Announcement about adverse effects and irregularities in quality of medicinal products in emergency situations:
Telephones 0-24h, only in emergency cases which could cause a recall of medicinal product.
Alija Uzunović, Tatjana Ponorac
+387 65 598-516
+387 61 473-605
Main switchboard, from 08-16 h
+387 51 456-040
+387 51 450-301 (telefax)
Medicinal products are one of the most regulated areas of legal legacy of European Union. Agency for medicinal products and medical devices of Bosnia and Herzegovina conducts intensive international cooperation so it would be prepared to function in integrated and regulated area/environment, when Bosnia and Herzegovina becomes a member of European Union.
As part of IPA-project (Instrument for Pre-Accession Assistance), in which are candidate countries and potential candidates for membership in EU, Agency’s experts participate as observers in certain boards and working groups of European Medicines Agency (EMA). Cooperation with EMA has started in 2009 and it is still current.
The Agency also cooperates with European Directorate for the Quality of Medicines & HealthCare (EDQM), which is part of Council of Europe in Strasbourg. The Agency participates in work of European Commission for pharmacopoeia, as in activities European Official Medicines Control Laboratories Network (OMCL Network), which includes conducting of inter-laboratory testing.
The Agency conducts intensive cooperation with regulatory bodies for medicinal products and medical devices in countries of region. Until now have been signed protocols of cooperation with the Medicines and Medical Devices Agency of Serbia (ALIMS), the Agency of Medicines and Medical Devices of Montenegro (CALIMS) and with Agency for Medicinal Products and Medical Devices of Croatia (HALMED).
The Agency has also signed contracts / agreements in the field of providing professional service within the scope / capacity of the Pharmacovigilance Head Office in Mostar with the Institute of Pharmacology of University-Clinical Centre in Banja Luka and the Centre of medicinal products of University-Clinical Centre of Sarajevo.
During our work, significant help and support have been provided to us by World Health Organization (WHO) – office in B-H, by organizing continuing / advancing trainings of several days in domain of pharmaceutical law.
Twinning Project“Strengthening of institutional capacity of the Agency for medicinal products and medical devices of Bosnia and Herzegovina”
- Duration of project:
- Starting date:
- Completion date:
- Budget from EU:
- 15 months
- 7. November 2011.
- 6. February 2013.
- 500.000 Euros
List of medicinal products with marketing authorisation and list of medicinal products which may cause risks.Read More
List of medical devices with certificates of registering in the Registry of medical devices.Read More
Register of manufacturers of medicinal products and medical devices in Bosnia and Herzegovina.Read More
Registers of wholesale distributers of medicinal products and of medical devices in Bosnia and Herzegovina.Read More
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.