Before you lodge your pre-submission planning form (PPF) you can use the below evaluation plan estimators to approximate the dates of the milestones in the prescription medicine registration process. The estimators derive dates representing an example timeline using the TGA's business rules.
For PPFs that have been lodged and deemed to pass the preliminary assessment the TGA provides sponsors with an Evaluation Plan specific to the submission.
For further clarification, please contact streamlinedsubmission@health.gov.au.
- All fields are required for the estimator to function
- Using the date picker enter the approximate date you intend to lodge your PPF
- Specify the application type (more information about application types can be found by hovering the mouse or tapping on the ? icon)
- Select the Section 31 response period you intend to nominate in your PPF
- Once you enter all details the estimator will show your batch information
Once you have entered the required information into the estimator it will automatically update. Changing any of the fields will also cause the estimator to automatically update.
Disclaimer
This estimator is provided by the TGA (a part of the Department of Health and Aged Care) solely for the purpose of providing general information on the TGA regulatory scheme. The dates derived through the estimator are consistent with the TGA’s business rules for the prescription medicines registration process, however they represent an example timeline only.
People requiring specific information or advice on the application of the therapeutic goods legislation in particular cases should make their own enquiries.
Whilst due care has been taken in its preparation, the Department of Health and Aged Care cannot guarantee, and assumes no legal liability or responsibility for the accuracy, currency or completeness of the information presented by the estimator.