Commercialisation of Healthcare (Poland)

OVERVIEW OF THE MEDICAL PRODUCT REGULATORY SYSTEM IN POLAND

1.1. Medical product regulators, such as government agencies

The key institutions regulating the medicinal product market include:

• the Ministry of Health, which issues decisions on reimbursement of medicinal products;
• the Office for the Registration of Medicinal Products, Medical Devices and Biocides (Registration Office), which issues decisions on marketing authorisations (see sections 2.1 and 2.4);
• the National Health Fund, which funds the national healthcare system; and
• the Main Pharmaceutical Inspector (MPI), which, for example, supervises medicinal product manufacturing and marketing requirements (see section 2.1).

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Source: The European Lawyer (Thomson Reuters), 2013