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Published aricles: 7


List of reimbursed medicinal products valid as of 1.1.2015

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

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

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


Information about the change in approach to the validation of the type II variation

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

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