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OTC new medicines registration process

27 August 2020

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This guidance is intended to assist applicants to register a non-prescription over-the-counter (OTC) medicine on the Australian Register of Therapeutic Goods (ARTG).

The following webpages:

  • identify the regulatory process you need to follow
  • navigate you through the process step-by-step
  • link to relevant guidance and forms.

Steps in the OTC registration process

  1. Verifying your OTC medicine and access to Business services

    Skip this step if you have already determined that you have:

    • an OTC medicine that requires registration
    • access to Business services.
  2. Checking for new medicine ingredients
  3. Determining your application level
  4. Checking guidelines and mandatory requirements
  5. Ensuring valid GMP evidence
  6. Compiling data for your application
  7. Completing and submitting your application
  8. Paying your fees
  9. Screening your application
  10. Evaluating and requesting information
  11. Making the OTC registration decision
  12. Finalising your OTC registration

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