Natural Health Products Ingredients Database Issue Form Guide

October 2010 - Version 2.0

About This Guide

This document describes the use of the Natural Health Products Ingredients Database Issue Form, which is designed to help applicants send NHPID data requests which are complete and accurate.

Should you have further questions after reviewing this guide, you can contact us by e-mail at ingredient_support@hc-sc.gc.ca.

Table of Contents

• About This Guide
• 1.0 Introduction
• 2.0 Filling Out an Issue Form
  • 2.1 Medicinal Ingredient Classification Request
  • 2.2 Non-medicinal Ingredient Purpose Request
  • 2.3 Other Modification to NHPID
• 3.0 Completing and Sending the Issue Form
  • 3.1 Tracking Numbers
• 4.0 Contact Information
• Appendix I - Medicinal Ingredient Request Information
• Appendix II - Non-medicinal Ingredient Purpose Request Information

1.0 Introduction

The Natural Health Products Ingredients Database (NHPID) is a repository of scientific terminologies which have been adapted for the Natural Health Products Online System (NHP Online System). Currently, no single internationally agreed-upon list or primary reference exists which comprehensively covers all substances or terms pertaining to natural health products (NHPs) in Canada. Therefore, the NHP Online System uses a combination of two existing standards:

1. Naming conventions for ingredients have been adapted from the Australian Therapeutic Goods Administration's (TGA) Approved Terminology for Medicines.
2. Terminologies for dosage forms, routes of administration, units and measurements have been adapted from the International Conference on Harmonization (ICH) M5 controlled lists, "Draft Guideline - M5 Data Elements and Standards for Drug Dictionaries (ICH M5)."

Further information about the scientific terminologies stored in the database can be found in the Natural Health Products Online System Standard Terminology Guide.  Currently, the database can be accessed only through the electronic Product License Application (e-PLA) form and the NHPID Web application.

Due to the vast quantity of information that has been entered into the NHPID, data quality issues are expected in the form of errors and/or omissions. Therefore, an issue form was created in order to manage changes to the ingredient information and standard terminology defined in the database.

All requests for additions or modifications to the NHPID must be submitted via the NHP Ingredients Database Issue Form.  All other methods of requesting a change will be disregarded.

2.0 Filling Out an Issue Form

All NHP Ingredients Database Issue Form fields with an asterisk (*) are mandatory and must be properly filled in before the form is submitted. Applicants must provide detailed and complete information to ensure fast processing of the issue.

Part 1 of the Issue Form, as shown in Figure 1: Part 1 of the Issue Form below, consists of information about the requester such as name and contact information. Collecting this data enables the Natural Health Products Directorate to inform the requester of its decision and to ask for clarifications when necessary.

Figure 1: Part 1 of the Issue Form

Part 2 of the form, where the Date field will be pre-filled when the form is finalized, consists of the request details. First, select the Type of Request as shown in Figure 2: Typeof Request Choices.

Figure 2: Type of Request Choices

The type of request you select will dictate the appearance of the rest of the form. As shown in Figures 3 through 5, each of the three possible request types generates different data requirements.

If you wish to revise your Type of request, you can switch request type at any time prior to finalizing the form.  Please note that when the Type of request is changed, it will generate a new Part 2 of the form and previous data entered in Part 2 will be deleted.  Please exercise caution when using this option.

2.1  Medicinal Ingredient Classification Request

Selecting Medicinal Ingredient Classification Request displays the fields shown in Figure 3: Medicinal Ingredient Classification Request section below.

Figure 3: Medicinal Ingredient Classification Request section

For a medicinal ingredient classification request, only naming information and references are required.  If the ingredient is already in the NHPID, its NHPID name is the only name that must be provided.  If the ingredient is not already present in the NHPID, we ask that you propose a proper name and at least one common name for the ingredient, and leave the NHPID name field blank.  References must be scientifically based and sent with the form.  Appendix I contains a list of helpful references.

2.2  Non-medicinal Ingredient Purpose Request

Selecting Non-medicinal Ingredient Purpose Request displays the fields shown in Figure 4: Non-medicinal Ingredient Purpose Request section below.

Figure 4: Non-medicinal Ingredient Purpose Request section

For a non-medicinal ingredient purpose request, naming information, excipient purpose and references are required.  You can search for pre-approved excipient purposes in the NHPID Web Application by executing a controlled vocabulary search and selecting "Non-Medicinal Ingredient Purposes" as the category.

For an organism, we request source information as well.  Appendix II contains a list of helpful references.

2.3  Other Modification to NHPID

Selecting a request for Other Modification to Ingredients Database displays the fields shown in Figure 5: Other Modification to Ingredients Database below. 

Figure 5: Other Modification to Ingredients Database

This type of request applies to the modification or addition of information to the NHPID other than the addition of a medicinal role and the addition of a non-medicinal purpose.  We request that you select from one of the three Data Categories as shown in Figure 6: Data Category.

Figure 6: Data Category

The Ingredient category is used to notify of changes to an ingredient not covered by the two previous types of requests and may include changes to a method of preparation, to a source material, to a sub-ingredient, for a common name addition or revision, and so on.  If the selected data category is Ingredient, the NHPID name will have to be entered. 

The Controlled Vocabulary category is used to notify of changes and/or additions to the controlled vocabulary listings (such as organism part, dosage form, test method and so on).  If the selected category is Controlled vocabulary, the controlled vocabulary category will have to be entered.  A listing of the controlled vocabulary categories can be found in the NHPID Web Application in the Category field of the Controlled Vocabulary Search.

The Monograph/AbLS category is used to notify of any monograph or AbLS issues including data inconsistencies, spelling errors, and so on.  If the selected category is Monograph/AbLS, the monograph or AbLS name will have to be entered.

Next, the request details and the references must be provided.  We ask that you provide as much information as possible in the Request Details field.  Finally, in order to assist with prioritization of the large number of issues that we receive, we need to know whether your change impacts the submission of an electronic Product Licence Application (e-PLA).

3.0 Completing and Sending the Issue Form

After entering all required information in the form for your type of request, select the Finalize button. This command launches a validation of the form which ensures that all mandatory fields are filled and all data is in the correct format. If any mandatory field is missing or any data has been entered incorrectly, the field(s) in question will be highlighted. Fill in or correct the highlighted fields and select the Finalize button again. When the request is complete, the message shown in Figure 7: Successful Validation Message will appear at both the top and bottom of the form. As well, at that time, the Tracking Number and Date fields will get populated.

Figure 7: Successful Validation Message

Please note that the Issue Form can be saved at any time. After the form has been finalized successfully, it is highly recommended that you save it immediately. A completed form cannot be altered unless one selects the Modify button. To validate a form that has been modified, the Finalize button must be selected once more.

Please note that, in order to receive unambiguous requests, only one Issue Form must be submitted per individual data modification.  Please be aware that the time required to process any issue will depend on both the quality of the provided information and the complexity of the request.

3.1  Tracking Numbers

Tracking numbers are used by the NHPD to uniquely identify Issue Forms submitted electronically. Any supporting documents and additional information in reference to a particular Issue Form must have the same tracking number as the Issue Form. This will ensure that all documents can be kept together and linked to the issue.

The tracking number is a unique seven-character number appearing in the top right corner of the form.  A tracking number is generated automatically when the Issue Form is successfully finalized for the first time.

4.0 Contact Information

An Issue Form for the NHPID may be sent by e-mail, fax or regular mail. The NHPD prefers to receive requests by e-mail.  Please note:  Any issues or inquiries received without an accompanying Issue Form will not be processed.

By e-mail:   
ingredient_support@hc-sc.gc.ca

By fax:
Natural Health Products Ingredients Database Support
613-957-8341

By regular mail:
Natural Health Products Ingredients Database Support
Natural Health Products Directorate
Health Canada
2936 Baseline Road, Tower A
Ottawa, Ontario 
K1A 0K9
Couriers: K2H 1B3

Appendix I - Medicinal Ingredient Classification Request Information

Natural Health Product means a substance set out in Schedule 1 or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine that is manufactured, sold or represented for use in:

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 set out in Schedule 2 or a homeopathic medicine or traditional medicine that is or includes a substance set out in Schedule 2.

See Natural Health Products Regulations.

Please consider this list of references as a helpful starting point to find supporting evidence for a request to add a MI to the NHPID.  Please note that this list is non-exhaustive.

Medicinal Ingredient Classification Request Information

Medicinal Ingredient Type	References
General	PubMed
Plants	NCBI Taxonomy Database
	Catalogue of Life
	Global Diversity Information Facility
	GRIN Taxonomy for Plants
	Integrated Taxonomic Information System
	International Organization for Plant Information
	The International Plant Names Index
	Plants Database
	Tropicos
Minerals	Minerals by Chemical Composition
Chemicals	ChemIDplus Advanced
	Natural Products alert
	United States Patent and Trademark Office
	Merck Index
	Dictionary of Natural Products
	Martindale: The Complete Drug Reference
	Herbal Medicine
Alga	Algaebase
Non-human animal materials	Animal Diversity Web
Enzymes	Enzyme Nomenclature Database
Bacteria/Probiotics	DSMZ - Search for bacterial nomenclature

Appendix II - Non-medicinal Ingredient Purpose Request Information

A non-medicinal ingredient is defined as any substance added to a NHP formulation to confer suitable consistency or form to the medicinal ingredients. In a manner consistent with existing regulations for conventional pharmaceuticals, non-medicinal ingredients should not exhibit any pharmacological effects of their own, should not exceed the minimum concentration required for the formulation, and should be safe in the amounts used. The presence of a non-medicinal ingredient must not adversely affect the bioavailability, pharmacological activity or safety of the medicinal ingredients. As well, non-medicinal ingredients must not interfere with assays and tests for the medicinal ingredients and, when present, antimicrobial preservative effectiveness. Non-medicinal ingredients should be the least toxic available that are appropriate to the formulation.

Please consider this list of references as a helpful starting point to find supporting evidence to add a NMI to the NHPID. Please note this list is non-exhaustive.

• World health Organization: Safety evaluation of certain food additives 2009
• Dictionary of Food Compounds (Yannai)
• Fenaroli's handbook of Flavor Ingredients sixth Edition (Burdock)
• Food additives Data Book (Smith and Hong-Shum)
• Handbook of Pharmaceutical Excipients sixth edition
• Fiedler Encyclopaedia of excipients sixth edition
• International Cosmetic Ingredient Dictionary and Handbook
• British Pharmacopoeia
• Joint FAO/WHO Expert Committee on Food Additives (JECFA)
• United States Pharmacopeia
• European Pharmacopoeia
• Martindale: The complete Drug Reference
• Merck Index
•  Food Chemicals Codex online
•  Cosmetic Ingredient Identification Database online
• Cosmetic Hot list ingredients (Please note: The Cosmetic Hotlist is a list of substances that are to be restricted or prohibited in cosmetics and may be applicable in some NHPs.)