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OTC medicines electronic lodgement and update of existing ARTG records

This document is divided into three parts:

  • General information - about the OPAL system, how to access it and security features
  • How to Use the OPAL System - provides guidance and tips for completing product applications
  • Update of ARTG records - provides information on how to update existing ARTG records for OTC and registered complementary medicines and details of supporting evidence required.

The document also includes information on how to validate an OTC or registered complementary medicine record using OPAL.

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OTC Medicines electronic lodgement and update of existing ARTG records (pdf,547kb)*