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Pressestelle DZP.

Commercialisation of Healthcare (Poland)

15.03.2013

Autoren:
Tomasz Kaczyński
Dr hab. Marcin Matczak
Piotr Najbuk

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).

The full content of the article is available in PDF file.

Source: The European Lawyer (Thomson Reuters), 2013