The Pharma Legal Handbook: Poland

Poland is the largest pharmaceutical market in Central and Eastern Europe and one of the EU's most commercially significant markets. The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) manages national product authorisation, while the Ministry of Health oversees reimbursement decisions through the Reimbursement Act framework.

Poland's reimbursement system has been substantially reformed in recent years, with the Reimbursement Act introducing official list management, price negotiations, and risk-sharing agreements. The pricing and reimbursement environment requires careful navigation, and the prices achieved in Poland are closely watched as a reference by other CEE markets.

The Pharma Legal Handbook: Poland provides comprehensive guidance on pharmaceutical regulation in Poland, covering URPL product authorisation, the Reimbursement Act pricing and listing process, clinical trial requirements, pharmacovigilance obligations, manufacturing standards, marketing rules, parallel imports, and intellectual property protection.