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Process to change a registered OTC medicine

V1.2, June 2017

10 July 2017

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Step 8 - Completing and submitting your application

To complete and submit your application to change an ARTG entry for an OTC medicine, follow these steps and save your information as you progress through each page.

Accessing the application form in business services

Log in to Business Services.

  1. Select 'Applications'.
  2. Select the appropriate application form under the heading Over the Counter Medicine - for example,
    • for single component medicines select 'Non-Prescription Medicine'
    • for composite packs select 'Non-Prescription Composite Pack'.
  3. Complete the application form - ensure you select all of the correct change codes.
  4. Attach your application dossier (compiled in Step 6) to the application form or submit the dossier on CD/DVD/USB.
  5. Select 'Submit' and agree to the declaration and relevant assurances.

Submission ID number

You will be automatically issued a Submission Number which uniquely identifies the application.

Use this submission number in all future communications about the application.

Simultaneous applications

Avoid submitting an application to make changes to a medicine whilst another application to change the medicine is in process, as approved changes from the first application may be deleted from the ARTG when the subsequent application is finalised.

If you cannot delay submitting the application:

  • Notify us of the submission ID numbers for the application(s) already in process.

Monitoring the application progress

You can monitor the workflow status of your applications through Business Services.

The application start date is the date that the fees are processed (Step 9).

When your fees have been processed the workflow status will change from 'Submitted' to 'Under Review', which means that the application is in screening (Step 10). For changes processed as notifications, the workflow status will temporarily display as 'Under Review' as the system automatically processes the change.

Withdrawal of applications

You can withdraw an application at any time up until the decision is made.

To withdraw an application:

  • Inform us in writing of the intention to withdraw the application.

If the application is withdrawn due to safety issues, we may ask you to provide any adverse safety data.

Refund when an application is withdrawn

We will refund the portion of the fees corresponding to evaluation if the application is withdrawn before the application enters the evaluation step in the process.

We do not refund the full fees.

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