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Appraisal of paediatric minor licence extensions

Position statement for paediatric minor licence extensions

AWMSG will no longer routinely appraise a medicine 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.

In these circumstances Health Boards should continue to add paediatric licence extensions to their formularies. This update to the AWMSG process aims to improve access to medicines for children, ensuring they can be made available as soon as is practically possible and aligns with NHS England and NHS Scotland.

AWMSG will no longer expect to routinely receive a submission for a paediatric minor licence extension; however, should the need arise (such as inequity of access in Wales, or uncertainty in the evidence base), then AWMSG reserves the right to appraise a medicine where there is a clear clinical need.

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