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Published aricles: 4


List of reimbursed medicinal products valid as of 1.11.2014

Acting in compliance with Section 39n(1) of Act No. 48/1997 Coll., on Public Health Insurance, as amended (“Act”), the State Institute for Drug Control publishes the List of Prices and Reimbursements for Medicinal Products and Foods for Special Medicinal Purposes (“List”).  


Scientific Advice provided by the Marketing Authorization branch

The Marketing Authorization branch of the State Institute for Drug Control (hereinafter the “Institute”) provides Scientific Advice upon request concerning procedural-regulatory issues and scientific requirements related in particular to applications for marketing authorization, variation  applications and marketing authorisation renewal applications. Scientific Advice is a paid service of the Institute and  is provided only outside the ongoing administrative proceedings  (e.g. before submission of a marketing authorization application in the phase of “medicinal product development”, before submission of a marketing authorisation variation or renewal application).  


Scientific Advice on Marketing Authorisation Issues

Upon request, the Marketing Authorisation Section of the State Institute for Drug Control (hereinafter referred to as the “Institute”) provides Scientific Advice concerning procedural-regulatory issues and scientific requirements associated, in particular, with applications for marketing authorisation and applications for variations to and renewals of marketing authorisation. Scientific Advice is a paid service of the Institute and it is provided only beyond the scope of ongoing administrative procedures (e.g., prior to the submission of a marketing authorisation application in the phase of “medicinal product development”, prior to the submission of an application for variation to or renewal of marketing authorisation).  


Notification concerning the establishment, the method of operation and the change of address of VPOIS

Notification concerning the establishment, the method of operation and the change of address of the Public Scientific Service (“VPOIS”) concerned with medicinal products.