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Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. OJ 2004;L136:1-33.
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Committee for Proprietary Medicinal Products (CPMP) and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): ICH Topic Q5B/Note for Guidance on quality of biotechnological products:analysis of the expression construct in cell lines used for production of r-DNA derived protein products. 2005;CPMP/ICH/139/95.
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Commission Directive 2005/28/EC of 8 April 2005 laying down the principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. OJ 2005;L91:13-19.
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