Goal of the EU project – Medicines and Medical Devices in Accordance with the EU Standards

The EU Twinning Project “Strengthening the institutional capacity of the Agency for Medicines and Medical Devices of Bosnia and Herzegovina” has started in November 2011 and it will last 15 months. The project is financed by the European Union from the Instrument for Pre-accession Assistance (IPA 2008) to the tune of 500,000.00 Euro and implemented by the Spanish Agency for Medicines and Medical Devices (AEMPS).

The Twinning is instrument established by the European Commission in 1998 with the aim to provide technical assistance to beneficiary countries (candidate and potential candidate countries) in the institution building. The task of the Twinning is to assist these beneficiary countries in development of the modern and efficient administrations, with the structures, human resources and management skills needed to implement the EU acquis.

The beneficiary institution of this twinning project is the Agency for Medicines and Medical Devices of Bosnia and Herzegovina. Through this project the EU will enable this Agency to strengthen its institutional capacities  to become  fully functional in accordance with EU standards.

The main purpose for establishing the Agency in 2008 was to protect and promote health in BiH by ensuring quality, safe and efficient medicinal products and medical devices for human use as well as establishing and supervising a single internal market for medicines and medical devices. Therefore, the implementation of this project and achievement of its objectives are in the best interest of the BiH citizens, health professionals and market agents. Efficient and functional Agency will among the others:
– Ensure proper control and enforcement of the single market for medical devices and their availability in BiH
– Establish functional, coordinated and common regulatory system of drugs and medical devices Throughout the BiH
– Establish an institution that shall provide information and support to health professionals.
– Support development of local pharmaceutical production according to European standards and trends in order to prepare them for the competition at the international level in terms of quality.