What you need to know
In this step, you can comment on the ESC report and consultation input on your application. This is your pre-MSAC response.
We will consider your response along with the ESC report, the other documents related to your application and the consultation input.
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If your application is integrated codependent, you will receive in the Health Products Portal:
- a copy of the joint ESC report by our ESC and the Pharmaceutical Benefits Advisory Committee (PBAC) Economics Sub Committee
- a summary of all consultation input we have received on your application
- a copy of consultation input we have received from organisations
- consultation input PBAC has received on your application
- the due date for comments.
If you have comments on the consultation input, include it with your comments on the joint ESC report.
Your response can be up to 6 A4 pages in Microsoft Word.
You will have 5 business days to provide your response in the Health Products Portal.
If your application is on the direct pathway, you will respond to the ADAR overview paper in your pre-MSAC response.
What you need to do
1. Access the documents
About 5 weeks before the MSAC meeting, you will receive in the Health Products Portal:
- a copy of the ESC report
- a summary of all consultation input on your application
- a copy of consultation input from organisations
- the due date for comments.
2. Comment on the documents
Your response can be up to:
- 5 A4 pages of text in Microsoft Word
- 2 pages of diagrams, graphs and tables.
If you have comments on the consultation input, include it with your comments on the ESC report.
3. Provide your response
Send your response to our secretariat in the Health Products Portal within 10 business days (or 5 business days for integrated codependent applications).
Next steps
If your application:
- meets the hearing eligibility criteria and you or our committee want to address specific issues – the next step is to request or receive notice of an MSAC hearing
- does not require or is not eligible for a hearing – the next step is MSAC consideration of your application.
Contact
Contact your application manager or our secretariat if you have any questions.
