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Published aricles: 9


Overview of issuance of decisions/notifications for MRP variations


The recommended procedures – update 12.2.2020

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)    


Powers of Attorney for clinical trials on pharmaceuticals

Specimens and procedures relevant to Powers of Attorney for clinical trials on pharmaceuticals only. The Powers of Attorney submitted to SÚKL shall be governed solely by the Czech legal order and interpreted under Czech legislation.  


Powers of Attorney for the area of marketing authorisations and Pricing and Reimbursement Regulation Section

Specimens and procedures relevant to Powers of Attorney for marketing authorisation activities, pricing and reimbursement regulation, pharmacovigilance, quality defects, good manufacturing and distribution practice. The Powers of Attorney submitted to SÚKL shall be governed solely by the Czech legal order and interpreted under Czech legislation.