Spain issues first specific regulations for medical gases:
This article was originally published in Clinica
Spain has passed a decree specifically regulating, for the first time, medical gases as medical products. The decree passed on December 26 2003 affects their approval, manufacture, marketing, registration and medical provision. It also sets out the need to assess the gas's quality, safety and efficacy, when it is to be used as a therapeutic product. Until now, only the manufacture of medical gases was regulated specifically, under European Directive 91/356/CEE. Manufacturers, importers and distributors have 18 months to adapt to the new provisions, which will come into force one month after the publication of the decree in the Boletin Oficial del Estado.