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OTC new medicines registration process

27 August 2020

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Step 11 - Making the OTC registration decision

Before making a decision on whether to register an OTC medicine, you may need to verify the details of the application, including any changes that may have been made during the evaluation.

Matters considered before making a decision

When making the decision, under section 25 of the Therapeutic Goods Act 1989 on whether to register the medicine on the ARTG, the decision maker (the delegate of the Secretary of the Department of Health) will:

  • review all documentation associated with the application, including:
    • the application and submission dossier
    • the evaluation reports
    • responses to requests for information
    • advice from expert advisory committees
    • other relevant advice or information.
  • consider the matters detailed under section 25 of the Act, including whether the quality, safety and efficacy of the medicine have been established.

Once the decision is made we will send you a written notification of the decision (Step 12).

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