Submit your application and dossier

Find out how to submit your prescription medicine application and dossier.

Certain information must be submitted to the TGA for prescription medicine applications to proceed to evaluation.

Before you lodge your application, make sure you read Mandatory requirements for an effective application

Key information for applicants

Submit data in eCTD format

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This information explains how to submit data in the electronic Common Technical Document (eCTD) format.
Submit data in NeeS format

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This information explains how to submit data in the Non eCTD electronic Submission (Nees) format.

Summary of fees and charges to applications submitted to the TGA

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Find out about fees and charges that apply from July 2024.
CTD Module 1: Administrative information and prescribing information for Australia

23 December 2020

Guidance

This guidance explains the administrative and prescribing (dossier) information you need to support the registration of a prescription medicine. It also applies to varying the details of an Australian Register of Therapeutic Goods (ARTG) registration for a prescription medicine.
Submitting a Drug Master File (DMF)

1 August 2024

Reference material

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

Forms

A list of TGA forms for prescription medicine sponsors.

Topics