Distribution, Manufacturing and Inspection

Manufacturing and Distribution Licences Database

• Database of Issued Licences
• Distance Sale of Medicinal Products
• Distance Sale of Medical Devices (Internet)
• List of Wholesalers/Brokers Seated Outside Croatia, in the EU

Manufacturing

• Legislative Framework
• Manufacturing and Importation
• Good Manufacturing Practice
• Supervision
• National and International Cooperation
• Instructions for Applicants

The highest permitted wholesale price of a medicinal product

• Medicinal product pricing system
• Highest permitted wholesale price of a medicinal product and exceptional increase of the price
• Annual calculation of medicinal product prices
• Submission of documentation for determining the price of a medicinal product
• Medicinal product price lists

Falsified Medicinal Products

The page is under construction.

Distribution

• Wholesale
• Retail
• Placing Medicinal Products on the Market
• Sunset Clause
• Batches of Vaccines and Blood/Plasma Derivatives on the Market
• Interruptions in the Supply Chain and Shortages
• Approvals
• Parallel Import and Distribution of Medicinal Products
• Certificate of Pharmaceutical Product (CPP)
• Drug Utilisation
• News

Inspection

• Inspectors
• Good Manufacturing Practice
• Pharmacovigilance Inspection
• News

Quality Defects and Recalls

• Procedures
• Notices on Recalls and Suspension of Distribution of Medicinal Products
• Notices on Falsified Medicinal Products
• Other Information