„Službeni list Crne Gore“ br. 035/23

Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima, published in „Službeni list Crne Gore“ br. 035/23 of 27 March 2023. It is made by the Upravni odbor Instituta za ljekove i medicinska sredstva Crne Gore — the Agency’s governing board, not the Agency itself and not the ministry — which is why that body is named as the publisher on this row rather than the registry regulator. In seven articles setting the fees for the professional services the Institute performs on devices, followed by the published act’s own explanatory note (OBRAZLOŽENJE), which is part of the act as gazetted and is carried in its four printed sections: I PRAVNI OSNOV, II RAZLOZI ZA DONOŠENJE, III IZJAVA O USAGLAŠENOSTI SA PRAVNOM TEKOVINOM EVROPSKE UNIJE and IV PROCJENA FINANSIJSKIH SREDSTAVA ZA SPROVOĐENJE PROPISA. The OBRAZLOŽENJE is where the figures are recoverable, and it matters here: **the two fee tables in Articles 2 and 3 (pages 2 to 4 of the served PDF) are page images with no text layer**, so the amounts themselves are not in the extract; what the extract does carry is the explanatory note’s prose account of the changes — for example the increase to 200–300 EUR for class IIb devices, import approvals rising from 60 to 250 EUR, annual maintenance at 80–100 EUR and vigilance fees of 10 to 45 EUR, with the stated increases of 66.7%, 50%, 42.9%, 33.3%, 20%, 14.3%, 16.7%, 2.9% and 6.7% by fee line. No OCR was applied: the scan is in Montenegrin and the installed OCR language packs cover no South Slavic language, so recognising the tables would have required inventing diacritics.

„Službeni list Crne Gore“ br. 035/23 is the official identifier CInMED uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.