Forms for sponsors of complementary medicines
Complementary medicines forms
- Application to list a new drug or to vary the particulars of a Listed drug for supply in Australia
This form is no longer available on this website. Sponsors are now required to use the Electronic Listing Facility (ELF) <https://www.ebs.tga.gov.au> to list new medicines in the Australian Register of Therapeutic Goods (ARTG) and to vary the particulars of medicines that are currently included in the ARTG. - New medicine registration application form (complementary medicines)
Use to register complementary medicines on the ARTG - Registered medicine variation form (complementary medicines)
Use to vary particulars of complementary medicines already on the ARTG - Application for an evaluation of a new complementary medicine substance
To be completed by or for each applicant who wishes the TGA Office of Complementary Medicines to assess whether a new complementary medicine substance should be permitted in listable or non-prescription registrable products - Application for selective non-disclosure of active herbal extract details
Allows confidential active herbal extract details to be entered onto the ARTG following an assessment process - Pre-clearance application for animal-derived ingredients (ELF)
Assist users of ELF seeking preclearance for animal derived ingredients by detailing what the TGA is looking for and what supporting documents need to be provided - Justification for a particular route of evaluation
<http://www.tga.gov.au/docs/html/forms/justsch10.htm>
To be completed when an applicant wishes to have their product or substance evaluated by an area of the TGA other than as specified in Schedule 10 to the Therapeutic Goods Regulations - Notification of a proprietary ingredient
<http://www.tga.gov.au/docs/html/forms/notifpi.htm>
Allows proprietary ingredient formulations to be entered onto the ARTG
Related (general) forms
- Client details form
<http://www.tga.gov.au/docs/html/forms/clientdt.htm>
To be completed by or for each client involved with the supply of the therapeutic goods in Australia for which the TGA requires address details - Australia-US Free Trade Agreement certificates
<http://www.tga.gov.au/international/usfta.htm>
The Australia-US Free Trade Agreement came into force on 1 January 2005 - Authorisation to cancel a product from the Australian Register of Therapeutic Goods
<http://www.tga.gov.au/docs/html/forms/artg-cancel.htm>
Use to request cancellation of the registration/listing/inclusion of medicines and/or devices on the ARTG - Request to transfer the sponsorship of an ARTG entry - relinquishing company
<http://www.tga.gov.au/meds/tsfrelinqco.htm>
Used by the relinquishing company to request to transfer the sponsorship of an ARTG entry - Request to transfer the sponsorship of an ARTG entry - accepting company
<http://www.tga.gov.au/meds/tsfacceptco.htm>
Used by the accepting company to request to transfer the sponsorship of an ARTG entry