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Published aricles: 8


List of reimbursed medicinal products valid as of 1.2.2019

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”).  


Important information for Applicants for Clinical Trials via VHP procedure

State Institute for Drug Control informs applicants for Clinical Trials, that it participates in all assessment of applications under Voluntary Harmonisation Procedure (VHP).  


Important Information for Applicants for Clinical Trials through the Voluntary Harmonisation Procedure on the Possibility of Involvement of Multicentric Ethics Committees, So Called VHP Plus (HMA CTFG website refers)

The State Institute for Drug Control hereby informs the sponsors of clinical trials  that as part of the VHP Plus project, starting from February 2018 in the Czech Republic, multicentric ethics committees may also be involved in the assessment of clinical trial applications under the Voluntary Harmonisation Procedure (VHP). The joint assessment process will be coordinated and safeguarded by coordinators of Czech competent authority the State Institute for Drug Control.  


Voluntary Harmonization Procedure (VHP)


New Method of SÚKL Code Notification for Centrally Authorised Medicinal Products

SÚKL hereby informs about a new method of SÚKL code notification, i.e. a change in the issuance of identification sheets for centrally authorised medicinal products as of 1 October 2018.  


Principles of Identification of Medicinal Products for Human Use in the Czech Republic

Several types of information assigned to individual products are used for unambiguous identification of medicinal products in the Czech Republic and the European Union. In addition to the name of the product, the marketing authorisation holder and other information required on the packaging of medicinal products, several types of codes are used to identify, simplify and refine the handling of the products. Various ways of allocating code identification have been gradually developed in response to the changing needs of their users and the development of legislation.    


KLH-19 version 2


DIS-13 - version 6