IP for Bosnia and Herzegovina

Does the informed consent form for Bosnia and Herzegovina need to be translated into all three languages, or is one sufficient?

According to the Rulebook on Clinical Trials of Medicines and Medical Devices, published in the Official Gazette of Bosnia and Herzegovina No. 04/2010, the patient information and the informed consent form must be in the local language.

The official languages of Bosnia and Herzegovina are Bosnian, Serbian, and Croatian, and the official scripts are Latin and Cyrillic.

For more information, visit:
http://www.almbih.gov.ba/_doc/regulative/pravilnik_klinicka_bos.pdf 

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