Initial information (Form A)

Why?

You should complete a Form A for all newly licensed medicines, and for each new indication and new formulation. Form A gives us the information needed to decide whether AWMSG should appraise a medicine.

When?

You should submit a Form A as early as possible and before marketing authorisation is received.

How?

Fill in a Form A using the documents given in the Form A submission pack below and send it to AWTTC.

What happens next?

After receiving your Form A, we will confirm if your medicine meets AWMSG’s criteria for appraisal as a licence extension for paediatric use, or whether we need a full submission (Form B) or a limited submission (Form C). If your medicine doesn't meet the criteria for appraisal then we will tell you that the medicine is 'excluded from HTA' and will not be appraised.

What goes on the AWTTC website at this stage?

Nothing. Your medicine will not be listed on this website once we've received your Form A, and your submitted Form A will never be published on our website. 

The medicine will be listed on our website at Stage 2 of the process:

• once we've received a Form A and have confirmed that the medicine meets AWMSG’s criteria for appraisal as a licence extension for paediatric use and the appraisal scope and schedule has been agreed; or
• once we've received a Form B or a Form C submission and have confirmed the appraisal scope and schedule for the appraisal; or
• if the medicine has been excluded from AWMSG's appraisal process; or
• on non-submission of a Form B or a Form C within three months of the medicine receiving its marketing authorisation.

Form A submission pack