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General guidelines PDF Print E-mail
Written by Věra Morávková   

Name of guideline

NumberEffective dateSourceNotice/document
 Requirements specifications for submission of the MA application and dossiers USKVBL/REG-1/2013 11.04.2013 ISCVBM public accessible document
 Detailed requirements concerning submissions of multiple applications for a marketing authosrisation of VMPs USKVBL/REG-5/2009 Rev.1 19.04.2010 ISCVBM public accessible document
  Note for guidance on draft texts to appear on the immeadiate single dose containers of IVMPs in other than the Czech language USKVBL/REG-1/2010 Rev.1 28.10.2013 ISCVBM public accessible document
 Application form for transfer of the marketing authorisation   USKVBL/REG-2/2009 1.4.2009 ISCVBM  public accessible document
 Application for CZ outgoing MR/DC procedures   USKVBL/REG-1/2009 30.3.2009 ISCVBM  public accessible document
 Summary of the dossier - Part 1A, application form USKVBL/REG-5/2008 12.1.2009 NTA  public accessible document
 Application for renewal of MA USKVBL/REG-2/2008/Rev.1 11.4.2013 NTA  public accessible document
 Providing consultations by the staff of the ISCVBM USKVBL/UST-2/2006 01.03.2006 ISCVBM public accessible document
Last Updated on Friday, 18 August 2017 08:49