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Drugs and Health Products

Natural Health Products Ingredients Database Issue Form

The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Please note that we are currently modifying documents to reflect this change.

Thank you for your patience and understanding.

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We would like to thank you for your time and efforts in helping us to create a higher quality Natural Health Product (NHP) ingredient database. Natural Health Product Directorate (NHPD) is not obliged to implement any change requested in the NHP Ingredients Database. Your issue will be processed and assessed in order of priority. You will be acknowledged once a decision/response has been finalized.

Tracking Number

Part 1- Requester

  • Name
    • Surname
    • Given Name
  • Title
  • Language preferred
    • English
    • French
  • Contact Address
    • Street / Suite / PO Box
    • City - Town
    • Country
    • Province - State
    • Postal/ZIP Code
  • Telephone No.
    • Ext.
  • Fax No.
  • Email

Part 2 - Request

(Please do your best to provide us with the appropriate information pertaining to your issue by filling in the details below)

Date

Type of Request

  • Medicinal Ingredient Classification Request
    • Please provide naming information along with one or more references that prove that this substance falls within the natural health product (NHP) definition. Applicants must ensure that the medicinal ingredients contained in the product are natural health product substances in accordance with Schedules 1 and 2 of the Natural Health Products Regulations before any Product Licence Application (PLA) is submitted. See Natural Health Products Regulations. Helpful references are provided at the end of the form.
    • Naming
    • If the ingredient exists in the NHPID, please indicate its NHPID name only.  If it is a new ingredient, please propose its proper name and at least one common name.
    • NHPID name (for ingredient found in NHPID):
    • OR
    • Proposed Proper Name:
    • Proposed Common Name(s):
    • References
    • Reference(s) (For pharmacopeias, specify the edition, preferably the latest. For scientifically validated web sites, specify the URL. For journal articles, specify the journal name, author name(s), volume, year and page number, and attach scanned full text.)
  • Non-Medicinal Ingredient Purpose Request
    • Please provide naming information along with excipient purpose and references that support the purpose for this ingredient. Suggested references are provided at the end of the form. If the ingredient is sourced from an organism, please also provide source information.
    • Naming
    • If the ingredient exists in the NHPID, please indicate its NHPID name only. If it is a new ingredient, please propose its proper name and at least one common name.
    • NHPID name (for ingredient found in NHPID):
    • OR
    • Proposed Proper Name:
    • Proposed Common Name(s):
    • Source information (required if sourced from an organism):
    • Excipient purpose (select from NHPID):
    • References
    • Reference(s) (For pharmacopeias, specify the edition, preferably the latest. For scientifically validated web sites, specify the URL. For journal articles, specify the journal name, author name(s), volume, year and page number, and attach scanned full text.)
    • Priority Types
    • To help us set priorities and provide faster service, please check one of the following:
    • Modification to the Ingredients Database not impacting an electronic Product Licence Application
    • Modification to the Ingredients Database that must occur to allow the submission of an electronic Product Licence Application
  • Other Modification to Ingredients Database
    • Note: To add a medicinal role or a non-medicinal purpose/role to an existing or new ingredient, please go back and select a different type of request. This option is to modify or add to an existing piece of information in the NHPID (e.g. new/revised common name, new sub-ingredient, new test method, typographical error, mistake in monograph, etc).
    • Please indicate if your modification is for an ingredient, controlled vocabulary or monograph/AbLS. Please state clearly the nature of the change and provide references to support it.
    • Data Category:
    • Ingredient
      • NHPID name:
    • Controlled Vocabulary
      • Controlled vocabulary category (select from NHPID):
    • Monograph/AbLS
      • Monograph/AbLS name:
    • Request details (Please try to be as detailed as possible):
    • References
    • Reference(s) (For pharmacopeias, specify the edition, preferably the latest. For scientifically validated web sites, specify the URL. For journal articles, specify the journal name, author name(s), volume, year and page number, and attach scanned full text.)
    • Priority Types
    • To help us set priorities and provide faster service, please check one of the following:
    • Modification to the Ingredients Database not impacting an electronic Product Licence Application
    • Modification to the Ingredients Database that must occur to allow the submission of an electronic Product Licence Application

Finalize

This form has been completed. Please email your completed issue form to ingredient_support@hc-sc.gc.ca

Modify

Information On Types Of Requests

(1) Medicinal Ingredient Classification Request

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:

a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;

b) restoring or correcting organic functions in humans; or

c) 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 Type

References

General

Plants

Minerals

Chemicals

Alga

Non-human animal materials

Enzymes

Bacteria/Probiotics

(2) Non-Medicinal Ingredient Purpose Request

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
  • Next link will take you to another Web site Food Chemicals Codex online
  • Next link will take you to another Web site 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.)

(3) Other Modification To Ingredients Database

Please use this option for any proposed change to the Ingredients Database not involving a medicinal ingredient classification or the evaluation of a non-medicinal ingredient purpose. Examples are: new/revised common name, new sub-ingredient for a given organism part, new test method, to report an inconsistency in a monograph, typographical errors, etc.

Footnotes

denotes mandatory