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What are the requirements for monitoring of Specific Therapeutic Programs (STP)? Are the respective specifications available?

The Regulation no. 228/2008 Coll., Section 2 (j) obliges STP submitters to monitor and evaluate safety and efficiency of the medicine; the method of performing the above is up to the submitter. An application for STP includes the plan of STP monitoring control proposed by the STP submitter, including the person responsible for STP monitoring. The report on the progress of STP will include information about the number of patients included in the program, assessment of occurrence of all adversary effects, and information about the number of packages used, which will also be included in the statement of SUKL for the STP.