In brief

  • In serious epidemics, the county sanitary veterinary directorates may themselves buy and use vaccines that are not authorised anywhere in the European Union. Until 15 October 2026, a vaccine brought into Romania under a temporary distribution authorisation could be bought and administered only by veterinary practices and clinics, on the basis of an order form. From 16 October 2026, in exceptional epidemiological situations linked to diseases on „list A” or to emerging diseases, the county directorates enter the chain themselves, for programmes of mass immunisation of animals.
  • The National Sanitary Veterinary and Food Safety Authority is given, in black and white, the power to reject an application for authorisation. The old wording of Article 251 paragraph (3) of the norm spoke only about assessing the documentation and issuing the authorisation. The new wording adds „or rejects the application for it”, and a new paragraph, (31), gives the authority three further grounds for refusing vaccines: the product would interfere with a national programme for diagnosis, control or eradication, it would make it hard to certify that the animals are free of disease, or the strain it protects against is practically absent from the area.
  • Vaccines donated by the European Commission now cost nothing to authorise, and the same vaccine may be authorised for several distributors. Those directly concerned are the wholesale distributors of veterinary medicinal products, the only ones who may apply for such an authorisation, and the sanitary veterinary and food safety directorates, the 41 county ones plus that of the city of Bucharest. Those indirectly concerned are the veterinarians in private practice, through whom the vaccine reaches the animals, and, through them, livestock farmers and pet owners. The deadline within which the authority replies is unchanged: at most 30 working days from a complete application.
Act: Order of the President of the National Sanitary Veterinary and Food Safety Authority no. 968/2026 on the amendment and supplementing of the Sanitary Veterinary Norm implementing Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC, as regards marketing authorisations, the approval of clinical trials and the pharmacovigilance of veterinary medicinal products, approved by Order of the President of the National Sanitary Veterinary and Food Safety Authority no. 59/2022
Published: Official Gazette of Romania (Monitorul Oficial), Part I, no. 866 of 16 October 2026, page 2
In force from: 16 October 2026, the date of publication, because Article II of the order lays down no other date and Article 12 paragraph (3) of Law no. 24/2000 on legislative drafting rules so provides for the orders of central public administration authorities

When a disease that kills animals by the thousand breaks out in a nearby country, as has happened several times with African swine fever or with avian influenza, the right vaccine is not always available on the European market. Sometimes it exists, but is authorised in another part of the world. Sometimes it arrives as a donation from the European Commission, in a batch put together for the states that have been hit. And a veterinary medicine that holds no authorisation in the European Union cannot simply be brought in and used: the law opens a narrow gate for it, called a temporary distribution authorisation.

That gate was opened in Romania in August 2023 and, ever since, has been built for individual cases: a distributor applies, the authority checks the papers, the vaccine reaches the veterinary practices. Order of the President of the National Sanitary Veterinary and Food Safety Authority (ANSVSA) no. 968/2026, published in the Official Gazette of Romania, Part I, no. 866 of 16 October 2026, widens it for the first time, so that a vaccination campaign run by the state can pass through it as well.

The order has three points and runs to a single page. The procedure stays as it is; two articles are amended and supplemented, Article 251 and Article 252 of the sanitary veterinary norm approved by Order no. 59/2022, published in the Official Gazette of Romania, Part I, no. 470 of 11 May 2022. That norm is the act by which Romania implements Regulation (EU) 2019/6 on veterinary medicinal products, a European regulation published in the Official Journal of the European Union L 4 of 7 January 2019 and applicable since 28 January 2022.

The division of powers is worth stating at the outset, because everything else depends on it: the European regulation sets out what may be done, while the Romanian norm sets out how it is applied for and who signs. Article 106(3) of the regulation expressly leaves Member States free to draw up their own procedures for implementing the derogations in Articles 110 to 114 and Article 116. Order no. 968/2026 moves only inside that procedural space. The substantive right, that of using a vaccine unauthorised in the Union when a serious disease breaks out, is not created by the Romanian order but by Article 110(2) of the regulation, and it existed before 16 October 2026 too.

The signature is that of the president of the authority, Alexandru Nicolae Bociu, given on 12 October 2026, on the basis of approval memorandum no. 1.173 of 1 October 2026, drawn up by the Directorate for the Coordination of Laboratories and Veterinary Medicinal Products.

What it changes in practice

The first effect is one of competence. Article 252 paragraphs (1) and (2) of the norm say, and continue to say, that a product brought in under a temporary distribution authorisation may be bought from distributors only by the units in which veterinary medical assistance activities are carried out, that is by practices and clinics, on the basis of an order form, and may be used only by them. The new paragraph (3) makes an exception from both rules: in exceptional epidemiological situations, the sanitary veterinary and food safety directorates, the authority’s county institutions, may themselves buy and use vaccines unauthorised in the Union, for programmes of active immunisation of animals.

The second effect changes the economics of a campaign. Article 251 paragraph (8) of the norm provides that a temporary distribution authorisation is issued for a single product and is valid for 2 years from the date of issue. The new paragraph (5) of Article 252 expressly derogates from that paragraph, in two ways at once. On the one hand, authorisations may be issued at the request of several distributors for vaccines with the same therapeutic indication, which means that the state no longer depends on a single supplier for a campaign. On the other hand, the period of validity is now set differently, „determined by the approved vaccination programmes”, so it may be both shorter and longer than those 2 years.

The third effect is a financial one, though limited. For an ordinary application, Article 251 paragraph (4)(d) requires the file to include proof that the fee has been paid into the account of the Institute for the Control of Biological Products and Veterinary Medicines, the reference institute subordinated to the authority. The new paragraph (6) of Article 252 lifts that requirement for vaccines unauthorised in the Union that are donated by the European Commission. Purchased vaccines remain outside the exemption, even when they are used in the same campaign.

The fourth effect is an obligation of the state towards the European Commission. When it issues authorisations in the exceptional situation under paragraph (3), the authority must inform the Commission without delay, under Article 110(4) of Regulation (EU) 2019/6. Neither the farmers nor the distributors pick up any extra formality from it, but the obligation explains why the exceptional procedure cannot be kept quiet.

The fifth effect works the other way round, against the applicant. The new paragraph (31) of Article 251 adds grounds for rejection for vaccines and serums, called in the language of the law immunological veterinary medicinal products. The grounds are the three conditions in Article 110(1) of the regulation: administering the product would interfere with a national programme for the diagnosis, control or eradication of a disease; it would make it harder to certify that live animals are free of disease, or it could contaminate food obtained from the treated animals; or the strains of the pathogens targeted are largely absent from the territory concerned. A distributor with a complete file may now be refused on any of these three grounds, hence for circumstances that have nothing to do with the documents filed.

What has changed compared with the previous situation

The chapter that contains the two articles touched by the order was inserted into the norm by Order of the President of the authority no. 101/2023, published in the Official Gazette of Romania, Part I, no. 752 of 18 August 2023, at point 11 of Article I. It lasted 1,155 days without a single amendment. Order no. 968/2026 is its first revision.

At Article 251 paragraph (3), the change is a matter of a few words and of an entire logic. The old text described a single way out: the authority assesses the documentation submitted by the applicant and issues the authorisation. The new text describes two: it assesses and „issues the temporary distribution authorisation for veterinary medicinal products or rejects the application for it”. The power to refuse was not, in reality, absent before, because an application that did not meet the conditions could not be approved, and paragraph (9) already allowed an authorisation once issued to be suspended and withdrawn. What is new is that refusal becomes a named outcome, therefore one that has to be reasoned and that can be challenged as such.

Still at Article 251, the reference to the deadline stays identical. Both the old and the new text point to the deadline in paragraph (5), that is at most 30 working days from the date on which a complete application is filed. Nothing has changed here, neither for ordinary applications nor for those in the exceptional situation: the new paragraph (5) of Article 252 expressly requires compliance with Article 251 paragraphs (4) and (5), hence with the 30 working days as well.

At Article 252, until 16 October 2026 the article had two paragraphs, both of them restrictive: who buys and who uses. It has grown to six, and the four that were added are all derogations. The proportion says something about the order: two thirds of the article is now exception.

There is one more change that does not show in the Official Gazette of Romania, because it happened between draft and publication. The version put out for public consultation by the authority on 28 September 2026 also had three points, but the third was a different one: it inserted an Article 253 by which the authority „may lay down special provisions” on the purchase, distribution and use of vaccines unauthorised in the Union and on the issuing of authorisations for them. It was a blank enabling clause, with no content and no shape: it could not be read from it which provisions, through which act, with what deadlines. In the published text, Article 253 has vanished, and in its place came the four concrete paragraphs of Article 252. For anyone who has to apply the norm, that is a real improvement: a written rule can be checked, an enabling clause cannot.

Advantages and disadvantages

What it improves

  • The state no longer depends on a single distributor during a vaccination campaign. The derogation from Article 251 paragraph (8) allows authorisations for several distributors, for vaccines with the same therapeutic indication. In an epidemic, that means several supply sources running in parallel.
  • Vaccines donated by the European Commission reach the animals faster. The new paragraph (6) removes from the file the only document that depends on a payment, and a payment from the public budget, with commitment and payment authorisation, can take longer than the assessment itself.
  • The validity of the authorisation now fits the campaign, not the other way round. Tying it to the approved vaccination programmes removes the situation in which a 2-year authorisation covers a three-month campaign, or expires in the middle of a longer one.
  • Refusal becomes a decision rather than a silence. A text that names rejection obliges the authority to pronounce it and to give reasons, which hands the applicant an act that can be challenged before the administrative courts. A file left without an answer is far harder to fight.
  • The blank enabling clause from the draft did not make it into the act. Replacing the Article 253 proposed on 28 September 2026 with four explicit paragraphs leaves the rules in plain sight instead of postponing them to some unnamed future act.

What remains a problem

  • The 30-working-day deadline has not been touched. For an application filed on Monday, 19 October 2026, it expires on 27 November 2026, that is 39 calendar days later. For a disease that spreads in days, a procedural exception is less convincing than the deadline it keeps in place.
  • The trigger for the exception is not defined. The new paragraph (3) starts from „diseases on list A or emerging diseases”, a phrase that appears nowhere else in the norm and that the European regulation does not use.
  • The fee exemption is written in the name of the institution that does not collect it. The fee derogated from is paid into the account of the Institute, yet the text says that the authority charges no fees.
  • The new grounds for rejection are not matched by a remedy procedure of their own. For the temporary distribution authorisation, the norm provides nothing resembling Article 13 paragraph (18), which expressly refers decisions refusing a marketing authorisation to Law no. 554/2004 on administrative litigation.
  • The order says nothing about applications already filed. A distributor who on 16 October 2026 was waiting for an answer within the 30 working days learns from the act that the answer may also be a refusal, on grounds that did not exist when the file was submitted.

Practical advice

  1. If you are a wholesale distributor preparing an application for a temporary distribution authorisation, check first whether the vaccine falls into any of the three situations in Article 110(1) of Regulation (EU) 2019/6. The easiest one to miss is the third, strains absent from the territory: a vaccine that is good for another region of Europe may be refused here precisely because the disease is not circulating.
  2. File a complete dossier the first time round. The 30 working days under Article 251 paragraph (5) run from the date on which a complete application is filed, not from the first piece of paper sent in, and the documents required are four: the package leaflet translated into Romanian, the marketing authorisation for the product, the justification of its use under the derogations, and proof that the fee has been paid into the account of the Institute.
  3. If the vaccine is a donation from the European Commission and is not authorised in the Union, do not attach proof of payment; instead, expressly invoke Article 252 paragraph (6) in the application. Also state what shows that it is a donation, because the exemption attaches to the origin of the product, not to its use in a campaign.
  4. Do not confuse the two routes. For a batch bought for the same campaign, the fee is paid as usual: the exception covers only donated products.
  5. If you are a county sanitary veterinary directorate buying under the new paragraph (3), ask the distributor for a copy of the temporary distribution authorisation and check what period of validity is written on it. From 16 October 2026, in the exceptional situation, the validity follows the approved vaccination programme, not the standard 2-year term.
  6. For every batch brought into Romania, do not forget the notification under Article 251 paragraph (7): quantity, batch number, shelf life, plus a copy of the quality or batch release certificate, the package leaflet and the label in Romanian. Failure to send this information is, under paragraph (9), a ground for suspending or withdrawing the authorisation.
  7. If you receive a refusal, ask for the reasons in writing and note the date on which it was communicated. The time limit for bringing administrative litigation proceedings runs from the communication of the act, and an unreasoned refusal is easier to challenge than a reasoned one.
  8. If you are a veterinarian in private practice and you are offered a vaccine unauthorised in the Union, ask under which authorisation it was brought in and whether this is a campaign run by the county directorate. Outside the exceptional situation under paragraph (3), purchase and use remain reserved to veterinary medical assistance units, on the basis of an order form.
  9. If you are a livestock farmer or a pet owner, ask for the name of the product administered and the batch number to be recorded in the animal’s file. For a product unauthorised in the Union, batch traceability is the only link with the quality certificate filed at authorisation.

Frequently asked questions

From what date does the order apply?
From 16 October 2026, the date of publication in the Official Gazette of Romania, Part I, no. 866. Article II of the order says only that the act is to be published, without laying down a later date, and for the orders of central public administration authorities Article 12 paragraph (3) of Law no. 24/2000 provides that they enter into force on the date of publication, unless the text states otherwise. The rule of 3 days from publication, which many apply by reflex, concerns laws and Government ordinances issued under an enabling law, not orders.
What is a temporary distribution authorisation?
A document by which the sanitary veterinary authority permits, for a limited period, the distribution in Romania of a veterinary medicine that cannot be marketed by the ordinary route, because its use rests on a derogation under Articles 110 to 114 or Article 116 of Regulation (EU) 2019/6. It is issued at the request of a wholesale distributor, for a single product, and its template is in Annex no. 4 to the norm.
What does „immunological veterinary medicinal product” mean?
The category that covers vaccines, serums and other products which act through the animal’s immune system rather than through an ordinary active substance. Everything new in this order concerns only that category, not veterinary medicines in general.
Who may apply for the authorisation after 16 October 2026?
Still only the wholesale distributors of veterinary medicinal products. Article 251 paragraph (2) was not touched by the order. What is new is that, in the exceptional situation, several distributors may obtain authorisations for vaccines with the same therapeutic indication, instead of just one.
May the county directorates buy any vaccine unauthorised in the Union?
No. The exception under the new paragraph (3) applies only in exceptional epidemiological situations linked to the course of diseases on „list A” or of emerging diseases, only for vaccines intended for programmes of active immunisation of animals, and only for products that have obtained a temporary distribution authorisation under Article 251. Outside these conditions, the rule in paragraphs (1) and (2) still holds.
How much does it cost to authorise a vaccine donated by the European Commission?
Under the new paragraph (6), nothing: the authority charges no fees for issuing temporary distribution authorisations for vaccines unauthorised in the Union that are donated by the Commission. The text, however, is drafted as an obligation of the authority, while the usual fee is paid into the account of the Institute, which leaves room for questions about the sums the institute may ask for. Until that is clarified, invoke paragraph (6) expressly in the application.
How long does the new procedure take?
Still at most 30 working days from the filing of a complete application. The new paragraph (5) of Article 252 expressly refers to Article 251 paragraphs (4) and (5), so it keeps both the list of documents and the deadline. For an application filed on the first working day after publication, Monday, 19 October 2026, the deadline expires on 27 November 2026.
Does the order change the rules on ordinary marketing authorisations?
No. The title of the amended norm covers marketing authorisations, clinical trials and pharmacovigilance, but Order no. 968/2026 touches only the chapter on the temporary distribution authorisation. Marketing authorisations, the opinions and the registration certificates issued by the Institute keep the procedure in Chapters II to IV of the norm.
What happens to applications filed before 16 October 2026?
The order lays down no transitional provision. The new grounds for rejection in paragraph (31) concern the substantive conditions of the product, not the form of the application, so they may be invoked for files under assessment on the date of publication as well. Anyone in that position has an interest in sending in, on their own initiative, the arguments showing that none of the three situations in Article 110(1) applies to their product.
Do livestock farmers have to do anything?
Nothing directly. The order creates no obligations for animal keepers. The effect for them is indirect: in an epidemic, the vaccine may arrive faster and through more channels, and in a campaign organised by the county directorate the vaccination may be carried out by the directorate’s staff, not only by the usual veterinary practice.
Where can I read the consolidated version of the norm?
On the legislative portal of the Ministry of Justice, legislatie.just.ro, under the sanitary veterinary norm of 21 April 2022 approved by Order no. 59/2022. The consolidated version includes the amendments of 18 August 2023 and of 16 October 2026, each marked with the act that produced it.

Errors and inconsistencies in the published text

  • Article I point 3, the new paragraph (3) of Article 252. The exception is triggered for „boli din lista A sau emergente”, diseases on list A or emerging diseases, yet which diseases those are cannot be established. The phrase „lista A” appears once in the whole sanitary veterinary norm, precisely in the new text, and it is not defined either in Article 1, which contains the definitions, or in Government Ordinance no. 42/2004, the act under which the order was issued. Regulation (EU) 2019/6, which the norm implements, does not use it at all: Article 110(2), the European basis for this derogation, names its trigger differently, by reference to the diseases provided for in Article 5 and the emerging diseases provided for in Article 6 of Regulation (EU) 2016/429, a regulation that the Romanian norm cites nowhere. The only „list A” with any tradition in sanitary veterinary matters is that of the World Organisation for Animal Health, abolished when lists A and B were merged into a single list with effect from 1 January 2005. Anyone wanting to find out whether the disease in progress triggers the exception, distributor or county directorate, is therefore left with two possible answers and a list that has not existed for more than twenty years.
  • Article I point 3, the new paragraph (6) of Article 252, read together with Article 251 paragraph (4)(d). The exemption from payment is written in the name of the institution that does not collect the money. The text derogates from point (d), that is from the obligation to attach proof that the fee has been paid „în contul Institutului”, into the account of the Institute, but frames the exemption as an obligation of the National Sanitary Veterinary and Food Safety Authority, which „nu percepe taxe”, charges no fees. The Institute for the Control of Biological Products and Veterinary Medicines is, under Article 1(a) of the norm, a separate legal person, subordinated to the authority. Two readings follow, with different financial consequences: either the fee is no longer owed to anyone, or only the document disappears from the file and the institute may still demand payment. For a donated vaccine, that difference decides whether the dossier can be filed free of charge or not.

Editorial analysis

The order solves a real problem, and it solves it in the right direction. The chapter on the temporary distribution authorisation, inserted in August 2023, was written for small cases: one vaccine, one distributor, one veterinary practice, two years of validity. Laid over an epidemic of a serious disease, that pattern jams in three places at once: a single distributor does not cover a national campaign, 2 years of validity bear no relation to the length of a vaccination programme, and the county directorates, which carry out mass vaccination, had the right neither to buy nor to use the product. The four new paragraphs unblock exactly those three places. The comparison with the draft put out for consultation on 28 September 2026 also shows a good choice: there, point 3 was an Article 253 by which the authority reserved itself the right to lay down „special provisions” later, without saying through which act or with what content. The published version gave up the blank enabling clause and wrote the rules into the norm.

What has not changed, however, says more than what has. The whole order deals with exceptional epidemiological situations, yet the deadline remains the one in Article 251 paragraph (5), at most 30 working days from a complete application. For an application filed on Monday, 19 October 2026, that deadline expires on 27 November 2026: 39 calendar days, almost six weeks. African swine fever and highly pathogenic avian influenza spread to new outbreaks in days, not in weeks. Through this order the authority has widened its freedom to refuse, but it has not shortened its own time to reply. In practice the balance is this: the addressee of the norm must have a complete file at the moment of filing, on pain of the deadline not starting to run, while the administration keeps almost six weeks in a situation that it itself describes as exceptional.

The second observation comes from putting the order together with the regulation it implements. The new paragraph (4) of Article 252 obliges the authority to inform the European Commission without delay when it issues authorisations in the exceptional situation, and refers for that purpose to Article 110(4) of Regulation (EU) 2019/6. The trouble is that Article 110(4) requires the Commission to be informed whenever paragraphs (1), (2) or (3) are applied, hence including paragraph (1), the very one from which the order takes its new grounds for rejection. The Romanian norm has taken over the favourable half of the European obligation, the one about authorisations, and left out the half about refusals. The European obligation exists in any case, since the regulation applies directly, but anyone reading only the national norm has no way of learning that every rejection based on paragraph (31) has to be notified to Brussels, together with the conditions imposed.

The third observation is about proportions. Until 16 October 2026, Article 252 had two paragraphs, both of them rules. From 16 October 2026 it has six, four of which are derogations: from paragraphs (1) and (2) of the same article, from Article 251 paragraph (8) and from Article 251 paragraph (4)(d). An article in which the exceptions outnumber the rules two to one is hard to read and even harder to apply, especially by someone opening it for the first time during an epidemic. After 1,155 days without amendment, Chapter VIII1 now has one article of principle and one made up almost entirely of exceptions.

What should be changed

  • Replacing the phrase „diseases on list A” with the exact European reference. The text should say, as Article 110(2) of the regulation does, the diseases provided for in Article 5 and the emerging diseases provided for in Article 6 of Regulation (EU) 2016/429. The practical effect: a county directorate could establish in a few minutes, from a list in force, whether the disease in progress triggers the exception, instead of hunting for a list abolished in 2005.
  • A short deadline of its own for the exceptional situation. If the authority thought it necessary to derogate from three provisions of the norm for epidemics, it should also derogate from the one that matters most, the deadline. A deadline of 5 or 10 working days for applications under paragraph (3) would make the difference between a vaccine that reaches the outbreak and one that arrives after it.
  • The fee, waived in the name of the institute. Reworded as „the Institute does not charge the fee provided for in Article 251 paragraph (4)(d)”, the exemption would close the question of who gives up which sum. In practice, the distributor would file the dossier without first asking for confirmation, and the institute would not have to interpret an exemption granted by someone else.
  • Taking over in full the obligation to inform the European Commission. Paragraph (4) should cover rejections based on the new paragraph (31) as well, not only authorisations. A refused applicant would then know that the decision reaches the Commission too, with its reasons, which is in itself a guarantee of serious reasoning.
  • An express reference to the remedy. Article 13 paragraph (18) of the same norm refers decisions refusing a marketing authorisation to Article 7 paragraph (1) of Law no. 554/2004 on administrative litigation. Since rejection has become a named outcome for the temporary distribution authorisation as well, the same reference should be inserted at Article 251. The practical effect: the distributor learns from the norm what to do within 30 days of being notified of the refusal, without legal advice.
  • A provision on pending applications. A single sentence saying whether the new grounds for rejection apply to files submitted before 16 October 2026 would spare the authority challenges on this point and the applicant a refusal on a ground that did not exist at the time of filing.

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. 866 of 16 October 2026, page 2 16 pages PDF, 122 KB the act starts on page 2

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