medicinal products are defined in Part IV of Directive 2003/63/EC
(amending Directive 2001/83/EC) as follows:
'… [A] gene therapy medicinal product means a product
obtained through a set of manufacturing processes aimed at the transfer,
to be performed either in vivo or ex vivo, of a
prophylactic, diagnostic or therapeutic gene (i.e. a piece of nucleic
acid), to human/animal cells and its subsequent expression in vivo.
The gene transfer involves an expression system contained in a delivery
system known as a vector, which can be of viral, as well as non-viral
origin. The vector can also be included in a human or animal cell.'