In brief
- The Ministry of Health has updated the National Catalogue of Medicine Prices: 14 new entries, 3 amended and 5 repealed.
- Ten of the 14 new entries are brought in under a special needs authorisation, through UNIFARM, in quantities of between 1 and 96 boxes. Another ten, partly a different set, carry codes from the therapeutic group of antineoplastic and immunomodulating agents. The most expensive reaches 228.067,97 lei a box, maximum retail price including VAT.
- The exception is a pair of ipratropium bromide inhalation solutions, listed by a Romanian company at 5.000 boxes each, at 73,22 and 68,61 lei, the only ones that come close to ordinary use.
Published: Official Gazette of Romania (Monitorul Oficial) no. 676 of 14 August 2026
In force from: 14 August 2026
One medicine added to the national catalogue on Friday costs as much, VAT included, as a new car: 228.067,97 lei for a box with three blisters, 27 capsules in all. The Ministry of Health has published in the Official Gazette of Romania Order no. 1.086/2026, signed on behalf of the interim Minister of Health by a secretary of state, which amends and supplements annex no. 1 to Order no. 5.994/2024, that is, the list of maximum prices for medicines for human use valid in Romania. Medicine prices have already been touched this summer, through the rewriting of the lists in eight national programmes.
The national catalogue is not a reimbursement list. It sets the ceiling above which a medicine may not be sold in Romania by the marketing authorisation holder, by wholesale distributors or by suppliers under contract with the Ministry of Health, the health insurance houses and the public health directorates. The catalogue price is a maximum, not a mandatory figure.
The shape of the update says more than the figures taken separately. Of the 14 new entries, 10 carry the words „special needs authorisation”, the mechanism through which a medicine not authorised in Romania may be brought in for a set number of patients. All 10 go through UNIFARM, the state company that handles the import of these products.
The quantities confirm how narrowly targeted they are: a single box for NORMOSANG, 6 each for ORSERDU and ITOVEBI, 12 for LIFYORLI, 13 for each of the three OGSIVEO entries, 24 for AUGTYRO. The largest are the two VYLOY batches, 96 and 84 boxes. These are not shelf medicines, they are treatments assigned to named patients.
The catalogue was updated again on 28 August 2026: MS Order no. 1,161/2026 touches 170 entries, 31 of which drop out of the catalogue, and the new prices apply from 1 September.
What it changes in practice
Fourteen new entries, from 7148 to 7161. They are inserted after entry 7147 and cover, among others, elacestrant (ORSERDU, 39.651 lei), inavolisib (ITOVEBI, 91.572,27 lei), nirogacestat (OGSIVEO, 111.976,12 lei, in three separate entries), zolbetuximab (VYLOY, at three entries, 7155, 7156 and 7158), repotrectinib (AUGTYRO, 24.017,28 lei), lomustine (CECENU, 2.289,55 lei), human hemin (NORMOSANG, 13.859,33 lei) and relacorilant (LIFYORLI, 228.067,97 lei). All the sums are maximum retail prices, VAT included.
Three existing entries are amended. Entry 154, ADOZIN 10 mg/2 ml with adenosine, now has a retail price of 126,54 lei and a sell-off clause: it may be marketed until existing stocks run out, but for no more than 12 months from the expiry of special needs authorisation no. 928/2024. Entry 6641, human anti-tetanus immunoglobulin TETANUS GAMMA, is listed at 115,37 lei, for 202 boxes, and entry 6713, the dactinomycin COSMEGEN LYOVAC, at 370,46 lei, for 780 boxes. These are far larger quantities than at any of the new entries carrying a special needs authorisation. The act publishes only the new values, not the previous ones, so it cannot be told from it whether the prices have gone up or down.
Five entries disappear from the catalogue. Point 3 of the annex repeals entries 6579, 6582, 6592, 6864 and 6949. The order gives no reason and does not name the products.
Every price has its own expiry date. For the new entries, the dates cluster between 8 and 21 July 2027, with a single exception: VYLOY in the ASTELLAS Pharma Europe variant, flagged as an orphan medicine, has a price valid only until 31 March 2027. For the amended entries the dates are scattered: 9 July 2027 for ADOZIN, that is ahead of 11 of the 14 new entries, 10 September 2027 for TETANUS GAMMA and 22 October 2027 for COSMEGEN LYOVAC.
Two medicines break the pattern of the rest. IPRATOM 500 mcg/2 ml and IPRATOM 250 mcg/2 ml, nebuliser inhalation solutions with ipratropium bromide, listed by a Romanian company, enter with 5.000 boxes each, at 73,22 and 68,61 lei. They are the only new entries listed in thousands of boxes. CECENU, with lomustine, also breaks the pattern, entering with 120 boxes and without a special needs authorisation.
The same medicine appears several times, under different authorisations. OGSIVEO occupies entries 7150, 7151 and 7152, with the same code, the same strength and the same price, but with separate special needs authorisations, nos. 1.246, 1.247 and 1.252/2026, and the price at 7152 is valid six days longer than at the other two. Likewise, VYLOY 100 mg appears at entries 7156 and 7158, under authorisations nos. 1.257 and 1.258/2026. The catalogue follows the authorisation, not the product.
The same box of VYLOY costs a fifth more on the UNIFARM route. It is the only direct comparison that this very order makes possible. Entry 7155, brought in by Astellas Pharma Europe, has a manufacturer price of 2.605,71 lei and a retail price including VAT of 3.022,96 lei. Entries 7156 and 7158, the same VYLOY 100 mg, brought in through UNIFARM under a special needs authorisation, stand at 3.162,00 lei at the manufacturer and 3.652,85 lei at retail. The difference is 629,89 lei a box, that is almost 21%. If the same quantity could have been brought in on the Astellas route, across the 180 boxes authorised at the UNIFARM entries the difference would come to around 113.000 lei. This is a hypothetical calculation: the act sets no quantity at entry 7155. The packaging is not identical, the UNIFARM vial is described as 20 ml, but the quantity of active substance, 100 mg zolbetuximab, is the same. The catalogue was corrected again on 11 September 2026, on 12 lines: the maximum price of the BCG vaccine rose tenfold ten days after it first entered the list.
What has changed compared with the previous situation
Until this order, the 14 medicines had no maximum price set in Romania. Without an entry in the catalogue, a product brought in under a special needs authorisation cannot enter the contractual circuit with the Ministry of Health and the health insurance houses. Publishing the price is the step that makes it usable within that circuit.
For the three amended entries, the change is one of price level. Entry 154 is a different case: it acquires a time limit that did not exist before, tied to the running down of stock and to the expiry of the 2024 authorisation. That is the signal that the product is on its way out of the catalogue.
The repeal of the five entries points the other way: those prices no longer exist in the national catalogue. The order does not say whether the reason is an expired authorisation, withdrawal from the market or replacement by a new entry.
Advantages and disadvantages
What it improves
- Patients who need these treatments gain a legal price framework, the condition for the medicine to be brought in and paid for through the contractual circuit.
- The prices are published ceilings, so anyone can check them, rather than being negotiated case by case outside a public list.
- Every entry has an expiry date, which forces the price level to be reassessed periodically.
- The two ipratropium bromide inhalation solutions, at 5.000 boxes each, come in at under 75 lei, in a widely used therapeutic area.
- The clause attached to entry 154 gives pharmacies and distributors still holding stock a clear horizon, instead of pulling the product out of circulation overnight.
What remains a problem
- The order repeals five entries without naming the products and without explaining why, so a patient on one of those treatments learns nothing from the act about what happens next.
- The authorised quantities are small, between 1 and 96 boxes, and four of the ten entries sit below 13 boxes, so access remains limited to patients who have already been named.
- Prices of tens or hundreds of thousands of lei a box appear in the catalogue with no information on how they are to be covered, which leaves the question of reimbursement entirely outside the act.
- Repeating the same product across several entries, purely because it holds different authorisations, makes the catalogue hard to read and hard to compare from one update to the next.
- The act sets no separate date of application and no transition period, so the prices change from publication.
Practical advice
- If you are a patient on one of these treatments, bear in mind that the catalogue price is a selling ceiling, not the sum you pay yourself. How the cost is covered is settled by other acts.
- If you work in a pharmacy or for a distributor, check the price expiry date for each entry separately. For the new entries the dates fall between 8 and 21 July 2027, apart from the ASTELLAS VYLOY, valid only until 31 March 2027.
- For entry 154, ADOZIN, watch the stock sell-off clause: marketing is allowed for at most 12 months from the expiry of special needs authorisation no. 928/2024.
- If you manage supply, note that OGSIVEO and VYLOY appear at several entries, under different authorisations. The quantity available is the one in each individual authorisation, not the visual sum of the entries.
- For the repealed entries, 6579, 6582, 6592, 6864 and 6949, check the consolidated catalogue directly to see which products were listed there. The order does not name them.
- The full text of the catalogue remains the one in Order no. 5.994/2024, published in Official Gazette of Romania no. 1284 and 1284 bis of 19 December 2024, as subsequently amended.
Frequently asked questions
What is the National Catalogue of Medicine Prices?
Does this mean these medicines are now reimbursed?
What is a special needs authorisation?
Why does the same medicine appear at several entries?
Which is the most expensive medicine in the update?
What happens to the repealed entries?
Original text of the legal act
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. 676 of 14 August 2026 16 pages PDF, 119 KB the act starts on page 12
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This article is for informational purposes only and does not constitute legal advice. For specific situations, consult a licensed attorney or tax advisor.