Source: https://www.global-regulation.com/translation/italy/619488/reclassification-in-accordance-with-art.-8%252c-paragraph-10%252c-of-the-act-december-24%252c-1993%252c-%2523-537%252c-the-medicinal-product-for-human-use-irinote.html
Timestamp: 2017-10-23 20:55:08
Document Index: 148117594

Matched Legal Cases: ['Art. 8', 'Art. 8', 'art. 8', 'art. 8', 'art. 1', 'art. 48', 'art. 12']

Machine Translation of "Reclassification In Accordance With Art. 8, Paragraph 10, Of The Act December 24, 1993, # 537, The Medicinal Product For..." (Italy)
Reclassification In Accordance With Art. 8, Paragraph 10, Of The Act December 24, 1993, # 537, The Medicinal Product For Human Use «Irinotecanstrides Arcolab International». (Resolution No. 1558/2014).
Original Language Title: Riclassificazione ai sensi dell'art. 8, comma 10, della legge 24dicembre 1993, n. 537, del medicinale per uso umano «IrinotecanStrides Arcolab International». (Determina n. 1558/2014).
Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-09&atto.codiceRedazionale=15A00037&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 rules on the organisation and the functioning 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 "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" with particular reference to art. 8; Visto l'art. 1, paragraph 40, December 23, 1996, law n. 662 on "rationalization measures of public finance", which identifies the margins of distribution for pharmaceutical companies, wholesalers and pharmacists; Visto l'art. 48, paragraph 33, read; November 2003, n. 326, which has negotiating the price for products reimbursed by S.S. 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 determination October 29, 2004 "Notes 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, September 29, 2006 concerning "maneuver for Government subsidized and non-subsidized pharmaceutical expenditure"; Given the decree by which the company's Strides Arcolab International LTD has been cleared for placing the medicinal product on Irinotecan Strides Arcolab International; View the determination regarding the classification of the medicinal product in accordance with art. 12, paragraph 5, reads November 8, 2012 # 189; Having regard to the application with which the firm Strides Arcolab International LTD has applied for reclassification of AIC code packs # 041617010 and AIC # 041617022; Having regard to the opinion of the scientific and Technical Advisory Committee of November 10, 2014; Having regard to the resolution of the Board of Directors of November 28, 2014 AIFA 43 adopted on a proposal from the Director General;
Causes: Art. for the purposes of Classification 1 rimbosabilita Strides Arcolab's Irinotecan medicine International packaging below is classified as follows: packaging: "20 mg/ml concentrate for solution for infusion" 1 glass vial 2 ml-AIC # 041617010 (10) 17Q1ML (based on 32). New listings ' class: h. price ex factory (VAT): €34.04. Retail price (IV): €56.18. Packaging: "20 mg/ml concentrate for solution for infusion" 1 glass vial 5 ml-AIC # 041617022 (10) 17Q1MY (based on 32). Rirnborsabilita class ': h. price ex factory (VAT): €77.27. Price to the public (VAT included): €127.53.