In brief

  • The Ministry of Health has published the list that decides how much medicine manufacturers pay into the health insurance fund for the second quarter of 2026: 25% of the value sold out of public money for type I medicines and 15% for type II ones.
  • The list has 5,469 entries and runs to 346 pages in a separate edition of the Official Gazette of Romania (Monitorul Oficial). Of those, 1,393 are type I, taxed at 25%, and 4,076 are type II, taxed at 15%.
  • The legal deadline for approving the list was 15 August 2026, and the contribution had to be declared and paid by 25 August 2026. The list appeared on 10 September, that is 26 days after its own deadline and 16 days after the money had already fallen due.
Act: Order of the Minister of Health, acting in an interim capacity, no. 1.246/2026 on the application, in the second quarter of 2026, of Article 38 of Government Emergency Ordinance no. 77/2011 establishing certain contributions for the financing of expenditure in the field of health
Published: Official Gazette of Romania no. 768 and no. 768 bis of 10 September 2026
In force from: 10 September 2026, the date of publication

On 10 September 2026 the list appeared that establishes how much every medicine manufacturer owes to the health budget for the second quarter of the year: a quarter of the receipts from public money on some medicines, 15% on the rest. Order of the Minister of Health, acting in an interim capacity, no. 1.246/2026 classifies 5,469 medicine entries as „medicamente de tip I” and „medicamente de tip II”, type I and type II medicines, and the difference between those two labels is worth ten percentage points of the value sold. This is the second act of September to touch medicines paid for out of public money, after the one through which the maximum prices of medicines changed from 1 September 2026.

The mechanism behind it has a name the industry has used for fifteen years, the clawback tax, and its purpose is simple to tell. The State pays for medicines out of the National Single Health Insurance Fund and out of the budget of the Ministry of Health, and that budget is fixed, while medicine consumption grows from one year to the next. Government Emergency Ordinance no. 77/2011 decided that the gap would not be covered by refusing to reimburse prescriptions, but by taking part of the money back from those who sold the medicines. Who pays: the holders of marketing authorisations, that is the manufacturers and their legal representatives in Romania. Who receives: the National Single Health Insurance Fund, through a return filed with the tax authority. The patient pays nothing extra and sees the tax nowhere on the pharmacy receipt.

Until the summer of 2023, the contribution was calculated with a variable percentage, the result of a formula comparing quarterly consumption with the approved budget, and it fell in the same way on every medicine. Law no. 225/2023 changed that through Article 38, Article 3 index 8, inserted into the ordinance. From the third quarter of 2023, medicines are split in two: those for which no generic and no biosimilar exists on the market stay at 25%, while all the others drop to 15%. The stated logic is that a cheap medicine, long since in competition with generics, can no longer bear the same tax as a medicine with no competitor.

The split is made every three months, because the market moves. Article 38(2)(a) requires a check on whether, in the last month of the quarter, there was at least one generic or biosimilar that met the conditions for marketing in Romania. For the second quarter of 2026 that month is June 2026. The classification is not made by the ministry but by the National Agency for Medicines and Medical Devices, and the minister merely approves and publishes the result, by order, by the 15th day inclusive of the second month following the end of the quarter.

The order itself has three articles and fits on a single page. Its substance sits in the annex, published separately in Official Gazette of Romania no. 768 bis of 10 September 2026, on pages 3 to 348. The annex is a single table, ordered alphabetically by international non-proprietary name, from abacavir to zuclopenthixol, with eleven columns: the entry number, the medicine identification code used by the National Health Insurance House, the international non-proprietary name, the pharmaceutical form, the trade name, the strength, the marketing authorisation holder, the ATC code, the type of prescription, the description of the packaging and, in the last column, the figure that decides the tax. The 5,469 entries cover around 1,150 substances and roughly 1,200 distinct ATC codes, from antibiotics and antihypertensives to cytostatics and medicines sold without prescription. The full edition, with the whole annex, can be opened and downloaded here, free of charge.

What it changes in practice

The order applies from the date of publication, 10 September 2026. The act provides no later date, and ministerial orders enter into force on publication, the three-day period in Law no. 24/2000 on legislative drafting rules being reserved for laws and ordinances. Its effect, however, does not concern the future but a quarter that closed on 30 June 2026: the order says, by the will of the ordinance, which medicine was type I and which was type II in June 2026.

For a manufacturer, the figure in the last column translates straight into money. For every million lei of centralised consumption, after VAT is deducted, the type I label means a contribution of 250,000 lei, and the type II label 150,000 lei. The difference, 100,000 lei per million, is exactly ten per cent of the receipts from public money. That is why an entry wrongly classified is not a form-filling error but a difference in the sum owed.

For the 5,469 entries, the distribution looks like this: 1,393 at 25% and 4,076 at 15%, so roughly a quarter of the entries in the heavy band and three quarters in the light one. The therapeutic concentration shows as well. The ATC group with the most type I entries is L, antineoplastic and immunomodulating agents, with 273 out of 757 entries, followed by A, the alimentary tract and metabolism, with 188. At the other end, group C, the cardiovascular system, has 794 entries, of which only 89 are type I, because there generics have reached almost everywhere.

For a patient, the order changes nothing on the day of publication. It does not touch the shelf price, it does not touch the reimbursement percentage, it takes nothing off and adds nothing to the lists of reimbursed medicines. Its effect on the patient is indirect and shows over time: a lower tax on cheap generics reduces the pressure to withdraw them from Romania, and a higher tax on medicines without a competitor is precisely the instrument that finances the reimbursement of the others. For actual access to treatment, the acts that matter are those on prices and reimbursement, such as the one through which new generics entered the national health programmes at the beginning of September 2026.

Not everything sold is counted. The ordinance exempts the holders of authorisations for medicines derived from human blood or plasma and for vaccines purchased through the national health programmes, and consumption covered by cost-volume and cost-volume-result contracts is also deducted from the value of centralised consumption. The consumption data communicated by the National Health Insurance House may be challenged within ten calendar days, but a challenge does not suspend the obligation to pay. The September lists brought their own correction: the maximum price of the BCG vaccine rose tenfold ten days after it entered the catalogue.

What has changed compared with the previous situation

The rules have not changed with this order. The 25% and 15% percentages, the definitions of the two types and the deadline for approving the list date from July 2023 and have been left untouched. What changes from quarter to quarter is the photograph of the market: a medicine that in March had no generic and was type I becomes type II in June, if in that month one appeared that met the conditions for marketing. The movement goes, in principle, in one direction only, towards the 15% band, because generics enter the market rather than leave it.

The previous list against which a verifiable comparison can be made is that of the fourth quarter of 2025, approved by Order of the Minister of Health no. 590/2026 and published in Official Gazette of Romania no. 186 and no. 186 bis of 11 March 2026. The legal deadline for it was 15 February 2026, so it arrived 24 days late and 14 days after the date on which the contribution for that quarter had to be paid, 25 February 2026. The pattern repeats itself, with a slightly longer delay: 26 days now, against 24 then.

That list also needed correcting. Order of the Minister of Health no. 377/2026, published in Official Gazette of Romania no. 511 of 22 June 2026, replaced a single entry in the annex, number 1,951, with denosumab, XGEVA 120 mg, solution for injection in a pre-filled syringe. The correction arrived 117 days after the payment deadline of the quarter it concerned. It is the only route of redress the system has, and it arrives after the money has been declared and transferred.

As to form, the order of 10 September 2026 brings a small change, but a useful one for anyone looking for the list: the annex goes into the bis edition of the same number, 768 bis, not into a number different from that of the order, which makes the link easier to follow.

Advantages and disadvantages

What it improves

  • The list exists and is public in full, so every manufacturer can check, entry by entry, in which category each pack of each of its products has been placed.
  • The classification is made per medicine identification code, not per substance, so two packs of the same medicine may be treated differently, and the table shows them separately.
  • The annex passes cleanly the only arithmetical check that can be applied to it: the 5,469 entries are numbered continuously, with no gap, and the 5,469 identification codes are all distinct, with no entry duplicated and no code classified once as type I and once as type II.
  • Three quarters of the entries, 4,076 out of 5,469, sit in the 15% band, the one designed not to push cheap generics out of the Romanian market.
  • The structure of the table, with an identification code, an international non-proprietary name and an ATC code on every row, allows automatic matching against a company’s own sales records.
  • No condition is added on top of the ordinance and no definition is reinterpreted: the act does exactly what Article 38(3) requires of it, and nothing more.

What remains a problem

  • The list appeared 26 days after its legal deadline and 16 days after the deadline for declaring and paying the contribution, so anyone who paid on time paid without the official document that sets the percentage.
  • The column that decides the tax is headed, in the published annex, „Tip_med_categ” and contains the figures 1 and 2, with no legend line saying that 1 means type I and 2 means type II, even though ten percentage points hang on it.
  • The order nowhere mentions the National Agency for Medicines and Medical Devices, although the classification is, by law, its job, and it does not cite the agency’s document on which the list rests.
  • The reference month, June 2026, does not appear in the text of the order. The reader has to deduce it from the ordinance, even though it is the only point in time that explains why a medicine is in one category and not the other.
  • There is no rectification mechanism with a deadline: a wrong entry can be put right only through another order, and the precedent of the fourth quarter of 2025 shows that it comes four months after payment.
  • The note at the end of the order sends the reader to a cash desk in Bucharest and to a printed edition of 350 pages costing 525 lei, without a word about the free electronic edition of the same number.
  • The column headings are database labels, not legal terms: „CIM_CNAS_consum”, „Tip_med_categ”, „DAPP”, „Forma Farm.”. The annex was published just as it came out of the IT system.

Practical advice

  1. Manufacturers should check every identification code reported for the second quarter of 2026, not just the substance. Classification is made per pack, so the same medicine may appear several times in the annex, with different figures in the last column.
  2. If you declared and paid by 25 August 2026 on the basis of your own estimate, compare that estimate now with the published list. Differences are corrected on the usual route of an amended return to the competent tax authority, and the order of 10 September 2026 is the document that justifies them.
  3. The ten-calendar-day period for a challenge concerns the consumption data communicated by the National Health Insurance House, not the classification as type I or type II. Do not confuse the two, and remember that a challenge does not postpone payment.
  4. Check whether your product falls outside the calculation base: medicines derived from human blood or plasma and vaccines from the national programmes are exempt, and consumption under cost-volume and cost-volume-result contracts is not included in the value to which the percentage is applied.
  5. If a generic of your product entered the market in June 2026 itself, that is the month which decides the category. Keep the evidence of marketing from that month, since it is the only argument on which a discussion with the agency can be conducted.
  6. The annex is ordered alphabetically by international non-proprietary name, not by trade name. Search for the substance, not the name on the box, or use the search function of your PDF viewer on the identification code.
  7. Patients have no business in this list. The pharmacy price and the reimbursement percentage are read from the national price catalogue and from the lists of reimbursed medicines, not from here.

Frequently asked questions

What is the clawback tax, briefly?
It is a quarterly contribution paid by medicine manufacturers, calculated as a percentage of the value of their medicines sold and reimbursed out of public money. It was introduced by Government Emergency Ordinance no. 77/2011, because the budget allocated to medicines is fixed while consumption grows. Instead of refusing reimbursement, the State recovers part of the money from those who sold.
Who pays and where does the money go?
The holders of marketing authorisations pay, that is the manufacturers, and for those who are not Romanian legal persons, their legal representatives. The contribution is declared to the competent tax authority and constitutes revenue of the budget of the National Single Health Insurance Fund. Pharmacies and patients do not pay it.
Why does it matter whether a medicine is type I or type II?
Because the percentage differs: 25% for type I medicines and 15% for type II ones. For every million lei of centralised consumption, excluding VAT, the difference is 100,000 lei. The list published on 10 September 2026 is the official document saying which category each of the 5,469 entries falls into.
How is a medicine’s category decided?
A type I medicine is, in essence, one for which in the last month of the quarter there was no generic and no biosimilar on the Romanian market meeting the conditions for marketing. Everything else, generics included, falls into type II. For the second quarter of 2026 the reference month is June 2026, and the classification is made by the National Agency for Medicines and Medical Devices.
The order appeared after the payment deadline. What do manufacturers who have already paid do?
The deadline for declaring and paying for the second quarter of 2026 was 25 August 2026, and the list appeared on 10 September 2026. Whoever paid on time used their own estimate of the categories. They can now compare that estimate with the official list and, where differences appear, correct the return on the usual route of amendment before the tax authority.
Does anything change in the pharmacy price?
No. The act does not touch maximum prices, it does not change the reimbursement percentage and it does not amend the lists of reimbursed medicines. It is an act concerning the relationship between manufacturers and the health budget, not the price paid at the till.
What is left out of the contribution calculation?
Medicines derived from human blood or plasma and vaccines purchased through the national health programmes are exempt. In addition, the value of centralised consumption does not include consumption of medicines for which cost-volume or cost-volume-result contracts have been concluded.
Where can I find the full list of the 5,469 entries?
In the Official Gazette of Romania, Part I, no. 768 bis of 10 September 2026, pages 3 to 348. The full edition in PDF format is attached to this article, in the section containing the original text of the act, and can be downloaded from there free of charge. The order itself, the three articles, is in number 768 of the same day, page 15.

Editorial analysis

The act itself is as simple as it could be and does exactly what it should: Article 38(3) of the ordinance requires a quarterly list approved by ministerial order, and without it the two percentages, 25% and 15%, cannot be applied to anyone. The order has three articles, invents no condition and reinterprets no definition. All of its value sits in the 346 pages of annex, which, once checked, prove clean on the only testable criteria: continuous numbering from 1 to 5,469, with no gap, 5,469 distinct identification codes, none repeated, none classified once as type I and once as type II. In a table of that size, that is no small thing.

The problem is not in the act, it is in the calendar, and it shows only if you count the days. The ordinance builds a chain: the National Health Insurance House communicates the value of centralised consumption by the end of the month following the end of the quarter, that is by 31 July 2026; the minister approves the list by 15 August 2026; the payer declares and transfers the contribution by 25 August 2026. The administration reserves 46 days for itself from the closing of the quarter, and leaves the payer 10. The order was signed on 3 September and published on 10 September 2026, that is 72 days after the quarter closed, 26 days past its own deadline and 16 days after the payer’s ten-day window had shut. The ratio between the two periods has been inverted in practice: the one with 10 days had to use them before receiving the data, and the one with 46 took 72.

This is not a one-round accident, and that shows when you compare it with the previous quarter we can verify. The list for the fourth quarter of 2025 was approved by Order no. 590/2026 and published on 11 March 2026, 24 days past the deadline of 15 February and 14 days after the payment deadline of 25 February. More than that, it needed correcting: Order no. 377/2026 replaced entry 1,951 in the annex, published on 22 June 2026, that is 117 days after the contribution had already fallen due. The system therefore has a single route for putting a wrong classification right, and that route arrives a whole quarter later than the moment the money left. The practical consequence, for a payer acting in good faith, is that the correct return is no longer the one filed on time but the one amended afterwards, and that becomes the rule rather than the exception.

The structure of the list deserves a look too, because it says something the order does not. If the value of consumption were split in the same proportion as the number of entries, 25.5% at 25% and 74.5% at 15%, the average effective percentage would be around 17.6%. In reality it is higher, because the definition itself concentrates value in the expensive band: type I is, by construction, the medicine that does not yet have a generic competitor, that is precisely the one whose price has not been pushed down by competition. It shows by therapeutic group as well: in the group of antineoplastic and immunomodulating agents, where most oncology treatments sit, 273 out of 757 entries are type I, while in the cardiovascular group only 89 out of 794 are. The 25% tax therefore falls mainly on oncology and on treatments without an alternative, which is both the declared intention of the law and, at the same time, the reason why an entry wrongly classified there hurts most.

One last detail, which has no legal consequence but says how the document was made. The column on which the whole tax hangs is headed, in the official annex, „Tip_med_categ” and contains the figures 1 and 2. Nowhere, neither in the order nor in the annex, is there a line saying that 1 means type I and 2 means type II. It can be deduced, without effort and without any real risk of getting it wrong, but it has to be deduced. Alongside „CIM_CNAS_consum” and „DAPP”, the column name shows that the file was exported from the database and sent to print just as it came out.

What should be changed

  • A legend line at the start of the annex. It is enough for it to say that the value 1 in the last column means a type I medicine, taxed at 25%, and the value 2 means a type II medicine, taxed at 15%. Effect: the column that establishes the sum owed no longer depends on a deduction by the reader.
  • A mention in the order of the reference month and of the agency’s document. The order should say explicitly that the classification reflects the situation in June 2026 and cite the act by which the National Agency for Medicines and Medical Devices transmitted the classification. Effect: a manufacturer challenging the classification knows what exactly it is attacking, and the file behind the decision becomes traceable from the act.
  • Tying the payment deadline to the publication of the list. Either the list is genuinely published by the 15th of the second month, or the deadline for declaring and paying runs from its publication. Effect: nobody declares and pays a contribution whose percentage they learn 16 days later.
  • A written deadline for rectifying the list. The ordinance provides nothing about correcting a wrongly classified entry, and practice shows a correction after four months. A period of 30 days from publication, with effect on the return, would settle that. Effect: the error is put right in the same fiscal cycle in which it was made, not in the next one.
  • Publication of the annex in a processable tabular format as well, on the Ministry of Health website. A CSV or XLSX file alongside the PDF, with the same 5,469 rows. Effect: matching against a company’s own sales records is done automatically, not by rereading 346 pages.
  • Replacing the column labels with proper Romanian names. „Cod de identificare a medicamentului”, „Deținătorul autorizației de punere pe piață”, „Categoria medicamentului”, that is medicine identification code, marketing authorisation holder and medicine category, instead of the database abbreviations. Effect: the annex becomes legible for those who have to apply it, not only for whoever exported it.

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. 768 and no. 768 bis of 10 September 2026 16 pages PDF, 114 KB the act starts on page 15

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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.