[ANNEX I U.K. ANALYTICAL, PHARMACOTOXICOLOGICAL AND CLINICAL STANDARDS AND PROTOCOLS IN RESPECT OF THE TESTING OF MEDICINAL PRODUCTS
[PART IV U.K. ADVANCED THERAPY MEDICINAL PRODUCTS
3. SPECIFIC REQUIREMENTS REGARDING MODULE 3 U.K.
3.2. Specific requirements for gene therapy medicinal products U.K.
3.2.1. Introduction: finished product, active substance and starting materials U.K.
3.2.1.4. In the case of products consisting of plasmids, non-viral vectors and genetically modified microorganism(s) other than viruses or viral vectors, the starting materials shall be the components used to generate the producing cell, i.e. the plasmid, the host bacteria and the master cell bank of recombinant microbial cells.] ] U.K.