State Institute for Drug Control

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.