Published aricles: 7
List of reimbursed medicinal products valid as of 1.1.2015
Whole Article Tuesday, 30. December 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”).
PHV-7
Whole Article Friday, 25. April 2014 | Author
SÚKL requirements for the production, content and distribution of educational materials targeting healthcare professionals and patients
Information about the change in approach to the validation of the type II variation
Whole Article Friday, 12. December 2014 | Author Bc. Lucie Mrázková
State Institute for Drug Control informs the MAHs about a change in the approach to the validation of Type II variations.
Information for marketing authorisation holder
Whole Article Tuesday, 9. July 2013 | Author Bc. Lucie Mrázková
Information about the change in approach to the validation of the type II variation
Whole Article Friday, 12. December 2014 | Author Bc. Lucie Mrázková
State Institute for Drug Control informs the MAHs about a change in the approach to the validation of Type II variations.
Variations to national marketing authorisations
Whole Article Tuesday, 9. July 2013 | Author Bc. Lucie Mrázková
The Commission Regulation (EU) no. 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products became effective on 4 August, 2013.
Information for marketing authorisation holder
Whole Article Wednesday, 31. July 2013 | Author Bc. Lucie Mrázková