The Peer Approved Clinical System (PACS) Tier One process is designed to provide an opportunity for clinicians, on a case by case basis for individual patients, to request the use of a licensed ultra-orphan medicine that is not recommended by the Scottish Medicine Consortium (SMC).The PACS Tier Two process is designed to provide an opportunity for clinicians, on a case by case basis for individual patients, to request the use of a licensed medicine (other than an ultra-orphan medicine) that:is a medicine for an indication that has been considered and not recommended by the SMC for routine use in NHS Scotland; oris a medicine accepted for restricted use by the SMC but the intended use is out with the SMC restrictions; oris a medicine which has been submitted to the SMC and is awaiting/undergoing evaluation.