The Rules Governing Medicinal Products for Human Use in the European Union
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KeywordsMedicinal Product Marketing Authorization Good Manufacturing Practice European Pharmacopeia Investigational Medicinal Product
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- European Commission (2003 a) Detailed guidance for the request for authorization of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial. (http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/10_05/CA_14-2005.pdf)Google Scholar
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