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References
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)
European Commission (2003 b) Detailed guidance on the European clinical trials database (EudraCT Database). http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2003/april/cp-guidance-eudract_230403.pdf)
European Commission (2005) Commission Directive 2005/28/EC of 8 April 2005 laying down 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.
European Medicines Agency (2004) CPMP/CHMP/QWP185401 Draft guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials. (http://www.emea.eu.int/Inspections/docs/18540104en.pdf)
European Parliament and the Council of the European Union (2001) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. (http://pharmacos.eudra.org/F2/eudralex/vol-l/DIR_2001_20/DIR_2001_20_EN.pdf)
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Verbruggen, A., Zolle, I. (2007). The Rules Governing Medicinal Products for Human Use in the European Union. In: Zolle, I. (eds) Technetium-99m Pharmaceuticals. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-33990-8_11
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