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Price List

Price registration services in CZ

Dossier submission and MA obtaining 2750,- Euro/application
Additional formulation of dossier (or additional strength.)     1650,- Euro/application
Renewals 1650,- Euro/application
Variation type I 440,- Euro/application
Variation type II 880,- Euro/application
SmPC compilation one language version
(Translation to local language) 		550,- Euro/SPC
Food supplements and medical devices 500,- Euro/application

Payment: 50% after MA application submission and 50% after MA decision (Cost not included administrative and dossier evaluation fees paid to DRA) SPC payment before submission of application. Price included application of MA submission, local support and management of registration process included cost for dossier evolution and additional documents development.

Price for pharmacovigilance and scientific services

QP for pharmacovigilance 1000,- Euro/month
monitoring       
phone cost (mobile 24 hours)    
computer maintenance    
QP services monitoring and reports to Drug regulatory Authorities    

training of responsible person for actual data compiling

   
24 hours information services according Medical Act No 129/2003    

SOPs for pharmacovigilance implementation on paper and electronic version (Lotus Notes) 3.000 euro/simple, calculated separately

Price for reimbursement services

support for MF price application   (will be specified)
VZP registration (insurance price application)   (will be specified)

Payment: after contract signature

Valid through December 31, 2006.