TGA use only

This form, when completed, will be classified as 'For official use only'.
For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA at <

Proposed ‘Herbal Substance Name’ (AHS)

Application form

This form is to be used to apply for a name for a herbal material that is fully characterised in a monograph or pharmacopoeia.
This application will be assessed by the TGA’s Herbal Ingredient Names Committee (HINC).
Refer to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) Part IV Section 17 ‘Naming of New Substances and Terminology’ for information on the naming of herbal substances. / Send completed form and attachments to:
Post:The Secretary
Herbal Ingredient Names Committee
Office of Complementary Medicines
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Fax: 02 6232 8577
Email:
Note this form is for the purpose of naming a herbal substance only, it does not imply approval for use of the substance in Listed medicines.

Proposed Approved Herbal Substance name (AHS)

Pharmacopoeial reference, edition, year, volume number

Herbal substance identity

Botanical name
Plant part used
Preparation

Does the herbal species in the proposed AHS have an Approved Herbal Name (AHN)?

Yes
No

If no, does the herbal species in the proposed AHS have a synonym that is an Approved Herbal Name (AHN)?

Yes
No- attach a completed Proposed Herbal Name application form

Is the herbal species in the proposed AHS approved for use in Listed medicines?

Yes
No- note that the proposed AHS, if approved, can only be used in Listed medicines if the herbal species included are approved for use in Listed medicines.

Product name

Product name (if applicable)

Person proposing name

Name
Position
Company
Client ID
Address
Telephone / Mobile
Email

Supporting material

A copy of supporting material must be attached

Supporting material (including copy of pharmacopoeial reference)

1.
2.
3.

TGA use only

Date received
Date sponsor notified of receipt of application
HINC meeting number & date
TRIM file number
Review outcome
Accepted
Not accepted
Incomplete
Comments
AHS
Reference
Action
Sponsor notified / Date
Entered in corporate code table / Date
Electronic Listing Facility (ELF) team notified / Date

Proposed ‘Approved Herbal Name’ (AHS) application form (July 2014)Page 1 of 3

For official use only