Initial information (Form A)

Why?

You should complete a Form A for all newly licensed medicines. 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 and 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.

Please note that AWMSG no longer routinely appraises medicines with a minor licence extension for the treatment of children and adolescents (aged up to 18 years) where the medicine is accepted for use by AWMSG or NICE for the same indication in the adult population. See the Additional information - Appraisal of paediatric licence extensions section for further information.

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 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