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

The Regulation no. 228/2008 Coll., Section 2 (j) obliges SpTP 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 SpTP includes the plan of SpTP monitoring control proposed by the SpTP submitter, including the person responsible for SpTP monitoring. The report on the progress of SpTP 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 specific treatment program.