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The Rules Governing Medicinal Products for Human Use in the European Union

  • A. Verbruggen
  • I. Zolle
Chapter
  • 1.7k Downloads

Keywords

Medicinal Product Marketing Authorization Good Manufacturing Practice European Pharmacopeia Investigational Medicinal Product 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 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
  2. 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)Google Scholar
  3. 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.Google Scholar
  4. 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)Google Scholar
  5. 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)Google Scholar
  6. Kristensen K (1979) Preparation and control of radiopharmaceuticals in hospitals. Technical Reports Series No. 194. International Atomic Energy Agency, ViennaGoogle Scholar

Copyright information

© Springer Berlin Heidelberg 2007

Authors and Affiliations

  • A. Verbruggen
    • 1
  • I. Zolle
    • 2
  1. 1.Onderwijs en Navorsing 2LeuvenBelgium
  2. 2.Department of Medicinal/Pharmaceutical ChemistryUniversity of ViennaViennaAustria

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