In brief
- The Health Ministry has extended, by order, the validity of the current maximum prices for human-use medicines, so there is no gap between the old prices and the ones recalculated each year.
- Prices listed in Canamed and the Public Catalogue remain valid until the order approving the recalculated prices from the annual correction takes effect, but no later than 31 March 2027.
- It directly affects drug manufacturers and distributors and pharmacies, and indirectly any patient who buys medicines with or without state reimbursement.
Published: Official Gazette of Romania no. 544 of 2 July 2026
Effective from: 2 July 2026
The maximum prices at which medicines are sold in Romania will not, at least for a while, be left without a valid legal basis. Order of the Minister of Health no. 707/2026 amending Order of the Minister of Health no. 368/2017, published in the Official Gazette of Romania (Monitorul Oficial) no. 544 of 2 July 2026, extends, through a single article amendment, the deadline until which the previously approved maximum prices for human-use medicines remain valid. In practice, the act avoids a legislative gap: without it, the approved prices could have expired before the Health Ministry finished its annual recalculation, leaving pharmacies and distributors, temporarily, without an official maximum price to refer to.
Order no. 368/2017 is the act that has, for nearly a decade, set out the calculation method and the procedure through which the Health Ministry approves the maximum prices of human-use medicines sold in Romania. Through this mechanism, the price of any authorized medicine is officially capped and published in two registers: Canamed, the catalogue listing the prices of medicines authorized for marketing, including those reimbursed or provided free of charge by the National Health Insurance House, and the Public Catalogue, containing the prices of medicines authorized in general. Once a year, these prices are recalculated through an “annual correction,” through which the Health Ministry updates them, usually by comparison with prices in other European Union member states. Until the annual correction is finalized and approved through a new order, the old prices must remain in force, otherwise there would be a period with no legally applicable maximum price. Three weeks later, another ministry order showed, in practice, how this price-setting mechanism works: ten new medicines, most of them cancer treatments, received a regulated maximum price through the update of the National Catalogue.
What it changes in practice
The amendment introduced by Order no. 707/2026 is limited to a single article, but its practical effect is significant for the entire pharmaceutical market.
The validity of already approved prices is extended. Article 32 of Order no. 368/2017 is rewritten to state explicitly that the maximum prices of medicines authorized for marketing, approved in Canamed and in the Public Catalogue, as well as the reference prices for generic, biosimilar and innovative medicines, “remain valid” until the order approving the new prices, resulting from the annual correction, enters into force.
A firm deadline is set. The new validity is not unlimited: the legislator introduced an explicit time cap, 31 March 2027, beyond which current prices can no longer be automatically extended on this basis, regardless of whether the annual correction order has been issued by then or not.
This order does not change any specific price. Order no. 707/2026 does not raise or lower the price of any medicine, it merely temporarily extends the validity of existing prices, acting as a bridge until the recalculated prices are approved. For patients, the immediate effect is continuity: medicines remain available at known prices, without interruptions caused by administrative procedures.
What has changed compared with the previous situation
- The old wording of Article 32 of Order no. 368/2017 provided for a different deadline or a different extension formula, insufficient to cover the interval until the completion of this cycle’s annual correction; Order no. 707/2026 replaces the entire text of the article with a new wording.
- For the first time, this article explicitly introduces a fixed calendar deadline (31 March 2027) until which the automatic extension of price validity can operate, instead of a more general wording tied only to the issuance of the correction order.
- The three categories of reference prices covered are explicitly mentioned, generic, biosimilar and innovative, alongside the prices in Canamed and the Public Catalogue, which clarifies the scope of the extension.
Advantages and disadvantages
What it improves
- Continuity for the pharmaceutical market: manufacturers, distributors and pharmacies continue to have an official maximum reference price, without the risk of a “gray” period with no legal basis for prices.
- Predictability for patients: medicines remain available at known prices, including those reimbursed or provided free of charge through the National Health Insurance House, without administrative delays that could affect access to treatment.
- A clear deadline (31 March 2027) indirectly forces the Health Ministry to finalize the annual price correction within a defined period, rather than indefinitely.
What remains a problem
- The order gives the public no information about the timeline or the actual outcome of the ongoing annual correction, so it is not yet known whether or how the actual prices of medicines will change.
- The text of the order remains strictly technical and administrative, with no further explanation of the criteria used to recalculate prices for the current year.
- If the annual correction order is not issued by 31 March 2027, the current text does not explicitly clarify what happens to prices after that date.
Practical advice
- You are a patient taking reimbursed or free medicines through the National Health Insurance House: you don’t need to do anything as a result of this order, it only maintains the validity of current prices, so your access to and cost of medicines remain, for now, unchanged.
- You are a pharmacist, distributor, or work in procurement for a healthcare facility: remember 31 March 2027 as the reference point for when current prices in Canamed and the Public Catalogue could be replaced by those resulting from the annual correction.
- You are a manufacturer or marketing authorization holder for medicines: follow the Health Ministry’s future communications on the status of the annual price correction, so you can anticipate any adjustments to the price of your own products.
Frequently asked questions
What does Health Ministry Order no. 707/2026 essentially change?
Do medicines become more or less expensive because of this order?
What are Canamed and the Public Catalogue?
What is the “annual correction” of prices?
What happens if the order with the recalculated prices does not appear by 31 March 2027?
For context, also in July 2026 the Health Ministry and the National Health Insurance House also adjusted the way medical leave is reported, through the introduction of separate entries for the 55%, 65% and 75% percentages of the calculation base.
Two weeks after this order, the Health Ministry and the National Health Insurance House also updated the therapeutic prescribing protocols for dozens of reimbursed medicines, from oncology to psoriasis and hepatitis B, through Joint Order of the Health Ministry/National Health Insurance House no. 824/1,313/2026.
Original text of the legal act
The full text, as published in the Official Gazette of Romania
Official Gazette of Romania no. 544 of 2 July 2026 64 pages PDF, 24 MB the act starts on page 53
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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.