We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
It begins when you submit a pre-submission planning form (PPF).
In this form, you will need to give us information about your prescription medicine registration application.
We will use this information to allocate resources.
Read more about the prescription medicines registration process.
Submit a PPF
In your PPF, you will need to give us details of what you will present in your dossier, including:
- applicant and product details
- details of the application
- a declaration.
You can fill out a PPF via Pre-submission Planning Form.
For instructions on organising and filling out a PPF, see Information for applicants completing a pre-submission planning form.
After you submit
After you submit your PPF, we will:
- Verify it's complete and acceptable.
- Plan resources for your application.
Estimate how long your application will take
To calculate approximate milestone dates for your application, use our evaluation plan estimators.