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Process to change a registered OTC medicine

27 August 2020

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Step 10 - Screening your application

For most change requests, we will screen your application to change your ARTG entry for your OTC medicine to verify that it can be accepted for evaluation. Requests processed as notifications are not screened.

During screening, we check that your application:

  • includes the correct change codes
  • has been submitted at the correct application level
  • is complete
  • is in the required format
  • includes the necessary supporting information.

We also assess the fees and, if necessary, issue an invoice for additional fees or a refund.

We rely on information in your application cover letter to confirm the correct selection of change codes and corresponding data requirements.

If your application cover letter does not contain information critical to verifying the change codes, we may not detect an application submitted at the incorrect level in Step 11.

Opportunity to correct minor errors

You will have an opportunity to correct minor errors that may be detected during screening, if the error can be rectified promptly. For example, if the cover letter refers to an attachment that we cannot locate, you will be given the opportunity to promptly provide the attachment.

Passing screening

For C2 to C4 level applications, when your application passes screening we will notify you that it has been accepted for evaluation.

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