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Written by Věra Morávková
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Name of guideline | Number | Effective date | Source | Notice/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 | 15.04.2010 | 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 MA variation type II /IA/IB notification | USKVBL/REG-3/2008 | 1.12.2008 | 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 |
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Last Updated on Wednesday, 17 April 2013 21:57 |
Authorisation & Approval 
