15.03.2013
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Overview of the regulatory framework for the commercialisation of medical products in Poland (requirements for drugs, medical devices, biological products and natural health products).
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