Reclassification Of The Medicinal Product For Human Use "oxygen Under Article 8, Paragraph Vivisol», 10 December 24, 1993, Act No. 537. (Resolution No. 276/2015).

Original Language Title: Riclassificazione del medicinale per uso umano «Ossigeno Vivisol», aisensi dell'articolo 8, comma 10, della legge 24 dicembre 1993, n.537. (Determina n. 276/2015).

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-28&atto.codiceRedazionale=15A02255&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

The DIRECTOR-GENERAL having regard to articles 8 and 9 of legislative decree July 30, 1999, # 300; Visto l'art. September 30, 2003, 48 of Decree-Law n. 269, converted into law November 24, 2003, n. 326, establishing the Italian medicines agency; Having regard to the Decree of the Minister of health in consultation with the Ministers for public administration and Economics and finance dated September 20, 2004, n. 245 laying down the rules of organisation and operation of the Italian Medicines Agency, pursuant to paragraph 13 of article. the aforementioned 48 as amended by order No. 53 of the Minister of health, in consultation with the Ministers for public administration and simplification and of economy and Finance of the March 29, 2012; Having regard to the Legislative Decree March 30, 2001, n. 165; Having regard to act July 15, 2002, # 145; Having regard to the Decree of the Minister of health of November 8, 2011, recorded by the Central Office of the budget to the register «simple» Visas, sheet # 1282, dated November 14, 2011, with which he was appointed Director General of the Italian Medicines Agency. Luca Pani, as from November 16, 2011; Having regard to act December 24, 1993, no. 537 concerning "public finance" corrective action with particular reference to art. 8; Visto l'art. 1, paragraph 40, December 23, 1996, law n. 662 laying «rationalization measures of public finance ", which identifies the margins of distribution for pharmaceutical companies, wholesalers and pharmacists; Having regard to article 48, paragraph 33, November 24, 2003, law # 326, which has negotiating the price for products reimbursed by the national health service between agency and marketing authorisation holders; Having regard to the Legislative Decree of April 24, 2006, n. 219, published in the Gazzetta Ufficiale della Repubblica Italiana n. 142 of June 21, 2006 on the introduction of Directive 2001/83/EC (and subsequent amending directives) on the Community code relating to medicinal products for human use and Directive 2003/94/EC; Having regard to the 1 February 2001 CIPE; View the "notes October 29, 2004 determination AIFA 2004 (Revision Notes CUF) ', published in the ordinary supplement in Official Gazette No. 259 of November 4, 2004 as amended; View AIFA'S determination of July 3, 2006 published in the official journal, General series No 156 of July 7, 2006; View AIFA determination of September 27, 2006 published in the official journal, General series No. 227 of September 29, 2006 concerning "maneuver to the Government subsidized and non-subsidized pharmaceutical shopping»; Given the decree by which the company Vivisol S.r.l. It was cleared for placing the medicinal product on OXYGEN VIVISOL; Having regard to the application with which the company Vivisol S.r.l. has applied for reclassification of the Pack with n. A.I.C. from 039058084 to 039058173; Having regard to the opinion of the scientific and Technical Advisory Committee at its meeting of January 19, 2015; Having regard to resolution No. 5 dated February 18, 2015 AIFA's Board of Directors adopted on the proposal of the Director General;
Causes: Art. 1 Classification for the purposes of new listings is the medicine's package below OXYGEN VIVISOL classified as follows: packaging: 200 bar compressed gas cylinder «medicinal» 5 l. -A.I.C. # 039058084 (10) 157YP4 (based on 32) new listings class ': A price ex factory (VAT): €6.82 retail price (VAT included): €10.64 «200 bar 5 l bottle compressed gas medicine». with valve-A.I.C. # 039058096 (10) 157YPJ (based on 32) new listings class ': A price ex factory (VAT): €6.82 retail price (VAT included): €10.64 «200 bar 7 l bottle compressed gas medicine». -A.I.C. # 039058108 (10) 157YPW (based on 32) new listings class ': A price ex factory (VAT): €9.55 retail price (VAT included): €14.89 «200 bar 7 l bottle compressed gas medicine». with valve-A.I.C. # 039058110 (10) 157YPY (based on 32) new listings class ': A price ex factory (VAT): €9.55 retail price (VAT included): €14.89 «200 bar compressed gas cylinder 10 l ' medicine. -A.I.C. # 039058122 (10) 157YQB (based on 32) new listings class ': A price ex factory (VAT): €13.64 retail price (VAT included): €21.27 «200 bar compressed gas cylinder 14 l. medicine» -A.I.C. # 039058134 (10) 157YQQ (based on 32) new listings class ': A price ex factory (VAT): €19.10 retail price (VAT included): €29.78 «200 bar compressed gas cylinder 14 l. medicine» with valve-A.I.C. # 039058146 (10) 157YR2 (based on 32) new listings class ': A price ex factory (VAT): €19.10 retail price (VAT included): €29.78 «200 bar compressed gas cylinder 27 l. medicine» -A.I.C. # 039058159 (10) 157YRH (based on 32) new listings class ': A price ex factory (VAT): €36.83 retail price (VAT included): €57.44 200 bar compressed gas cylinder 27 l. medicine» with valve-A.I.C. # 039058161 (10) 157YRK (based on 32) new listings class ': A price ex factory (VAT): €36.83 retail price (VAT included): €57.44 «200 bar compressed gas cylinder 30 l ' medicine. -A.I.C. # 039058173 (10) 157YRX (based on 32) new listings class ': A price ex factory (VAT): €40.92 retail price (VAT included): €63.82