L 93/56 Official Journal of the European Union 9.4.2015 COMMISSION DIRECTIVE (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to 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 (!), and in particular Article 9(4) thereof, Whereas: (1)  Directive 2004/23/EC lays down standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of all human tissues and cells intended for human application, and for the donation, procurement, and testing of human tissues and cells contained in manufactured products intended for human application where those products are covered by other Union legislation, so as to ensure a high level of human health protection in the Union. (2)  Exchanges of tissues and cells increasingly take place on a worldwide basis and Directive 2004/23/EC therefore requires that imports of tissues and cells are undertaken by tissue establishments accredited, designated, authorised or licensed by Member States for that purpose. Exceptions to that requirement are laid down in Article 9(3) of Directive 2004/23/EC allowing competent authorities to directly authorise the import of specific tissues and cells under the conditions laid down in Article 6 of Commission Directive 2006/17/EC (}) or in case of emergency. These exceptions are regularly used, but not limited to, allowing the import of haematopoietic stem cells from bone marrow, peripheral blood or cord blood which is used in the treatment of a number of life- threatening conditions. (3)  Directive 2004/23/EC, furthermore, requires Member States and importing tissue establishments to ensure that imports of tissue and cells meet standards of quality and safety equivalent to the ones laid down in Directive 2004/23[EC and calls for the establishment of procedures to verify the equivalency of the quality and safety standards of imports of tissues and cells. Those procedures should be laid down in this Directive without prejudice to the Union legislation on customs. (4)  In particular, it is appropriate to establish authorisation and inspection schemes mirroring the verification process in place for activities related to tissues and cells carried out within the Union. It is also appropriate to lay down the procedures to be followed by importing tissue establishments in their relations with their third country suppliers. (5)  With the exception of imports directly authorised by competent authorities pursuant to Article 9(3) of Directive 2004/23[EC, all imports of tissues and cells from third countries must be undertaken by importing tissue establishments. Where competent authorities do directly authorise imports pursuant to Article 9(3) of Directive 2004/23[EC, the responsibility to ensure that such imports meet quality and safety standards equivalent to those laid down in that Directive falls upon the competent authorities. (6)  Tissues and cells should normally be imported by tissue banks or units of hospitals which are accredited, designated, authorised or licensed as importing tissue establishments for the purpose of their import activities. Tissue banks or units of hospitals should be considered to be importing tissue establishments where they are a party to a contractual agreement with a third country supplier for the import of tissues and cells. Where an organisation offering brokerage services is a party to a contractual agreement with a third country supplier to facilitate the import of tissues and cells but not for the import itself, it should not be considered to be an importing tissue establishment. Member States may choose to regulate such services outside the scope of this Directive. () OJL102,7.4.2004,p. 48. () Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (O] L 38, 9.2.2006, p. 40)