Change to SMC outwith remit criteria

SMC has introduced a more streamlined and consistent approach for biosimilar, generic and hybrid medicines.

From 1 March 2024, all generic, biosimilar and hybrid medicines are outwith SMC remit, irrespective of SMC advice for the originator medicine.  

‘Accepted’ and ‘accepted restricted’ SMC advice will still apply to the originator medicine following the availability of generics or biosimilars; any associated Patient Access Scheme (PAS) will remain available for the originator medicine. 

However, ‘not recommended’ advice for the originator medicine will no longer be applicable once generic or biosimilar medicines become available.  All SMC advice will remain on the SMC website.

Where there is a clinical need, health boards may make decisions about the continued application of ‘not recommended’ SMC advice, for example, inclusion in local / regional formularies.  

Please refer to the ‘Guidance to companies on medicines outwith SMC remit’ at https://www.scottishmedicines.org.uk/making-a-submission/