Strategies for Initial Review of Products to Determine Eligibility for Australian Approvals

How do you know if a new product can be marketed in Australia? The answer lies in the very first questions you ask.In this episode of the Cognitio podcast, ARCS Australia CEO Tim Boyle sits down with Dr Helena Dickinson, a regulatory affairs consultant with over 30 years of experience in medicines and medical devices. Together, they unpack the critical steps in classifying a product and determining its eligibility for approval.Helena shares practical insights on:Why country of manufacture and GMP clearance are the first hurdles to clearHow ingredient names and monographs shape eligibilityThe importance of dosage forms and poison scheduling in classificationHow claims and indications can bump a product from listed to OTC—or OTC to prescriptionCommon pitfalls when relying on overseas approvalsWhether you’re working with listed medicines, OTCs, or prescription products, this episode offers a step-by-step framework to guide your initial review and avoid costly delays.🔗 Learn more about ARCS and join the community shaping the future of medicines, devices, and data at arcs.com.au.

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