Medicinal gases

Draft Regulations on medicinal gases (33 pages, in Spanish)

The notified draft Regulations establish the technical and administrative rules and other conditions governing the sanitary registration, production, packaging, importation, entry, storage, distribution and sale of medicinal gases for human use, with a view to ensuring that these processes are properly controlled so as to guarantee product quality and traceability and the safe use of the product in a closed clinical environment, an out-patient setting or the home environment, as appropriate.