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 which established the Italian medicines agency; Having regard to Decree No 245 of the Minister of health to grant you with the Ministers for the civil service and of economy and Finance of September 20, 2004 laying down rules on the organisation and the functioning of the Italian Medicines Agency, issued pursuant to paragraph 13 of article. 48 above; Seen the Decree March 29, 2012, # 53 of regulation and functioning of Agenzia italiana del farmaco (AIFA), in implementation of article 17, paragraph 10, of the Decree-Law July 6, 2011, n. 98, converted, with amendments, by law July 15, 2011, # 111; 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 on November 14, 2011, with which Prof. Luca Pani has been appointed Director General of the Italian Medicines Agency with effect from November 16, 2011; Having regard to the Ministerial Decree of May 24, 2004, concerning "Restatement of the amounts of the fees and charges for services rendered on request and usefulness of stakeholders '; Having regard to the Ministerial Decree of December 21, 2012 bearing "update amounts of fees and charges for services rendered on request and usefulness of stakeholders '; Having regard to act August 7, 1990, n. 241, concerning «new rules on administrative procedure and the right of access to administrative documents "; Having regard to Act May 15, 1997, n. 127 and s containing "urgent measures to streamline administrative activities and processes of decision and control», published in the Official Journal No. 113 of May 17, 1997; Having regard to the Legislative Decree of April 24, 2006, n. 219 s and establishing a "implementation of Directive 2001/83/EC (and subsequent amending directives) on the Community code relating to medicinal products for human use", and in particular art. 52-bis; Having regard to the Legislative Decree of February 19, 2014, # 17, 2011/62/EU implementing directive amending Directive 2001/83/EC on the Community code relating to medicinal products for human use in order to prevent the entry of falsified medicines in the supply chain; Having regard to the determination of April 13, 2011 bearing identification of non-essential changes «» chemical and pharmaceutical workshop, pursuant to art. 50, paragraph 5-bis, Legislative Decree No 219 April 24, 2006; Having regard to the determination of July 29, 2011 on the review of the non-essential changes April 13, 2011 bearing determination discovery «» chemical and pharmaceutical workshop, pursuant to art. 50, paragraph 5-bis, Legislative Decree No 219 April 24, 2006, published in the Official Gazette No. 194 of August 22, 2011, and, in particular, article. 4, according to which the Italian medicines agency reserves the right to carry out its review; View the January 23, 2013 # 72 determination on the review of the determination July 29, 2011 bearing identification of non-essential changes «» chemical and pharmaceutical workshop, pursuant to art. 50, paragraph 5-bis, Legislative Decree No 219 April 24, 2006; Considered appropriate to proceed to a Determination in consideration of current legislation with regard to the production and/or import of active substances in accordance with the provisions of art. 52-bis, paragraph 6, Legislative Decree No 219 April 24, 2006;
Causes: Art. 1 scope 1. This determination applies to manufacturers and importers of active substances established in Italy whose activity is subject to registration regime and identify and regulate the procedure of annual statement of changes occurring in relation to ' non-essential ' production activities and/or importing non-sterile active substances and active substances not of biological origin.