• Pharma Regulatory Services in Poland

    Overview

    Poland has the largest Pharmaceutical market in Central and Eastern Europe and a structured healthcare system boasting good market opportunities for aspiring medicinal product manufacturers. For compliant market access, manufacturers must register their medicinal products with Chief Pharmaceutical Inspectorate of Poland. As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:  

  • Regulatory Services in Poland

    Overview

    Situated in Central Europe, Poland stands a good access point for other regions in Europe. In addition, Poland’s steadily growing economy predominantly boasts a good fortune for foreign medicine and medical devices manufacturers for investments. However, the health sector is highly regulated and the Ministry of Health oversees the regulations regarding necessary market authorizations and market approvals. In addition, lack of profound knowledge on local regulatory rules would pose a great challenge for manufacturers to sail through the approval procedures.