This talk covers herbal medicines used in Listed medicines. Listed medicines are lower risk and can be purchased off the shelf from pharmacies, health shops, and supermarkets. Unlike registered medicines, the TGA does not assess each listed medicine for efficacy before it goes onto the market. The TGA also does not approve the medicine label before it reaches the market.
A thorough understanding of the Therapeutic Goods Administration (TGA) naming requirements and ingredient documentation is essential for ensuring compliance and product quality.  There are different low risk ingredients used in listed medicines. One of them is herbal ingredients. Herbal ingredients differ from pharmaceutical ingredients in that they are complex multi-component substances.   Natural variation, modification or selective breeding of a plant can lead to changes in the chemical composition of herbal ingredients. This may decrease the safety of the original, approved material.   This session is designed to support participants in this learning journey and provide a comprehensive guide to herbal ingredient and their components.    Nosheen will discuss the challenges of using herbal substances and provides necessary information and guidance to identify the herbal materials correctly and determine the correct Australian Herbal name to include in ARTG listings of the products, with examples and case studies.    The course  will explore the TGA’s ingredient naming categories, including Australian Approved Names (AAN) and Australian Herbal Names (AHN). Attendees will learn how to determine the appropriate naming category for a given substance and the implications for regulatory submissions, product specifications, and labels.      At the end of this session, attendees will learn:  
1.              A deeper understanding of herbal materials & herbal extracts naming. 
2.         How to identify herbal material & extracts  
3.             How to write a complete approved herbal name for listing with ARTG. 
4.             What are Herbal components 
5.            What are Modified Herbal Ingredients   
Who should attend 
•              Anyone new to therapeutic goods regulatory affairs in Australia or preparing to embark on a regulatory career.  •             Anyone working in complementary/ Listed medicines industry and wants to learn more about listing complex herbal ingredients. 
•   Those who would like to transition to a regulatory career from another related field or students who would like to complement their theoretical knowledge with a practical workshop. 
•                Professionals working with regulatory affairs colleagues in the complementary medicines, industries or who could benefit from an understanding of the discipline.