The Agency for medicinal products and medical devices of Bosnia and Herzegovina was established by the Act of medicinal products and medical devices ("Official Gazette of B-H, no.58/08") as an authority in the area of medicinal products and medical devices used in medical practices in B-H. It started with its work on 01 May 2009.

The Agency is established for the purpose of:

protecting and promoting public health care by ensuring a supply of quality, safe and efficient medicinal products and medical devices for use in human medicine, and for the purpose of establishing a functional, coordinate and uniform system for regulation of medicinal products and medical devices;

establishing and supervising a unified market for medicinal products and medical devices and ensuring their availability on the whole territory of B-H; Implementing cooperation and providing professional assistance to the relevant State and Entities Ministerial Authorities responsible for public health care through outlining policies, preparing proposals and implementing national policies for use of medicinal products and medical devices in human medicine;

Making proposals and amendments of legislation in the area of medicinal products and medical devices, and harmonizing the regulations with the international standards.