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- 2001_83_cons2009_en.pdf accessdate "2014-11-17".
- 2001_83_cons2009_en.pdf isCitedBy Process_qualification.
- 2001_83_cons2009_en.pdf publisher "European Commission".
- 2001_83_cons2009_en.pdf title "--11-06".
- 2001_83_cons2009_en.pdf url "http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons2009/2001_83_cons2009_en.pdf".