Vocabulary Search of the NHP Ingredients Database.

7.4. Medicinal Restrictions

Based on the definition provided in Section 6.1 for medicinal ingredients, some

product ingredients could be classified as prescription drugs under The Prescription

Drug List, at some quantity levels or for some routes of administration. These

Prescription Drug List restrictions, along with some NHPD and TPD monograph

limits as well as other types of medicinal limits, are captured for selected medicinal

ingredients.

7.5. Non-Natural Health Product Restrictions

Normally, ingredients with a non-NHP role can never be medicinal. However, there

are some ingredients that are non-NHPs that can also have a medicinal role below a

well-defined threshold. For those ingredients, a non-NHP restriction is provided

indicating at which level they become non-NHPs. Below the well-defined threshold,

the ingredient is medicinal while above the threshold it is a non-NHP.

7.6. Sub-Ingredients

Sub-ingredient rules are an important part of the NHP Ingredients Database. An

ingredient is sometimes equivalent to certain amounts of ingredients or made up of

certain components which are known as sub-ingredients in the NHP Ingredients

Database. Sub-ingredients are associated with the source, which can be a chemical

substance, a protein substance or an organism part. The quantity of the sub-

ingredient in the source chemical substance is given in percentage (%). The

quantity of sub-ingredient in a specific part of an organism often is given in

microgram/g.

In the NHP Online System, if a chemical substance has an indicated sub-ingredient,

then that chemical substance is considered to be an acceptable source of the

indicated sub-ingredient. For example, Thiamine hydrochloride has Thiamine

indicated as a sub-ingredient, which implies that Thiamine hydrochloride is an

acceptable source of Thiamine. Similarly, Calcium carbonate has Calcium as an

indicated sub-ingredient, which implies that Calcium carbonate is an acceptable

source of Calcium. However, for medicinal ingredients, such as vitamins and

minerals, that are sub-ingredients of chemical substances in the NHP Ingredients

Database, bioavailability may not have been shown. In NHPD monographs,

bioavailability of the medicinal ingredient from the source ingredients listed in the

monograph has been supported by evidence.

For sub-ingredients of organism parts, the database contains the organism name,

part name, and the reference where the information was found. Two of the

references used for the dataset are Dr. Duke's Phytochemical and Ethnobotanical

Databases and “Phytochemical Dictionary: A Handbook of Bioactive Compounds

from Plants.” The latter is also used to assign HCN chemical classes and subclasses.

(see Appendix, section 11.2 for additional authoritative references.)

7.7 Source Ingredients and Source Materials

The origin of the ingredients can be source ingredients or source materials. Source

ingredients are other ingredients, often chemical substances that are sources of the

ingredient, while Source materials are parts of organisms containing the ingredient.

For example, Limestone is a source ingredient of Calcium, and the leaf of the

organism Urtica dioica is a source material for Calcium.

8. International Conference on

Harmonization M5 Controlled Vocabularies

Controlled vocabularies in the context of health products are being developed by

the International Conference on Harmonization (ICH) to facilitate the exchange and

practical use of medicinal product data by regulators and the pharmaceutical

industry (see “ICH; Draft Guideline M5 Data Elements and Standards for Drug

Dictionaries”). The ICH M5 defines controlled vocabulary as a standards related to

the following terminologies:

1) Active ingredients

2) Pharmaceutical dosage forms

3) Routes of administration

4) Units and measurements.

The NHP Online System project has adapted the TGA Terminology for naming

medicines (see Section 2) since this terminology suits the NHPD requirements for

naming substances included in natural health products for sale in Canada. NHP

Online has recognized the remaining terminologies, namely dosage forms, routes of

administration, and units and measurements from ICH M5 and has integrated these

controlled vocabularies as part of the overall standard.

8.1. Dosage Form Standard Terminology

Dosage form standard terminology captures all of the dosage forms approved by

NHPD. The dosage form controlled vocabulary includes pharmaceutical dosage form

terms of standard terminologies in use by the regulators in the ICH regions and

observer countries. A dosage form as defined by ICH is a physical manifestation

[“entity”] that contains the medicinal and/or non-medicinal ingredients that deliver

the dose of the medicinal product. The key defining characteristics of the dosage

form can be the state of matter, delivery method, release characteristics, and the

administration site or route for which the product is formulated. All dosage forms

for natural health products are among those approved by Canada Vigilance for

adverse reaction reporting. NHPD has also recognized approved synonyms for

dosage forms. All of the approved dosage forms, their synonyms, and definitions

can be found with a Controlled Vocabulary Search of the NHP Ingredients Database.

8.2. Routes of administration Standard Terminology

Routes of administration standard terminology captures all routes of administration

approved by NHPD. The routes of administration controlled vocabulary uses terms

from standard terminologies in use by regulators in the ICH regions and observer

countries and defined in the ICH M5 guideline “Data Elements And Standards For

Drug Dictionaries”. The route of administration indicates the part of the body

through or into which, or the way in which, the medicinal product is intended to be

introduced. The approved routes of administration can be found with a Controlled

Vocabulary Search of the NHP Ingredients Database.

8.3. Units Standard Terminology

Units standard terminology captures all of the units approved by NHPD. The units

and measurements controlled vocabulary includes units and measurements in use

by the regulators in the ICH regions and observer countries and defined in the ICH

M5 guideline “Data Elements And Standards For Drug Dictionaries.” All of the

approved units can be found by using the NHP Ingredients Database.

9. Non-medicinal Ingredient Purposes

Standard Terminology

Non-medicinal ingredient purposes standard terminology captures all of the

approved non-medicinal ingredient purposes approved by NHPD. A list of these

purposes can be found with a Controlled Vocabulary Search of the NHP Ingredients

Database.

10. Test Methods

As part of the quality requirements to obtain a license to sell a natural health

product, applicants must provide information on the test methods used for identity,

microbial testing, chemical contaminant testing, and so on. The Controlled

Vocabulary Search section of the NHP Ingredients Database allows for a search on

pre-cleared test method names and types. To request addition of missing test

methods to the database, the NHP Ingredients Database Issue Form should be filled

and submitted as described in section 1.3 above.

11 Appendices

11.1Organism Substance Preparation Information Required in Electronic Product Licence

Application Form

Please note that new methods of preparation are constantly being added and that the information below was correct as of October

2013.

Table 7: Organism Substance Preparation Information

Approved

Name

Potenc

Ratio

Quantity

Crude

Equivalent

Original

Material

Used

Solvents

Absolute

Required

X:1

Required

all

Attenuated

Cold infusion

Required

X:1

Required

all

Concentrated

juice

Required

X:1

Required

all

Decoction

Required

1:X

Required

all

Decoction

concentrate

Required

X:1

Required

all

Decoction

concentrate

standardise

Require

Required

X:1

Required

all

Decoction

standardise

Require

Required

1:X

Required

all

Defatted,

ground

Approved

Name

Potenc

Ratio

Quantity

Crude

Equivalent

Original

Material

Used

Solvents

Distillation

Required

1:X

Required

Water –

potable;

Water -

purified

Distillate

concentrate

Required

X:1

Required

Water –

potable;

Water -

purified

Distillate

concentrate

standardise

Require

Required

X:1

Required

Water –

potable;

Water -

purified

Distillate

standardise

Require

Required

1:X

Required

Water –

potable;

Water -

purified

Dry

damaged

Dry

standardise

Require

Extract dry

Required

X:1

Required

all

Extract dry

standardise

Require

Required

X:1

Required

all

Extract

liquid

Required

1:X

Required

all

Approved

Name

Potenc

Ratio

Quantity

Crude

Equivalent

Original

Material

Used

Solvents

Extract

liquid

standardise

Require

Required

1:X

Required

all

Fermentation

Fluid extract

Required

1:1

Required

all

Fluid extract

standardised

Require

Required

1:1

Required

all

Freeze-dried

Fresh

Gelatinized

Inactivated

Infusion

Required

1:X

Required

all

Infusion

concentrate

Required

X:1

Required

all

Infusion

concentrate

standardise

Require

Required

X:1

Required

all

Infusion

standardise

Require

Required

1:X

Required

all

Juice

powdered

Approved

Name

Potenc

Ratio

Quantity

Crude

Equivalent

Original

Material

Used

Solvents

Juice

powdered

standardise

Require

Required

Juice

standardise

Require

Required

Killed

Live

Oil, Animal

fixed (render)

Oil, Animal

fixed (render)

Standardised

Require

Oil, Essential

(Distillation

from absolute)

Oil, Essential

(enfleurage)

Oil, Essential

(enfleurage)

Standardised

Require

Oil, Essential

(expression)

Oil, Essential

(expression)

Standardised

Require

Approved

Name

Potenc

Ratio

Quantity

Crude

Equivalent

Original

Material

Used

Solvents

Oil, Essential

(other methods

of preparation)

Oil, Essential

(other methods

of preparation)

Standardised

Require

Oil, Essential

(water steam

distillation)

Oil, Essential

(water steam

distillation)

Standardised

Require

Oil fixed

standardise

Require

Oil infused

standardise

Require

Oil, Medicated

from dried

plant

Oil, Medicated

from fresh

plant

Approved

Name

Potenc

Ratio

Quantity

Crude

Equivalent

Original

Material

Used

Solvents

Oil, Plant fixed

(expression)

Oil, Plant fixed

(expression)

Standardised

Require

Oil, Plant fixed

(solvent)

Oil, Plant fixed

(solvent)

Standardised

Require

Ointments and

salves

Powdered

standardise

Require

Preservation

Pressed

(mechanical)

extraction

Required

X:1

Required

all

Pressed

(mechanical)

extraction

standardised

Require

Required

X:1

Required

all

Roasted ground

Tincture

Required

1:X

Required

all

Tincture

standardise

Require

Required

1:X

Required

all

Approved

Name

Potenc

Ratio

Quantity

Crude

Equivalent

Original

Material

Used

Solvents

Traditional

Chinese

Medicine

Traditional

Chinese

Medicine

extract 1:X

Required

1:X

Required

all

Traditional

Chinese

Medicine

standardise

Require

Traditional

Chinese

Medicine

standardise

d extract

1:X

Require

Required

1:X

Required

all

Traditional

Chinese

Medicine

standardise

d extract

X:1

Require

Required

X:1

Required

all

Traditional

Chinese

Medicine

Required

X:1

Required

all

Approved

Name

Potenc

Ratio

Quantity

Crude

Equivalent

Original

Material

Used

Solvents

extract X:1

Traditional

extract 1:X

Required

1:X

Required

all

Traditional

extract X:1

Required

X:1

Required

all

Traditional

standardise

Require

Traditional

standardise

d extract

1:X

Require

Required

1:X

Required

all

Traditional

standardise

d extract

X:1

Require

Required

X:1

Required

all

11.2 Some Authoritative References

11.2.1 Organism Scientific Names

Plants

• Germplasm Resources Information Network (GRIN) [Online Database].

http://www.ars-grin.gov/cgi-bin/npgs/html/queries.pl?language=en

• Integrated Taxonomic Information System (ITIS) [Online Database].

http://www.itis.gov/

• Catalogue of Life [Online Database]. http://www.catalogueoflife.org/annual-

checklist/2010/search/all

• Global Biodiversity Information Facility (GBIF) [Online Database].

http://data.gbif.org/welcome.htm

• International Organization for Plant Information (IOPI) [Online Database].

http://bgbm3.bgbm.fu-berlin.de/iopi/gpc/default.asp

• International Plant Names Index (IPNI) [Online Database]. http://www.ipni.org/

• Plants Database [Online Database]. http://plants.usda.gov/

• The Plant List. [Online Database]. http://www.theplantlist.org/

• Tropicos [Online Database]. http://www.tropicos.org/

• Herbs of Commerce, 2

edition (McGuffin et al. 2000) [Book]

Various Organisms

• Integrated Taxonomic Information System (ITIS) [Online Database].

http://www.itis.gov/

• Catalogue of Life [Online Database]. http://www.catalogueoflife.org/annual-

checklist/2010/search/all

• Global Biodiversity Information Facility (GBIF) [Online Database].

http://data.gbif.org/welcome.htm

• National Center for Biotechnology Information (NCBI) Taxonomy [Online

Database]. http://www.ncbi.nlm.nih.gov/guide/taxonomy/

• World Register of Marine Species (WoRMS) [Online Database].

http://www.marinespecies.org/

• Index to Organism Names (ION) [Online Database].

http://www.organismnames.com/query.htm?searchType=tree&q=Organisms

Non-human animals

• Animal Diversity Web [Online Database].

http://animaldiversity.ummz.umich.edu/site/index.html

• Fishbase [Online Database]. http://www.fishbase.org/search.php

Algae

• Algaebase [Online Database]. http://www.algaebase.org/search/species/

Fungi

• Index Fungorum [Online Database].

http://www.indexfungorum.org/Names/Names.asp

Bacteria/Probiotics

• German Collection of Microorganisms and Cell Cultures [Online Database].

http://www.dsmz.de/

• J.P. Euzéby: List of Prokaryotic names with Standing in Nomenclature [Online

Database]. www.bacterio.net

11.2.2 Organism Substances

• Approved Terminology for Medicines (Australian TGA) [Online].

http://www.tga.gov.au/industry/medicines-approved-terminology.htm

• Pharmacopoeia of the People's Republic of China [Book]

• Chinese Herbal Medicine, Materia Medica (Bensky et al. 2004) [Book]

• Chinese Medical Herbology and Pharmacology (Chen and Chen 2004) [Book]

• A Comprehensive Textbook of Chinese Herbology (Lu 1999) [Book]

• British Herbal Pharmacopoeia [Book]

• British Pharmacopoeia [Online/Book]

• Food Chemicals Codex [Online/Book]

• Ayurvedic Pharmacopoeia of India [Online/Book].

http://www.ayurveda.hu/api/API-Vol-1.pdf

http://www.ayurveda.hu/api/API-Vol-2.pdf

http://www.ayurveda.hu/api/API-Vol-3.pdf

http://www.ayurveda.hu/api/API-Vol-4.pdf

http://www.ayurveda.hu/api/API-Vol-5.pdf

11.2.3 Chemicals

• Merck Index [Online/Book]

• Dictionary of Natural Products [Online Database]

• Martindale: The Complete Drug Reference [Online/Book]

• British Pharmacopoeia [Online/Book]

• United States Pharmacopeia [Online/Book]

• European Pharmacopoeia [Online/Book]

• USP Dictionary [Online/Book]

• ChemIDplus [Online Database]. http://chem.sis.nlm.nih.gov/chemidplus/

• International Union of Pure and Applied Chemistry [Online]. www.iupac.org/

• NAPRALERT [Online Database]. http://www.napralert.org/

• US Patents [Online]. http://patft.uspto.gov/

• MeSH [Online Database]. http://www.ncbi.nlm.nih.gov/mesh

• Chemical Abstracts Service [Online]. http://www.cas.org/

• International Nonproprietary Names [INN] [Book]

• Principles of Chemical Nomenclature: a Guide to IUPAC Recommendations [Book]

• Food Chemicals Codex [Online/Book]

• Joint FAO/WHO Expert Committee on Food Additives (JECFA) Monographs &

Evaluations [Online]. http://www.inchem.org/pages/jecfa.html

• Herbal Medicines (Barnes et al. 2007) [Book]

Minerals

• Mineralogy Database [Online Database]. http://webmineral.com/chemical.shtml

• Mindat [Online Database]. http://www.mindat.org/

11.2.4 Proteins

• Enzyme Nomenclature (Nomenclature Committee of the International Union of

Biochemistry and Molecular Biology) [Online Database].

http://www.chem.qmul.ac.uk/iubmb/enzyme/

• Merck Index [Online/Book]

• Martindale: The Complete Drug Reference [Online/Book]

• ChemIDplus [Online Database]. http://chem.sis.nlm.nih.gov/chemidplus/

• United States Pharmacopeia [Online/Book]

Enzymes

• Enzyme Nomenclature (Nomenclature Committee of the International Union of

Biochemistry and Molecular Biology) [Online Database].

http://www.chem.qmul.ac.uk/iubmb/enzyme/

• Enzyme [Online Database]. http://enzyme.expasy.org/

• BRENDA [Online Database]. http://www.brenda-enzymes.org/

11.2.5 Chemical Constituents and Herbal Components

• Merck Index [Online/Book]

• Phytochemical Dictionary [Book]

• ChemIDplus [Online Database]. http://chem.sis.nlm.nih.gov/chemidplus/

• United States Pharmacopeia [Online/Book]

• European Pharmacopoeia [Online/Book]

• Dr. Duke’s Phytochemical and Ethnobotanical Database [Online Database].

http://www.ars-grin.gov/duke/

• Handbook of Phytochemical Constituents of GRAS Herbs and Other Economic

Plants (Duke 2001) [Book]

• NAPRALERT [Online Database]. http://www.napralert.org/

• Journal of Natural Products [Online]. http://pubs.acs.org/loi/jnprdf

11.2.6 Non-medicinal Ingredients

• Merck Index [Online/Book]

• Martindale: The Complete Drug Reference [Online/Book]

• Handbook of Pharmaceutical Excipients [Online/Book]

• Fenaroli’s Handbook of Flavor Ingredients (Burdock 2010) [Book]

• Handbook of Pharmaceutical Additives (Ash and Ash 2002) [Book]

• Joint FAO/WHO Expert Committee on Food Additives (JECFA) Monographs &

Evaluations [Online]. http://www.inchem.org/pages/jecfa.html

• British Pharmacopoeia [Online/Book]

• United States Pharmacopeia [Online/Book]

• European Pharmacopoeia [Online/Book]

• Fiedler Encyclopaedia of Excipients [Book]

• Flavouring Substances [Online Database].

https://webgate.ec.europa.eu/sanco_foods/main/?event=display

• Food Chemicals Codex [Online].

• Food Additives Electronic Handbook (Ash and Ash 2008) [Compact Disc]

• Cornucopia II: A Source Book of Edible Plants (Facciola 1998) [Book]

• Canadian Nutrient File [Online Database]. http://www.hc-sc.gc.ca/fn-

an/nutrition/fiche-nutri-data/index-eng.php

• EAFUS: A Food Additive Database [Online Database].

http://www.fda.gov/food/ingredientspackaginglabeling/foodadditivesingredients/uc

m115326.htm

• International Cosmetic Ingredient Dictionary and Handbook [Book]

• Cosmetic Ingredient Identification Database (Personal Care Products Council)

[Online Database]. http://gov.personalcarecouncil.org/jsp/gov/GovHomePage.jsp

• CosIng [Online Database].

http://ec.europa.eu/consumers/cosmetics/cosing/index.cfm?fuseaction=search.sim

ple

• Cosmetic Hot list ingredients [Online]. http://www.hc-sc.gc.ca/cps-

spc/person/cosmet/info-ind-prof/_hot-list-critique/hotlist-liste-eng.php(Please note:

The Cosmetic Hotlist is a list of substances that are to be restricted or prohibited in

cosmetics and these restrictions may be applicable in some NHPs.)

11.2.7 Additional References

• PubMed. [Online Database].

http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed

• National Center for Biotechnology Information (NCBI) [Online].

http://www.ncbi.nlm.nih.gov/

• International Code of Botanical Nomenclature [Book]

• SCIRUS [Online Database]. http://www.scirus.com/srsapp/