Imported Tissues

Directive 2004/23/EC requires Member States and importing tissue establishments to ensure that tissue and cells imports 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. All tissues and cells imports from third countries must be undertaken by importing tissue establishments. Importing tissue establishments shall have in place written agreements with third country suppliers where any of the activities of donation, procurement, testing, processing, preservation, storage or export to the Union of tissues and cells to be imported into the Union are carried out outside of the Union. Importing tissue establishments shall provide copies of written agreements with third country suppliers to the competent authority as part of their application for authorisation.

Directive EU 2015/566 of 8 April 2015  

Ministerial Decree of 29 July 2015