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Published aricles: 7


List of reimbursed medicinal products valid as of 1.7.2014

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”).  


Submission of Documentation via the CESP Portal

The State Institute for Drug Control (hereinafter referred to as the "Institute") hereby informs about the possibility to submit authorisation applications and related documents through the CESP Portal starting from 1 July 2014.  


2014

Summary information on supplies of medicines to distributors and operators authorised to supply medicines in ČR and abroad.  


2013

Summary information on supplies of medicines to distributors and operators authorised to supply medicines in ČR and abroad.  


eSubmission


Correction of the List of reimbursed medicinal products valid as of 13.6.2014

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”).  


Centralised Procedure Documentation – change in submission to Czech NCA

The introduction of the Common Repository in February 2014 by European Medicines Agency has enabled Czech NCA to use the system as the only source of Centralised Procedure submissions, therefore there is no longer required to submit additional copies of submissions in form of CDs/DVDs by mail. This applies to all types of Centralised Procedure related to centrally authorised products submitted in eCTD format apart of listed exceptions.