Pre-submission planning: prescription medicines

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.