Medicines for special needs: threshold drops to 70%

In brief

A second supplier can be sought earlier. Where a medicine that has no marketing authorisation in Romania is nonetheless brought in, because there is nothing else to treat the patient with, the distributor receives an authorisation for special needs, for a quantity and a period fixed in advance. Until now, the National Agency for Medicines and Medical Devices of Romania could issue a second authorisation, to another distributor, only after the first had sold 90% of the quantity it had been authorised for. From 15 September 2026, the threshold drops to 70%.
The agency takes over the start of the procedure, and the ministry drops out of the chain. Previously, the agency notified the Ministry of Health, the ministry asked the specialist committees to estimate the quantity needed, the committees replied to the ministry, and the ministry sent the report back to the agency so that it could publish the notice for distributors. Now the agency asks the committees directly and publishes the notice itself, within no more than 3 working days of receiving the report. For the first time, it can ask the National Health Insurance House for the medicine’s actual consumption history.
Tracking stocks becomes a duty, not an option. The agency must monitor on a permanent basis the stocks of medicines authorised for special needs and, within no more than 3 working days of the 70% threshold being reached, if the medicine still cannot be found through the usual channels, go back to the specialist committees to have the estimated quantity confirmed. The order enters into force on 15 September 2026, the date of publication.

Act: Order of the Minister of Health, acting in an interim capacity, no. 1.310 of 14 September 2026 amending and supplementing the Rules implementing the provisions of Article 703(1) and (2) of Law no. 95/2006 on healthcare reform concerning medicines used to meet special needs, approved by Order of the Minister of Health no. 85/2013
Published: Official Gazette of Romania (Monitorul Oficial) no. 783 of 15 September 2026
In force from: 15 September 2026, the date of publication

The Ministry of Health has rewritten the rules under which medicines that have no marketing authorisation in Romania reach the country all the same, because there is nothing else to treat the patient with. These are the medicines that circulate on an authorisation for special needs, the same one under which seven of the nine new positions that entered the national price catalogue on 11 September were brought in, mostly oncology medicines. Order of the Minister of Health, acting in an interim capacity, no. 1.310/2026 was signed on Monday, 14 September 2026, published the next day, and applies from the day of publication.

The order has two articles and no free-standing new text: it changes five points of the rules approved in 2013 by Order of the Minister of Health no. 85/2013, published in the Official Gazette of Romania, Part I, no. 93 of 14 February 2013. It was issued on the basis of approval report no. 1.310 R of 14 September 2026 of the Pharmaceutical and Medical Devices Directorate, that is from the same day as the order itself, and bears the signature of the Minister of Health, acting in an interim capacity, Cseke Attila-Zoltán.

The 2013 rules have two chapters, for two situations that are easily confused. Chapter I covers the case in which a doctor requests an unauthorised medicine for patients in their direct care, on an unsolicited order, made in good faith and accompanied by supporting documentation. Chapter II covers the case in which the state finds that a medicine is missing from the market and organises its supply itself: the specialist committees estimate the quantity needed for up to 12 months, the agency publishes a notice, wholesale distributors express their interest, the one with the lowest price is given the quantity needed and, once the documentation has been filed, the authorisation. Order no. 1.310/2026 touches only the second chapter. The route by which a doctor requests a medicine for a particular patient stays unchanged, article by article.

The legal basis is the same as in 2013: Article 703(1) and (2) of Law no. 95/2006. Paragraph (1) allows medicines supplied to the order of a qualified person, for patients under their direct responsibility, to be excluded from the usual marketing rules. Paragraph (2) allows the agency to authorise temporarily the distribution of an unauthorised medicine in the event of an epidemic, of the spread of chemical agents or nuclear radiation or, the formula used in practice, „în alte cazuri de necesitate neacoperite de medicamentele autorizate” (in other cases of need not covered by authorised medicines). When the rules were adopted, the article was numbered 699; it became Article 703 when the law was republished, and the title of the rules was brought into line only on 6 January 2017.

What it changes in practice

The order enters into force on 15 September 2026, the date of publication in the Official Gazette of Romania. It is an act of the head of a central specialised body of the public administration, and the three-day term does not apply to such acts: under Article 12(3) of Law no. 24/2000, they enter into force on the date of publication unless they themselves set a later date. Article II of the order sets none and contains no transitional provision, so the new rules catch authorisations already under way as well.

The first effect is felt by the patient on a course of treatment that is running out. By construction, the authorised quantity covers no more than 12 months. If the medicine is consumed evenly, the old threshold of 90% was reached only after 10.8 months, leaving 1.2 months of treatment in stock, around 36 days. The new threshold of 70% is reached after 8.4 months and leaves 3.6 months in stock, roughly 110 days. The gap between the two moments is 2.4 months, almost ten weeks.

The figure matters because replacing a supplier is not instantaneous. Adding up only the deadlines written into the rules, at least 21 working days pass between the shortage being reported and a new authorisation being issued where a single distributor comes forward, and 28 working days where several do and the sealed-envelope price round is opened. In calendar days, that is between one month and a month and a half, on top of which comes the window for expressing interest, which the rules leave entirely to the notice. Under the old threshold, the 36 days of remaining stock barely covered the procedure, and sometimes did not cover it at all. Under the new threshold, the 110 days cover it almost three times over.

The second effect is a duty the agency did not have. Permanent monitoring of stocks, with a reaction within no more than 3 working days of the 70% threshold being reached, is new text, inserted as paragraph (2²) of Article 14. Until now, the 90% threshold appeared only as a substantive condition for issuing a second authorisation; nobody was obliged to check when it was reached.

The third effect concerns the route the paperwork takes. The specialist committees in the Ministry of Health still reply within 3 working days, but they reply to the agency, not to the ministry’s specialist directorate. The National Health Insurance House is no longer an alternative source for the quantity needed, but a source of additional information, which the agency may expressly ask about the consumption history recorded for that medicine. It is the first time the rules have tied the estimate of the quantity needed to actual reimbursed consumption, rather than to a committee’s judgment alone.

The fourth effect is a relaxation, the only one in the whole order. The deadline within which the agency has to report the problem to the ministry used to be „de îndată” (without delay). It has become 2 working days. In exchange, the step that previously had no deadline at all, forwarding the report and publishing the notice, now has a limit: no more than 3 working days from receipt of the medical justification report.

The fifth effect concerns distributors. Information about the deadline by which they can actually place the medicine on the market must now go to the agency as well, not only to the ministry’s specialist directorate, which removes an intermediary. The window in which that information is sent has, however, been moved from the deadline for expressing interest to the deadline for placing on the market, and the consequence is discussed below, under errors.

What has changed compared with the previous situation

The previous version of the rules is not the 2013 one. The text has been amended nine times so far, most recently by Order of the Minister of Health no. 1.995/2023, published in the Official Gazette of Romania, Part I, no. 539 of 16 June 2023, which itself rewrote one of the paragraphs touched now. The comparison below is made with the version in force between 16 June 2023 and 14 September 2026.

Article 11(2¹). The old text had a single substantive sentence: the agency reported the discontinuity „de îndată” (without delay) to the ministry’s specialist directorate, and the authorisation was issued in compliance with Article 12¹. The new text gives the agency 2 working days, adds the duty to ask the specialist committees itself for the medical justification report and for the estimate of the quantity needed over up to 12 months, and opens up access to the data held by the National Health Insurance House. The express cross-reference to Article 12¹ has disappeared from the text.

Article 11(2²) is repealed. This was the step in which the ministry, within 3 working days of receiving the notification, asked the specialist committee or the insurance house for the quantity needed over 12 months. Its role has been moved, through paragraph (2¹), to the agency. The ministry remains informed but no longer sets anything in motion.

Article 12¹(1). The old text ran the 3 working days from the ministry’s request and sent the quantity needed, in the form of a medical justification report, back to the ministry. The new text runs the deadline from the agency’s request and sends the information to the agency. Who replies changes too: previously the committees „or” the insurance house replied, as the case might be; now the committees „and” the insurance house reply, the latter only if additional information has been requested from it.

Article 12¹(2). The 2023 version said that the ministry forwards the medical justification report to the agency with a view to publishing the notice, with no deadline. The new version takes the ministry out of this step and gives the agency no more than 3 working days from receipt of the report to publish the notice. Interest in obtaining the authorisation is, however, still expressed to the ministry’s specialist directorate, not to the agency.

Article 12¹(4). The distributor now informs the agency as well, not only the ministry, and what is communicated is called „termenul” (the deadline) rather than „durata maximă” (the maximum period) within which the medicine can be placed on the market. The window has moved: previously the information was sent within the period laid down in paragraph (3)(a), that is while interest is being expressed; now it is sent „în interiorul perioadei prevăzute la alin. (3) lit. b)” (within the period laid down in paragraph (3)(b)), that is within the deadline for placing on the market, which is calculated from the moment the authorisation is issued.

Article 14(2). The threshold falls from 90% to 70%. The same sentence also changes who communicates, through Article 12¹, the quantity for which the authorisation is granted: until now the ministry’s specialist directorate, from now on the specialist committees. The duration of the authorisation remains equal to the period for which the quantity was estimated, but no longer than 12 months.

Article 14(2²), new text. The agency monitors stocks on a permanent basis and, within no more than 3 working days of 70% of the authorised quantity being reached, if the medicine still cannot be secured through the usual channels, it applies to the specialist committees for verification and confirmation of the quantity estimated earlier and informs the ministry.

Advantages and disadvantages

What it improves

The safety margin grows substantially. On a 12-month authorisation consumed evenly, the moment when a second supplier can be sought arrives almost ten weeks earlier, and the stock left at that moment goes from around 36 to around 110 days of treatment.
The decision chain loses an intermediary. The agency asks the committees directly and publishes the notice itself, instead of waiting for the ministry to send the report back to it.
The step that until now had no deadline at all, publication of the notice for distributors, is given a written limit of 3 working days.
Tracking stocks becomes an express duty of the agency, with a written reaction time, rather than an administrative practice left to the institution’s discretion.
The estimate of the quantity needed can rest, for the first time, on the consumption history recorded by the insurance house, and not only on a committee’s judgment.
The distributor communicates the deadline for placing on the market directly to the agency that issues the authorisation, which shortens the path of the information on which the decision rests.

What remains a problem

The window for expressing interest, the one link that can stretch the whole procedure indefinitely, still has neither a minimum nor a maximum in the rules. It is set in the notice, case by case.
Permanent monitoring of stocks rests on monthly reporting. Distributors notify their stocks by the 15th of each month, under Article 15(d) of the rules, and outside that deadline only on request, within one working day. The day on which the 70% threshold is reached may therefore come to light several weeks late.
The order says what the agency does when the threshold is reached, but not what comes next. Article 12¹(10), unamended, lists exhaustively the situations in which the selection procedure may be restarted, and reaching the 70% threshold is not among them.
The route is now mixed. The quantity needed reaches the agency, but distributors still express their interest to the ministry, and paragraphs (5) and (7) of Article 12¹ still leave it to the ministry to pass the quantity on to the winning distributor.
The only deadline that has grown longer is the agency’s: reporting to the ministry moves from „de îndată” (without delay) to 2 working days.
Nothing limits the total duration of a solution described as temporary. The authorisation can run for 12 months, the extension for another 12, and the sale of the remaining stock for a further 12, so three years in which a medicine circulates without a marketing authorisation in Romania.
The order has no transitional provisions. For authorisations already issued, nothing is said about the moment from which the 70% threshold is calculated or about who checks stocks retrospectively.

Practical advice

If your treatment uses a medicine brought in on an authorisation for special needs, ask your doctor or the pharmacy where you collect it not only whether there is stock, but also how long the authorisation is valid. It is the term of the authorisation, not the stock on the shelf, that sets the procedures in motion.
Do not confuse the two routes. A request made by a doctor for a particular patient, on the basis of supporting documentation, falls under Chapter I of the rules and has not been touched by this order. The present changes concern medicines the state brings in because they are missing from the market.
Wholesale distributors should from now on watch the notices on the agency’s website, in the dedicated section, rather than the ministry’s communications. The notice is published within no more than 3 working days of receipt of the medical justification report, so the time available to react has been shortened and has become predictable.
Interest in obtaining the authorisation is still expressed to the specialist directorate of the Ministry of Health, not to the agency. The new text changes who publishes the notice, not who it is answered to.
Send the information about the deadline by which the medicine can be placed on the market in duplicate, to the ministry and to the agency, by the time the deadline for expressing interest expires. The cross-reference in the published text is questionable, and anyone waiting for the window in point (b) risks dropping out of the selection.
The documentation laid down in Article 14(1), the seven categories of documents, is filed within no more than 5 working days of receiving the quantity needed. Missing the deadline is reported to the ministry, which assesses whether to restart the procedure.
The application for price approval is filed within no more than 2 working days of the authorisation being issued, under the rules approved by Order of the Minister of Health no. 368/2017. If it is not filed in time, the ministry notifies the agency with a view to cancelling the authorisation.
An extension of validity is applied for at least 30 working days before expiry. An application filed later can no longer be registered, and the remaining quantity is blocked.
The specialist committees and the insurance house have 3 working days from the agency’s request. The deadline is the same whether only the committee replies or consumption data are also sought from the insurance house, so the material has to be prepared in parallel, not in sequence.
Hospital pharmacies and the wards that report consumption should send their data up to date. Both the estimate of the quantity needed and the moment at which the agency finds the 70% threshold reached rest on them.

Frequently asked questions

What is a medicine for special needs?

It is a medicine that has no valid marketing authorisation in Romania but is brought in all the same, either because a doctor requests it for patients in their direct care, or because the state finds that there is nothing on the market to replace it with. The authorisation is issued by the National Agency for Medicines and Medical Devices of Romania, for a specified quantity and period.

What changes in practice for a patient?

Nothing in the way they receive the medicine. What changes is the moment from which the state is allowed and, from now on, obliged to look for a second supplier: when the first has sold 70% of the authorised quantity, not 90%. In practice, the margin between the stock running out and a new supplier arriving grows from around 36 to around 110 days, on a 12-month authorisation consumed evenly.

Why does the 70% threshold matter in particular?

Because behind it lies a simple piece of arithmetic. Bringing in a new supplier takes, from the deadlines written into the rules alone, at least 21 working days with a single bidder and 28 with several, plus the window for expressing interest. At the 90% threshold, roughly 36 days of treatment were left in stock, that is exactly as long as the procedure takes, at best. At 70%, roughly 110 days are left.

Who decides how much of the medicine is needed?

The specialist committees within the Ministry of Health, through a medical justification report, within 3 working days of the request. From now on, the request comes from the agency rather than from the ministry, and the reply goes to the agency too. The National Health Insurance House may be asked for additional information, including about the consumption history recorded for that medicine.

How long does it take, from the shortage being identified to the authorisation?

Adding up only the deadlines in the rules: 2 working days for reporting and requesting, 3 for the committees’ reply, 3 for publishing the notice, then the window for expressing interest, which has no fixed length, 1 working day to pass on the quantity needed if a single distributor has come forward or 8 working days if the price round is opened, 5 working days for the documentation and 7 for issuing the authorisation. That gives 21 or 28 working days respectively, plus the window for expressing interest.

For how long can a medicine brought in this way be sold?

The authorisation is granted for no more than 12 months. If the quantity has not been used up by the time it expires, its validity can be extended by no more than a further 12 months, on an application registered at least 30 working days beforehand. Once the extension expires, existing quantities may still be sold for no more than another 12 months. Up to three years in total.

Who pays for the medicine?

The rules do not deal with payment. The maximum price is approved under the rules for calculating the prices of medicines for human use, approved by Order of the Minister of Health no. 368/2017, on the distributor’s application, filed within no more than 2 working days of the authorisation being issued. Whether and how much is reimbursed from public funds depends on the programme or list the medicine falls into, not on this order.

Does anything change for medicines requested for a single patient?

No. The order amends only articles in Chapter II of the rules, the one implementing Article 703(2) of Law no. 95/2006, that is the situation in which the state organises the supply of a medicine missing from the market. Chapter I, covering orders made on the doctor’s initiative for patients under their direct responsibility, is untouched.

What does a wholesale distributor have to do now?

Watch the notices on the agency’s website, express its interest to the ministry’s specialist directorate within the deadline set in the notice, also send the agency the information about the deadline for placing on the market, file the documentation within 5 working days of receiving the quantity needed, and apply for price approval within 2 working days of the authorisation being issued.

From when does it apply?

From 15 September 2026, the date of publication in the Official Gazette of Romania. Ministerial orders enter into force on the date of publication unless they set a later date, and this one does not. There are no transitional provisions, so the rules apply to procedures and authorisations already under way as well.

Errors and inconsistencies in the published text

Point 3, Article 12¹(4): the information that decides the selection is communicated in a window that opens only after the selection. The new text requires the distributor to communicate „în interiorul perioadei prevăzute la alin. (3) lit. b)” (within the period laid down in paragraph (3)(b)) the information about the deadline by which it can place the medicine on the market. Point (b) of paragraph (3), which the order does not amend, designates „termenul-limită până la care solicitantul se angajează să pună pe piață medicamentul, calculat din momentul eliberării autorizației privind furnizarea de medicamente pentru nevoi speciale” (the deadline by which the applicant undertakes to place the medicine on the market, calculated from the moment the authorisation for the supply of medicines for special needs is issued), so a period that starts running after the authorisation is issued. Yet the same information is used before issue: paragraphs (5) and (6) of the same article are triggered „la împlinirea termenului prevăzut la alin. (3) lit. a)” (on expiry of the deadline laid down in paragraph (3)(a)) and assume that it is already known whether the distributor has undertaken to deliver within the deadline in point (b). What is more, Article 14(5)(c) withdraws the authorisation if the distributor does not place the medicine on the market „în interiorul duratei maxime comunicate conform art. 12¹ alin. (4)” (within the maximum period communicated under Article 12¹(4)), that is it penalises the overrunning of a deadline that, on a reading of the new text, could be communicated after the deadline itself has started to run. In the previous version, the information was communicated within the deadline in point (a), and the chain closed. The reference to point (b) opens it.
Points 3 and 4: the quantity for which the authorisation is granted has, in the text left in force, three different sources. Point 3 moves the communication of the quantity needed from the ministry’s specialist directorate to the agency: the committees „au obligația de a comunica către ANMDMR informațiile prevăzute la art. 11 alin. (2¹)” (are required to communicate to ANMDMR the information laid down in Article 11(2¹)). Point 4 rewrites Article 14(2) and says that the authorisation is granted for the quantity communicated under Article 12¹ „de comisiile de specialitate din cadrul Ministerului Sănătății” (by the specialist committees within the Ministry of Health). Two provisions pointing elsewhere are left unamended, however: Article 12¹(5) requires the ministry’s specialist directorate to send the sole remaining distributor „necesarul comunicat conform alin. (1)” (the quantity needed as communicated under paragraph (1)), and paragraph (7) provides that the distributor with the lowest price is sent, again by the ministry, „necesarul stabilit conform alin. (1)” (the quantity established under paragraph (1)), that is precisely the document which, after the amendment, is no longer addressed to the ministry; Article 14(1)(b) requires the documentation filed by the distributor to include „justificarea medicală și cantitatea comunicată de către direcția de specialitate din cadrul Ministerului Sănătății” (the medical justification and the quantity communicated by the specialist directorate within the Ministry of Health). Until 14 September 2026 all three said the same thing. After the amendment, the quantity that caps the authorisation is attributed, within the same act, to the specialist committees, to the ministry’s specialist directorate and to a circuit running through the agency, and whoever applies the text has no way of knowing which version prevails.

Editorial analysis

The order solves a real problem, and the solution chosen is the right one. A medicine brought in for special needs is, by definition, the only one available for those patients; when its stock nears zero, the alternative is not another product but nothing at all. The 90% threshold was always too close to the bottom of the warehouse, and moving it to 70% is a cheap measure that requires no budget and changes nobody’s rights. The less convincing part is not the idea but the way it has been stitched into the existing text.

The first thing you do not see reading the order end to end is the relationship between the figure that has changed and the length of the procedure it serves. The authorisation covers at most 12 months. At even consumption, the 90% threshold was reached after 10.8 months and left 1.2 months in stock, around 36 days. Bringing in a new supplier takes, counting only the deadlines written into the rules, 21 working days where a single distributor comes forward and 28 where the sealed-envelope price round is opened, so between 29 and 40 calendar days, on top of which comes the window for expressing interest, which the rules do not bound in any way. In other words, under the old rule the remaining stock and the procedure were practically the same length, and every day of delay translated directly into days without treatment. The 70% threshold leaves around 110 days in stock, roughly three times the length of the procedure. That is in fact what this order is about, and it is written nowhere in it.

The second observation comes from putting the new text together with an article the order does not touch. The agency is required to react within no more than 3 working days of the 70% threshold being reached and to monitor stocks on a permanent basis. The only source of data provided for in the rules is Article 15(d): the distributor notifies the agency of the quantity imported and sold, and of the stock, „la fiecare intrare/ieșire” (on each entry and exit) and „până pe data de 15 a fiecărei luni” (by the 15th of each month), and outside that calendar only at the agency’s request, within one working day. A threshold reached on the 16th of the month may therefore become known almost thirty days later, while the 3 working days run from the event, not from learning of it. Either the agency questions distributors almost daily, which the rules permit but do not provide for, or the deadline stays on paper. The order would have needed a single extra sentence, in Article 15(d), to secure its own workability.

The third observation concerns what happens after the alarm. The new paragraph says that the agency applies to the committees „în vederea verificării și susținerii necesarului estimat anterior” (with a view to verifying and confirming the quantity estimated earlier) and informs the ministry. There the text stops. It does not say what follows if the quantity is confirmed, refers to no procedure and sets no deadline for the next step. And Article 12¹(10), unamended, lists exhaustively the situations in which „procedura prevăzută de prezentul articol se poate relua” (the procedure laid down in this article may be restarted): where no distributor has expressed interest, and where the authorisation has ended through exhaustion of the stock, has been suspended or has been withdrawn. Reaching the 70% threshold while the authorisation is still valid is not among them. It can be argued that the situation falls within the scenario in Article 11 anyway, since the medicine continues to be unavailable through the usual channels, but that means the official applying the text has to reconstruct on their own a route the order does not point them to.

Finally, the reorganisation of the route is less radical than it looks. The ministry loses the power to set the procedure in motion and to receive the report, but keeps two functions that count: it receives distributors’ expressions of interest and passes the quantity needed to the winner. The result is a mixed circuit in which the central document, the medical justification report, goes to the agency, while the selection decisions stay with the ministry. The sum of the express deadlines from reporting to publication of the notice rises from 6 to 8 working days, because the agency’s deadline for reporting moves from „de îndată” (without delay) to 2 working days. In exchange, the step that previously had no deadline is given a limit of 3 working days, which means that the whole interval is, for the first time, bounded. It is a fair trade: two extra days of paperwork in return for removing a step that could last indefinitely.

What should be changed

Correcting the cross-reference in Article 12¹(4), from point (b) to point (a) of paragraph (3). Effect: the information on which the selection of the distributor rests becomes available again before the selection, and the withdrawal of the authorisation under Article 14(5)(c) once more has a deadline communicated at the right moment.
Aligning Article 12¹(5) and (7) and Article 14(1)(b) with the new route of the quantity needed. Effect: who passes the quantity to the winning distributor and what document goes into the file become questions with a single answer, not three.
Setting a minimum and a maximum in the rules for the deadline for expressing interest, laid down in Article 12¹(3)(a). Effect: the total length of the procedure becomes predictable, and the 110 days of stock gained by lowering the threshold can no longer be eaten up by a single window set at will in the notice.
Tying permanent monitoring to reporting more frequent than monthly, by supplementing Article 15(d) with a duty to notify when a given percentage of the authorised quantity is reached. Effect: the agency’s 3 working days start running from an event the agency can know about on the day it occurs.
Specifying the procedure that follows confirmation of the quantity needed, by adding the situation in Article 14(2²) to the list in Article 12¹(10). Effect: the 70% alarm leads to a new notice on a written legal basis, not on an interpretation.
Introducing a limit on the cumulative duration of an authorisation for special needs, today up to three years through the interplay of paragraphs (2), (3) and (3¹) of Article 14. Effect: the solution that the rules themselves call temporary stops being able to stand in for a marketing authorisation, and the holder is pushed to obtain one.

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. 783 of 15 September 2026 8 pages PDF, 83 KB the act starts on page 5

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