Questions regarding specific therapeutic programs

Questions and answers.  

Specific therapeutic programs (hereinafter "SpTP"):

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

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

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

Who is responsible for labelling of medicines in SpTP?

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


SpTP from the viewpoint of pharmacovigilance (collection and provision of monitoring sheets, SAE reports, non-SAE by a doctor, pharmacist, distributor)?

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

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

May medicines of SpTP 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?