ALMBiH ALMBIH,ALMBIH, Spisak od 30.10.2025
ALMBIH, Spisak od 30.10.2025 is the official ALMBiH identifier for “Spisak neophodne dokumentacije za izmjenu i/ili dopunu upisa u Registar medicinskih sredstava (30 October 2025)”. ALMBIH, Spisak od 30.10.2025 is the official identifier ALMBiH uses for this instrument.
- Instrument
- ALMBIH,
- Full name
- ALMBIH, Spisak od 30.10.2025
- Category
- Registration
- Authority source
- Bosnian
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Spisak neophodne dokumentacije za izmjenu i/ili dopunu upisa u Registar medicinskih sredstava (30 October 2025)
The Sektor za medicinska sredstva’s documentation list of 30 October 2025 for amending or supplementing an existing entry in the register — the counterpart to MSU-1.2 for changes rather than first registration. The list is organised the way the Agency’s change form is: a head entry, DOPUNA UPISA U REGISTAR MEDICINSKIH SREDSTAVA; then one numbered tačka per change type on the application — 1 change of the manufacturer’s name or address, 2 change of the name or address of the holder of the entry certificate, 3 change of the holder itself, 4 change of the device’s name, 5 change of the manufacturer, 6 change or addition of a manufacturing site, 7 change of the finished-product test procedure (change of standard or method), 8, 9 change or supplement of the device’s shape, packaging or dimensions, 10, 11 change of the shelf life, 12 change of the storage conditions, 13 change of the manner and place of supply, 14 other changes; then the four lettered subdivisions of „other changes“ — a) the instructions for use, b) the EC certificate of conformity where the change requires it, c) the device’s catalogue number, d) documentation already filed on registration; and finally the Agency’s own „Napomene vezane za zahtjeve za izmjenu i dopunu upisa“. Two of the numbered heads (tačka 8 and tačka 10) carry no printed caption in the source and are ingested with their number only rather than an invented title.
ALMBIH, Spisak od 30.10.2025 is the official identifier ALMBiH uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.