Bosnia and Herzegovina

Act on Medical Products and Medical Devices

On May 1st 2009 the Agency for medical products and medical devices in Bosnia and Herzegovina has started with work. The Act on Medical Products and Medical Devices defines Agency's jurisdiction, how to apply for MA in Bosnia and Herzegovina, documentation for registration, pharmacovigilance, advertising.

This law also applies to the medical products that contain drugs and psychotropic substances, as well as the raw materials used in their production.

Only the products with approval from the Agency can be placed on the market in Bosnia and Herzegovina.

More details is available from our local consultant from Sarajevo, Bosnia and Herzegovina 

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