Czech medicines regulator in Prague, founded in 1952 and operating under the health ministry, responsible for human medicines, medical devices, narcotics and human tissues and cells. Assesses and registers medicines, inspects manufacturers and distributors for good manufacturing and distribution practice, runs the national pharmacovigilance system with adverse reaction reporting and the requirements for qualified and local persons for pharmacovigilance, sets prices and reimbursement and runs its own laboratories for quality control testing.
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