Prescription medicines collection

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

This user guide describes how to change sponsor details in the Product Information (PI) and labels for prescription medicines

A user guide on how to change sponsor details in PI and labels.