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Published aricles: 5

List of reimbursed medicinal products valid as of 1.2.2014

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”).  

Changes in Sending Decisions/Notifications/Notices to Physical Entities and Foreign Legal Entities without a Data Box

The State Institute for Drug Control (hereinafter referred to only as the “Institute”) informs marketing authorisation holders about the new method of sending the decisions/notifications/notices concerning applications for marketing authorisation, renewal, variation, transfer of marketing authorisation as well as applications for parallel import authorisation, etc. to physical entities and foreign legal entities without a data box, with effect from November 6, 2013.    

Change concerning the submitting of applications for renewal of marketing authorisation

The State Institute for Drug Control (SÚKL) hereby informs of a change concerning the submitting of applications for renewal of marketing authorisation introduced by the amended Act on Pharmaceuticals.  

Termination of MRP type I and II variations without a decision on marketing authorisation variation

Information for marketing authorisation holders  

Field Safety Corrective Actions in 2014

Field Safety Corrective Actions (FSCAs) are actions taken by manufacturers to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device. The FSCAs may include e.g. withdrawal of medical devices (hereinafter referred as the „MDs“) or supplementary information for use of MD. The manufacturer informs about Field safety Corrective Action via a Field Safety Notice (FSN).