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Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation
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This is the original version (as it was originally adopted).
1.Member States shall ensure that organ exchange with third countries is supervised by the competent authority. For this purpose, the competent authority and European organ exchange organisations may conclude agreements with counterparts in third countries.
2.The supervision of organ exchange with third countries may be delegated by the Member States to European organ exchange organisations.
3.Organ exchange, as referred to in paragraph 1, shall be allowed only where the organs:
(a)can be traced from the donor to the recipient and vice versa;
(b)meet quality and safety requirements equivalent to those laid down in this Directive.
Member States may conclude or allow a competent authority to conclude agreements with European organ exchange organisations, provided that such organisations ensure compliance with the requirements laid down in this Directive, delegating to those organisations, inter alia:
the performance of activities provided for under the framework for quality and safety;
specific tasks in relation to the exchanges of organs to and from Member States and third countries.
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