Australian Complementary Medicine TGA Registration Application

Register Your Complementary Medicine with the TGA

Navigating the Therapeutic Goods Administration (TGA) registration process for complementary medicines in Australia requires careful attention to regulatory requirements, evidence standards, and sponsor obligations. This Australian Complementary Medicine TGA Registration Application form template streamlines the entire process, helping manufacturers, importers, and sponsors compile the necessary documentation for ARTG listing.

Whether you're applying for an AUST L (Listed) medicine based on traditional use claims or an AUST R (Registered) medicine requiring evaluated evidence, this form captures all essential information including formulation details, ingredient specifications, manufacturing quality standards, labelling requirements, and sponsor licensing credentials.

Designed for Australian regulatory compliance, this template incorporates TGA-specific requirements including ABN verification, GMP certification status, evidence of traditional use documentation, and detailed claims substantiation. It's particularly valuable for complementary medicine companies, contract manufacturers, regulatory affairs consultants, naturopaths launching product lines, and importers bringing overseas formulations into the Australian market.

The form supports both initial applications and variations, with conditional logic that adapts questions based on your product classification, ingredient schedule status, and intended therapeutic claims. By centralising information collection in one professional, brand-aligned form, you can reduce back-and-forth with regulatory teams and accelerate your pathway to market.

Paperform's calculation and conditional logic features make it easy to automatically determine applicable fees, route submissions to the right internal reviewers, and trigger follow-up workflows. Combined with Stepper, you can automate post-submission tasks like document verification, internal review cycles, payment processing, and TGA portal submission preparation—keeping your regulatory pipeline moving efficiently.

For businesses managing multiple product registrations, Paperform's Agency+ plan allows you to manage different sponsor entities, maintain secure records of submissions, and generate compliance reports—all from one platform that meets SOC 2 Type II security standards.