Definitions
Article 2
For the purposes of this Directive, the following definitions apply: (a) ‘emergency’ means any unforeseen situation in which there is no practical alternative other than to urgently import tissues and cells from a third country into the Union for immediate application to a known recipient or known recipients whose health would be seriously endangered without such an import; (b) ‘importing tissue establishment’ means a tissue bank or a unit of a hospital or another body established within the Union which is a party to a contractual agreement with a third country supplier for the import into the Union of tissues and cells coming from a third country intended for human application; (c) ‘one-off import’ means the import of any specific type of tissue or cell which is for the personal use of an intended recipient or recipients known to the importing tissue establishment and the third country supplier before the importation occurs. Such an import of any specific type of tissue or cell shall normally not occur more than once for any given recipient. Imports from the same third country supplier taking place on a regular or repeated basis shall not be considered to be ‘one-off imports’; (d) ‘third country supplier’ means a tissue establishment or another body, established in a third country, which is responsible for the export to the Union of tissues and cells it supplies to an importing tissue establishment. A third country supplier may also carry out one or more of the activities, which take place outside of the Union, of donation, procurement, testing, processing, preservation, storage or distribution of tissues and cells imported into the Union.