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Questions regarding specific therapeutic programmes

Questions and answers.  

Specific therapeutic programs (hereinafter "STP"):

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

Who pays for the medicines in the transitory period between approval of the STP by Ministry of Health of ČR and determination of the price and payment for a specific medicine in the STP?

How long does it take to determine the maximum price and payment?

Who is responsible for labelling of medicines in STP?

A medicine is included in a STP. At the same time, the identical medicine has been registered. Is it possible for a medicine within STP to run simultaneously with a registered medicine?

May a medicine from a specific treatment program be used for indication different from the indication of the STP?

Is it possible to include in STP any entities different from the ones listed in the decision on STP?

Does a prescription need to bear the information that an unregistered medicine is being used within a STP?

May medicines of STP be sold via mail order?

Is there a specific sanction for a healthcare facility in case it does not report usage of unregistered medicine to SUKL?

How to report an adverse reaction within a STP?