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Published aricles: 7

List of reimbursed medicinal products valid as of 1.2.2018

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”).       

Specification of requirements governing the submission of marketing authorisations in the form of duplicates

SÚKL hereby specifies the requirements governing marketing authorisation of duplicates and documentation to be submitted as part of applications for marketing authorisation of duplicates effective as of 1 January 2018.   

Information for sponsors of clinical trials/submitters of Development Safety Update Reports (DSURs)

Sponsors shall submit the DSUR for the investigational medicinal product on an annual basis. The DSUR shall reflect any newly available information obtained in the course of the period to which the report pertains. The report shall contain information as referred to under ICH guideline E2F, Note for guidance on development safety update reports, September 2010.  

The recommended procedures

The recommended procedures for submitting correct and complete reporting of marketing authorization holders on the volume of supplies of human medicinal products placed on the market in the Czech Republic (REG-13).  

Information to fulfill legal obligations of marketing authorisation holders

The State Institute for Drug Control (hereinafter referred to as the “Institute”) wishes to draw the attention to the obligations set out in Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (hereinafter referred to as the “Act on Pharmaceuticals”).