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Cap. 483 · cap/483 (Cap. 483)

Cap. 483 Art. 15Import or export of human tissues and cells.

PART IV

Van krachtOfficiële tekst

(1) No person shall import tissues and cells from third countries unless:

(a) such an activity is undertaken by a licensed tissues and cells establishment;

(b) the imported tissues and cells can be traced from the donor to the recipient and vice versa in accordance with the procedures established by regulations under this Act;

(c) the tissues and cells establishments that receive such imports from third countries ensures that they meet standards of quality and safety equivalent to the ones laid down in Directive 2004/23/EC.

(2) No person shall export tissues and cells to third countries unless:

(a) such activity is undertaken by a licensed tissues and cells establishment; meet quality and safety standards equivalent to those laid down in Directive 2004/23/EC, directly authorise:

(a) the import or export of tissues and cells referred to in article 12(2)(c);

(b) the import or export of certain tissues and cells in case of emergency.