On September 1, 2026, the Government of Montenegro published a binding decree that establishes the criteria and procedures for adding and removing medicines from the national basic and supplementary reimbursement drug lists. Issued by the Ministry of Health under the enforcement authority of the Law on Medicines (Zakon o ljekovima), the Uredba o kriterijumima za stavljanje, odnosno skidanje lijeka sa osnovne i doplatne liste ljekova codifies the rules that decide whether a medicine earns or keeps reimbursed status in Montenegro. For marketing-authorisation holders operating in the country, the decree reshapes the dossier, pricing and procedural expectations attached to list placement.
The instrument was published the same day on the Government portal and is administered by CInMED (Institut za lijekove i medicinska sredstva Crne Gore), the independent regulator established by the Law on Medicines. It sits one tier below statute in Montenegro's civil-law hierarchy: a Government Uredba adopted under Article 100 of the Constitution and Article 24 of the Law on State Administration to give binding force to the list-placement rules the medicines statute authorises.
What does the decree establish, and which lists does it govern?
The decree sets binding criteria and procedures for two reimbursement lists that together determine which medicines the national health insurance system pays for. The basic list (osnovna lista) carries the medicines with the highest reimbursement coverage. The supplementary list (doplatna lista) carries medicines reimbursed under co-payment arrangements. Placement on either list is the gateway to paid market access in Montenegro, and removal strips reimbursement.
By codifying the add and remove criteria in a single Government decree, Montenegro moves the reimbursement gate onto a predictable, rule-based footing. The decree supersedes the ad hoc layering of prior instruments, among them the Decision on establishing the basic and supplementary drug lists and the periodic revised list editions, with a standing framework that MAHs can build submissions against.
| List | Montenegrin term | Reimbursement role |
|---|---|---|
| Basic | osnovna lista | Highest coverage; core reimbursed medicines |
| Supplementary | doplatna lista | Co-payment tier; conditional reimbursement |
Who must align, and what is at stake for pharma market access?
The directly exposed audience is regulatory affairs and market access teams at pharmaceutical companies that hold, or are seeking, reimbursement-list placement for a medicine in Montenegro, plus the CInMED-registered MAHs that file the underlying dossiers. The decree's criteria will define the evidence a submission must carry to gain or keep a list slot, and the procedures that govern delisting when a medicine no longer meets the threshold.
What is at stake is paid access to the Montenegrin market: a medicine outside both lists is, for reimbursement purposes, an out-of-pocket product for patients. MAHs must align three workstreams in parallel. Market access strategy, because the criteria set the value-evidence bar for inclusion. Pricing, because list placement drives the reimbursement price the health insurance fund recognises. And submission dossiers, because the procedures fix what CInMED and the fund expect in an inclusion, variation or retention filing.
How does this fit Montenegro's medicines regime and EU alignment track?
Montenegro is not an EU Member State, so EU pharmaceutical law does not transpose or apply directly. The country aligns (usklađuje) its national legislation with the EU acquis under the Stabilisation and Association Agreement, and the Law on Medicines received a positive European Commission opinion on acquis alignment. Montenegro is the most advanced accession candidate, with 14 of 33 negotiation chapters provisionally closed as of April 2026.
The decree is therefore a national instrument that operationalises a national reimbursement competence, not the implementation of an EU reimbursement regulation. That mirrors the EU architecture, where the Health Technology Assessment Regulation (EU) 2021/2282 runs Joint Clinical Assessments on clinical value only and leaves pricing and reimbursement to Member States. Comparator systems in the region, such as Romania's CNAS reference-price lists and Portugal's SiNATS, keep the same national grip on the reimbursement lever. Montenegro's decree sits squarely in that national-competence tradition.
Continuous, per-jurisdiction monitoring catches a decree like this at publication on the Government portal, before it ripens into a list update that moves a product's reimbursement status.
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Read the decree text against your current Montenegro portfolio: identify which products sit on the basic list, which on the supplementary list, and which are in submission, then map each against the new criteria. Audit your dossiers and pricing references for alignment with the procedural requirements the decree introduces, and brief your regulatory and market access leads on the delisting triggers, because the removal criteria now carry binding Government-decree force. With Obsidian tracking Montenegro's medicines and reimbursement instruments alongside the EU frameworks they align with, the next list revision lands on your radar the day it publishes, not the quarter after.
