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Evaluation Plan Estimators

Evaluation plan estimators to approximate dates of milestones in the prescription medicine registration process.

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Before you lodge your pre-submission planning form (PPF) 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 more information email .

How to use the estimators

  • 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.

This evaluation plan estimator is designed for sponsors who intend to lodge applications for prescription medicines under the PPF-Only Pre-submission Phase Option. This includes:

Approximate dates for COR report-based process milestones are available by contacting contacting streamlined submission team

  

Application type:
Application type:

S31 response period you intend to nominate in your PPF:

S31 response period you intend to nominate in your PPF:
Milestone Description Date

Submission due to be provided to the TGA by
 

2

Outcome of submission assessment - Notification Letter
 

3

Outcome of 1st round evaluation - Consolidated s.31 request
 

4

End of   day s.31 response period

 

5

Completion of evaluation phase

 

Deadline for notification to the TGA of errors/omissions in evaluation reports

 

Delegates request for ACM advice

 

Pre-ACM response

 

Proposed ACM meeting

 

6

ACM outcomes

 

7

Initial decision by Delegate – Decision Letter

 

8

Completion of administrative and registration activities

 

This estimator is designed for sponsors who intend to lodge Category 1 ‘standard’ applications for prescription medicines.

  
Application type:
Application type:

S31 response period you intend to nominate in your PPF:

S31 response period you intend to nominate in your PPF:
Milestone Description Date

1

Outcome of PPF assessment - Planning Letter
 

Submission due to be provided to the TGA by
 

2

Outcome of submission assessment - Notification Letter
 

3

Outcome of 1st round evaluation - Consolidated s.31 request
 

4

End of   day s.31 response period

 

5

Completion of evaluation phase

 

Deadline for notification to the TGA of errors/omissions in evaluation reports

 

Delegates request for ACM advice

 

Pre-ACM response

 

Proposed ACM meeting

 

6

ACM outcomes

 

7

Initial decision by Delegate – Decision Letter

 

8

Completion of administrative and registration activities

 

The next working day is applicable for dates that fall on weekends or public holidays.

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.

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