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Legislation

Plasma and PDMPs are regulated by an extensive European and national legislation, including laws concerning transfusion activities as well as Directive 2001/83/CE (Community code relating to medicinal products for human use) and the guidelines of the European Medicines Agency (EMA).

Self-sufficiency of plasma, PDMPs, blood and blood components represents one of the goals of the Law 219/2005 which aims at guaranteeing equal conditions of quality and safety of the transfusion therapies to all citizens.
Self-sufficiency is a national supra- local and supra-regional goal; its achievement shall be ensured also thanks to the contribution of both Regions and Healthcare Authorities.
Law 219/2005 confers a fundamental role to the Associations and Federations of voluntary blood donors. Indeed, they contribute to achieve the goals of the National Health Service through the promotion and development of timely blood donations and donor protection.

National Plasma and PDMPs Programme.

As provided by the Legislative Decree No. 261 of December 20, 2007, the Ministry of Health, in agreement with the Regions and the Autonomous Provinces, on the basis of the indications given by the Italian National Blood Centre, defines a programme aimed at ensuring both the development of plasma collection and the promotion of the rational and appropriate use of PDMPs.
The Ministerial Decree 2 December, 2016 contains the first Programme ever published in Italy that pursues the national self-sufficiency in plasma and PDMPs. It states principles and the strategic objectives at national and regional level to be reached in the period 2016 – 2020.

National Plasma and PDMPs system
The Regions, individually or in consortia, provide the manufacturers identified in the Ministerial Decree of December 5, 2014 with the plasma collected at the Blood Establishments and at the Collection Units. Regions receive the final products back on the basis of specific toll-fractionation agreements and contracts.

According to the Ministerial Decree of April 12, 2012 the production of PDMPs is defined in a quantitative and qualitative production plan agreed between the Regions and the manufactures. Regions remain the fully-entitled owners of the plasma and of all pharmaceutical specialities derived from it.

Toll-fractionation contracts must consider the production of at least albumin, polyvalent immunoglobulins for intravenous administration (IVIg), coagulation factor VIII concentrates. Furthermore, they must include also services of both pre-processing (collection, storage of plasma, etc.) and post-production (batch release, storage and delivery of final products, etc.). Plasma for fractionation, PDMPs and intermediates can be exchanged among Regions on the basis of national tariffs defined in the State-Regions Agreement of October 20, 2015

Quality and safety of plasma
Plasma, obtained either by separation of the whole blood or through apheresis, can be intended for clinical use or for industrial manufacturing as “raw material” for the production of PDMPs. The quality and safety requirements are specified in the Ministerial Decree of November 2, 2015, which transposes the prescriptions included in Directive 2002/98/CE and in the related technical ones.
Plasma and PDMPs are regulated by the Directive 2001/83/CE (Community code relating to medicinal products for human use), the guidelines of the European Medicines Agency (EMA) and the indications provided by the national authorities.

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