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Process to change a registered OTC medicine

V1.2, June 2017

10 July 2017

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Step 12 - Making the decision

When we complete the evaluation of your application to change an ARTG entry for your registered OTC medicine and prior to the decision:

  • You may need to verify the accuracy of the details of the application, including any changes that may have been made during the evaluation.

The decision maker (the delegate of the Secretary) reviews all documentation associated with the application, including:

  • the application and submission dossier
  • any evaluation reports
  • responses to any requests for information
  • advice from expert advisory committees
  • other relevant advice or information.

The delegate considers the matters detailed in the relevant section of the Therapeutic Goods Act 1989:

  • Safety related requests (SRR); subsection 9D(2).
  • Self-assessable requests (SAR); subsection 9D(1) or subsection 9D(3).
  • Approvable changes (A); subsection 9D(3) or section 25 for applications made under section 23.

Once the decision is made we will send you a written notification of the decision (Step 13).

Changes processed as notifications

After a notification application is successfully submitted and the fees are processed, a computer program automatically makes the approval for the Secretary.

An acknowledgement email is then sent that informs the sponsor that a decision has been made to vary the medicine as requested.

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