In brief

  • The BCG vaccine sees its catalogue price multiplied tenfold, ten days after it got there. Position 7203 had been introduced on 1 September 2026 with a producer price of 126.00 lei a box and a maximum retail price of 172.31 lei. The new order rewrites it at 1,260.00 lei producer price and 1,470.75 lei on the shelf, that is from 0.86 to 7.35 lei a dose. The quantity, 500 boxes, and the price validity, 13 August 2027, are untouched. Only the three price columns have changed.
  • Nine new positions enter the catalogue, all supplied by CN Unifarm, and seven of them under authorisations for special needs. They are mostly oncology medicines: ORSERDU 345 mg, 39,651.00 lei for a box of 28 tablets, AUGTYRO 40 mg, 24,017.28 lei a box, and IMDYLLTRA 10 mg, 107,049.12 lei for a single vial. Together with the three amended positions, the 12 batches are worth 8,578,073.77 lei at the retail ceiling.
  • The prices apply from 11 September 2026, the day of publication. The order sets no later date and says nothing about the stock delivered until then at the old ceiling. For a pharmacist, that means zero days between learning the price and being obliged to observe it.
Act: Order of the Minister of Health, acting in an interim capacity, no. 1.287 of 8 September 2026 amending and supplementing Annex no. 1 to Order of the Minister of Health no. 5.994/2024 approving the maximum prices of medicines for human use, valid in Romania, which may be used or marketed by the holders of marketing authorisations for medicines or their representatives, by wholesale distributors and by providers of medical services and medicines for those medicines that are the subject of a contractual relationship with the Ministry of Health, the health insurance houses and/or the county public health directorates and that of the municipality of Bucharest, included in the National Catalogue of the prices of medicines authorised for marketing in Romania, of generic reference prices and of innovative reference prices
Published: Official Gazette of Romania (Monitorul Oficial) no. 774 of 11 September 2026
In force from: 11 September 2026

On 11 September 2026 the Ministry of Health published an order that touches only 12 lines of the National Catalogue of maximum medicine prices, but one of them concerns the vaccine given to almost every newborn in Romania. Position 7203, the BCG vaccine, had entered the catalogue ten days earlier, through the revision that touched 170 positions from 1 September, with a producer price of 126.00 lei a box. Order no. 1.287/2026 rewrites it at 1,260.00 lei, exactly ten times more.

The difference shows at the end of the chain too. The maximum wholesale price excluding VAT rises from 138.60 to 1,290.00 lei, and the maximum retail price including VAT, the one that counts at the till, from 172.31 to 1,470.75 lei a box. The box contains 20 ampoules of powder holding 10 doses each for children under 12 months, plus 20 ampoules of solvent, so 200 doses. Per dose, the ceiling goes from 0.86 lei to 7.35 lei.

The rest of the line is identical: the same code W72161001, the same holder, Alliance Healthcare Romania, the same quantity of 500 boxes and the same price validity, 13 August 2027. Those 500 boxes mean 100,000 doses, and at the new ceiling the batch is worth 735,375 lei, against the 86,155 lei it would have been worth at the ceiling set on 1 September. Nowhere does the order explain why the figure is changing: the annex republishes the line in full, without marking what has been altered within it.

The same silence applies to the other two rewritten positions. Position 6647, PROSTIN VR 500 mcg/1 ml from Pfizer România, a medicine used in newborns with heart defects, remains in the catalogue at 207.10 lei for a box of one ampoule, for 1,432 boxes. Position 6712, TRETINOIN 10 mg from Pharma Pro Expres, used in acute promyelocytic leukaemia, appears at 1,032.30 lei for a box of 100 soft capsules, for 380 boxes. In both cases, anyone wanting to know what has changed must keep the previous edition of the catalogue open beside them.

The second part of the annex adds nine new positions, numbered from 7206 to 7214, immediately after position 7205, which was the last in the catalogue. All have the same supplier, CN Unifarm, the state company through which hard-to-source medicines are brought into the country, and seven of them carry in the remarks column a number of an authorisation for special needs: 1.259, 1.264, 1.265, 1.279, 1.280, 1.281 and 1.283, all from 2026. The other two, CLONIDINA CLORIDRATO 150 mcg/ml and JAMP PILOCARPINE 5 mg, enter without such a mention.

What it changes in practice

The order applies from 11 September 2026, the date of publication. Article II merely states that the act is published in the Official Gazette of Romania, without providing for a later date, and for orders of the heads of central specialist bodies of public administration the three-day rule does not apply: under Article 12(3) read with Article 11(1) of Law no. 24/2000, they enter into force on the date of publication unless they themselves provide otherwise.

The immediate consequence is that, from 11 September, the ceiling that can be enforced for a box of BCG vaccine is 1,470.75 lei, whereas between 1 and 11 September it was 172.31 lei. For the quantities delivered during that interval at the previous ceiling there is no transitional provision, so the text is silent about them.

For the nine new positions, the effect is of a different kind. A medicine without a position in the catalogue has no approved maximum price, so it cannot enter the contractual relationship with the Ministry of Health, the insurance houses or the public health directorates. Once listed, the seven medicines brought in under an authorisation for special needs have a public, verifiable ceiling that neither the distributor nor the provider of medical services can exceed.

For the patient who arrives at the pharmacy with a prescription, the direct effect is small and indirect. The maximum retail price is a ceiling, not the sum that comes out of the pocket. What is actually paid depends on the reimbursement list and on the percentage applied, and the BCG vaccine is not even bought over the counter: it is given in the maternity ward, under the national immunisation programme, so the figure that changes concerns the public purchaser, not the parent. Most of the new positions are likewise hospital medicines, for cancer treatment.

The only position in the order built to pharmacy scale is 7210, JAMP PILOCARPINE 5 mg: 10,000 vials of 100 film-coated tablets each, with a ceiling of 385.37 lei a vial, that is 3.85 lei a tablet. Pilocarpine in tablet form is used for severe dryness of the mouth, common after radiotherapy of the head and neck.

What has changed compared with the previous situation

The clearest comparison remains the one at position 7203. In the form introduced by Order no. 1.161/2026 and applicable from 1 September, the BCG vaccine appeared at 126.00 lei producer price, 138.60 lei wholesale excluding VAT and 172.31 lei retail including VAT. In the form of 11 September, the same three columns read 1,260.00, 1,290.00 and 1,470.75 lei. The producer price is multiplied exactly by ten, and the shelf price by 8.54, because the mark-ups and the tax do not rise proportionally.

For the other two amended positions, the order offers no term of comparison. The annex reproduces the whole line, with all its columns, without indicating which of them has changed and without stating the previous value.

On the supplementation side, the catalogue grows from 7,205 to 7,214 positions. The structure of the nine new lines says something about the route these medicines take: none comes from a marketing authorisation holder that markets it routinely in Romania, all come through CN Unifarm, and seven arrive under an authorisation for special needs, the instrument through which an unauthorised or unavailable medicine is brought in for a particular patient.

One structural detail is worth remembering for anyone searching the catalogue. ORSERDU 345 mg appears three times, at positions 7211, 7212 and 7214, with the same code W71220001, the same pack of 28 film-coated tablets and exactly the same three prices, 34,953.75, 35,333.29 and 39,651.00 lei. The three lines differ only in the authorisation number, in the quantity, 6 plus 12 plus 12 boxes, and in the date to which the price is valid, 30 August 2027 for two of them and 2 September 2027 for the third. In all, 30 boxes of ORSERDU, 1,189,530 lei at the retail ceiling.

The validity of the prices in this order stretches over almost one year and three months. The first to expire is that of position 7207, WILZIN 50 mg, on 28 July 2027, 320 days after publication. The last is that of position 6712, TRETINOIN, on 29 October 2027.

Advantages and disadvantages

What it improves

  • The price of the BCG vaccine is corrected within ten days, before the gap has time to block a delivery or to produce reimbursement disputes.
  • Seven medicines brought in under an authorisation for special needs receive a ceiling published in the Official Gazette of Romania, that is a figure anyone can check, rather than a price negotiated case by case.
  • Every position carries a quantity and a price expiry date, so the ceiling does not outlive the batch for which it was calculated.
  • The order enters into force immediately, so there is no window in which two maximum prices circulate in parallel for the same product.
  • Position 7210, with 10,000 vials of pilocarpine, covers a pharmacy need, not only a hospital one, at a ceiling of 3.85 lei a tablet.

What remains a problem

  • The annex does not show what has changed in the three amended positions. The line is republished in full, so the difference can be seen only by comparing it with the previous edition of the Official Gazette of Romania.
  • A tenfold change on a vaccine in the national programme is left without any explanation in the text, and approval note no. 1.287R is not published.
  • There is no transitional rule for the stock put into circulation between 1 and 11 September at the previous ceiling.
  • Three separate positions for the same product, with the same code and the same price, make the catalogue harder to search and can lead to double reporting.
  • The Stat_anm column exists in the table header but is not filled in for any of the 12 positions.
  • Zero days between publication and application means a pharmacist learns the new ceiling on the very day he is already obliged to observe it.

Practical advice

  1. When you check a price in the catalogue, search by the product code and by the position number, not by the name. The same ORSERDU 345 mg occupies three lines, with three different numbers.
  2. The column that counts at the counter is „Maximum retail price including VAT”. The other two, the producer price and the wholesale price, are intermediate stages and are not paid by the patient.
  3. The ceiling is not the price to be paid. What you take out of your pocket depends on the reimbursement list and on the percentage applied to the prescription, and for hospital medicines you pay nothing at the counter.
  4. Check the „Price validity” column before using a figure in a contract or in a tender. The prices in this order expire in stages, between 28 July and 29 October 2027.
  5. For medicines brought in under an authorisation for special needs, the authorisation number in the remarks column identifies the batch. A different number means a different position, even if the product and the price are identical.
  6. The annex is printed as a table, on two pages. Its complete and legible form is in the official PDF attached to this article, on pages 14 and 15.
  7. If a pharmacy charges more than the catalogue ceiling, the complaint goes to the county public health directorate, with the position number and the figure in the retail column.

Frequently asked questions

From when do the new prices apply?
From 11 September 2026, the date of publication in the Official Gazette of Romania. The act does not provide for a later date, and ministerial orders enter into force on publication, under Article 12(3) of Law no. 24/2000.
How much does a dose of BCG vaccine cost now?
The ceiling is 1,470.75 lei for the box of 200 doses, that is 7.35 lei a dose. Previously, between 1 and 11 September 2026, the ceiling was 172.31 lei a box, that is 0.86 lei a dose.
Does that mean parents will pay for the BCG vaccine?
No. The BCG vaccine is given in the maternity ward, under the national immunisation programme, and is not bought at a pharmacy. The figure in the catalogue is the ceiling at which it can be procured, so it concerns the public purchaser.
How many positions does this order touch?
Twelve. Three existing positions are amended, 6647, 6712 and 7203, and nine new positions are added, from 7206 to 7214.
Why does the same medicine appear at several positions?
Because each position corresponds to a batch brought in under a separate authorisation. ORSERDU 345 mg has three positions, with authorisations no. 1.280, 1.281 and 1.283 of 2026 and with 12, 6 and 12 boxes respectively, but at the same price.
What is an authorisation for special needs?
It is the instrument through which a medicine is brought into the country outside the ordinary commercial circuit, for specific needs. In this order, seven of the nine new positions carry such a number, and all nine are supplied by CN Unifarm.
What happens to the stock bought at the old price?
The text does not say. The act contains no transitional provision for the quantities put into circulation before 11 September 2026, at the previous ceiling.
Until when are these prices valid?
Each position has its own date, entered in the „Price validity” column. The nearest is 28 July 2027, at position 7207, and the furthest is 29 October 2027, at position 6712.

Editorial analysis

The order settles quickly something that needed settling quickly. Ten days is a good turnaround for rewriting a ceiling ten times too low on a vaccine given to every newborn, and the fact that the rest of the line was left untouched, the same quantity of 500 boxes and the same validity until 13 August 2027, shows this was not a renegotiation but the correction of a figure. The problem is not the speed but that nobody reading the order can learn as much. The annex republishes the whole line and leaves the reader to work out for himself, by setting two editions of the Official Gazette of Romania side by side, that what changed is only the three price columns.

Proportions help calibrate the stakes. The 12 positions touched account for 0.17% of a catalogue that has reached 7,214 lines, and their combined value at the retail ceiling is 8,578,073.77 lei, of which 7,153,857.57 lei belong to the nine new positions. The surprise comes when the figure is broken down: the most valuable line in the order is none of the oncology medicines priced at tens of thousands of lei a box, but the pilocarpine at 3.85 lei a tablet, which reaches 3,853,700 lei through sheer volume, 10,000 vials. All the new oncology positions together, IMDYLLTRA, ORSERDU and AUGTYRO, come to 3,061,408.89 lei, that is less than that single line.

The second observation that does not jump out concerns who brings the medicines in. All nine new positions come through CN Unifarm, and seven of them carry an authorisation number for special needs issued in 2026. In other words, no position added in this round comes from a marketing authorisation holder that sells the product routinely in Romania. The catalogue records the fact, but does not name it and does not group it, even though these are precisely the lines a patient is waiting on.

Finally, the deadlines. The order was signed on 8 September and published on 11, so the administration took three days for its own circuit, while requiring the addressee, the distributor or the pharmacist, to comply from the very day of publication. At position 7203 the asymmetry is sharper, because the ceiling it replaces had entered into force only on 1 September: the same line was written twice in eleven days, with a difference of an order of magnitude, without either of the two orders saying why.

What should be changed

  • The annex should mark the amended column. A republished line showing the old value in brackets, or at least a column indicating what has changed, would show a pharmacist at a glance what has moved, instead of a manual comparison between two editions of the Official Gazette of Romania.
  • A transitional provision for stock already delivered. A sentence saying whether the quantities put into circulation before entry into force stay at the previous ceiling would close the one question the order leaves open, that of reimbursing the deliveries made between 1 and 11 September.
  • Compulsory reasoning above a variation threshold. Where a maximum price changes by more than double against the form in force, the order should briefly reproduce the grounds from the approval note. For a tenfold change on a vaccine in the national programme, a single sentence of reasoning would replace speculation with a verifiable explanation.
  • A single position per product and strength, with the authorisations listed in the remarks. The three identical ORSERDU lines would become one, with 30 boxes and three authorisation numbers, and a search by code W71220001 would return one result rather than three with the same price.
  • The Stat_anm column, either filled in or removed. A column header with no value on any of the 12 lines conveys nothing and leaves the reader to assume the information was lost at the printing stage.

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. 774 of 11 September 2026 16 pages PDF, 127 KB the act starts on page 13

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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.