F1ANNEX IANALYTICAL, PHARMACOTOXICOLOGICAL AND CLINICAL STANDARDS AND PROTOCOLS IN RESPECT OF THE TESTING OF MEDICINAL PRODUCTS
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Amendments (Textual)
F2PART IVADVANCED THERAPY MEDICINAL PRODUCTS
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Amendments (Textual)
3.SPECIFIC REQUIREMENTS REGARDING MODULE 3
3.2.Specific requirements for gene therapy medicinal products
3.2.1.Introduction: finished product, active substance and starting materials
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.
Substituted by Commission directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (Text with EEA relevance).