to the point: Healthcare & Life Sciences Q1/2026

Event Review

Sarah Rosenthaler

Schoenherr's Healthcare & Life Sciences team has been active across Europe with two recent events focused on the sector's evolving regulatory and investment landscape.

In Sofia, Hristo Hadzhiiliev, Elena Todorova and Gergana Roussinova-Ivanova led the We Love Pharma event on 12 February 2026, addressing the EU Pharma Package – the most significant overhaul of medicines legislation in over 20 years – with a focus on its implications for market entry dynamics, reimbursement, shortage obligations and M&A in the generics and biosimilars space.

In Vienna, Sarah Rosenthaler and Niklas Kerschbaumer co-hosted an exclusive Masterclass and Investors' Lounge with invest.austria on 10 March 2026, bringing together legal experts, investors and innovators to discuss the regulatory classification of lifestyle products, M&A trends, as well as start-up scaling and Buy & Build strategies in the HCLS sector.

Both events underline Schoenherr's commitment to providing practical, cross-border guidance at the intersection of regulation, transactions and life sciences.

Rankings

March has been full of good news for Schoenherr’s Healthcare & Life Sciences practice - the 2026 Chambers Europe rankings honoured the Austrian team with a Band 1 practice ranking, accompanied by a Band 1 personal ranking for Partner Andreas Natterer.

Soon after, the 2026 Legal 500 rankings were released, featuring a Tier 2 ranking of our Bulgarian Healthcare & Life Sciences team. Congratulations to all!

2026 Legal Bites: EU regulatory landscape in transition

Elena Todorova, Alexandra Minioti

A practical overview of several EU legal amendments and interpretations that will have effect or begin to apply in 2026:

• BPA restrictions (Regulation 2026/250):

Single-use final food-contact articles manufactured with BPA that do not comply with the new rules may continue to be placed on the market for the first time until 20 July 2026. Certain categories, such as preservation packaging for fruits, vegetables and fishery products, or articles with BPA coatings applied only to the exterior, will benefit from an extended deadline of 20 January 2028. Multi-use articles first placed on the market by 20 July 2026 may remain available until 20 July 2027.

• Food additives (Regulation 2026/196):

Updated specifications for hydrocolloids (E 410, E 412, E 414, E 415, E 440 and E 1450) apply from 18 August 2026. Sell-through provisions, including for infant formulae and foods for special medical purposes intended for infants, permit continued marketing of goods lawfully placed on the market before that date until the expiry of their minimum durability or use-by date.

• Pesticide MRLs (Regulations 2026/140 and 2026/147):

These regulations introduce updated maximum residue levels for several active sub-stances, with a key transition date of 12 August 2026. Adjusted official sampling frequen-cies for contaminant controls under Implementing Regulation 2025/2246 have been ap-plied since 1 January 2026.

• Feed additive 6-phytase (Implementing Regulation 2026/91):

The transitional measures apply to existing stocks produced and labelled before 4 August 2026.

• Medical Devices (Implementing Decision 2026/193):

Updated standards under the Medical Device Regulation entered into effect on 30 January 2026, addressing biocompatibility testing, sterilisation validation and clinical investigation requirements.

• Biocidal products (CJEU Case C-473/24):
  
  A product may qualify as a "biocidal product" even where its biocidal function is only secondary. The EU Biocides Regulation applies exclusively to products falling within a listed product type and product-type 4 does not apply to products used to disinfect food itself. Accordingly, vinegar-based "multi-purpose" sprays marketed for food disinfection fall outside the scope of the Biocides Regulation.

EU Pharma Package: on the home straight

Sarah Rosenthaler

The most significant overhaul of EU pharmaceutical law in over two decades is entering its final legislative stretch. Following agreement at EU Council level on the December 2025 trilogue outcome, the final texts of the new Directive and Regulation on medicinal products for human use are now officially available (see here). The European Parliament's SANT Committee voted on both texts on 18 March 2026, with formal adoption, publication in the Official Journal and entry into force, subject to transition periods, to follow.

Looking ahead to implementation, the European Medicines Agency (EMA) has launched a dedicated webpage to support stakeholders through the transition (see here). Organised around six core areas, including the centralised authorisation procedure, development support, environmental risks, quality and manufacturing, medicine shortages, and regulatory and legal aspects, the site will grow into a comprehensive guidance resource as the legislative process concludes. EMA anticipates transition periods running until 2028, making early preparation advisable for manufacturers, regulators and practitioners operating under the current framework.

Labelling for vegetarian meat substitutes remains permitted in EU

Sarah Sayahpour

After lengthy discussions, "veggie burgers", "seitan schnitzel" or "soy sausage" may continue to be labelled as such.

Bans are only intended to apply to specific terms such as "beef (rump)", "pork", "chicken leg/nuggets" or "bacon", which may not be used for vegetarian or vegan substitute products.

The European Parliament and the Council of the 27 Member States must still give final ap-proval to the package. The decision is expected to apply until the end of 2027.

Further discussions are anticipated next year.

Personal data safeguards and cybersecurity incident reporting in proposed amendments to EU Medical Devices Regulation

Marin Demirev

In December 2025, the European Commission published a landmark legislative proposal to update the rules governing medical devices across the EU. The proposal reinforces the principle that privacy and digital security now form the foundation of how medical devices will be regulated in the EU.

While much of the discussion has focused on safety standards and market access, the proposal contains important measures concerning the handling of personal data and the obligations imposed on manufacturers when digital security is compromised.

Personal data in Eudamed subject to strict safeguards

The proposal clarifies that the central EU database for medical devices (Eudamed) may only store personal data to the extent strictly necessary for the electronic systems to collate and process information in accordance with the Medical Devices Regulation. Such data must not be retained longer than is necessary, and the European Commission serves as the formal data controller responsible for the operation of Eudamed. The rules further confirm that data processed in the context of clinical investigations, including the secondary use of personal data initially collected for other investigations, is to be treated as processing for scientific research purposes within the meaning of Article 9(2)(j) of the GDPR.

Proposed requirement to report cybersecurity incidents

One of the most significant proposed requirements is the obligation on manufacturers of connected medical devices, such as smartwatches, glucose monitors and connected diagnostic tools, to report all actively exploited vulnerabilities, as defined in Article 3(42) of Regulation (EU) 2024/2847, and any severe incident, as referred to in Article 14(5) of Regulation (EU) 2024/2847, having an impact on the security of the device. Such reports must be submitted to the computer security incident response teams (CSIRTs) designated as coordinators of the Member States where the device has been made available, and to the EU's cybersecurity agency, ENISA, within 30 days of discovery, through Eudamed. This closes a gap in the existing rules, under which such incidents went unreported if they did not qualify as "serious incidents" within the meaning of the Medical Devices Regulation (i.e. cybersecurity-related incidents that do not concern public health or patient safety).

What this means in practice

Manufacturers of medical devices that connect to the internet or transmit data will be legally required under the Medical Devices Regulation to notify the relevant authorities through Eudamed if a device has been hacked or compromised not only in cases constituting "serious incidents" within the meaning of the Medical Devices Regulation but also in cases of cybersecurity-related incidents that do not directly concern public health or patient safety. This proposed requirement aims to ensure faster responses, better oversight and, ultimately, stronger protection for the data of patients and users.

Telemedicine across borders

Elena Todorova

In its ruling under Case C-115/24, the Court of Justice clarified what constitutes "telemedi-cine" under European Union law and how cross-border rules apply when healthcare is deliv-ered remotely. In short, telemedicine means healthcare delivered entirely at a distance, with no face-to-face contact between patient and provider. If any step in the treatment pathway takes place in person, that particular step falls outside the telemedicine framework.

The essence of the judgment

• For telemedicine, the "Member State of Treatment" is the country where the healthcare provider is based. By contrast, any in-person communication is governed by the country where it physically takes place.
• Telemedicine can also qualify as an "information society service", which means the EU's e-commerce rules apply as well.
• The EU rules on recognising professional qualifications do not apply to remote-only care, because they assume the professional is physically present in the host country.

What does this mean in practice for providers and platforms?

For fully remote services, providers must comply with the quality, safety and professional conduct rules of the country in which they are based. The patient's home country generally does not impose a second layer of licensing for those remote services, unless EU law permits specific, narrowly defined restrictions. This opens a clear path for telemedicine platforms to serve patients EU-wide from a single base.

Practical takeaways for this service model

• Clinical pathways must be designed as "purely remote" wherever possible, so that the entire service can rely on a single country-of-origin rule.
• Where physical examinations, sampling or procedures are unavoidable, these will count as local care in the country where they occur and must meet that country's regulatory requirements.
• Bulgarian-based clinicians offering cross-border care must confirm their right to practice remotely and maintain full professional membership, registration and e-prescribing ca-pabilities under Bulgarian rules.

Austria's Supreme Court clarifies cross-border digital health services

Sarah Rosenthaler

Building on the CJEU's ruling of September 2025 (C-115/24), Austria's Supreme Court has de-livered concrete guidance on hybrid telemedicine models.

The case concerned an Austrian dentist cooperating with a German dental company offering clear aligner treatment. The Austrian Dental Chamber sought to prohibit this cooperation as an unlawful encroachment on Austria's dental professional monopoly. The Austrian Supreme Court dismissed the claim on three grounds:

1. Treatment components must be assessed separately. App-based remote monitor-ing by the German provider qualifies as telemedicine, governed exclusively by Ger-man law. Physical services performed by the Austrian dentist remain subject to Aus-trian law, but only the Austrian dentist, not the German company, qualifies as the relevant "healthcare provider" for those services under the Patient Mobility Di-rective.
2. Contract structure is irrelevant. What matters is who actually and lawfully performs the service, not who holds the patient contract. This significantly limits the reach of national professional rules over foreign digital health platforms.
3. No unlawful conduct. Because the dentist's legal interpretation was reasonably de-fensible, she could not be held liable under Austrian unfair competition law.

Takeaway: The key question for cross-border digital health services is no longer contractual, but factual: who actually delivers the service on the ground?

Austrian Parliament passes Anti-Deceptive Packaging Law

Sarah Sayahpour

The law is intended to combat "shrinkflation". Starting from April 2026, retailers will be re-quired to explicitly indicate when a product contains less content while the packaging size remains the same. The labelling must be displayed for a period of 60 days. The law is initial-ly set to expire in mid-2030.

Life Sciences M&A: The patent cliff creates opportunity

Niklas Kerschbaumer

The global life sciences M&A market is accelerating rapidly. The main driver is the so-called "patent cliff" – the sharp revenue drop pharma companies face when blockbuster drugs lose exclusivity and cheaper generics flood the market. Patent expirations are projected to erode nearly USD 300bln in global biopharma revenue by 2028. With internal R&D pipelines rarely sufficient to fill the resulting gap, M&A has become the preferred lever: acquiring innovative biotech companies or early-stage assets allows Big Pharma to rapidly access new compounds and therapeutic platforms that would otherwise take years to develop in-house.

According to a recent McKinsey report, total deal value in life sciences reached USD 372bln in 2025 – up 47 % year-over-year – with average deal size growing by nearly 63 %, reflecting a clear shift toward fewer but higher-impact transactions. With more than half of top pharma deals in 2024 already targeting Phase I or earlier-stage assets, the pool of differentiated late-stage targets is shrinking fast.

McKinsey notes that EMEA accounted for 17 % (USD 62bln) of global life sciences deal value in 2025, and the region's role as a source of innovation is growing. This trend is also reaching CEE, exemplified by the landmark transaction in which US private equity firm GTCR acquired the Czech pharmaceutical group Zentiva for EUR 4.1bln.

For European and CEE-based life sciences companies, this dynamic creates a concrete opportunity: differentiated assets – whether early-stage biotech, platform technologies or niche therapeutics – are exactly what Big Pharma is hunting for.

For more detail, see McKinsey's Life Sciences Dealmaking report and CNBC's coverage of the patent cliff.

Bulgarian Cybersecurity Act

Hristo Hadzhiiliev

The amendments to the Bulgarian Cybersecurity Act (Закон за киберсигурност), which entered into force in February 2026, bring the national framework into alignment with the EU's NIS 2 Directive. These amendments mark a significant expansion of the regulatory scope for cybersecurity obligations in Bulgaria.

One sector visibly affected by this broadened scope is healthcare.  Under the previous iteration of the Cybersecurity Act there was limited effect on the sector. It was listed in Appendix I and the entities falling within it were limited to healthcare establishments, including hospitals and private clinics, defined by reference to providers of healthcare within the meaning of Article 3(g) of Directive 2011/24/EU, alongside Article 21(1), (2) and (3) of the Bulgarian Health Act and several provisions of the Medical Establishments Act. This meant that, in practice, only entities directly delivering health services - and meeting the criteria for an operator of essential services - were subject to cybersecurity obligations. Additionally, the old Cybersecurity Act had limited practical application.

The amended Act reshapes this scope. Healthcare remains listed in Appendix I as one of the critical sectors, but it now covers considerably more types of entities. First, the category of healthcare providers as defined by Directive 2011/24/EU is retained. Beyond that, however, the new Appendix I now expressly includes EU reference laboratories within the meaning of Article 15 of Regulation (EU) 2022/2371. It further encompasses entities carrying out re-search and development of medicinal products as defined in Article 1(2) of Directive 2001/83/EC. Additionally, the effect on the pharmaceutical sector is evident in the inclusion of entities manufacturing basic pharmaceutical substances and preparations, as classified under Section C, Division 21 of NACE Rev. 2.1 from Delegated Regulation (EU) 2023/137. Finally, Appendix I covers entities manufacturing medical devices deemed critical during public health emergencies, as referred to in Article 22 of Regulation (EU) 2022/123. Separately, Appendix II - which covers other critical sectors – including the manufacture of medical de-vices and in-vitro diagnostic medical devices as a standalone manufacturing subsector, bringing general medical device manufacturers into the regulatory net as potentially obligated entities.

The entities now covered by the amended Cybersecurity Act have a wide range of practical aspects to consider. Under the amended Act, entities listed in Appendix I and II that exceed the threshold for medium-sized enterprises are classified as essential entities, while those meeting the criteria for medium-sized enterprises are also captured and may qualify as important entities. Both essential and important entities are subject to comprehensive obligations. Their governing bodies must approve cybersecurity risk management measures and undergo training themselves and must organise training for their staff. The entities them-selves must implement a broad suite of risk management measures, including policies on risk analysis and information system security, incident handling procedures, business continuity and crisis management, supply chain security, vulnerability management and human resources security with access control. Essential and important entities are further required to report significant cyber incidents to the relevant Sectoral Computer Security Incident Response Team (CSIRT), with an early warning due within 24 hours, an incident notification within 72 hours and a final report within one month of resolution.

Failure to comply with risk management obligations may result in sanctions of up to EUR 10m or 2 % of global annual turnover for essential entities and up to EUR 7m or 1.4 % of global annual turnover for important entities, with minimum thresholds of EUR 25,000 and EUR 12,500, respectively. Members of the governing bodies of non-compliant entities face individual fines ranging from EUR 500 to EUR 5,000. A transitional concession does apply: sanctions for violations committed before 1 June 2026 are reduced by 50 %. Additionally, secondary legislation based on the new Cybersecurity Act will be implemented within eight months of the new Act's entry into force. This is expected to clarify the obligations and requirements for essential and important entities, as well as the processes of communication.

New honey labelling rules: what changes in June 2026?

Alexandra Minioti

The European Union produces around 280,000 tons of honey each year, yet about 40 % of the product consumed in Europe is imported, mainly from Ukraine and China. This heavy reliance on imports has raised questions about transparency and quality.

Since 2022, geopolitical tensions and rising transport costs have disrupted global supply chains, pushing the EU toward shorter, more regional sourcing. At the same time, consumers have become increasingly interested in knowing where their honey comes from. Many Member States had already called for stricter origin disclosure on honey blends as early as 2021. These pressures created the momentum for new EU-wide labelling rules.

Centralised public procurement of medicinal products for healthcare providers: new powers under the Public Health Insurance Act

Monika Voldánová

Since 1 January 2026, Section 40d of Act No. 48/1997 Coll., on Public Health Insurance, has introduced a new mechanism allowing health insurance companies to centralise public procurement of certain medicinal products for healthcare providers.

Health insurance companies may now centralise public procurement for supplies of medicinal products intended for providers that have been granted the status of a centre of highly specialised healthcare. The measure is therefore targeted at tertiary level facilities dealing with complex, often oncological or rare disease treatments, rather than routine outpatient care.

A covered "medicinal product" is:

1. a drug that is to be invoiced to the insurer together with a corresponding healthcare ser-vice; or
2. a drug that can only be used in inpatient (hospital) care.

This means that the new centralised procurement applies only to products without generic competitors on the market, i.e. largely originator or niche products where price competition at the level of substitutes is absent.

From a policy perspective, the amendment can be seen as an attempt to insert health insurers into the procurement chain for high budget, often monopoly type medicines, using competitive tendering to influence price levels without directly regulating prices administratively. However, limiting the amendment to drugs without generic competition raises questions about its real impact. In the absence of therapeutic substitutes, the scope for meaningful price competition is narrow, and the mechanism may primarily shift procurement decisions from hospitals to insurers rather than significantly reducing costs.

The food ombudsman: a new institutional actor in the Czech food supply chain

Monika Voldánová

In February 2026, the Czech Ministry of Agriculture established the position of a food ombudsman, conceived as a mediation body within the food supply chain linking farmers, manufacturers, retailers and consumers. The role is primarily intended to strengthen dialogue, increase transparency and provide a central point of contact for concerns regarding unfair practices, contractual terms and pricing conduct, rather than to serve as a fully fledged enforcement authority.

The ombudsman acts as a filter for complaints and suggestions, analyses potential abuses (such as disproportionately wide price margins or unbalanced commercial relationships) and channels its findings to relevant authorities. In legal terms, the institution supplements existing agricultural, food, consumer and competition law without creating a fundamentally new regulatory or sanctioning power structure.

However, the measure has also faced criticism. The main concern, repeatedly voiced in the media and professional discussions, is that establishing the ombudsman as a public official may lead to intervention in private-law relationships or exert pressure on companies' pricing policies, potentially undermining the principle of contractual freedom and the autonomy of market actors.

What the new government has in store for the healthcare and life sciences sector: key legal developments

Kateřina Lehečková

The new government that emerged from the autumn 2025 elections has presented its healthcare policy priorities. For clients in the HCLS sector, we provide an overview of the anticipated legislative changes and regulatory developments that may require legal and compliance adjustments.

Drug reimbursement reform

A comprehensive amendment to Act No. 48/1997 Coll., on Public Health Insurance, is antici-pated, targeting the pricing and reimbursement procedures for medicinal products. The proposed changes aim to streamline administrative proceedings before the State Institute for Drug Control (SÚKL) and introduce new criteria for health technology assessment (HTA). For marketing authorisation holders, this may require revisions to regulatory submissions, updates to pricing dossiers, and potentially the renegotiation of existing reimbursement agreements with health insurance funds.

Support for clinical research

The government has declared its interest in making the Czech Republic a more attractive destination for clinical trials. Expected amendments to the implementing regulations under Act No. 378/2007 Coll., on Pharmaceuticals, aim to align national procedures with the EU Clinical Trials Regulation (EU) 2014/536. Sponsors should anticipate changes to ethics com-mittee procedures, informed consent requirements and contractual frameworks with trial sites.

Digitalisation and eHealth

New legislation implementing the European Health Data Space Regulation (EU) 2025/327 is expected. Healthcare providers will face new legal obligations regarding patient data porta-bility, consent management and data security standards. Software developers must ensure compliance with the Medical Devices Regulation (EU) 2017/745 for health IT products and prepare for upcoming AI Act requirements applicable to high-risk AI systems in healthcare. Contracts with IT vendors should be reviewed to address liability allocation and regulatory compliance responsibilities.

"No added sugar" – purpose matters, not just composition

Kacper Gabryjańczyk

A recent judgment of the Voivodeship Administrative Court in Poznań of 16 January 2026 (I SA/Po 87/26) provides useful guidance on the interpretation of the "no added sugar" claim under EU food law. The ruling confirms that the mere presence of an ingredient that naturally contains sugars does not, in itself, prevent a product from bearing such a claim.

The case concerned a still fruit-flavoured drink containing 32 % apple juice from concen-trate. The market surveillance authority took the view that, because apple juice naturally contains sugars, its inclusion in the recipe was incompatible with the use of a "no added sug-ar" claim. On that basis, it issued post-inspection recommendations requiring the claim to be removed. The food business operator challenged those recommendations.

The court ruled in favour of the food business operator. Referring to Article 3(2)(e) of Regu-lation (EC) No 1333/2008, it held that the decisive question is not whether an added ingredi-ent contains naturally occurring sugars, but whether that ingredient was added for its sweetening properties. The assessment must therefore be functional rather than purely compositional: an ingredient such as fruit juice may be added for flavour, colour, aroma or other technological purposes, and not necessarily to sweeten the product.

Importantly, the court found that the market surveillance authority had produced no evi-dence that the apple juice from concentrate had been used as a sweetener. The inspection report did not address that question at all. Instead, the authority appears to have assumed that the addition of any sugar-containing ingredient automatically rendered the claim un-lawful. The court rejected that approach as arbitrary and legally insufficient.

For food business operators, the judgment serves as a practical reminder that the legality of a "no added sugar" claim depends on the purpose for which the ingredient is used in the fi-nal product, rather than simply on the fact that the ingredient naturally contains sugars.

Digital access to cosmetics information: what the new draft law means in practice

Oana Grecu, Ionut Sava

A shift in how product information reaches consumers

The Romanian Parliament is advancing legislation that would allow cosmetics manufacturers and responsible persons to deliver certain product information to consumers through digital means rather than exclusively through physical labelling. The draft law, which amends Law No. 296/2004 (the Consumer Code), is moving through the legislative process.

What can and what cannot go digital

The draft draws a clear line between information that may be digitised and information that must remain on the physical label.

Permitted for digital delivery via QR code:

• Usage precautions
• Product function/purpose
• Ingredient list

Must remain on the physical container or packaging: All other items under Article 19(1) of Regulation (CE) No. 1223/2009, including the product name, nominal content, nominal dura-bility date and the responsible person's details.

Obligations tied to the digital channel

Where a QR code is used, the linked webpage must be maintained in Romanian throughout the product's marketing period and for a minimum of 12 months after the last batch unit is placed on the market. In the event of technical unavailability, the responsible person must make the relevant information accessible through alternative channels, such as their main website or customer service.

Why this reform makes sense

This initiative directly responds to the well-documented practical shortcomings of the cur-rent physical labelling regime. Under the existing framework, all mandatory information must appear in Romanian on the physical label. Importers are therefore required to manual-ly apply additional stickers to their products, creating higher costs, operational risks and vis-ually overloaded packaging that is often difficult to read, especially on small containers. Ad-ditionally, the reform may assist economic operators in more effectively meeting the strict requirements imposed by the National Authority for Consumer Protection (ANPC) regarding the provision of labelling in Romanian and extensive information, as the digital format offers a more reliable and verifiable means of ensuring compliance with the requirements.

By introducing electronic means of communication, consumers gain access to clear, techno-logically adapted and permanently up-to-date information, while economic operators can reduce administrative costs without diminishing consumer protection. The removal of sup-plementary physical labels also reduces material consumption and supports EU objectives regarding the circular economy and sustainable packaging.

The reform brings Romania closer to the EU's broader digitalisation and sustainability objec-tives. Far from reducing transparency, this initiative modernises how information reaches consumers, making it more accessible, more legible and easier to keep current.

Serbia adopts Official Controls Law

Marija Vranic

The Official Controls Law was adopted in Serbia in December 2025 and will be applicable as of 1 June 2026. It establishes the organisation of official controls and other official activities at all stages of the production, processing and distribution of animals and relevant goods.

"Farm to fork" supervision

The Law introduces a system of comprehensive controls to verify compliance with regula-tions governing a range of areas, including:

• food and food safety at all stages of production, processing and distribution;
• animal health and welfare;
• organic production and labelling of organic products.

Unannounced controls

The Law provides that official controls shall be carried out without prior notice, except where advance notice is necessary and justified for the purpose of conducting the control.

Where an operator requests an official control, the competent ministry may decide whether to conduct the official control with or without prior notice. Announced official controls do not preclude unannounced controls.

Import controls

• Common Health Entry Document ("CHED") – For each consignment imported into Serbia or in transit, comprising animals, products of animal origin, plants and other prescribed categories, the operator responsible for the consignment is required to provide a CHED.
• Import restrictions – The customs authority may not permit the release for free cir-culation of a consignment where a finalised CHED confirming that the consignment is safe has not been submitted.
• Border control posts – Official controls of animals and goods shall be carried out at border control posts that meet stringent technical requirements.

Rationale for adoption

The Law has been aligned with a range of EU acts, primarily Regulation (EU) 2017/625 on of-ficial controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products.

Serbia increases excise duties on cigarettes, tobacco and e-cigarettes refill liquids through 2030

Marija Vranic

Amendments to the Serbian Excise Tax Law entered into force on 12 December 2025 and have been applicable since 1 January 2026. The amendments provide for a gradual increase in excise duties on certain product categories over the next five years.

Heated tobacco and herbal products

The excise duty on heated tobacco and herbal products for smoking/heating, as well as water pipe products (shisha flavourings), will be levied per kilogram of the mixture at the rate of 110 % of the minimum excise duty on 1,000 cigarettes in 2026, increasing to 150 % by 2030 (annual increase of 10 %).

E-cigarette liquids

The excise duty on e-cigarette refill liquids will increase from RSD 13.12/ml in 2026 to RSD 17.12/ml by 2030, with an annual increase of RSD 1/ml.

Cigarettes

The excise duty on cigarettes will increase semi-annually, commencing at RSD 106.90/pack in the first half of 2026 and reaching RSD 120.40/pack as of 1 July 2030. The increase amounts to RSD 1.50 every six months.

Additional provisions

The first subsequent adjustment of the dinar-denominated excise duty on cigarettes will take effect from January 2027, following the end of the calendar year in which the consumer price index exceeds 2 %.

The first subsequent adjustment of the dinar-denominated excise duty on e-cigarette refill liquids will take effect from January 2027, based on the consumer price index for 2026.

Rationale of the amendments

The amendments have been adopted to align with Directives 2011/64/EU and 2014/40/EU. Their objective is to ensure the stability of budgetary revenues while accounting for the decline in the tobacco products market and the shift of cigarette consumers to alternative products, particularly heated tobacco.

Serbia's new Organic Production Law

Marija Vranic

A new Organic Production Law was passed in Serbia in December 2025, applicable as of 1 June 2026.

The Law aligns with Regulation (EU) 2018/848 on organic production and labelling of organic products, as well as the accompanying regulations adopted thereunder.

Given that the previous law was based on Regulation (EC) 834/2007, it was necessary to align the national legislation in this area with the EU acquis, with a view to its further development.

Register of Organic Operators

Prior to placing products on the market as organic or as products from the conversion period, operators must notify the Ministry of Agriculture of their activities for the purpose of registration in the Register of Organic Operators – a new public register maintained in electronic form. Additionally, producers must enter into an agreement with a selected control body that verifies the compliance of their production and activities with the Law.

New control system

For the first time, the control system in organic production is based on official controls in accordance with the law governing official controls, entailing supervision of the activities of authorised control bodies and operators.

Group production

A processor may no longer act as the organiser of production or as the certificate holder for a group. Producers must organise themselves by establishing a legal entity and becoming the certificate holder. Furthermore, new rules have been introduced regarding who may form part of group production.

Introduction of the common catalogue of irregularities

Previously, each control body maintained its own catalogue, which resulted in different corrective measures possibly being prescribed for the same irregularity.

Control bodies now apply a common catalogue of measures for cases of suspected non-compliance and established non-compliance, as prescribed by the Ministry of Agriculture.