Zdravila za somatsko celično zdravljenje ljudi v tej prilogi pomenijo uporabo avtolognih (ki izvirajo iz bolnika samega), alogenskih (ki izvirajo iz drugih ljudi) ali ksenogenih (ki izvirajo iz živali) somatskih živih celic, katerih biološke lastnosti so znatno spremenjene, kar je posledica njihovega spreminjanja, da s pomočjo presnovnih, farmakoloških in imunoloških sredstev pridobijo zdravilni, diagnostični ali preventivni učinek.
For the purposes of this Annex, somatic cell therapy medicinal products shall mean the use in humans of autologous (emanating from the patient himself), allogeneic (coming from another human being) or xenogeneic (coming from animals) somatic living cells, the biological characteristics of which have been substantially altered as a result of their manipulation to obtain a therapeutic, diagnostic or preventive effect through metabolic, pharmacological and immunological means.