Listing complementary medicines on the Australian Register of Therapeutic Goods (ARTG) is a crucial step for ensuring compliance with TGA regulations. This process involves navigating specific requirements, from gathering the necessary information to
understanding the certifications required for submission. As a sponsor, maintaining compliance extends beyond listing, encompassing ongoing responsibilities such as product monitoring and reporting obligations. This training session will demystify the ARTG listing process, guiding participants through the key steps, documentation requirements, and critical considerations for successful submissions. Attendees will also learn about the responsibilities of sponsors post-listing and the certifications that underpin compliance in this regulated environment.
Learning objectives:
At the end of this session, attendees will:
1. Understand the steps involved in listing complementary medicines on the ARTG.
2. Identify the key information and documentation required for submissions.
3. Learn the specific certifications necessary for compliance.
4. Gain insight into the ongoing responsibilities of sponsors, including recordkeeping and reporting requirements.
5. Be equipped to confidently manage ARTG listing processes and maintain compliance post-listing.
Who should attend:
This session is designed for:
• Regulatory affairs professionals involved in listing complementary medicines on the ARTG.
• Quality assurance personnel responsible for maintaining compliance with TGA requirements.
• Small to medium-sized business owners navigating ARTG listings.
• Entrepreneurs in the health and wellness industry looking to market compliant complementary medicines in Australia.
• Graduates or professionals transitioning into regulated industries who want to build foundational knowledge of ARTG listings and sponsor responsibilities.
Whether you are new to the field or seeking to enhance your understanding of ARTG processes, this training will provide actionable insights and practical knowledge.
Tina Bird: RegPartners | Director & Principal Consultant
With over 20 years of experience in the pharmaceutical industry, Tina has a proven track record in guiding businesses through the complexities of complementary and over-the-counter medicines. She has worked with leading companies such as Bristol- Myers Squibb, Catalent Pharma Solutions, and Blackmores Group, delivering strategic solutions to bring high-quality products to markets across Australia, New Zealand, Asia, and the USA. Tina’s expertise spans regulatory strategy, new product development, TGA compliance, GMP quality systems, and the development of customized training ã 2024 RegPartners 8 programs. Known for her practical and results-driven approach, she ensures businesses overcome regulatory and quality challenges efficiently and with confidence.
As the director of RegPartners, Tina is passionate about empowering health and wellness companies to achieve compliance and drive growth. Through her tailored support in regulatory affairs, quality management, advertising compliance, and training, she is committed to fostering collaboration, promoting industry best practices, and making a meaningful impact in the industry.