Regulation of prices and reimbursements for pharmaceuticals

Decision-making in the area of maximum prices of medicinal products and the amounts and conditions of reimbursements for medicinal products. The process of determining the maximum prices and amounts and conditions of reimbursements is individual and may be re-visited, it is conducted in the mode of an administrative procedure with fixed timelines and fully complies with the European transparency directive. Applications and initiatives will be reviewed in particular on the basis of efficacy, safety, and cost efficiency assessments. The parties to the administrative procedure are, pursuant to the law, health insurance companies and marketing authorisation holders. Initiatives may be submitted also by patient organisations or professional associations.  

The staff of the information centre will be happy to answer your general questions.

 

Methodology of pricing and reimbursement procedures


 

Explanatory notes:
Non-registered copy – the methodologies published on the Institute´s website bear the “Non-managed copy” watermark, in order to maintain compliance with the internal regulations governing document management within the scope of the quality management system as per ISO 9001
W-identification of a directive – an amended version of an internal directive for publication on the Institute´s website 



General information: