(5) As in the treatment of tissues and cells, an intensive worldwide exchange is desirable to have

Directive 2004/23 / EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
(1) The transplantation of human tissues and cells is a rapidly expanding field of medicine offering great opportunities for the treatment hanna imports of as yet incurable diseases. Should be ensured, the quality and the safety of these preparations, in particular in order to prevent the transmission of disease.
(2) The availability of human tissues and cells for treatment depends on citizens who are willing to donate. In order to protect public health and prevent the transmission of infectious diseases by these tissues and cells, it is necessary at the time of the donation, procurement, testing, processing, hanna imports preservation, storage, distribution and utilization into account all safety precautions.
(3) At the national and European level is necessary to promote information and awareness campaigns on the donation of tissues, cells and organs, whose motto is "we are all potential donors". The aim of these campaigns should be to help European citizens to have the life choices to become donors and to their wishes known to their families or legal representatives. Given the need to ensure the availability of tissues and cells for the treatment of Member States hanna imports should promote the donation of tissues and cells, including hematopoietic stem cells, which must be of high quality and safe, and thereby increase self-sufficiency in the Community.
(4) To ensure high standards of quality and safety for obtaining, testing, processing, storage and distribution of tissues and cells throughout the Community, as well as to facilitate the exchange of donated tissues and cells of patients each year receive such treatment are urgently needed single Framework conditions. It is essential, therefore, that Community provisions ensure that human tissues and cells, irrespective of their intended use, quality hanna imports and safety comparable. The establishment of such standards, therefore, will help to reassure the public that human tissues and cells obtained in another Member State, nonetheless hanna imports carry the same guarantees as those in their own country.
(5) As in the treatment of tissues and cells, an intensive worldwide exchange is desirable to have standards hanna imports that apply to the whole world. The Community should therefore strive for the highest possible level of protection to safeguard public health regarding quality hanna imports and safety of tissues and cells. The Commission, in its report to the European Parliament and the Council information on the progress that has been made in this area.
(6) Tissues and cells intended for industrial products, including medical devices are covered by this Directive only as far as donation, procurement and testing, while the processing, preservation, storage and distribution hanna imports are regulated by other Community legislation. Further processing is covered by Directive 2001/83 hanna imports / EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (4).
(7) This Directive should hanna imports apply to tissues and cells, including hematopoietic cells from peripheral blood, (blood) and stem cells from the bone marrow, reproductive cells (eggs, sperm), fetal tissues and cells and embryonic stem cells and embryonic adult.
(8) This Directive excludes blood and blood products (other than haematopoietic progenitor cells) and human organs as well as organs, tissues or cells of animal origin. Blood and blood in the progenitor Directive 2001/83 / EC in2000 / 70 / EC (1), Recommendation 98/463 / EC (2), Directive 2002/98 / EC (3). From this Directive are also excluded tissues and cells used as an autologous graft (tissues removed and transplanted back to the same person) in a single surgical procedure and without being subjected to any banking. hanna imports The quality and safety in relation to this process are completely different.
(9) Although the issues that arise in connection with the use of organs to some extent the same question regarding the use of tissues and cells, there are also important differences, which makes these two areas should be covered by one directive.
(10) This Directive covers tissues and cells intended for human applications, including hanna imports human tissues and cells used for the preparation of cosmetic products. However, due to the risk of transmission of infectious diseases the use of human cells, tissues and products in cosmetic products is prohibited by Commission Directive 95/34 / EC of 10 July 1995 adapting to technical progress Annexes II, III, VI and VII of Council Directive 76/768 / EEC on the approximation of the laws of Member States relating to cosmetic products (4).
(11) This Directive does not cover research involving the use of human tissues and cells for purposes other than for the treatment of people, for example. Research in vitro or in animal models. Only those cells and tissues that are used in clinical trials for treating