Reclassification Of The Medicinal Product For Human Use «Biresp Spiromax» Under Art. 8, Paragraph 10, Of The Act December 24, 1993, # 537. (Resolution No. 419/2015).
Original Language Title: Riclassificazione del medicinale per uso umano «BiResp Spiromax» aisensi dell'art. 8, comma 10, della legge 24 dicembre 1993, n. 537.(Determina n. 419/2015).
Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-27&atto.codiceRedazionale=15A03014&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; Visto l'art. 48, paragraph 33, November 24, 2003, law No. 326, which has negotiating the price for products reimbursed by authorisation holders between agency and S. N.; 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 to the official journal # 259 of November 4, 2004 as amended; View AIFA'S determination of July 3, 2006 published in the official journal-General series-# 156 of July 7, 2006; View AIFA determination of September 27, 2006 published in the official journal-General series-# 227 of September 29, 2006 concerning "maneuver to the Government subsidized and non-subsidized pharmaceutical shopping»; Given the decree by which the company Teva Pharma B.V. has been cleared for placing the medicinal product on BiResp Spiromax (budesonide and formoterol); Having regard to the 729/2014 of July 17, 2014, n. determination published in the Gazzetta Ufficiale della Repubblica italiana n. 185 of August 11, 2014, on the classification of the medicinal product in accordance with art. 12, paragraph 5, reads November 8, 2012, # 189, of medicinal products for human use centrally approved; Having regard to the application with which the company Teva Pharma B.V. has applied for reclassification of 043365016 and 043365042 numbers A.I.C. packs (s); Having regard to the opinion of the scientific and Technical Advisory Committee at its meeting of December 10, 2014; Having regard to the opinion of the Committee at its meeting of March 5, 2015 and reimbursement rates; Having regard to resolution No. 6 on March 25, 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 BiResp Spiromax (budesonide and formoterol) in the boxes below and is billed as follows: container: 160 mcg/4.5 mcg inhalation powder-inhalation use-inhaler-1 inhaler (120 servings);
A.I.C. # 043365016/E (10) 19CDNS (based on 32);
New listings ' class: «A»;
Ex factory price (excluding VAT): €33.11;
Price (VAT included): €54.64. Package: 320 mcg/9 mcg inhalation powder-inhalation use-inhaler-1 inhaler (60 doses);
A.I.C. # 043365042/E (10) 19CDPL (based on 32);
New listings ' class: «A» price ex factory (VAT): €33.11;
Price (VAT included): €54.64. Half-year sales data transmission borne by the company as negotiating conditions. The company strives to publish in the official journal-part two-the new prices to achieve revenues negotiations. Validity of the contract: 24 months.
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