Forms for sponsors of OTC medicines
OTC medicines forms
- New medicine registration application form (OTC medicines)
Use to apply for inclusion of new OTC products in the ARTG - Registered medicine variation form (OTC medicines)
Use to vary the particulars of OTC medicines which are already registered in the ARTG - New substance application form (OTC medicines)
Use to apply for approval to use new substances in OTC medicines - 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