Oncology hospital medicines tender closed; two‑year framework worth BGN 2.555 bn
The Health Ministry finalized the centralized e-tender for hospital medicines fully covered by NHIF, primarily for oncology and haematology therapies, signing a two-year framework. Sixteen wholesalers submitted 55 bids across 236 INN-based groups; the procedure, estimated at BGN 2.555 billion or EUR 1.31 billion (excluding VAT), was launched in September 2024 and completed after surviving KZK and Supreme Administrative Court appeals. Officials stated that this ensures continuous access to modern cancer therapies in state hospitals. Source: Ministry of Health
New pricing rules: Cabinet amends the Pricing Ordinance, tightens oncology measures
On August 8, the Council of Ministers adopted Decree No. 155/2025, amending the ordinance on price regulation. Changes align the National Council on Prices & Reimbursement (NCPR) with the EU HTA Regulation (2021/2282), require a published methodology for “ex‑factory” price calculation, expand external referencing (incl. EURIPID), and refine rules for parallel distribution price reductions. The package also targets the availability of oncology drugs (cytotoxic and hormonal/anti-hormonal agents) referenced against essential medicine benchmarks and periodic re-referencing, to reduce disputes and ensure supply. Source: Ministry of Health
Euro‑denominated drug prices go live ahead of 2026 currency switch
To smooth the euro changeover, the Health Minister ordered early publication of regulated medicine prices in euros. From August 8, registries will display prices in both BGN and EUR, as reflected in the mobile app; this step aims to ensure predictability before January 1, 2026. Source: BTA
“MedicinePrice” app launched; NCPR adds “report a violation”
On August 12, the Health Ministry and NCPR launched MedicinePrice, a free mobile app that displays current regulated prices in BGN and EUR. Two days later, NCPR enabled an in‑app function for citizens to flag pharmacies that charge above the listed retail ceiling—part of a push to tighten enforcement. Source: BTA
The application can be downloaded on both Android and iOS devices.
Free antibiotics for children under 7: rollout and expansion in Q3
The NHIF’s 2025 budget measure took effect in early July: an initial two antibiotics became fully reimbursed for home treatment of acute infections in children up to seven (with ~BGN 10 m earmarked for 2025), followed by three additional medicines added to the Positive Drug List on September 5, taking the total to five. Civil-society groups welcomed the step but warned in August that a narrow list and slow inclusion pace could lead to misuse and resistance.
Six‑month export ban on NeoRecormon (epoetin beta) to protect dialysis patients
On August 14, the Health Minister halted export of NeoRecormon for six months, through February 15, 2026, after stock analyses and MAH notices about suspended sales and delayed deliveries. The aim is to provide uninterrupted access for patients with chronic kidney disease. Source: BTA
One‑month export restrictions on selected insulins, SGLT‑2 inhibitors, Ozempic, and pediatric antibiotic suspensions
By Order X РД‑01‑416/25.08.2025 the Health Ministry temporarily banned export from Aug 26 to Sep 24 of multiple insulin presentations (e.g., Fiasp, Levemir, Insulatard, Tresiba, Actrapid), Forxiga 10 mg, Jardiance 10 mg, Ozempic, and oral‑suspension antibiotics (amoxicillin/clavulanic acid, cefuroxime, azithromycin). The order cites supply irregularities affecting 32–68% of regions for some insulins and rising SGLT-2 consumption (Jardiance patients nearly doubled year-over-year; Forxiga up ~1.6 times). Source: Ministry of Health
Government signals stricter price controls; oncology availability specifically highlighted
Alongside Decree №155, the government communicated further refinements to external price referencing and oversight (including OTC ceilings), explicitly citing access to cytotoxic and hormonal cancer therapies as a goal, without additional budget pressure. Medicines included on the WHO Model Lists of Essential Medicines may be subject to periodic price referencing in Bulgaria, which can be mandated every 24 months. Source: Investor.bg
NCPR deadlines: maintain reimbursement status or risk delisting
On August 25, NCPR published a list of products nearing the three‑year reimbursement renewal mark, reminding MAHs to file between four and three months before expiry (cut‑off Sep 30, 2025 for this tranche) under Article 57b. The move is intended to prevent administrative lapses that disrupt supply or reimbursement. Source: ncpr.bg
Primary care access plan for small settlements announced
On September 10, the Health Minister outlined measures to bolster front-line access, including incentives and scholarships for trainees, housing and family support for clinicians in remote areas, and a new pay standard linked to qualifications, to address chronic workforce shortages outside major cities. Source: BTA
Immunization calendar: chickenpox (varicella) vaccine proposed for 2026
In a September 14 interview, the Health Minister stated that the team’s ambition is to introduce a varicella vaccine into the 2026 national immunization schedule, potentially on a mandatory basis, with the regulatory process already underway. Source: BTA
EU transparency: Bulgaria notified the draft export‑ban order to the Commission
Separately, Bulgaria filed an EU TRIS notification (2025/0515/BG, received on September 10) for a draft order prohibiting the export of certain medicinal products—part of its ongoing transparency and proportionality obligations regarding shortage management. Source: TRIS
Notes on scope: All items reflect developments in Q3 2025 (July–September) and are sourced from official institutions (MoH/NCPR), BTA, and established Bulgarian media outlets. Figures and dates are as reported in the cited materials.
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