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OTC new medicines registration process

27 August 2020

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Step 9 - Screening your application

We will screen your OTC medicine application to verify that it has been submitted at the correct application level and it meets the requirements to be effective.

Requirements for an effective application

Your application is effective if it meets the requirements under section 23(2) of the Therapeutic Goods Act 1989. This means:

  • The prescribed application fee has been paid.
  • The application includes all information required, for the correct application level, to enable us to make a decision.
  • Applications for restricted medicines include a product information in the form approved under section 7D of the Act (section 23(2)(ba) of the Act).
  • Samples of the medicine have been delivered to the TGA (only if requested).

We rely on information in your application cover letter to confirm the application level and corresponding data requirements.

If your application cover letter does not contain information critical to verify the application level, we may not detect an application submitted at the incorrect level until evaluation in Step 10. This can have implications for you as explained in Step 10.

Opportunity for minor corrections

You will have an opportunity to make minor corrections, detected during the screening process, if the issue can be rectified promptly. For example, if we cannot locate an attachment that is mentioned in the cover letter, we will give you an opportunity to provide the attachment.

Effective applications

If your application is effective, we will:

  • accept it
  • undertake the evaluation
  • send you both:
    • a notification email, advising the application has been accepted for evaluation
    • an invoice for the remaining evaluation fees, if applicable.

Not effective applications

If your application is not effective:

  • we will:
    • not accept it for evaluation
    • remove your application from business services
    • write to you and explain why the application is not effective
    • refund the evaluation fee.
  • you will forfeit the application fee.

If you reapply to register the medicine on the ARTG, ensure your application meets the requirements for an effective application.

You cannot lawfully import, supply or export the medicine until you have an ARTG registration.

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