In brief

  • From 1 September 2026 the national catalogue of medicine prices changes in 170 entries: 90 amended, 31 taken out altogether and 49 added.
  • Most of the amended entries are in the group of antineoplastic and immunomodulating agents, that is treatments for cancer and for autoimmune diseases, followed by those for the nervous system.
  • Among the new arrivals are the BCG vaccine for children under 12 months, at 172.31 lei a pack, and a cancer treatment at 107,049.12 lei a pack, both in limited quantities, approved for special needs.
Act: MS Order no. 1.161/2026
Published: Official Gazette of Romania (Monitorul Oficial) no. 718 and no. 718 bis of 28 August 2026
In force from: 1 September 2026

The Ministry of Health publishes the autumn update of the catalogue of maximum medicine prices: 33 pages of tables in the bis edition, touching 170 entries and taking effect on Monday. MS Order no. 1.161/2026 amends Annexes nos. 1 and 2 to Order no. 5.994/2024, the base catalogue. It is the second update of the catalogue published in August, after the one in the middle of the month, with 14 new entries. Prices inside the national health programmes changed separately, through MS Order no. 1.212/2026 and CNAS Order no. 1.566/2026.

The maximum price is the ceiling above which a medicine may not be sold in Romania. The catalogue has three price columns: the ex-factory price, the maximum wholesale price excluding VAT and the maximum retail price including VAT, which is exactly the figure the patient sees at the pharmacy counter. Annex no. 1 contains the maximum prices themselves, and Annex no. 2 the reference prices, the ones on which reimbursement is calculated.

What it changes in practice

The first effect is numerical. The annex amends 90 entries in Annex no. 1, repeals 31 and adds 44 new ones, numbered from 7162 to 7205. In Annex no. 2, one entry is added to List A and four to List B. The net result in Annex no. 1 is an increase of 13 entries, and the total number of entries touched by this order is 170.

The second effect concerns which therapeutic classes are moving. Of the 90 amended entries, the largest group is L, antineoplastic and immunomodulating agents, that is treatments for cancer and for autoimmune diseases. Next comes group N, the nervous system, then group A, the alimentary tract and metabolism, and group B, blood and blood-forming organs. Among the newly introduced entries, group L is again first, followed by group J, anti-infectives for systemic use, then group N and group C, the cardiovascular system.

The third effect is the arrival in the catalogue of medicines brought in for special needs, in limited quantities. Entry 7202 is IMDYLLTRA 10 mg, active substance tarlatamab, brought in by CN UNIFARM S.A.: ex-factory price 94,476.37 lei, maximum retail price including VAT 107,049.12 lei, special-needs authorisation no. 1.268/2026, quantity 12 packs. Entry 7204 is atovaquone with proguanil, an antimalarial, 106.98 lei for a pack of 12 tablets, 2,000 packs. Entry 7205 is magnesium sulphate for injection, 19.11 lei a pack, 24,400 packs.

The fourth effect concerns the BCG vaccine. Entry 7203 introduces BCG VACCINE, brought in by Alliance Healthcare Romania, at an ex-factory price of 126.00 lei and a maximum retail price including VAT of 172.31 lei. The pack contains 20 vials of 10 doses each for children under 12 months, plus 20 vials of solvent, and the approved quantity is 500 packs.

The fifth effect is the horizon of the prices. The great majority of the entries carry a note saying that the prices are valid until 31 March 2027, that is until the next annual correction. A few entries have deadlines of their own: three of those on the eight-month regime expire in October 2026, and the ones brought in for special needs in July and August 2027.

The sixth effect is a short validity regime for ten entries. These carry in the observations column a note saying that the prices are approved for a period of 8 months, under Article 4(5^2) and (5^3) of the Rules approved by Order of the Minister of Health no. 368/2017. That is the regime applicable, among other cases, to medicines whose price documentation is not complete at the time of approval.

What has changed compared with the previous situation

Compared with the previous form of the catalogue, the biggest change is the disappearance of 31 entries. Repealing an entry means that the product concerned, in that pack size and at that strength, leaves the catalogue and can no longer be sold at an approved maximum price. Four of the repealed entries are consecutive, nos. 5051 to 5054, and another eight fall within a single range, nos. 6534 to 6547, which points to portfolio withdrawals rather than isolated departures.

The make-up of the reference lists has changed as well. Annex no. 2, List A, gains paricalcitol, a treatment for secondary hyperparathyroidism in chronic kidney disease, with a generic reference price of 133.33 lei. List B gains somatostatin and three strengths of the combination of rosuvastatin with ezetimibe, made by Antibiotice S.A., with reference prices of 46.80, 52.48 and 51.87 lei.

What has not changed is the form of publication. The order in the ordinary edition runs to five paragraphs and refers to the bis edition for all its content. The base catalogue, Order no. 5.994/2024, was published in the same way, in Official Gazette of Romania no. 1284 and no. 1284 bis of 19 December 2024. The same catalogue prices feed into a different calculation, the clawback tax: the type I and type II list for the second quarter of 2026 arrived 16 days after the payment deadline.

Advantages and disadvantages

What it improves

  • The BCG vaccine for infants enters the catalogue with an approved price, at a time when supply has been difficult.
  • Forty-four new entries mean more pack sizes and strengths available at a capped price.
  • The combination of rosuvastatin with ezetimibe, made in Romania, enters the list of reference prices, which opens the way to reimbursement.
  • Medicines brought in for special needs receive a maximum price, so they are not sold at whatever the importer asks.
  • The common validity deadline, 31 March 2027, aligns most of the entries on the same correction cycle.
  • The order takes effect on a fixed calendar date, 1 September, rather than on publication, so pharmacies have four days to prepare.

What remains a problem

  • The annex publishes only the new price, not the old one, so the act itself does not show whether a price has gone up or down.
  • The 31 repealed entries disappear without any explanation of why the product was withdrawn and without a replacement being indicated.
  • The tables are published only in the bis edition, which costs 54 lei to buy, even though the price at the pharmacy counter depends on them.
  • The quantities approved for special-needs medicines, between 12 and 24,400 packs, come with no estimate of what is actually needed.
  • Ten entries have a price approved for only 8 months, and the act does not say what happens to them when that expires.
  • The table format, four pages wide, makes the catalogue practically unreadable for a patient who wants to check a single figure.

Practical advice

  1. If you are on long-term treatment, check the price displayed at the pharmacy from 1 September. The column that matters to you is the maximum retail price including VAT.
  2. Pharmacies and distributors: update your price lists before Monday. Repealed entries can no longer be sold at a catalogue price.
  3. If your medicine is among the 31 repealed entries, ask your doctor about an equivalent. The order does not point to any replacement.
  4. For medicines brought in for special needs, the approved quantity is written in the catalogue. Check availability before making the trip to the pharmacy.
  5. The reference price in Annex no. 2 is not the price you pay, but the basis on which reimbursement is calculated. The difference up to the shelf price is yours to cover.
  6. The complete tables are in Official Gazette of Romania no. 718 bis of 28 August 2026, pages 3 to 35. The order in the ordinary edition contains no figures at all.

Frequently asked questions

When do the new prices apply?
From 1 September 2026. Article II of the order fixes that date expressly, even though the act was published on 28 August.
How many medicines are affected?
170 entries: 90 amended and 31 repealed in Annex no. 1, 44 added there as well, plus 5 added in Annex no. 2, one in List A and four in List B.
Are prices going up or down?
The act does not say. The annex publishes only the new price of each entry, without the previous one, and a comparison would require the base catalogue of December 2024 together with every amendment made since.
What does it mean for an entry to be repealed?
That the product concerned, in that pack size and at that strength, leaves the national catalogue of maximum prices. Without an entry in the catalogue, there is no approved maximum price for it.
What is a special-needs authorisation?
A mechanism by which a medicine not authorised through the ordinary route is brought in in a set quantity, for identified patients. In the catalogue, these entries carry the approved quantity, from 12 packs up to 24,400.
How long are the new prices valid?
Most of them until 31 March 2027. The entries brought in for special needs have deadlines of their own, and ten entries have a price approved for only 8 months.

Errors and inconsistencies in the published text

  • The annex, point 1, the list of amended entries. The list reads „7018, 7019, 054, 7122”, and entry „054” matches no row in the table that follows. The row actually amended, sitting between 7019 and 7122, is entry 7054, SOTYKTU 6 mg, film-coated tablets, deucravacitinib, ATC group L04AF07. The figure 7 is missing from the list in the printed Gazette too, not only in the electronic version. The consequence is not cosmetic: entry 54 does exist in Annex no. 1 and concerns a different medicine, so the list points to a real entry, but the wrong one. Anyone who checks the list of amended entries without cross-checking it against the table concludes that the price of a product that was not touched has changed, while entry 7054 appears unamended.

Editorial analysis

The order does what an act of this kind has to do and sets out to do no more: it brings the catalogue up to date. The figure of 170 entries touched suggests a normal maintenance rhythm, and the common validity deadline, 31 March 2027, shows that the ministry works on an annual cycle, with corrections along the way.

What is not visible when reading the act is that it does not even allow the direction of the movement to be worked out. The annex publishes the new price, not the old one. To say whether a price has gone up or down, the reader would have to open the base catalogue of December 2024 and every amendment made since, that is dozens of orders. It is the one piece of information everybody looks for, from the patient to the insurance house, and the one the act does not give. A column with the previous price would have cost a centimetre of table.

The second observation comes out of a multiplication. A pack of BCG vaccine contains 20 vials of 10 doses each, that is 200 doses, and the approved quantity is 500 packs, which makes 100,000 doses for children under 12 months. Around 150,000 children are born in Romania every year, and BCG vaccination is carried out in the maternity ward, in the first days of life. The approved figure therefore covers about two thirds of a year of newborns. That is not an error, because the vaccine also arrives through other channels, but it shows that the newly introduced entry is not a token reserve, it is a volume that matters for the national immunisation programme.

The third observation concerns the repealed entries. Eight of them, between no. 6534 and no. 6547, form an almost continuous block, and four, nos. 5051 to 5054, are consecutive. Withdrawals in a block from a price catalogue usually mean that a marketing authorisation holder is taking a whole range off the market. The act does not say which products these are, who held them or whether an equivalent stays on the market. For a patient taking one of them, the only way to find out is to go to the pharmacy and see.

What should be changed

  • Correcting entry „054” in the list to „7054”. For as long as it stands, the list of amended entries points to a medicine other than the one actually amended in the table.
  • A column with the previous price, next to the new one. It would turn a reference table into a document that can be read, and the question whether a price has gone up or down would no longer require reconstructing the entire history of the catalogue.
  • A note against the repealed entries, giving the reason for withdrawal. A portfolio withdrawal, the expiry of a marketing authorisation and missing price documentation are different situations, and the patient needs to know which one applies.
  • Publishing the annex in open tabular format on the ministry’s website. The catalogue of medicine prices is read by pharmacies, distributors, insurance houses and patients; publishing it only in a printed edition that has to be paid for cannot be justified.
  • An explicit regime for the ten entries with a price approved for 8 months. The act does not say what happens when that expires, and for three of them the date falls before the common deadline of March 2027.

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. 718 and no. 718 bis of 28 August 2026 32 pages PDF, 475 KB the act starts on page 5

Open the official PDFDownload the PDF

The viewer is not shown on small screens. Use the buttons above to open or download the file.

This article is for informational purposes only and does not constitute legal advice. For specific situations, consult a licensed attorney or tax advisor.