The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Introduction
The Mandatory requirements for an effective registered complementary medicine application describes the information, consistent with the CTD format, that must be submitted to the TGA in order for an application to register a complementary medicine to be considered effective and proceed to evaluation.
The General dossier requirements provides guidance for applicants to meet the general information requirements for an application for evaluation of a new registered complementary medicine.
This document provides guidance for applicants on information required in dossiers for registered complementary medicines for Module 1 to be consistent with the Common Technical Document (CTD) format.
For information required in dossiers for registered complementary medicines for Module 2- 5 refer to:
For general information on registered complementary medicine applications refer to: