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OTC new medicines registration process

27 August 2020

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Step 7 - Completing and submitting your application

In this step, you will be completing the OTC medicine application form and submitting your application.

How to complete the application form

To complete and submit your application, follow these steps and save your information as you progress through each page.

  1. Log in to Business services.
  2. Select 'Applications'.
  3. Select the appropriate application form under Over the Counter Medicine - for example, for single component medicines select 'Non-Prescription Medicine and for composite packs select 'Non-Prescription Composite Pack.
  4. Complete the application form - ensure you select the correct application level.
  5. Attach your application dossier (compiled in Step 6) to the application form or submit the dossier on CD/DVD/USB.
  6. 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.

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 (see Step 8). 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 9).

Withdrawing an application

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If the application is withdrawn due to safety issues, we may ask you to provide any adverse safety data.

Note

When an application is withdrawn, we may retain the application and any material submitted in connection with the application.

Refund when an application is withdrawn

We will refund the evaluation fee if the application is withdrawn before it enters the evaluation step in the process.

We do not refund the application fee.

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