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President of the Office is a government administrative authority, competent for matters concerning marketing authorization of medicinal products and clinical trials – within the scope determined by the Act on Pharmaceutical Law of 6 September 2001 (the Official Journal [O.J.] Dziennik Ustaw Rzeczypospolitej Polskiej, Dz.U. 2008, No 45, Item 271, with amendments) (http://dokumenty.rcl.gov.pl/D2008045027101.pdf)
The Office is a public administration body supporting the President of the Office in realization of the above matters.

The rules and the scope of responsibilities is determined by the Act of 18 March 2011 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (O.J. 2011, No 82, Item 451, with amendments (http://dokumenty.rcl.gov.pl/D2011082045101.pdf)