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Published aricles: 3


VHP procedures since 23rd October 2020

Important Information for Applicants for Clinical Trials through the Voluntary Harmonisation Procedure  


Information on documentation to be submitted for clinical trials on medicinal products for the treatment of COVID-19

The State Institute for Drug Control hereby informs about the requirements for documentation to be submitted for clinical trials on medicinal products containing genetically modified organisms (GMO) intended for the treatment of COVID-19, submitted at the time of the COVID-19 pandemics. In terms of pharmaceutical, preclinical, and other documentation, the requirements set forth by guideline KLH-20 are still applicable. For clinical trials (CT) on medicinal products intended for the treatment or prevention of COVID-19, submitted at the time of the COVID19 pandemics, however, some other requirements shall apply, as stipulated below.  


List of reimbursed medicinal products valid as of 1.10.2020

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”).