What changed, at a glance
On 8 August 2025, the Council of Ministers adopted Decree №155/2025, amending the 2013 ordinance on the regulation and registration of medicine prices. The decree was promulgated in the State Gazette issue 66/12.08.2025 and took effect the same day. Key changes: formal alignment with the EU HTA Regulation (2021/2282); a published methodology for calculating “price ex‑factory”; explicit acceptance of EURIPID as an official price data source; more explicit rules to lower prices ex officio for products under parallel import/parallel distribution; and a new, targeted mechanism to protect the availability of oncology essentials, including periodic re‑referencing obligations.
Ex‑factory price formation & external reference pricing (EPR)
Article 8 now requires the National Council on Prices & Reimbursement (NCPR) to adopt and publish a methodology for computing the price ex‑factory (“цена на производител”) used in regulated price formation. For external comparisons, the decree explicitly adds the EURIPID Collaboration database as an acceptable official source alongside national price registers. The 10‑country basket for Bulgaria’s EPR remains: Belgium, Greece, Spain, Italy, Latvia, Lithuania, Romania, Slovakia, Slovenia, and France.
Parallel import/distribution: price‑lowering triggers and alignment
Multiple articles (14, 23, 35) are revised so that the NCPR reduces prices ex officio for medicines with parallel import (PI) or parallel distribution (PD) authorization whenever the identical or similar reference product has a lower registered ceiling price (or lower ex‑factory price under art. 8). For OTCs, the maximum sales price of a PI/PD product must be the same as or lower than that of the identical/similar product already registered; if the reference price goes down, NCPR automatically lowers the PI/PD product’s maximum sales price and notifies the holder.
Guardrails against price resetting
A new rule in art. 24a(2) prevents rapid price escalation via deregistration and re-registration. If a price is deleted and the holder applies to re-register within 12 months, the new price may not exceed the last deleted price plus the CPI for the intervening period. In addition, the NCPR must publish a standard methodology for computing CPI‑based adjustments (also cross‑referenced in art. 19 and 41).
Oncology‑specific availability measure (Annex 6a)
The decree introduces Annex 6a, a list of 47 INNs drawn from the WHO Essential Medicines List, including cytotoxic and hormonal/anti-hormonal agents (e.g., cisplatin, cyclophosphamide, doxorubicin, methotrexate, paclitaxel, tamoxifen, abiraterone, enzalutamide). For products on this list included in the Positive Drug List (PDL) whose reference value is formed by grouping (and where no other MAH products participate in that group), the MAH must submit a declaration every 24 months confirming that the conditions for that grouping/reference remain met. Transitional rules clarify that the 24‑month clock starts from the last price approval; any art. 43 submissions made before entry into force are archived. This establishes a periodic re-referencing discipline designed to reduce disputes and stabilize supply for core oncology regimens.
HTA alignment with EU Regulation 2021/2282 (JCA integration)
The ordinance now codifies the rights and duties of the NCPR as a member of the EU HTA Coordination Group; recognizes Joint Clinical Assessment (JCA) outputs as part of the national HTA; and sets 30‑day deadlines for Bulgaria to provide the Coordination Group with information on how JCA reports were taken into account and to share national HTA reports after completion. The NCPR must establish a specialized working group (with COI declarations and conflict-of-interest checks) and requires applicants to provide PICO-structured information and methodology-compliant pharmacoeconomic analyses (guidance to be adopted and published by the NCPR).
Wholesale pricing clarity
The decree reiterates that wholesalers may not sell above the approved manufacturer’s price plus statutory markup plus VAT, as recorded in the official register (PLS/NCPR). This closes interpretative gaps and ties enforcement directly to registered price elements.
Early notification & documentation upgrades
For centrally authorized products, the holder must notify NCPR no later than 10 days after filing the EMA/EC application under Reg. 726/2004 (art. 7a), and the notification template now requires a summary of clinical trial results and a country PICO scope for HTA planning.
What this means in practice (Q3–Q4 2025)
- MAHs should prepare to: (i) map ex‑factory calculations to the forthcoming published methodology, (ii) ensure EURIPID entries and national prices are harmonized, (iii) set up 24‑month controls and dossier updates for Annex 6a oncology molecules, and (iv) re‑check PI/PD price linkages to the reference product to avoid ex officio reductions.
- NCPR/MoH must publish two methodologies (ex‑factory and CPI calculations) and HTA guidance (pharmacoeconomic methods), and operationalize the EU HTA data‑sharing routines within 30 days of each case.
- Distributors/wholesalers should verify that ERP-driven manufacturer prices and registered mark-ups fully cap wholesale invoices, as now specified in Article 21/42.
Effective date & transitional clauses. The amendments take effect on 12 August 2025. The 24‑month oncology declaration cycle runs from the last approved price per product, prior art. 43 filings (before entry into force) are archived.
