to the point: Healthcare & Life Sciences Q4/2025

EUDAMED – the EU's central database for medical devices and IVDs under the MDR and IVDR – has so far been only partially functional and, therefore, voluntary at the EU level. This is about to change. With Commission Decision (EU) 2025/2371, published on 27 November 2025, the European Commission confirmed that four core modules meet the required MDR specifications. This triggers a six-month transition period, making their use mandatory from 28 May 2026.

Which modules are now confirmed?

• Actor Registration
• UDI / Device Registration
• Notified Bodies & Certificates
• Market Surveillance (for authorities)

What does this mean for manufacturers?

• UDI/Device registration becomes compulsory on 28 May 2026.
• Legacy product series placed on the market before that date must be registered by 27 November 2026 to remain available.
• New product series introduced after 28 May 2026 must be registered before first placement on the market.

Modules for Clinical Investigations & Performance Studies and Vigilance & Post-Market Surveillance are still pending validation. Until confirmed, their use remains optional, and national systems must continue to be used where applicable.

With these developments, the "construction site" EUDAMED enters a decisive phase. Now is the time for manufacturers, system and procedure pack producers, importers and notified bodies to align processes and ensure readiness for the 2026 deadlines.

On 10 December 2025, the EU reached a landmark agreement on the most comprehensive pharmaceutical reform in more than 20 years.

The new Pharma Package seeks to accelerate patient access to safe, affordable medicines while reinforcing incentives for innovation, particularly in antibiotics, paediatrics and rare diseases. Key elements include updated reward mechanisms for companies, such as data or market protection periods, enhanced measures to mitigate supply shortages and clearer environmental compliance obligations.

Together, these elements aim to strengthen Europe's pharmaceutical competitiveness, resilience and long-term sustainability.

The new framework will enter into force once the provisional agreement has been formally approved by the Council and the European Parliament and published in the EU Official Journal. With the legislative process still ongoing, close monitoring is essential.

Nevertheless, companies should already assess potential impacts on their pipelines, exclusivity strategies and supply-chain obligations to ensure timely alignment with the forthcoming regulatory environment.

The increasing popularity of non-alcoholic beverages has recently led to the emergence of non-alcoholic alternatives to spirits, which often seek to use the typical designations of traditional spirits. Unlike beer or wine, however, Regulation (EU) 2019/787 provides strict designation protection for spirits. According to Article 10(7) of the Regulation, the use of the legal names referred to in para. 2 of this Article in the description, presentation or labelling of any beverage that does not comply with the requirements of the relevant category set out in Annex I will be prohibited. This prohibition will also apply where such legal names or geographical indications are used in conjunction with words or phrases such as "like", "type", "style", "made", "flavour" or any similar terms.

Moreover, an allusion to the legal names provided for in one or more categories of spirit drinks set out in Annex I will be authorised only on the condition that the alcohol used in producing the foodstuff originates exclusively from the spirit drink or drinks referenced in the allusion. It was therefore only a matter of time before the ECJ had to address the question of admissibility. The case concerned a beverage called "non-alcoholic Virgin Gin".

The CJEU clarified that the above provisions prohibit the use of the name "non-alcoholic gin" in the presentation and labelling of a non-alcoholic beverage on the grounds that it does not comply with the requirements set out in point 20(a) and (b) of Annex I to that regulation for the category of spirit drinks corresponding to the legal name "gin" (Judgment 13 November 2025, C-563/24).

The result is not surprising. First, by prohibiting allusions, the legislator has partially adopted the strict rules governing the protection of geographical indications of origin into the regulation of spirit designations. The European Commission has also clearly advocated for a ban on using designations reserved for spirits in connection with non-alcoholic alternatives (OJ 2022/C 78703, No 3.3). Consequently, it was not difficult to predict this outcome some years ago (see Natterer, Lebensmittelrecht², mn 4.277).

Dealroom's European Spinouts Report 2025 highlights how university spinouts are shaping Europe's innovation economy. Access the full report here.

Life sciences at the forefront

Academic spinouts are central to healthcare innovation. Life sciences spinouts (particularly biotech and pharma) now represent USD 263bln in combined enterprise value, more than doubling since 2019. Over 4,100 VC-backed spinouts have raised USD 32bln since 2020, including USD 4bln in 2025 alone. Spinouts account for 40 % of all new deep tech and life sciences start-ups since 2019, an 80 % increase compared to the previous decade.

Which universities are leading

Oxford and Cambridge lead Europe, followed by ETH Zurich, EPFL Lausanne and TU Munich. Switzerland ranks first in value creation per capita, with Denmark and Sweden close behind. In Schoenherr jurisdictions, activity is growing but remains modest compared to Western Europe's clusters. According to the Austrian Startup Monitor 2024, spinouts from universities and research institutions account for 23 % of all new Austrian start-ups. This corresponds to around 90 academic spinouts founded annually. The Austrian government has set an ambitious goal: to significantly increase this number and double it by 2030.

Funding and exits

2025 is projected to be the second-strongest year for spinout exits, driven by six USD 1bln+ transactions. M&A dominates, while IPOs have disappeared since 2021. Late-stage funding remains a challenge: nearly 50 % of USD 100m+ rounds come from outside Europe, mainly the US.

Spinout deal terms

The European Spinouts Report 2025 calls for more transparency and standardisation in deal terms between universities, founders and investors:

• Equity: University stakes should be capped at 25 % (ideally 10–15 %, fully dilutable). Excessive equity can deter investors and slow growth.
• Exit fees: Universities may charge 1–2 % on exit to capture upside without burdening early-stage capital.
• Royalties: For life sciences IP, 1–2 % royalties are common; higher rates risk making the business model unviable.
• Time-to-spinout: Negotiations should conclude within three months. Delays beyond six months are seen as a red flag for founders and investors.
• Board seats: Mandatory university board representation should be minimised to avoid governance friction.

Why this matters for you

Spinouts are not just IP transactions. They involve governance, funding and exit strategy. Universities, founders and investors need clear, fair agreements to enable growth and global competitiveness.

The European Investment Bank (EIB) has announced an agreement with Angelini Ventures, the venture capital arm of the Italian industrial group Angelini Industries, to strengthen Europe's healthcare innovation ecosystem. The initiative will deploy EUR 150m over six years to finance seven to ten high-potential biotech, medtech and digital health start-ups across Europe.

Key facts at a glance

• Total commitment: EUR 150m
• Focus: Biotech, medical technology and digital health ventures close to market launch
• Timeframe: Six years
• Target: 7–10 start-ups with strong growth potential
• Strategic context: Part of the EIB Group's broader TechEU initiative, aimed at mobilising EUR 250bln in private investment for innovation

Europe's start-up ecosystem faces structural challenges: only 8 % of global scale-ups are based in Europe, and nearly 30 % of European unicorns relocated outside the EU between 2008 and 2021. In 2024, the US recorded 15,000 funding rounds totalling EUR 210bln, Asia had 11,000 rounds worth EUR 70bln, while Europe saw 9,600 rounds with EUR 57bln – a decline of 16 % in deal count and 8 % in value compared to 2023. By contrast, the US grew funding by 29 % in the same period. (Source: EIB press release quoting Venture Capital Report by Growth Capital and Italian Tech Alliance)

The European Commission's Digital Omnibus package, which was unveiled on 19 November 2025, aims to simplify and harmonise key elements of existing digital regulations. It comprises two proposals: a Digital Omnibus on AI and a broader Digital Legislation Omnibus, which collectively target the AI Act, GDPR, Data Act and NIS2, among others.

For the health and Medtech sector, the implications are both practical and material. A central feature of the AI Omnibus is a conditional extension of compliance timelines for high-risk AI systems, including AI embedded in medical devices and in vitro diagnostics. Medtech companies may benefit from staggered application dates linked to the availability of harmonised standards, with a long-stop date until August 2028 for Annex I systems.

Crucially, the proposal confirms that sectoral conformity assessments and quality management systems under MDR/IVDR will take precedence, meaning that the substantive AI Act requirements can be assessed within existing medical device assessment frameworks rather than through a separate, standalone AI Act audit.

On data protection and research, the proposal clarifies that information should not be treated as personal data for an entity that cannot reasonably re-identify an individual, aligning the GDPR's scope more closely with recent CJEU case law. Moreover, the proposal would introduce a more practical definition of "scientific research", such that research conducted for commercial interests remains covered by GDPR research exemptions.

Beyond AI and GDPR, the package also seeks to streamline data legislation by simplifying cybersecurity incident reporting – measures that, if adopted, could reduce compliance complexity across health-related digital operations.

As negotiations proceed through the European Parliament and Council in 2026, Medtech and health-sector stakeholders should closely monitor the legislative process and its evolving compromises.

Europe's healthcare shift in 2026: where to place your bets

Europe enters 2026 turning big ideas such as data sharing, clinical AI, genomics and remote care into everyday infrastructure. The push is driven by clinician shortages, reimbursement fragmentation and fragile supply chains. What will these bring to the healthcare sector?

European Health Data Space moves from concept to use

The European Health Data Space (EHDS) is shifting to local deployment. Member States are building systems for both primary care use and the secondary use of health and research data, alongside governance frameworks. We will expect real pilots and the first operational services for research teams in 2026. National access bodies and secure data environments such as Germany's FDZ, France's Health Data Hub, Finland's Findata and Denmark's Health Data Agency will offer structured routes for researchers and will align with EHDS rules on secondary use of data.

Clinical AI enters the "prove it" phase

For clinical AI, 2026 will be about regulatory implementation, controlled rollouts, lifecycle documentation and systematic post-market monitoring. In parallel, the European Commission plans a targeted legislative initiative to streamline the medical devices and in vitro diagnostics frameworks, aiming to cut administrative burdens and speed responsible adoption.

Genomics and ATMPs

Pan-European genomic infrastructure and reference population projects are advancing, supported by national programmes and focused EU funding for advanced therapy medicinal products (ATMPs). Yet pricing and reimbursement differences across Member States will continue to produce unequal patient access and unpredictable demand signals for the innovators.

IoMT scales into routine care

The Internet of Medical Things is moving from pilots to standard use in hospitals and homes, with Member States formalising legal rules. In 2026, priorities include sustainable financing, device lifecycle management and secure data integration into clinical workflows. The main obstacles are high initial and ongoing (technical) support costs and cybersecurity risks.

In short, Europe is moving from pilot projects to early operations in three converging areas: data reuse via EHDS, clinical AI and genomics/ATMPs, with IoMT enabling patient delivery. These areas, individually or in combination, are set to anchor investment opportunities in 2026.

The EU Council has agreed on its general approach to the Critical Medicines Act ("CMA"), a draft regulation to strengthen the availability and supply security of critical medicinal products, as well as the accessibility of medicinal products of common interest such as antibiotics, insulin and painkillers. The CMA will complement the wider pharmaceutical legislative package.

What can be expected?

Public buyers will be required to apply resilience criteria in tenders for critical medicines. These can include stockholding obligations, diversified suppliers, supply‑chain monitoring and delivery performance. If the Medicines Shortages Steering Group identifies a vulnerability showing high dependency on non‑EU sources, contracting authorities may favour EU‑manufactured products or active substances, in line with international commitments. The Commission must publish practical guidance within six months of entry into force, and Member States must set up national programmes within 12 months to embed these rules.

To introduce cross-jurisdictional collaboration, the Commission can facilitate cross‑border procurement by three or more Member States for medicines of common interest. If at least six Member States jointly request it, the Commission can run procurement on behalf of or in the name of those states for certain critical or common‑interest medicines, with safeguards on volumes and competition.

Member States will have to share information on contingency stock requirements, which must be proportionate, transparent and avoid distortions of the internal market.

Projects that expand or modernise EU manufacturing of critical medicines, active substances and key inputs can be recognised as strategic projects, benefiting from faster permits, administrative and regulatory support (including from EMA), and potential EU and national funding. A new Critical Medicines Coordination Group (CMCG), co‑chaired by the Commission and Member States, will steer priorities, coordinate funding signals and advise on vulnerability assessments.

The Medtech industry underlines that medical devices, diagnostics and digital health solutions remain excluded from the proposed Critical Medicines Act.

What are the next steps?

Parliament will now adopt its position before trilogue negotiations. If agreed, the CMA will phase in procurement obligations after application, with Commission guidance expected within six months.

Austria is overhauling its regulatory framework for tobacco, nicotine and vaping products through two major initiatives that will significantly impact manufacturers, importers and retailers.

Tax and monopoly reform: adopted by the National Council on 10 December 2025

Amendments to the Tobacco Monopoly Act and Tobacco Tax Act will tighten market access and restructure distribution. Key elements include:

• From 1 April 2026 on, e-liquids may be sold only via tobacconists (Trafiken) or licensed specialist e-cigarette shops. Sell-off periods for existing stock vary.
• Likewise, nicotine pouches will fall fully under the tobacco monopoly and be limited to tobacconists. Again, sell-off periods for existing stock vary.
• Smokable hemp (<0.3 % THC) will be restricted to tobacconists, with a transition period for existing hemp shops until the end of 2028.
• Tobacco taxes will rise stepwise from February 2026, and taxation will extend to e-liquids and nicotine pouches from April 2026.

TNRSG amendment: under consultation until 21 January 2026

A separate draft amendment to the Tobacco and Non-Smoker Protection Act (not yet adopted) proposes regulating new nicotine and stimulant products (such as nicotine pouches), banning disposable e-cigarettes, extending ingredient restrictions to all e-liquids, clarifying the mail-order ban and shifting to a notification system for novel products. This aligns with the EU's smoke-free generation 2040 goal.

Business impact

Companies supplying the Austrian market should anticipate higher price levels, tighter market access and distribution channels, and expanded compliance duties, particularly around licensing, labelling and supply-chain planning.

So-called "shrinkflation" – a reduction in product contents while the package size and price remain unchanged – has recently caused quite a stir in many EU countries. Following the introduction of regulations in countries such as Italy and France, Austrian lawmakers have now taken action as well. According to the currently available draft legislation, a new "anti-deceptive packaging law" is to be introduced. The draft indicates that the labelling requirement will apply to retailers and manufacturers must inform retailers of the changed quantities. The law is expected to come into force on 1 April 2026 and expire on 30 June 2030. The draft legislation has already been discussed in the National Council and has been welcomed in principle by all parties, making its eventual passage likely. At the same time, more extensive price labelling is to be introduced through an amendment to the Price Labelling Act.

Whether the Austrian regulations can be aligned with EU requirements on basic price label-ling remains to be clarified. After all, consumers already receive all necessary information from net quantity and basic price labels. For this reason, the once mandatory net quantities for foodstuffs were largely abolished in 2009.

Austria's Constitutional Court clarified in its judgment of 6 October 2025 that the blanket ban on "social egg freezing" is disproportionate and unconstitutional.

The Reproductive Medicine Act (Fortpflanzungsmedizingesetz) regulates the prerequisites for permissibility, procedural rules, and rights and obligations in connection with medically assisted reproduction.

Section 2b(1) of the Reproductive Medicine Act provides that sperm, oocytes and testicular and ovarian tissue may also be retrieved and stored for future medically assisted reproduction if a physical illness, or its treatment in accordance with the state of medical science and experience, creates a serious risk that pregnancy can no longer be achieved through sexual intercourse.

A woman who, according to her submissions, did not currently wish to have children but planned to do so at a later date, applied for the annulment of this prohibition.

The Constitutional Court granted the woman's application and annulled the statutory ban on social egg freezing as disproportionate and therefore unconstitutional. According to the Constitutional Court, the desire to have a child, and thus to use a natural or medically assisted method of reproduction, is part of private life and therefore constitutes a fundamental right under Article 8 of the European Convention on Human Rights.

The annulment enters into force on 1 April 2027. To achieve a constitutionally compliant legal framework, several new regulations will in any event be necessary. Accordingly, the Constitutional Court has ordered that Section 2b(1) of the Reproductive Medicine Act remain in force until 31 March 2027.

Food industry: changes in competencies

A draft law amending the Foodstuff Act would shift responsibility for registering fortified foods (those with added vitamins and minerals) from the Ministry of Health to the Bulgarian Food Safety Agency. The procedure itself remains unchanged; only the competent authority is changing.

The draft also clarifies the retail and storage of certain specialised foods (food supplements, foods for special medical purposes, weight‑control foods, baby and infant foods) in pharmacies and drugstores registered under the Medicinal Products in Human Medicine Act. In practice, this would formalise the role of pharmacies and drugstores in retailing these products.

Pharma industry: calls for a more predictable clawback system

Innovative therapies continue to advocate for the reform of Bulgaria's clawback system. Currently, companies repay part of their revenues when national medicines spending exceeds a set budget. These repayments are negotiated annually, only for one year, and there are no caps. By contrast with other EU Member States, the absence of multi‑year frameworks and ceilings makes planning difficult and, according to the innovative medicinal therapies industry, delays sustainable patient access to new treatments and technologies.

Healthcare: EU Commission refers Bulgaria to the EU Court

The European Commission has referred Bulgaria to the Court of Justice of the EU for failing to correctly transpose Directive 2014/24/EU on public procurement. The Commission argues that Bulgarian law currently excludes privately owned medical establishments from EU procurement rules, even when they receive more than 50 % public funding.

Under EU rules, entities must follow public procurement procedures if they are established to meet general‑interest needs, have legal personality and are largely financed, managed or supervised by public bodies. Many Bulgarian private hospitals meet these criteria, given their public‑interest role and funding from the National Health Insurance Fund. A court case is likely to prompt changes to Bulgaria's procurement framework.

In November, the World Health Organization published its study on how European countries are navigating health data governance and the use of artificial intelligence in healthcare.

Member State profiles reflect a clear shift. Governments are moving from research to implementation: building oversight structures, engaging in trust-building and upskilling the workforce. Health data governance is maturing. Most countries report key foundations, including national health data strategies and health data bodies, along with the increasing use of health data hubs. Many allow extraction from electronic health records to populate registries and routinely aggregate data sets in regional or national repositories. To date, only a small number of Member States have issued detailed guidelines on the secondary use of health data for research or established clear rules for sharing health data with private partners for public-interest research or for cross-border scientific research. However, all Member States share a strong recognition of AI's potential to improve care, reduce pressure on the workforce and increase system efficiency. Progress is being hindered by legal uncertainty, concerns about affordability and uneven data quality standards.

Bulgaria's profile reflects this regional transition. In terms of data, in 2024 the country adopted a National Strategy for e-Health and Digitalisation of the Health System 2030, signalling its political commitment to managing health data as a strategic asset. The next logical step is to develop the regulatory framework, which involves translating the strategy into concrete requirements for data architecture, streamlining extraction from clinical systems, and clarifying rules for secondary use and responsible sharing. This should unlock research and innovation while increasing trust.

While there is political commitment and strategic planning, the actual deployment of AI in the Bulgarian health sector remains limited. The barriers faced by the country mirror those observed across Europe, along with local cultural concerns that may hinder AI implementation. Overcoming legal uncertainty, improving data quality standards, ensuring adequate financing and building broad stakeholder engagement and public trust will be crucial for the successful implementation of AI in Bulgaria's health sector.

Environmental, social and governance (ESG) expectations are catching up with the fast-fashion sector. Textile and apparel companies are facing growing compliance pressures, driven by legislative initiatives across the European Union.

To begin with, the CSRD has introduced reporting obligations for many companies, including those in the textile sector, requiring them to disclose ESG data according to European Sustainability Reporting Standards (ESRS). The CSDDD, on the other hand, focuses on human rights, which can greatly reflect on the low-paid labour, excessive overtime and dangerous working conditions typical for fast-fashion factories.

The Eco-design for Sustainable Products Regulation (ESPR) and the Digital Product Passports (DPPs) enhance the traceability of materials and product composition, while establishing requirements for durability and recyclability, as well as restrictions on the use of hazardous substances.

The extended producer responsibility (EPR) was also stretched to the textile industry. Towards the end of 2025, the EU Parliament approved new rules under which EU countries should set up schemes to ensure textile producers cover the costs of collecting, sorting and recycling their products.

On a national level, Bulgaria has yet to fully implement all minimum requirements for the separate collection of textile waste. However, the Council of Ministers has submitted a bill amending and supplementing the Waste Management Act. The draft amendments introduce a mandatory separate collection of textile and footwear waste, which should align national law with the EU requirements. If the bill is adopted without further amendments, the sector will face stricter sanctions and clearer compliance obligations regarding textile waste.

On 1 January 2026, the euro will become Bulgaria's official currency, marking a structural change with wide-ranging implications for consumers, businesses and foreign investors. The initial transition period will be particularly challenging due to the practical complexities of switching currency and the compliance requirements embedded in the Bulgarian Euro Introduction Act. The legislative framework introduces general obligations on all businesses, as well as certain pharma-specific legal considerations that must be taken into account.

The Euro Introduction Act establishes a temporary conditional price fix on consumer goods until August 2026. Throughout Bulgaria's dual price display period, retailers must set prices in good faith and act transparently. Any price increase must be grounded in objective economic factors. These are defined as external, documentable circumstances such as changes in production, delivery, storage or sales costs, new regulatory requirements, or force majeure events that have a direct and material impact on cost price. Businesses are required to substantiate these factors upon request by the authorities, notably the Commission for Consumer Protection. The purpose of this regime is to deter unjustified price increases, safeguard consumers, and preserve market integrity during the transition to the euro.

The Act also empowers the Council of Ministers to adopt temporary countermeasures if there is a significant increase in the prices of essential goods, including medicinal products. This mechanism specifically targets essential prescription-only drugs that are not reimbursed. Although time-limited, this tool is viewed with caution by the business community because it may foster expectations of broader regulatory intervention beyond the immediate transition needs.

During the dual price display period, medicinal product retailers with an annual turnover exceeding BGN 10m must publish daily information on the individual sale prices of goods that fall within the "large consumer basket" defined by the Commission for Consumer Protection (CCP). The CCP has issued the list and includes medicinal products identified by INN and ATC codes. Retailers that do not operate a website must submit the data directly to the CCP. Where the same products are sold at different prices across multiple outlets, each outlet's pricing must be reported separately.

Publicly available price lists must specify the store, product name, brand, net quantity, retail price, category, any discounts, the duration of discounts, the reference price, the current discounted price and the percentage change. The CCP is to maintain a publicly accessible portal that publishes all submitted data daily and provides guidance on compliance. Retailers below the mandatory turnover threshold may submit data voluntarily under the same rules, and those submissions will likewise be published on the CPC portal.

Taken together, these measures are intended to ensure a transparent approach to pricing during euro adoption and to equipe the authorities with targeted tools to address price volatility and hikes. For pharmaceutical retailers and distributors, the emphasis will be on detailed documentation, timely reporting, and a carefully planned price-setting strategy throughout the period in which these measures remain in effect.

Peel-off labels for foodstuff in Poland

Food producers must ensure clear and legible labelling. To include all legally required information, producers sometimes use "peel-off" labels, where some mandatory information appears on the front, while the rest is accessible only after opening the label. This typically occurs with small products of unusual shapes (e.g. bars or vitamin shots) or with multilingual labels where there is insufficient space to include all required languages.

Position of the Chief Sanitary Inspectorate

The Chief Sanitary Inspectorate (Główny Inspektorat Sanitarny – "GIS"), together with the Ministry of Agriculture and the Agricultural and Food Quality Inspection, has taken a restrictive stance. The GIS stated that placing Polish labelling on inner layers creates accessibility issues, particularly for elderly or disabled persons. The authority recommended placing only non-mandatory information (recipes, promotional content or additional languages) on inner layers, while all mandatory Polish labelling must appear on the outer surface.

Court rulings

The Provincial Administrative Court in Rzeszów (judgment of 1 February 2023, case II SA/Rz 926/22) rejected the GIS's position, ruling that peel-off labels can be used for mandatory information under certain conditions.

The Court held that information is only "hidden" under Article 13(1) of Regulation 1169/2011 where it is concealed by other prints, illustrations or material other than the label itself, and where the label's construction prevents easy access. If the outer layer indicates what information appears on the next layer, includes instructions to read the entire label and displays a graphic symbol showing where to open it, mandatory information on the inner layers is not considered obscured – provided that the label can be easily peeled off and reattached without damage.

This ruling is final. In its judgment of 15 February 2024 (case no. II GSK 678/23), the Supreme Administrative Court dismissed the appeal lodged by the GIS.

Practical requirements

Considering the above, peel-off labels are acceptable in Poland if:

• the outer layer clearly indicates which mandatory information appears on the inner layers;
• clear instructions or symbols show how to access the inner layers;
• the label can be easily peeled and reattached without damage; and
• accessibility for the average consumer is ensured.

Winter is here, bringing with it the season when people increasingly turn to food supplements and medicines. Unsurprisingly, the number and frequency of advertisements for such products rise across the media we consume. In Romania, advertisements broadcast on TV, radio or other audiovisual media must also comply with the requirements introduced by the new Audiovisual Content Regulation Code (the "Code"), which has recently entered into force.

Which media does the Code apply to?

The Code applies to television and radio programmes, video-on-demand services transmitted through electronic communications networks, and programmes and videos provided through video-sharing platforms, which are under the jurisdiction of Romanian law.

Key advertising restrictions

Broadcasting advertising for food supplements, OTC medicines, medical treatments, homeopathic products or medical devices that are presented or recommended by public personalities, cultural, scientific or sports figures, or other persons who, by virtue of their celebrity, may encourage consumption of these products is prohibited. This prohibition also extends to the promotion of pharmacies through association with promotional offers for such products.

Medical personnel or pharmacists cannot recommend or endorse food supplements, medicines, medical treatments, homeopathic products or medical devices in advertising. Recommendations or endorsements from medical associations are also prohibited.

Advertising for food supplements, medicines, medical treatments, homeopathic products and medical devices in programmes intended for minors, or in advertising breaks preceding or following such programmes, is prohibited. In addition, producers and distributors of these products may not sponsor programmes or broadcasts intended for minors.

Advertising for food supplements must include specific warnings, as well as the information presented on the product label, in accordance with the Food Supplements Law. Recently, this requirement was amended to allow label information to be presented in written form, rather than requiring oral pronunciation.