The Pharma Legal Handbook: Romania

Romania is one of the largest pharmaceutical markets in Central and Eastern Europe and a strategically important market for companies building a regional presence. The National Agency for Medicines and Medical Devices (ANMDM) manages product authorisation and post-market surveillance, while the National Health Insurance House (CNAS) oversees reimbursement decisions.

Romania's reimbursement system involves a positive list for reimbursable products with price negotiations and a well-developed managed entry agreement framework. The claw-back mechanism, which requires companies to pay a quarterly levy based on the growth of reimbursed sales above a threshold, is a distinctive feature of the Romanian market.

The Pharma Legal Handbook: Romania provides comprehensive guidance on pharmaceutical regulation in Romania, covering ANMDM product authorisation, CNAS reimbursement pathways, the claw-back mechanism, clinical trial requirements, pharmacovigilance obligations, manufacturing standards, marketing rules, parallel imports, and intellectual property protection.