THE MINISTER OF HEALTH Having regard to Law 21 October 2005, n. 219, entitled: "New discipline of the attivita 'of national production and transfusion of blood products," and subsequent amendments thereto, and in particular: Article. 1, which provides, among the purpose 'of the law, to achieve regional self-sufficiency and national blood, blood components and blood products drugs; Article. 2, which recognizes, as an integral part of the National Health Service, the activities' transfusion, and in particular those concerning the promotion of blood donation and the production of blood products drugs, based on voluntary donation, Periodicals responsible, anonymous and unpaid blood human and its components; Article. 5, which includes among the Essential Levels of Health Care in the field of activity 'transfusion, paragraph 1, letter a), point 3, the processing of blood and blood components, including plasma for the purpose' of the production of blood products medications and plasma send the same centers and enterprises of blood products manufacturers, an agreement according to the procedures' in art. 15 of that Act; Article. 11, paragraph 1, which states that the self-sufficiency of blood and blood products is a national interest and supra-regional sovraziendale not be divided for the achievement of which and 'required the cooperation of the regions and health organizations; Article. 12, paragraph 4, which provides that the National Blood Center performs functions of coordination and technical and scientific control, in agreement with the permanent Technical Council for the transfusion system established by Article. 13, in the areas covered by this law; Article. 14, governing the annual program for national self-sufficiency and identifies specific programming mechanisms, organization and financing of the national blood system; Article. 15 on the production of blood derivatives medications; Article. 16 on import and export; Article. 27, paragraph 3, which provides that the agreements between the regions, in accordance with art. 10, paragraph 2, of the Law of 4 May 1990, n. 107, shall be extended until the date of entry into force of the new agreements provided for by art. 15, paragraph 1, of the law 21 October 2005 n. 219; The Order of the Minister of Health March 3, 2005, stating: 'Protocols for the suitability' assessment of donor blood and blood components ", published in the Official Journal of 13 April 2005, n. 85; The Order of the Minister of Health March 3, 2005, entitled: "Characteristics and methods' for the donation of blood and blood components", published in the Official Gazette of 13 April 2005, n. 85; Having regard to Legislative Decree of 9 November 2007, n. 207, entitled: "Implementation of Directive 2005/61 / EC implementing Directive 2002/98 / EC as regards the prescription regarding traceability 'of blood and blood components intended for transfusion and notification of adverse or serious adverse effects »; Having regard to Legislative Decree of 9 November 2007, n. 208, entitled: "Implementation of Directive 2005/62 / EC implementing Directive 2002/98 / EC as regards Community standards and specifications relating to a quality 'system for blood"; Having regard to Legislative Decree 20 December 2007, n. 261, entitled: "Review of the Legislative Decree 19 August 2005, n. 191, implementing Directive 2002/98 / EC setting standards of quality 'and safety for the collection, testing, processing, storage and distribution of human blood and blood components' and in particular Articles 3, related to the authorities 'competent, 5, on inspection and control measures on transfusion and united services' collection, and 26, on the production of medicinal products derived from blood or plasma; The Order of the Minister of Health 'March 19, 1998, stating:' Provisions relating to medicinal products derived from human blood or plasma ', published in Official Gazette dated 9 April 1998, n. 83; In view of art. 48 of the Decree-Law of 30 September 2003, n. 269, converted with amendments by Law 24 November 2003, n. 326, establishing the Italian Medicines Agency; The Order of the Minister of Health September 24, 2004, entitled: "Provisions on the documentation which must accompany applications for marketing authorization of medicines for human use in the implementation of Directive 2003/63 / EC of 25 June 2003 ", published in the Official Journal of 28 October 2004, n. 254; Having regard to Legislative Decree 24 April 2006, n. 219, entitled: "Implementation of Directive 2001/83 / EC on the Community code relating to medicinal products for human use, as well as 'the Directive 2003/94 / EC', as amended and supplemented, and in particular art. 136, which includes provisions to Community self-sufficiency in human blood or human plasma, as well as' Schedule 1, Part III, paragraph 1.1, entitled 'plasma-derived medicinal products'; Seen in particular art. 139 of the aforementioned Legislative Decree, which regulates the state control of medicinal products derived from blood or human plasma, for which the Minister of Health, feel the Istituto Superiore di Sanita 'and the Superior Council of Health', can 'be subjected to state control, even for individual types, from blood-derived medicinal products or human plasma, in bulk or already 'ready for use and that, with the same requirements and procedure mode' for carrying out such control, which must be completed within sixty days of receipt of the samples; The Order of the Minister of Health March 31, 2008, entitled: "Technical requirements and procedures for the enforcement of controls of batches of immunological medicinal products and medicinal products derived from human blood and human plasma", according to the said Article. 139 of Legislative Decree 24 April 2006, n. 219, published in the Official Journal of 16 April 2008, n. 90; Given the guidelines, published by the European Commission in 'The rules governing medicinal products in the European Union "; Having regard to Law 4 June 2010, n. 96, entitled: "Provisions for the fulfillment of obligations deriving from Italy to the European Communities' - Community Law 2009" and in particular art. 40, paragraph 2, in which changes were introduced art. 15 of the Law of 21 October 2005, n. 219; Considering the Agreement between the Government and the Regions and Autonomous Provinces of Trento and Bolzano on organizational requirements, structural and technological Activities 'of transfusion services and united' blood collection and blood components and the model for the verification visits , sanctioned by the permanent Conference for relations between the State, Regions and Autonomous Provinces of Trento and Bolzano, 16 December 2010 (Rep. acts n. 242 / CSR), adopted in implementation of art. 19 of Law 21 October 2005, n. 219; Given the Decree-Law of 29 December 2010, no. 225, converted with amendments by Law 26 February 2011, n. 10, stating: "Extension of deadlines set by laws and urgent action on tax matters and support to businesses and families," and in particular art. 2, paragraph 1-sexies, letter c), which provides that the Minister of Health, by decree, "discipline, pending the complete implementation of the provisions of the aforementioned Agreement of 16 December 2010, which in any case must 'be by 31 December 2014, the modalities 'through which the Italian Drug Agency ensures the placing of medicinal products in blood products from plasma collected in the national territory as well as' the export of the same for processing in the EU countries and the Higher Institute of Sanita 'ensures its status control'; The Order of the Minister of Health May 26, 2011, entitled: "Establishment of a national list of evaluators for the transfusion system for conducting investigations at blood establishments and units 'blood collection and blood components' within Article. 2, paragraph 1-e, letter a) of the aforementioned Decree-Law of 29 December 2010, n. 225, published in the Official Gazette of July 14, 2011, n. 162; Considering that the called State-Regions Agreement of 16 December 2010 provides for a commitment shared by the regions and autonomous provinces to adjust blood establishments and joined 'collection to the minimum requirements defined and perform the verification visits and control measures , provided for by art. 5 of Legislative Decree 20 December 2007, n. 261, within thirty-six months of availability 'national list of evaluators of the transfusion system; Considered, altresi ', that such availability' and 'was put into effect in a note to the National Blood Centre of 30 November 2011, prot. 1960, which 'was forwarded to the Regions and Autonomous Provinces the decree of the Director of the National Blood Centre of 16 November 2011 establishing the first national list of evaluators for the transfusion system, published on the website of the National Blood Centre www.centronazionalesangue .it; Considering that the effective application of the mode 'for the marketing of medicines blood products from plasma collected in the national territory, subject to this decree, requires a transitional period, necessary for the implementation of relevant procedures and for the systematization of the information inherent in the plasma as a raw material for industrial processing; It found it necessary to regulate the mode 'through which the Italian Drug Agency ensures entry for medicinal products blood products from plasma collected in the national territory, including the mode' and the times to ensure a systematic and comprehensive description of the information inherent to the Italian plasma as a raw material for industrial processing required by the regulatory provisions in force in the European Union, up to the full implementation of the said State-Regions Agreement of 16 December 2010 to be achieved no later than 31 December 2014; Given, therefore, pending the effective implementation of the modalities 'for the marketing of medicinal products from blood plasma collected in the national territory covered by this Decree, the need' to allow the use of existing Permissions Marketing Authorisation for the production of medicines blood products from domestic plasma and control the status of the same by the Istituto Superiore di Sanita ', in order to avoid any possible continuity' solution in production and to provide regional and national self-sufficiency and continuity ' therapeutic; Considered, finally, must be defined at the outset procedures for export and import of domestic plasma, its intermediate products and finished products, in relation to the conventions of art. 15, paragraph 1, of the law 21 October 2005 n. 219, while waiting for the decree mentioned in art. 16 of the Act, concerning the import and export of blood and its products; Receiving the report of the Permanent Council for Technical Transfusion System in the sitting of 8 September 2011; Having obtained the opinion of the Permanent Conference for relations between the State, Regions and Autonomous Provinces of Trento and Bolzano in the meeting of 19 January 2012; Decrees: Art. 1 1. Pending the complete implementation of the provisions of the Agreement between the Government and the Regions and Autonomous Provinces of Trento and Bolzano sanctioned by the Permanent Conference for relations between the State, Regions and Autonomous Provinces of Trento and Bolzano of 16 December 2010 concerning the minimum structural requirements, technological and organizational activities of the 'health of the transfusion services and united' collection and the model for the verification visits, in accordance with art. 2, paragraph 1-sexies, letter c) of the Decree Law of 29 December 2010, no. 255, and 'allowed the use of human plasma collected by the Italian transfusion services for the production of blood products medicines as part of a procedure of the Marketing Authorisation (hereinafter AIC) at the sole national importance and that includes the use the only domestic plasma. The control status of the batches of medicinal products derived from domestic plasma and 'assured by the Institute Superiore di Sanita' (hereinafter ISS). 2. Companies, whose agreements are extended under Article. 27, paragraph 3 of Law 21 October 2005, n. 219 and those which will enter into agreements with the Regions and Autonomous Provinces in conformity 'to the schema-type of Convention adopted by the Minister of Health in accordance with art. 15, paragraph 1, of the law 21 October 2005 n. 219, for the production and marketing of medicinal products that result are required to submit the Italian Pharmaceutical Agency (AIFA below) documents relating to the characteristics of national plasma National plasma collected in Italy. The marketing authorization dossier of such products, can 'refer to the same process of production of other gia' authorized medicinal marketing authorization. 3. Documentation relating to the characteristics of national plasma, referred to in paragraph 2 shall contain the essential elements listed in the Annex to this decree, which forms an integral part, for the purposes of evaluation, the quality 'and plasma safety national used for the production of medicinal products. Such documentation and 'also used by the ISS for the control of plasma pools within the state of batches of medicinal products derived from plasma national control. 4. For the purpose of correct and complete collection of information relating to National characteristics of plasma, including information concerning the epidemiological data and the related recognition criteria, the National Blood Center (hereafter CNS) may 'issue specific instructions and guidelines. The regional coordinating structures for the activities' transfusion, in art. 6, paragraph 1, letter c) of the law 21 October 2005 n. 219 and subsequent amendments and additions, have undertaken to promote and facilitate at blood establishments operating in their respective territorial areas the collection of information by the companies referred to in paragraph 2. 5. The AIFA, in order to ensure the placing on the trade of medicines blood products from domestic plasma, acquires the technical opinion of the CNS on the documentation referred to in paragraph 3 and on the same change referred to in paragraph 6. in order to formulate the aforementioned opinion, the CNS can 'make use of the ISS, establishing the same the necessary synergies, subject to the ISS expertise in the decree of the Minister of Health '19 March 1998. This opinion shall be made by the CNS within 90 days of the request being made by the AIFA. 6. Documentation relating to the characteristics of national plasma referred to in paragraph 3, and 'updated annually by the MAH Companies, according to the requirements specified by the decree of the Minister of Health in art. 14, paragraph 2, of the law 21 October 2005 n. 219, on the basis of indications from the CNS, in agreement with the AIFA and after hearing the regions and autonomous provinces, with the goal of achieving full compliance 'of transfusion system to the existing provisions in the European Union no later than 31 December 2014. 7. the failure to satisfy the requirements of paragraphs 3:06 implies the impossibility 'of national plasma used for the production of blood products medicines. 8. The companies, which, to date, have already 'signed agreements with the Regions and Autonomous Provinces, have to AIFA, within 270 days from the entry into force of this decree, the description of the characteristics of national plasma referred to in paragraph 3, the purpose of the inclusion of this documentation in the marketing authorizations for medicinal products and to the execution of state control by ISS. 9. For the purposes of the provisions of paragraph 1 of this Article, for the marketing of medicinal products from blood plasma collected in the national territory referred to in paragraph 1, and 'allowed the use of existing marketing authorizations for the production of blood products from medicinal national plasma and performing, with the current mode ', the state of control by the ISS.