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
<http://www.tga.gov.au/about/tga-information-to.htm>.
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: [email protected]
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
PO Box 100 Woden ACT 2606 ABN 40 939 406 804
Phone: 1800 020 653 Fax: 02 6203 1605 Email: [email protected] www.tga.gov.au
Reference/Publication AHS(1010)
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.
Proposed ‘Approved Herbal Name’ (AHS) application form (July 2014)
For official use only
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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)
For official use only
Page 3 of 3