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Published aricles: 33


List of reimbursed medicinal products valid as of 1.3.2014

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”).  


Reporting ADRs related to MP of biological origin


What should not be reported from the Patient Support Programme - PSP?


Amendment to the Decree on Marketing Authorisation


Who is the PSUR to be submitted to?


What is the maximum period for submitting the PSUR after the DLP?


Is it necessary to submit the PSUR for hybrid medicinal products?


In what format shall the protocol be submitted (to PRAC and to SÚKL)?


Where, when and how to register PASS? Which PASS are to be registered?


When should I submit the updated RMP?


In what format should the RMP be submitted?


Should I introduce a risk management plan for my medicinal product?