The DIRECTOR GENERAL Saw art. September 30, 2003 48 of Decree Law No 269, converted into law no 326 November 24, 2003, 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 with which the company Zeta Farmaceutici S.p.a. has obtained authorisation for the medicinal product dextromethorphan Hydrobromide Zeta; Having regard to the Commission report No 30 November 2014 the sitting of 10-11 scientific technique, which approves the regime change of supply by C/SOP to C/OTC of specialty medicine dextromethorphan Hydrobromide Zeta;
Causes: Art. 1 Review provision To specialty medicine dextromethorphan Hydrobromide Zeta (dextromethorphan), the following provision applies: medicinal product not subject to medical prescription over the counter (OTC).
Negotiating conditions remain unchanged.