ALMBiH „Službeni„Službeni glasnik BiH“ br. 4/10
„Službeni glasnik BiH“ br. 4/10 is the official ALMBiH identifier for “Pravilnik o medicinskim sredstvima (Rulebook on Medical Devices)”. „Službeni glasnik BiH“ br. 4/10 is the official identifier ALMBiH uses for this instrument.
- Instrument
- „Službeni
- Full name
- „Službeni glasnik BiH“ br. 4/10
- Category
- Registration
- Authority source
- Bosnian
- Readable HTML
- 92 articles · 1 language version
- Published
- January 19, 2010
- Effective
- —
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Pravilnik o medicinskim sredstvima (Rulebook on Medical Devices)
Pravilnik o medicinskim sredstvima, made by the ministar civilnih poslova on the proposal of the Stručno vijeće of the Agencija za lijekove i medicinska sredstva BiH, signed 10 December 2009 and published in „Službeni glasnik BiH“ br. 4/10 of 19 January 2010. It is issued under Article 99(7), Article 100(4), Article 106(5), Article 112(3) and Article 113(4) of the Zakon o lijekovima i medicinskim sredstvima, so the issuer is the ministry and the Agency is the proposer — the registry regulator label is used for the row and the distinction is stated here. In twelve parts and 92 articles, with five annexes: I Osnovne odredbe; II Klasifikacija i razvrstavanje medicinskih sredstava; III Pravila za razvrstavanje medicinskih sredstava, itself in four glavas (I Opšte o pravilima, II Neinvazivna, IV Aktivna, V Posebna pravila); IV Registar medicinskih sredstava; V Proizvodnja; VI Ispitivanje; VII Utvrđivanje usklađenosti i označavanje, in two glavas (I Opšte, III Označavanje i izjava o usklađenosti); VIII Kategorije medicinskih sredstava; IX Uslovi za upis u registar, the part the ALMBIH MSU-1.2 documentation list is read against; X Promet; XI Oglašavanje; XII Prijelazne i završne odredbe. Annexes: Prilog 1 and Prilog 2 (classification rules tables), the OBRAZAC REG-IV-MS registration application form (Prilog 3), Prilog 4 and Prilog 5. **The printed instrument’s own part and glava numbering has gaps** — DIO TREĆI runs GLAVA I, II, IV, V (no GLAVA III) and DIO SEDMI runs GLAVA I and III (no GLAVA II) — and the block ids follow the part rather than a dense renumbering, so the missing glava numbers remain visible rather than being silently closed up. Ingested from the ALMBIH PDF of the gazette, with reading order and the legacy character set restored.
„Službeni glasnik BiH“ br. 4/10 is the official identifier ALMBiH uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.