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Published aricles: 7


List of reimbursed medicinal products valid as of 1.11.2018

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”).    


GDPR


Personal Data Protection


Personal Data Protection


BREXIT – Important Notice to Sponsors of Clinical Trials on Pharmaceuticals

Sponsors are hereby notified and reminded of the fact that due to the announcement of the United Kingdom (hereinafter referred to as the “UK”) of 29 March 2017 of their intention to leave the EU, from the perspective of effective legislation of the European Union (hereinafter referred to as the “EU ” ), as of 30 March 2019, the UK will become a “third country” and it is necessary to consider the legal consequences and impacts arising from the aforementioned in the sphere of clinical trials on medicinal products. The conditions which will be negotiated between the UK and the EU by that time shall be applicable also to the sphere of clinical trials.  


The recommended procedures – update 9.10.2018

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 – update 9.10.2018

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”).