Guidance Providing an Overview of Listed Medicines and Listed Assessed Medicines Pathways and Legislative Requirements: Understanding the Legislative Framework for Listed Medicines

Guidance Providing an Overview of Listed Medicines and Listed Assessed Medicines Pathways and Legislative Requirements: Understanding the Legislative Framework for Listed Medicines

“Guidance for Applicants of Listed Medicines (AUST L) and Assessed Listed Medicines (AUST L(A))

This guidance document provides comprehensive information for applicants seeking to list medicines in the Australian Register of Therapeutic Goods (ARTG), specifically for listed medicines (AUST L) and assessed listed medicines (AUST L(A)). Key points include:

Regulatory Framework for Listed Medicines: 

• Overview of the pathways and legislative requirements for lower-risk medicines.
• The process for listing medicines in the ARTG, which allows for sale without a full pre-market assessment by the TGA on safety, quality, and efficacy.

  Application Process: 

• Step-by-step guidance on the application process, including access to TGA Business Services and the online application portal.
• Information on submission procedures, application fees, and TGA processing.
• Finalization and approval of listings.

 Conditions of Listing: 

• Details on statutory and additional conditions of listing, including substance-specific conditions and those linked to TGA assessed claims.
• Procedures for imposing and changing conditions of listing.
• Rights of the sponsor to appeal and undergo compliance reviews of listed medicines.

This document ensures applicants understand the regulatory processes, listing conditions, and rights and responsibilities associated with listing medicines in the ARTG.

Region: Australia
Source: https://www.tga.gov.au/resources/guidance/understanding-legislative-framework-listed-medicines