Prescription medicines collection

This page is for industry stakeholders (e.g. manufacturers of active pharmaceutical ingredients) who provide Drug Master Files (DMF) to the TGA

Change of sponsor name forms are now available

Update about the transitionary arrangements for reformatting Product Information, including accessing a fee waiver

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

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

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. 

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.

Explanatory guide on the quality modules to be submitted for influenza vaccine registration, for manufacturers and sponsors.

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.

The evaluation plan estimators can be used to approximate the dates of the milestones in the prescription medicine registration process