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Competent Authorities

Let's focus on Competent Authorities…

Competent Authorities are organizations that have the legally delegated or invested authority, capacity or power to perform a designed function.

In tissues, haematopoietic and reproductive (ART, Assisted Reproduction Technology) cells context, as defined by the European Directive 23/2004 , Competent Authorities are organizations, designed by Member States, in charged of the implementation of quality and safety standards related to donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
Quality standards, fixed by the European Directive 23/2004 and ratified or implemented by all Competent Authorities, ensure a high level of protection in case of human applications.

Furthermore, every Member State has the faculty of appointing more than a competent authority responding to specific roles and spheres of competence and expertise (i.e.: a competent authority engaged in inspection procedures for tissue banks and another one delegated to supervise procedures for tissues and cells procurement ).

The functions of the Competent Authorities are the following:

  • supervision of human tissue and cell procurement thanks to a qualified personnel who oversees that all procedures respond to fixed quality criterias, as stated on art. 5, 2004/23/CE;
  • accreditation, designation, authorisation or licensing of tissue establishments and tissue and cell preparation processes, as stated on art. 6. 2004/23/CE;
  • inspections and control measures, as stated on art. 7, 2004/23/CE;
  • assurance of the traceability of all human tissues and cells, as stated on art. 8, 2004/23/CE;
  • management of import-export activity related to human tissues and cells from or to third countries are undertaken by tissue establishments under fixed quality, safety and traceability guidelines, as stated on art. 9, 2004/23/CE;
  • registration of all licensed tissue establishments and reporting obligations on their activity, as stated on art. 10, 2004/23/CE;
  • notification of serious adverse events and reactions, as stated on art.11,2004/23/CE

According to the European Directive 23/2004, which encourages Competent Authorities to publish every year an accessible register on their tissue establishments activity, Member States and the Commission decided to establish a network, Eurocet, in order to collect activity data from every Competent Authorities and to provide a link between them.

Documents

Published 03-06-2008 in Competent Authorities , last update 24-03-2014

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