„Službeni glasnik BiH“ br. 58/08

Zakon o lijekovima i medicinskim sredstvima Bosne i Hercegovine, adopted by the Parlamentarna skupština BiH (PSBiH broj 217/08 of 17 June 2008), published in „Službeni glasnik BiH“ br. 58/08 of 21 July 2008. It is the state-level framework statute for both medicines and medical devices, and Chapter IV (Medicinska sredstva, Articles 96 to 123) is the device part: Article 96 defines a medical device and excludes the medicinal-product, transplant, blood and tissue cases; the chapter then covers the classification and conformity-assessment duties, the register of medical devices, manufacture, clinical investigation, vigilance, advertising and the disposal of devices taken out of use. The **scope of this ingest differs from the round-207 triage note**, which described the document as „Poglavlje IV. Medicinska sredstva, članovi 96–129“: the bytes ALMBIH serves are the 26-page gazette excerpt of the **entire** statute as printed — Chapters I to VII, Articles 1 to 142 — and Chapter IV runs from Article 96 to Article 123, because Article 124 already opens Chapter V (Farmaceutsko-inspekcijski nadzor). The whole statute is therefore ingested, not the chapter, and the chapter boundary is recorded here as the print states it. Parts: I Osnovne odredbe; II Agencija za lijekove i medicinska sredstva Bosne i Hercegovine, which constitutes the Agency; III Lijekovi; IV Medicinska sredstva (Arts. 96–123); V Farmaceuts ko-inspekcijski nadzor; VI Prekršajne odredbe; VII Prijelazne i završne odredbe. Ingested from the ALMBIH PDF of the gazette, with reading order restored from the two-column setting and the legacy pre-Unicode Bosnian character set mapped back to its letters.

„Službeni glasnik BiH“ br. 58/08 is the official identifier ALMBiH uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.