HEALTH MINISTER having regard to law No 219 October 21, 2005, establishing a "new transfusion activities and discipline of the national production of blood products», and in particular art. 15 on the national production of blood products and subsequent amendments and additions; Having regard to act March 28, 2001, n. 145 laying «ratification and implementation of the Council of Europe Convention for the protection of human rights and the dignity of the human being with regard to the application of biology and medicine: Convention on human rights and Biomedicine, Oviedo made the April 4, 1997 as well as the additional protocol of January 12, 1998, # 168, on the prohibition of cloning human beings; Having regard to act June 4, 2010, n. 96, bearing provisions for the fulfilment of the obligations arising from Italy's membership of the European communities-Community Law 2009», and in particular art. 40, paragraph 2, amending art. 15 October 21, 2005, law # 219; See paragraph 5 of art. 15 of the aforementioned law October 21, 2005, # 219, and subsequent amendments and additions, which provides that "the Minister of health, by Decree, after consulting the Standing Conference for the relations between the State, the regions and the autonomous provinces of Trento and Bolzano, the National Blood Center under art. 12 and the Consulta, locates between the centres and the production of blood products companies dividing and those authorized to conclude agreements '; See, in particular, paragraph 3 of art. 15 October 21, 2005, law # 219, which provides that the establishments of firms ' must be suitable for processing in accordance with the national and European Union regulations as a result of checks carried out by the respective national authorities in accordance with their legal systems, and those of the Italian national authorities '; Having regard to the Decree of the Minister of health April 12, 2012 bearing ' pattern type of Convention between the regions and autonomous provinces and the manufacturers of blood products for the manufacture of medicinal products plasma collected in the national territory ", published in the Official Gazette of June 26, 2012, # 147; Having regard to the Decree of the Minister of health April 12, 2012 bearing ' rules ' for the submission and evaluation of instances aimed at obtaining the inclusion among the centers and manufacturers of medicinal products authorised to conclude agreements with the regions and autonomous provinces for processing of plasma collected in the national territory ", published in the Official Gazette of June 26, 2012 , # 147; Having regard to the instances of companies Baxter Manufacturing s.p.a, Biotest Pharma GmbH, CSL Behring, Grifols Kedrion s.p.a, Italy S.p.A. S.p.A., Octapharma Italy s.p.a, presented, in terms, in accordance with art. 1, paragraph 1, of the aforementioned Decree April 12, 2012, and aimed at obtaining the inclusion among the centers and manufacturers of medicinal products authorised to conclude agreements with the regions and autonomous provinces for processing of plasma collected nationwide, transmitted to the AIFA for evaluation, in accordance with art. 1, paragraph 5 of that Decree; Having read the reviews by the AIFA on the instance of the Manufacturing company Baxter S.p., made January 29, 2013 and May 31, 2013, from which results the requisites, as attested by the legal representative, letters a), b) and d) of art. 1, paragraph 3 of the Decree of April 12, 2012, and the validity of the documentation presented under point e); Having read the reviews by the AIFA on the instance of the company Biotest Pharma GmbH, made on January 29, 2013 and June 26, 2013, from which results the requisites, as attested by the legal representative, letters a), b) and d) of art. 1, paragraph 3, of the Decree of April 12, 2012, while not owning a requirement referred to in point e), as lacking the manufacturing authorisation presentation and GMP certificate for establishments sites in Belgium, used in backup mode; Having read the reviews by the AIFA on the instance of the company CSL Behring S.p.A., made on January 29, 2013 and June 6, 2013, from which results the requisites, as attested by the legal representative, established by a), b), d) and e), as regards the requirement referred to in point c), in order to point 1), relative to the location of the establishments where the Division takes place in Switzerland , Non-European country, for which there is the mutual recognition agreement with the European Union, the AIFA considers acceptable as represented by the company on the basis of document EMEA/MRA/22/03, while as regards point 2), the AIFA not satisfied owning requirement as missing by the legal representative, claim that "the plasma collected is not transferred to profit '; Having read the reviews by the AIFA on the instance of the company Grifols Italy S.p.A., made on 1 St August June 12, 2013 and January 29, 2013, 2013, which turns out to possess the requisites, as attested by the legal representative, letters a), b) and d), art. 1, paragraph 3, of the Decree of April 12, 2012, and the validity of the documentation presented under letter e); Having read the reviews by the AIFA on the instance of the company Kedrion S.p.A., made on January 29, 2013 and May 21, 2013, from which results the requisites, as attested by the legal representative, letters a), b) and d), art. 1, paragraph 3, of the Decree of April 12, 2012, and the validity of the documentation presented under letter e); Having read the reviews by the AIFA on the instance of the company Octapharma Italy S.p.A., made on January 29, 2013 and May 29, 2013, from which results the requisites, as attested by the legal representative of the company, letters a), b) and d), art. 1, paragraph 3 of the Decree of April 12, 2012, whereas for letter e), highlights the lack of authorization for the production of the factory in Vienna; Took note of the expressed by AIFA in evaluations of the instances of companies Baxter Manufacturing s.p.a, Biotest Pharma GmbH, Grifols Italy S.p.A., Kedrion S.p.A. and Octapharma Italy S.p.A., with respect to the possession of the requirement referred to in point c) of art. 1, paragraph 3, of the April 12, 2012 Decree, which refers to the judgement of this Ministry the interpretation of the standard in light of what is reported in the "Report from the Commission to the European Parliament, Council, the European Economic and Social Committee and the Committee of the Regions-Brussels 23/03/2011", in which Italy, Spain, Germany and Sweden, as appears in the countries in which they are granted some form of incentives to donors (such as for example reimbursement of travel expenses and time spent by donation) that essentially does not differ from the right of the donor employee to refrain from work on the day of the donation, as provided for by art. 8 October 21, 2005, law # 219; Considered to make use, for the purposes of the enactment of the Ordinance under art. 15, paragraph 5, of law October 21, 2005, n. 219 and subsequent modifications and integrations, scientific support of national blood Centre (CNS), for evaluation of instances received from companies, particularly with respect to the possession of the requirement referred to in point c), art. 1, paragraph 3, of the Decree of April 12, 2012; Having regard to the report of the CNS, contextual evaluation of individual instances, dated November 15, 2013, if you observe, first, that article. 8 October 21, 2005, law # 219, quoted above gives a benefit that does not affect the gratuity of the donation but with it's compatible not royalty or form of remuneration and that the Report of Brussels, also mentioned above, should be read in connection with the report that accompanies the Oviedo Convention in significant point where recognizes a reasonable allowance for technological and logistical activities and secondly that the principle of non-remunerated donation goes distinguished from the principle of non-commercialisation of plasma; Given that, then, the principle of non-remunerated donation should be kept separate from the principle of non-commercialisation of plasma requirement under art. 1, letter c) of Decree April 12, 2012; Having regard to the assessment of CNS on instance Baxter Manufacturing S.p.A., from which it appears that the documentation substantially complies with all the requirements referred to in points a, b), c), d)) and e), art. 1, paragraph 3, of the Decree of April 12, 2012; Having regard to the assessment of CNS instance of Biotest Pharma GmbH, from which it appears that the documentation meets the requirements of paragraphs), b) and d) of art. 1, paragraph 3, of the Decree of April 12, 2012, that the condition referred to in point c) is not satisfied, as the statement made by the company does not appear consistent with the provisions of art. 15 October 21, 2005, law # 219 and its subsequent amendments, while the requirement referred to in point e) is not satisfied in relation to settlements sites in Belgium, used in backup mode, because missing manufacturing authorisation and GMP certificate; Having regard to the assessment of CNS instance of CSL Behring S.p.A., from which it appears that the documentation meets the requirements referred to in points a and b), d))) of art. 1, paragraph 3, of the Decree of April 12, 2012, while for the requirement referred to in point c) there is no evidence to express the evaluation as it does not present any declaration by the legal representative certifying the possession thereof; Having regard to the assessment of CNS instance of Grifols Italy S.p.A., from which it appears that the documentation meets the requirements referred to in points a, b, d))) and e), art. 1, paragraph 3, of the Decree of April 12, 2012, and that for the requirement referred to in point c) the statement is not formally complete because does not have the explicit statement of the legal representative that in Spain, where the national plasma fractionation process, «the plasma collected is not transferred for profit»; Having regard to the assessment of CNS Kedrion S.p.A. instance, from which it appears that the documentation meets the requirements of paragraphs), b), c), d), and e), art. 1, paragraph 3, of the Decree of April 12, 2012; Having regard to the assessment of CNS on the application for Octapharma Italy S.p.A., from which it appears that the documentation meets the requirements referred to in points a, b), c)) and d), art. 1, paragraph 3, of the Decree of April 12, 2012, and that the requirement referred to in point e) is not evaluated because it is missing the certificate of manufacturing authorisation of establishments websites in Vienna; Considered, based on the assessments made by AIFA and CNS, to require companies respectively CSL Behring S.p. and Grifols Italy S.p.A., concluding the statement with regard to the possession of the requirement referred to in point c) of art. 1, paragraph 3, of the Decree of April 12, 2012 as the company Octapharma Italy S.p.A., the presentation of the certificate of manufacturing authorisation of establishments websites in Vienna on the requirement referred to in point e); Acquired the required evaluations by the AIFA, made on January 20, 2014 and February 21, 2014 and CNS, made on December 20, 2013 and January 10, 2014, on additional information supplied by the Companies, from which results the conformity with the requirements; Noted that on the basis of the above ratings companies in possession of all the requirements prescribed by the Decree April 12, 2012, are Baxter Manufacturing S.p.A., CSL Behring, Grifols Kedrion s.p.a, Italy S.p.A. S.p.A. and Octapharma Italy s.p.a, Acquired the opinion of CNS expressed a note of March 12, 2014; Acquired the opinion of Browse permanent technique for transfusion system expressed at its meeting of March 24, 2014; Acquired the opinion of the Standing Conference between the State, the regions and the autonomous provinces of Trento and Bolzano expressed at its meeting of November 27, 2014 (Rep. Acts # 170/CSR);
Decrees: Art. 1 1. Blood fractionation and production companies authorised to conclude agreements with the regions and autonomous provinces of Trento and Bolzano plasma processing collected throughout the country, are identified in the following: Baxter Manufacturing S.p.A., with facilities for plasma fractionation process sites in Rieti, Italy;
CSL Behring S.p.A., with facilities for plasma fractionation process sites in Bern, Switzerland;
Grifols Italy S.p.A., with facilities for plasma fractionation process sites at Instituto Grifols, S.A., Barcelona, Spain;
KEDRION S.p.A., with facilities for plasma fractionation process sites in Newcastle upon Tyne, Gallicano, Lucca, Italy;
Octapharma Italy s.p.a, with facilities for plasma fractionation process sites in Stockholm, Sweden. 2. this Decree shall enter into force on the day following its publication in the official journal of the Italian Republic. This Decree is conveyed in the control bodies compliance expertise.
Rome, December 5, 2014 the Minister: Lara recorded at the Court of Auditors on March 31, 2015 supervising office of acts of the MINISTRY of EDUCATION, MINISTRY of CULTURE, Min. Health & Min. work, sheet # 1229