Change To Determine November 8, 2011, # 2703 Laying: «Dirimborsabilita's Regime And Sale Price Of The Medicinal Product For Human Use "ellaone (Ulipristal)».
Original Language Title: Modifica alla determina 8 novembre 2011, n. 2703, recante: «Regime dirimborsabilita' e prezzo di vendita del medicinale per uso umano«Ellaone (ulipristal)».
Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-05-08&atto.codiceRedazionale=15A03360&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
The DIRECTOR GENERAL Saw art. September 30, 2003 48 of Decree-Law n. 269, converted into law November 24, 2003, n. 326, establishing the Italian medicines agency, and as amended and supplemented; 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 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; View the determination November 8, 2011, # 2703, published in the Official Gazette of November 17, 2011, General series No. 268, with which the company Laboratoire Hra Pharma has obtained authorisation for the medicinal product ELLAONE (ulipristal); Having regard to the European Commission decision C (2015) 51 of January 7, 2015, amending the marketing authorisation for the medicinal product for human use Ellaone (ulipristal), issued by Commission decision C (2009) 4049; Having regard to the opinion of the technical-Scientific Committee at its meeting on 23-25 March 2015, which has found it necessary to comply with the European Commission decision invoked, eliminating the pregnancy test ' being obligatory, at the same time, establishing a system of dispensing without a prescription (SOP) for adult patients, while retaining the requirement of a prescription exclusively for underage patients;
Causes: Art. 1 Repeal art. 3 determination no. 2703/2011 art. 3, entitled ' usage ', path Constraints of determination November 8, 2011, # 2703, published in the Official Gazette of November 17, 2011, General series no 268, is repealed.
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