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væv, organer eller biologiske væsker, hvorfra cellerne stammer, samt doneringens autologe, allogene eller xenogene karakter og dens geografiske oprindelse dokumenteres.
tissues, organs or biological fluids from which cells are derived as well as the autologous, allogeneic, or xenogeneic nature of the donation and its geographical origin shall be documented.
hvis der er tale om cellebaserede lægemidler, der indeholder dyreceller, skal de dermed forbundne specifikke sikkerhedsproblemer, f.eks. overførsel af xenogene patogener til mennesker, løses.
in the case of cell-based products containing animal cells, the associated specific safety concerns such as transmission to humans of xenogeneic pathogens shall be addressed.