The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Purpose
The Application requirements for new substances in listed medicines (ARNS), provides guidance for applicants requesting evaluation of a substance for use in listed medicines [AUST L listed medicines and AUST L(A) assessed listed medicines]. It replaces guidance formerly included in the ARGCM V 8.0 Part C.
The guidance includes:
- Application process for new substances
- How the TGA regulates market exclusivity of a new substance before and after approval
- Administrative, quality and safety information requirements for a substance application
- A summary of core information requirements for different substance types