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Calendar

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.

Contact persons:
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)

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Home Documents Regulative

Legislation at the state level
Medicinal Products and Medical Devices

  • ORDINANCE ON MEDICAL DEVICES – English

    PDF

    (809 KB)
  • ORDINANCE ON THE CONTENT AND MANNER OF LABELLING OF OUTER AND IMMEDIATE PACKAGING OF MEDICINAL PRODUCT – English

    PDF

    (208 KB)
  • ORDINANCE ON THE CONDITIONS, CIRCUMSTANCES AND PROCEDURE FOR THE USE OF AUTHORIZED LABORATORIES – English

    PDF

    (156 KB)
  • ORDINANCE ON QUALITY CONTROL OF THE MEDICINAL PRODUCT – English

    PDF

    (156 KB)
  • ORDINANCE ON THE CONTENT AND MANNER OF LABELLING OF OUTER AND IMMEDIATE PACKAGING OF MEDICINAL PRODUCT – English

    PDF

    (199 KB)
  • ORDINANCE ON CLINICAL TRIALS ON MEDICINAL PRODUCTS AND MEDICAL DEVICES – English

    PDF

    (267KB)
  • ORDINANCE ON ADVERTISING OF MEDICINAL PRODUCTS AND MEDICAL DEVICES – English

    PDF

    (206 KB)
  • ORDINANCE ON THE METHODS OF MONITORING OF QUALITY DEFECTS IN MEDICINAL PRODUCT – English

    PDF

    (111 KB)
  • ORDINANCE on the type, amount and method of payment of costs for the activities conducted by the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina – English

    PDF

    (117 KB)
  • Medicinal Products and Medical Devices Act (“Official Gazette of B-H, no.58/08”) – English

    PDF

    (3499 KB)


Medicinal Products

List of medicinal products with marketing authorisation and list of medicinal products which may cause risks.

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Medical Devices

List of medical devices with certificates of registering in the Registry of medical devices.

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Manufacturers

Register of manufacturers of medicinal products and medical devices in Bosnia and Herzegovina.

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Wholesale distributers

Registers of wholesale distributers of medicinal products and of medical devices in Bosnia and Herzegovina.

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Clinical Trials

News, announcements and information about clinical trials.    

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About us

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.

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© 2012 Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina. All rights reserved

Moja Reklama | kreativna e-rješenja