Classification Of The Medicinal Product For Human Use «Xultophy», The Meaning Of Article 12, Paragraph 5, Of Law November 8, 2012 # 189-Approved Centrally. (Resolution No. 326/2015).

Original Language Title: Classificazione del medicinale per uso umano «Xultophy», ai sensidell'articolo 12, comma 5, della legge 8 novembre 2012 n. 189 -approvato con procedura centralizzata. (Determina n. 326/2015).

Read the untranslated law here:

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 law No 537 as amended December 24, 1993 with particular reference to art. 8 paragraph 10 (c)); 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. 48 above, 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 Decree of the Minister of health November 8, 2011, registered at the Central Office of the budget to the register «simple» Visas, sheet # 1282 of November 14, 2011, with which he was appointed Director General of the Italian Medicines Agency. Luca Pani, as of November 16, 2011; Having regard to the Decree-Law September 13, 2012, # 158, converted, with amendments by law November 8, 2012, n. 189 laying down "urgent provisions to promote the development of the country through a higher level of health protection ' and, in particular, article. 12, paragraph 5; Having regard to Council Regulation (EC) No 726/2004 of the European Parliament and of the Council of March 31, 2004, laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency; Having regard to Council Regulation (EC) no 1901/2006 of the European Parliament and of the Council of December 12, 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC and Regulation (EC) No 726/2004; Having regard to the Legislative Decree of April 24, 2006, n. 219, published in the official journal of the Italian Republic No. 142 of June 21, 2001, concerning the implementation of Directive 2001/83/EC, as amended, on the Community code relating to medicinal products for human use, as well as of Directive 2003/94/EC; Having regard to Council Regulation (EC) no 1394/2007 of the European Parliament and of the Council of November 13, 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004; Having regard to regulation for the organisation, administration and the organisation of the Italian medicines agency staff, adopted by the Management Board of the Agency by resolution of November 6, 2014, # 41, whose publication on its website and was given notice in the Gazzetta Ufficiale-serie generale-# 22 of January 28, 2015; Having regard to the official journal of the European Union of October 31, 2014 reporting the summary of decisions of the European Union concerning the marketing authorisation of medicinal products from 1 September to September 30, 2014 and shows all the new packaging; Having regard to the opinion on the system of classification for the purpose of expressing, on a proposal from the European Commission's scientific, technical assessment Office (CTS) 10-11 date November 2014 AIFA; Having regard to the letter of the Office of the March 13, 2015 pharmacovigilance (PV 25873 Protocol/P) which authorized the educational material of the product XULTOPHY;
Determines the following medicinal products for human use: the packages of reauthorization, including number of AIC and classification for the purpose of: XULTOPHY are described in detail in the annex, which forms an integral part of this provision, are placed in a special section of the class referred to in art. 12, paragraph 5 of law no 189 November 8, 2012, called class C (nn), dedicated to drugs not yet evaluated for the purposes of new listings, pending the presentation by the company concerned of a possible application for different classification. The mAh before the start of the marketing must have observed, where applicable, conditions or restrictions with regard to the safe and effective use of the medicinal product and must inform the AIFA-Office prices ex factory price, refund-& retail price and the start date for the marketing of the medicinal product. This resolution shall enter into force on the day following its publication in the official journal.
Roma, March 25, 2015 Director General: Pani