We aim to give advice about all licensed medicines meeting our appraisal criteria within 6–9 months of the medicine receiving its licence. Information about the stages of an AWMSG appraisal and the documentation needed for each stage are given below.
After receiving your Form A, we will confirm if your medicine meets AWMSG’s criteria for appraising it 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 our criteria for appraisal then we will inform you that the medicine is 'excluded from HTA' and will not be appraised.
Without a submission (a Form B, Form C, or, in the case of licence extensions for paediatric use, a Form A only), there are two courses of action we may take: