Published aricles: 5
Whole Article Friday, 31. January 2014 | Author PharmDr. Kamil Kalousek
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
Whole Article Tuesday, 5. November 2013 | Author Petra Špimrová
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.
Whole Article Thursday, 21. March 2013 | Author Lucie Šustková
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.
Whole Article Tuesday, 22. May 2012 | Author Lenka Jeglová
Information for marketing authorisation holders
Whole Article Tuesday, 7. January 2014 | Author Jan Krupička
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).