Inserting A Therapeutic Indication Of Medicine For Usoumano «Bevacizumab-Avastin» In The List Under Law N. 648/1996-Partial Amendment To Resolution No. 622 Dg/2014 Of June 23, 2014 And Windshield Replacement Thereof. (Determines # 79/2015). (15 ...

Original Language Title: Inserimento di una indicazione terapeutica del medicinale per usoumano «Bevacizumab - Avastin» nell'elenco ex lege n. 648/1996 -parziale modifica alla determina n. 622 DG/2014 del 23 giugno 2014 esostituzione della stessa. (Determina n. 79/2015). (15...

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-16&atto.codiceRedazionale=15A01013&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

The DIRECTOR GENERAL Saw art. September 30, 2003, 48 of Decree-Law n. 269, converted, with amendments, into law November 24, 2003, n. 326 which established the Agenzia italiana del farmaco (AIFA); Having regard to the September 20, 2004 Decree n. 245 of the Minister of health, in consultation with the Ministers of economy and finance and civil service, laying down rules on the organisation and functioning of the AIFA, as amended; Having regard to regulation for the organisation, administration and the organisation of staff of AIFA, published in the Gazzetta Ufficiale della Repubblica italiana, General series No. 254 of October 31, 2009; Having regard to the Decree of the Minister of health of November 8, 2011, recorded by the Central Office of the budget to the registry simple visas, f. # 1282, dated November 14, 2011, with which professor Luca Pani has been appointed Director General of AIFA; Having regard to the Decree-Law October 21, 1996, n. 536, converted by law No 648 December 23, 1996; See, in particular, article 4, paragraph 1-bis of Decree-Law n. 536/1996, converted into law No. 648/1996 cited above, as inserted by article 3, paragraph 2, of Decree-Law No 36, signed into law March 20, 2014 May 16, 2014, # 79, which included the possibility of enlistment that law No 648/1996, national health service, with delivery of medicines that can be used for a therapeutic indication other than that authorised, even if already licensed therapeutic alternative as long as this information is known and subject to research conducted within the medical and scientific community, nationally and internationally, according to parameters of economy and appropriateness; View AIFA'S determination of May 23, 2007 laying down ' inserting the drug bevacizumab (Avastin) in the list of medicinal products granted the sole responsibility of the national health service, in accordance with article 1, paragraph 4, of Decree Law October 21, 1996, # 536, converted by law December 23, 1996, # 648, neovascular glaucoma in treatment of exudative and maculopathy ', as amended by the decisions of October 28, 2010 and March 4, 2009 AIFA; View AIFA determination of October 18, 2012 laying ' exclusion of medicine bevacizumab (Avastin) in the list of medicinal products granted the sole responsibility of the national health service, under the law of December 23, 1996, # 648», with which it was repealed determining AIFA of October 28, 2010; Having regard to the opinion of the High Council of health, section V, made at its meeting of April 15, 2014; Having regard to the requests of the Veneto and Emilia Romagna regions aimed at inclusion in the list of medicinal products granted the sole responsibility of the national health service of the drug bevacizumab (Avastin) for the therapeutic indication «age related macular degeneration (AMD); Having regard to the opinion in favour of this inclusion in the list of medicinal products granted the sole responsibility of the national health service, made by the scientific and Technical Advisory Committee (CTS) June 10, 2014 at its meeting of 9 and the AIFA, referred to the excerpt of the minutes of the June 19, 2014; Considered therefore necessary and urgent to insert, in accordance with article 1, paragraphs 4 and 4-bis of Decree-Law No. 536/1996, converted into law No. 648/1996, the drug bevacizumab (Avastin) in the list of medicinal products granted the sole responsibility of the national health service for the therapeutic indication «age related macular degeneration (AMD); Having regard to resolution No. 622 DG/2014 of June 23, 2014 (Official Gazette No 147 of June 27, 2014), inserting a therapeutic indication of the drug bevacizumab-Avastin in the list under law n. 648/1996; Having regard to the report of the competition authority and the market, in accordance with art. 21 of law no 287/1990 dated January 13, 2015 prot. 0011091, aimed at the inclusion of highly specialized centres also private for treatment with the drug bevacizumab (Avastin); Having regard to the opinion in favour of this enlargement, made by the scientific and Technical Advisory Committee (CTS) at its meeting of 19-20-AIFA 21 January 2015.
Causes: Art. 1 insert the medicine bevacizumab-Avastin in the list under law No.
648/1996 1. The drug bevacizumab-Avastin is added to the list established in accordance with art. 1, paragraphs 4 and 4-bis of Decree-Law No 536/1996, converted into law No. 648/1996, for the therapeutic indication «age related macular degeneration (AMD).