President of the Office is a government administrative authority, competent for matters concerning:

1)      marketing authorization of medicinal products, excluding medicinal products which do not need marketing authorization – within the scope determined by the Act of 6 September 2011 on Pharmaceutical Law (O.J. 2008, No 45, item 271, with later amendments);

2)      marketing authorization of biocidal products  - within the scope determined by the Act of 13 September 2002 on biocidal products (O.J. 2007, No 39, item 252, with later amendments);

3)      marketing and use of medical devices – within the meaning and on the basis of the Act on Medical Devices of 20 May 2010 (O.J. No 107, item 679);

4)      clinical trials, including veterinary clinical trials – within the scope determined by the Act of 6 September 2001 on Pharmaceutical Law and the Medical Devices Act of 20 May 2010.

 

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.