What you need to know
Your response to the overview paper on your ADAR and any consultation input is your pre-MSAC response.
We will consider your response along with the overview paper, the ADAR, your application and any consultation input.
This step is for applications on the direct pathway.
If your application is on the standard pathway or expedited pathway, you will respond to the ESC report in your pre-MSAC response.
What you need to do
1. Access the overview paper
In the Health Products Portal, you will receive:
- a copy of the overview paper on your ADAR
- a summary of all consultation input on your application
- a copy of consultation input from organisations
- the due date for comments.
You can expect to receive these on the date that ESC reports are provided to applicants - see key dates for applicants.
2. Review the overview paper
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 overview report.
You should not include extra clinical trial information or substantially amended economic or financial models in your response. Our secretariat will seek the appropriate advice if you provide new evidence in your response.
3. Provide your response
Send your response to our secretariat through the Health Products Portal by the due date. To find out how to do this, see uploading your pre-committee response.
Next steps
The next step is MSAC consideration of your application.
Contact
Contact your application manager or our secretariat if you have any questions.
