You are here

Proposing a new ingredient name

TGA approved terminology for therapeutic goods

11 November 2019

If an ingredient name is not on the Approved Names List, you can submit a proposal for it to be included.

You can do this:

  • as a 'stand-alone' proposal for a new approved ingredient name, or
  • by including your proposal with the related application.

Preparing your proposal

There are four steps in the approval process for a new name.

Step 1 - Select the appropriate form

Choose the most appropriate form for your substance from the list in Table 14. If you are unable to determine the correct form, please contact TGA names by email: tganames@tga.gov.au.

Table 14: Ingredient name proposal categories
Ingredient type Form link
Chemical ingredients Proposed Australian Approved Name (AAN)
Biological ingredients Proposed Approved Biological Name (ABN)
Herb (plant) Proposed Approved Herbal Name (AHN)
Herbal substance Proposed Approved Herbal Substance Name (AHS)
Cell and Tissue ingredients Proposed Approved Cell and Tissue Name (ACN)

Step 2 - Prepare and submit your proposal form and supporting information

You will need to:

  • Provide a monograph or other reference that contains enough information to allow the name to be defined with certainty. This includes any details about salts and other derivatives.
  • Provide a justification if you are proposing a name that differs to an existing INN for that substance.
  • Check the relevant application form for any additional requirements for supporting information.

Step 3 - Consideration of the proposed name

  • We will check the form for completeness, including attached references.
  • We will not process incomplete forms until you provide the required information.

If insufficient information is provided

  • There may be delays in processing your proposal.
  • We may decide to reject the proposal.

Reviewing your proposed name

Relevant technical experts at the TGA will consider the proposed name for approval.

We have three internal committees to review proposed names:

  • Australian Approved Names Committee (AANC) - considers naming of AANs and terminology, as well as AANs for chemical substances derived from plants.
  • Approved Biological Names Committee (ABNC) - considers naming of ABNs and ACNs, as well as new terms for animal: parts, origins and preparations.
  • Herbal Ingredient Names Committee (HINC) - considers naming of AHNs, AHSs, AINs and HCNs, as well as new terms for plant parts and plant preparations.

Please note

The naming committees do not consider names for finished goods, e.g. trade names for medicines.

Step 4 - Approval

We will advise you of the outcome of our considerations in writing.

If the proposed name is accepted

We will update the Ingredients Table on the TGA Business Services website with enough information to identify the ingredient.

You can then use the approved ingredient name in other applications. For more information on searching for ingredient names in the Ingredients Table, refer to Appendix 3.1.1.

If your proposed name is not accepted

We will notify you and outline the reasons why the proposed name is unacceptable. Alternatively, we may propose an alternative name.

Please note

  • TGA approval of a name does not mean that the ingredient has been approved (or recommended) for use in therapeutic goods.

Proposing a new herbal ingredient name

When proposing a new herbal ingredient name, follow the process in section 9.1. You will also need to refer to the following:

Proposing a new plant part or preparation

There is no form for proposing a new plant part or plant preparation.

To do this, please contact TGA names by email: tganames@tga.gov.au.