title: [Regulations on gases for medical use in France].
abstract: In 1989, a European directive extended the definition of proprietary medicinal products, and consequently the necessity to hold a marketing authorization (MA), for all industrially manufactured products, including medicinal gases. In France, the directive 89/341/CEE was transposed in the French law on December 8(th), 1992 and France was the first Member State to implement provisions for the obtention of MAs for gases for medical use. Since then, France has stayed at the forefront in this area. Following the inclusion of gases in the scope of pharmaceutical products, gases require on MA obtained following the same methods as for drugs and be manufactured and distributed in authorized sites. Moreover, the European directive has led the French authorities to classify gases according to their use. Gases for medical use are thus considered either as medicinal products or as medical devices.
authors.affiliation: Droit & Pharmacie, PAREXEL, 12 rue de Lorraine, 92300 Levallois-Perret, France.
authors.forename: P
authors.initials: P
authors.lastname: Poitou
authors.forename: C
authors.initials: C
authors.lastname: Fouret
authors.forename: E
authors.initials: E
authors.lastname: Duffau
mesh_terms: D004339:Drug Compounding / Q000592:standards; D005062:European Union; D005602:France; D005740:Gases / Q000592:standards*; D006801:Humans; D007880:Legislation, Drug
chemical_list: D005740:Gases