At a glance
- Romania’s Ministry of Health has updated the National Catalogue of Medicine Prices: 10 new medicines receive a maximum regulated price, while 3 existing entries are revised.
- Most of the newly added products are cutting-edge oncology treatments (lung cancer, breast cancer, gastric cancer), brought into Romania under special-needs authorisations.
- One entry in the catalogue, number 6643, is removed entirely (repealed).
Who is affected: patients who need these treatments and the doctors who prescribe them, health insurance funds, pharmacies, wholesale distributors and marketing authorisation holders.
Effective date: 23 July 2026, the date of publication in the Official Gazette of Romania (Monitorul Oficial).
What the order changes
The Ministry of Health has amended, through Order no. 895/2026, Annex no. 1 to the Minister of Health’s Order no. 5,994/2024, the act that keeps up to date the National Catalogue of prices for human-use medicines available in Romania. In practice, this catalogue is the official list from which health insurance funds, hospitals and pharmacies read the maximum price at which a medicine may be sold, whenever that medicine is subject to a contractual relationship with the state. The order is part of the same regulatory mechanism set out through Order MS no. 368/2017 and the recent extension of the validity of already-approved prices, ordered through Order MS no. 707/2026.
The order was signed on 20 July 2026 by Stela Firu, Secretary of State, by delegation from the acting Minister of Health, and was published in the Official Gazette of Romania, Part I, no. 601 of 23 July 2026. The amendment has three components: updating the prices of 3 medicines already in the catalogue, adding 10 new medicines, listed under entries 7099 to 7108, and removing one old entry from the catalogue, number 6643.
What it changes in practice
The main effect is that the 10 new medicines gain, from the date of publication, a regulated maximum price in Romania. Without this catalogue listing, a medicine cannot be reimbursed or used under a contractual relationship with the Ministry of Health and the health insurance funds, even if it already holds a marketing authorisation.
Most of the newly added products are modern oncology therapies, brought into the country through a mechanism called a “special-needs authorisation,” used when a patient needs a treatment that is not yet standard-authorised in Romania, but is available and approved in other countries. These include:
- Krazati (adagrasib), a treatment for a specific form of lung cancer;
- Orserdu (elacestrant), for breast cancer, listed under two separate entries with distinct special-needs authorisations;
- Imdyllitra (tarlatamab), for small-cell lung cancer, in two strengths, 1 mg and 10 mg;
- Vyloy (zolbetuximab), for gastric cancer;
- Loqtorzi (toripalimab), an oncology immunotherapy.
Alongside these, the catalogue also gains Normosang (human hemin, used to treat porphyria), Flunarizin Actavis (for migraine prophylaxis) and Luminal (phenobarbital, used as an anticonvulsant and sedative). The 3 updated entries concern the prices of Artesunat Amivas (used to treat severe malaria) and of the two already-existing entries for the medicine Imdyllitra 1 mg, under separate special-needs authorisations.
What has changed compared with the previous situation
Compared to the previous version of the catalogue, published in Official Gazette of Romania no. 1284 and 1284 bis of 19 December 2024, what changes is the regulated availability of the 10 new medicines, which before this order had no maximum price set in Romania and could not, therefore, be reimbursed through the public health system. The prices for the 3 already-existing entries are also updated, and entry 6643 disappears from the catalogue.
The order does not explicitly state which medicine corresponded to the repealed entry 6643, the text of the act limiting itself to mentioning its removal. Anyone who needs details about this product can consult the consolidated version of the catalogue on the portal of the National Medicines Agency or the updated version on legislatie.just.ro.
Advantages and disadvantages
What it improves
- Patients with rare or advanced forms of cancer gain regulated, price-capped access to modern treatments that would otherwise only be available at full personal cost or through more cumbersome individual procedures.
- Capping the retail price protects patients and the health system from arbitrary pricing for cutting-edge medicines, which are often very expensive.
- The periodic update of the catalogue keeps the list of reimbursable medicines current as new internationally approved treatments emerge.
What remains a problem
- Prices remain very high overall (some products exceed 50,000 lei per box at retail price), which shows just how costly these therapies are for the public system.
- Access remains conditional on an individual special-needs authorisation, a separate administrative process that this order does not simplify.
- The lack of detail about the medicine removed under entry 6643 makes it difficult to assess the exact impact of the repeal for anyone who was using that product.
Practical advice
- If you are undergoing oncology treatment with one of the medicines mentioned, ask your treating physician whether it now falls under the regulated price and how reimbursement through your health insurance fund works.
- Always check, before buying a medicine from this list, that the pharmacy or supplier is applying the maximum retail price set by the order, not a higher one.
- For medicines requiring a special-needs authorisation, the access procedure goes through the specialist physician and, as a rule, through the specialist commissions of the health insurance fund, a separate step from simply being listed in the catalogue.
Frequently asked questions
What is the National Catalogue of Medicine Prices?
Which new medicines were added through Order MS 895/2026?
From when do the new prices apply?
What happens to the medicine under entry 6643?
Do the prices set now remain valid indefinitely?
This article is for informational purposes only and does not constitute legal or medical advice. For specific situations, consult a specialist physician, pharmacist or legal advisor.
A few days before this order, the Ministry of Health and the National Health Insurance House (CNAS) had updated the therapeutic prescribing protocols for dozens of reimbursed medicines, through Joint Order MS/CNAS no. 824/1,313/2026.
The text below is reproduced in Romanian, the official language of publication in Romania’s Official Gazette of Romania, so that readers can consult the exact wording of the enacted order.
The text below is reproduced in Romanian, the official form of publication.
The full text, as published in the Official Gazette of Romania Official Gazette of Romania no. 601 of 23 July 2026 16 pages PDF, 116 KB the act starts on page 12 Open the official PDFDownload the PDF The viewer is not shown on small screens. Use the buttons above to open or download the file.Original text of the legal act
This article is for informational purposes only and does not constitute legal advice. For specific situations, consult a licensed attorney or tax advisor.