Division 2.1 Gene therapy medicinal productF1F2

Gene therapy medicinal product means a biological medicinal product which has the following characteristics:

1. (a)

   it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence;

2. (b)

   its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.

Gene therapy medicinal products shall not include vaccines against infectious diseases.