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