Prescription medicines collection

How to search TGA business services for approved ingredients and accepted TGA terminology.

This document replaces AU eCTD specification - Module 1 and regional information Version 3.0 and contains updated information.

Sponsors can use this form to apply for an additional trade name for a registered prescription medicine, under section 23 of the Therapeutic Goods Act 1989. 

Use this form for Category 1 and Comparable Overseas Regulator (COR) report-based prescription medicines applications, or variations.

Find out what process to follow if a product is manufactured using a human embryo or a human embryonic stem cell, or any material sourced from such an embryo or stem cell.

The Pre-submission Planning Form (PPF) provides the TGA with the necessary information on the scope and scale of application to arrange appropriate resourcing for the processing and evaluation of an application.

Application form to import, supply or export a therapeutic good that does not comply with standards.

Find out how the free trade agreement affects your application to include a product on the Australian Register of Therapeutic Goods.

Find out when you should use a literature-based submissions (LBS) for your application.

User guide on how to submit shortage/discontinuation notifications to the TGA