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Excluded medicines


The exclusion criteria provide broad guidance on medicines that fall outside AWMSG's role and remit, and are unlikely to progress to a formal appraisal.


When you fill in our Form A, you should state whether you think any of our exclusion criteria would apply. We will decide whether a medicine meets AWMSG's criteria for appraisal. The All Wales Therapeutics and Toxicology Centre (AWTTC) will tell you what's been decided.


When filling in our Form A, you should refer to the AWMSG exclusion criteria (PDF, 430Kb)  to see if any criteria apply to your medicine. 

What happens next?

We will confirm (by email or letter) whether a medicine meets one or more of AWMSG's exclusion criteria and will not be appraised. 

If a medicine is 'excluded' from AWMSG appraisal, health boards in Wales can consider whether it is appropriate to include it in the local formulary, unless it is excluded because NICE is appraising it. The resulting NICE guidance will apply in Wales.

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. In these circumstances, there is an expectation that Health Boards will continue to add paediatric licence extensions to their formularies. See the appraisal of paediatric minor licence extensions webpage for further information.

Will the decision be published on the AWTTC website?

Medicines excluded from AWMSG appraisal are listed on this website (once market authorisation has been granted) along with the reason for their exclusion. However, new paediatric license extensions will not be listed.


AWMSG exclusion criteria (PDF, 430Kb)

See our Initial information (Form A) page for guidance and documents to fill in a Form A.

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