Spain introduces new compassionate use legislation
This article was originally published in SRA
Executive Summary
A royal decree that regulates the availability in Spain of medicinal products in special situations – ie for compassionate use – came into force on 20 July1. The long awaited decree (No 1015/2009) also introduces new procedures and the conditions for authorising the off-label use, which will only be in exceptional circumstances, as well as for authorising access to medicinal products that are either still under clinical investigational or are legally marketed in other countries but are not authorised in Spain.