We are pleased to announce that all three hearings concluded successfully, resulting in favorable outcomes for our clients. We did it!

Joanna Uchańska appeared before the Supreme Administrative Court (NSA) in a case involving regulations governing the highly sensitive area of food intended for patients, as well as the application of administrative law provisions by the Chief Sanitary Inspectorate (GIS) in relation to entities operating within the healthcare sector.

Meanwhile, Edyta Oleszczuk-Romańska represented a client before the Provincial Administrative Court in Łódź (WSA Łódź). The case concerned issues of significant importance from the perspective of food law practice, current administrative court jurisprudence, and the regulatory approach of sanitary authorities.

Representing clients in proceedings before administrative courts is an important part of our practice. It enables us not only to effectively protect our clients’ interests but also to stay abreast of evolving interpretations of regulations that are of key importance to participants in the Life Sciences sector.

We would like to thank our clients for their trust and for the opportunity to support them in matters requiring specialized expertise in regulatory law and administrative court proceedings.

If you would like to benefit from our expert knowledge and experience, please contact us: office@ajlaw.pl, juchanska@ajlaw.pl

The changes include not only an increase in the rates but also modifications to the method of determining them, introducing a clearer distinction between cases with a specified value of the subject matter of the dispute and cases in which such value cannot be determined.

Arkadiusz Myrcha, Deputy Minister of Justice, emphasizes that:
“The solutions introduced by the regulation take into account the needs of mediators and the necessity of maintaining the real costs of mediation.”

The new provisions also clarify the rules for reimbursing expenses incurred by the mediator in connection with conducting the mediation proceedings. For cases referred to mediation before 17 February 2026, the previous rules continue to apply.

Mediation is an effective and flexible dispute-resolution tool that allows the parties to maintain control over the outcome of their case while significantly reducing the costs and duration of the proceedings.

At AJ LAW, we conduct mediations not only as legal representatives of the parties. Dr. Joanna Uchańska is also a court-appointed mediator at the Regional Courts in Warsaw, Kraków, Katowice, Poznań, Lublin, and Gdańsk.

You can read more about mediation here:
Mediation and negotiation services – Do you want to be right or keep the relationship? – AJ Law – law firm

We encourage you to contact us:
office@ajlaw.pl

What was it like?

Pursuant to Article 94a(1) of the Pharmaceutical Law, a categorical ban on the advertising of pharmacies, pharmacy outlets, and their activities applies in the Polish legal order, with the only permissible exception being the provision of information on the location and opening hours of the establishment. In judicial practice, this concept had so far been interpreted extremely broadly – advertising was considered to be virtually any action directed to the public that aimed to encourage the purchase of goods or services in a specific pharmacy, regardless of the form of communication (Voivodeship Administrative Court in Warsaw, VII SA/Wa 2215/07); therefore, it covered press advertisements, leaflets, banners, promotional brochures, communication of price promotions, and, of course, all online activity.

This ban also applied to non-pharmacy retail outlets with regard to medicinal products and medical devices, and its breach was punishable by a financial penalty imposed by the Provincial Pharmaceutical Inspector. The severity of these regulations is confirmed by numerous fines for seemingly informational activities: the Greater Poland Provincial Pharmaceutical Inspector imposed, among others, a fine of PLN 1,000 for displaying a basket with the “%” symbol and PLN 10,000 for an overly expressive advertisement of a COVID-19 vaccination point, while the Subcarpathian Provincial Pharmaceutical Inspector fined a pharmacy PLN 4,000 for placing prices in colorful stars. Administrative courts consistently upheld these decisions, considering as illegal all loyalty programs, discount vouchers, promotional leaflets, and even informing about the preparation of compounded medicines “within 15 minutes”, which, according to the Supreme Administrative Court (II GSK 501/21), constituted an unlawful incentive.

In this rigorous system, a special role was attributed to pharmacists and pharmacy managers. The Act on the Profession of Pharmacist and the Code of Ethics of the Pharmacist expressly prohibit them from participating in advertising, and due to statutory professional independence, a pharmacy manager may be held disciplinarily liable even for marketing activities imposed by the owner of a chain.

However, the culminating point in the debate on the limits of these prohibitions became the judgment of the Court of Justice of the European Union (CJEU) in case C-421/07 (Frede Damgaard), which shed new light on liability for advertising communication. The Court indicated that disseminating information about a product may be considered advertising even when carried out by a third party acting on its own initiative, completely independently of the manufacturer or seller. Although this judgment confirmed the broad definition of advertising, it simultaneously prompted reflection on whether Polish regulations, prohibiting pharmacies from almost all communication, go one step too far in relation to EU freedoms. Currently, this ban covers not only pharmacies but also non-pharmacy retail outlets with regard to medicinal products, which makes the Polish pharmaceutical market (still due to the regulations) one of the most restrictive areas in terms of communication with patients in the entire European Union. However, this should change soon.

What is it like now?

The CJEU ruled that the Polish ban is incompatible with EU law because it is total, unconditional, and disproportionate to the declared objectives of protecting public health. The judgment was delivered in the case European Commission v. Poland and was based, inter alia, on Article 8(1) of Directive 2000/31/EC (e-commerce) and Articles 49 and 56 TFEU (internal market freedoms), as we wrote in the article of 24 June last year: CJEU: Polish ban on pharmacy advertising incompatible with EU law – groundbreaking judgment of 19 June 2025 – AJ Law – law firm.

The Court pointed out the lack of distinction in Polish regulations between neutral information and commercial advertising. Such a restrictive approach resulted in the elimination from the market of substantive and useful communications for patients, which was considered a violation of the freedom to provide services and the freedom of establishment, particularly in the area of digital communication. As a result, the excessive rigidity of the regulation limited citizens’ right to reliable information about available healthcare services.

Following this ruling, Article 94a ceased to constitute an effective basis for imposing financial penalties. Although the provision formally still appears in the Act, in practice it remains ineffective, which forced the government to undertake legislative work on its amendment. The need to adapt the national legal order to EU standards has become a priority in order to restore system coherence and legal certainty.

What will it be like? Assumptions of the amendment: draft UD291

In response to the CJEU judgment, the Ministry of Health prepared a draft amendment (No. UD291), which abolishes the general ban and introduces a framework for permissible advertising. The draft was entered into the list of legislative works and public consultations on 12 December 2025. The draft constitutes an attempt to implement the judgment of the Court of Justice of the European Union (CJEU) of 19 June 2025 (case C-200/24), in particular by departing from the total ban on advertising of pharmacies and pharmacy outlets. However, the changes introduce other limitations that may have a significant impact on activities carried out not only in pharmacies but also in non-pharmacy retail outlets.

The essential elements of the draft (in consultation versions) include, inter alia:

a. Substantive issues:

A definition of pharmacy advertising as activity informing or encouraging the use of the offer in order to increase sales of assortment or services — with a catalogue of prohibited techniques (including no benefits in exchange for purchase, prohibition of comparative advertising, no messages addressed to children, prohibition of using the image of publicly known persons, scientists and persons with medical education). Thus, the draft is to repeal the current, rigorous Article 94a of the Pharmaceutical Law. In its place, it introduces a statutory definition of pharmacy advertising, which covers both informing about the offer and encouraging the purchase of assortment (medicines, supplements) or the use of services (e.g., pharmaceutical care). Therefore, this is the end of the era of a ban on everything, but with significant limitations.

Advertising becomes legal, but it is surrounded by a long list of prohibitions intended to protect the patient from manipulation. In principle, pharmacy advertising may NOT:

a) Buy loyalty: prohibition of offering any benefits (free items, points, rewards) in exchange for purchases or use of services.

b) Attack competition: prohibition of comparative advertising.

c) Use authorities: prohibition of engaging doctors, pharmacists, scientists, known persons and persons “pretending” to be medical professionals (both their image and voice).

d) Engage children: prohibition of directing advertising to persons under 18 years of age and of using their image.

e) Play on emotions: prohibition of evoking fear, suggesting deterioration of health without purchase, and exerting pressure on the patient.

f) Violate ethics: the message must comply with the law, good practices and the principles of professional ethics of the pharmacist.

2. Procedural issues:

b. Tightening of sanctions (raising the upper limits of fines) while enabling the provision of information about pharmaceutical services in an objective and neutral manner, which, of course, in practice will remain a huge challenge.

c. Discontinuation of pending proceedings concerning advertising conducted on the basis of the existing provisions on the date the Act enters into force.

What draws attention is that the draft Act introduces an important element related to comparative advertising. The proposed wording of Article 94a(2)(2) of the Draft, introducing a prohibition of comparative advertising of pharmacies, raises significant concerns. The adopted construction may lead to unjustified cross-distortion of the understanding of the catalogue of acts of unfair competition.

It is worth recalling that pursuant to Article 16(1) of the Act on Combating Unfair Competition, prohibited advertising also includes messages that are:

· contrary to the law, good practices or infringing human dignity;

· misleading and capable of influencing the customer’s purchasing decision;

· exploiting fear, superstition or children’s credulity;

· concealed in the form of neutral information (so-called covert advertising);

· burdensome and interfering with privacy (e.g., through persistent solicitation or abuse of communication means).

The current wording of the Draft generates a risk of serious interpretative conflicts in the practice of law application. This results from the lack of correlation between individual provisions.

Note: Part of the catalogue of restrictions and definitions results from published draft versions and may be clarified at the stage of governmental/parliamentary work, of which we will certainly inform you. The entire draft is available at the link: Draft.

Public consultations: different communities and different voices.

The Supreme Medical Council raised that allowing advertising may increase drug consumption and intensify mail-order sales, which is undesirable from the perspective of patient safety. As context, reference was made, inter alia, to thousands of hospitalizations due to drug poisoning in recent years.

Entrepreneurs’ organizations (Lewiatan Confederation) took a different stance, supporting the direction together with a request for clarification. Lewiatan positively assessed the abolition of the general ban (compliance with the CJEU judgment), but appealed for precise definitions and consideration of broader liberalization (for example, the lack of consent to advertising of non-pharmacy outlets remains controversial). Similarly, other industry organizations expressed comparable positions.

The pharmacy self-government also presented its position, in the background expressing concerns about “marketing wars” and sales pressure.

In turn, in its opinion of 30 January 2026, the Legislative Council supported the direction of lifting the ban, emphasizing that it concerns the necessary implementation of the CJEU judgment. At the same time, the Council pointed out the need to clarify the definition of advertising, proportionality of sanctions and avoidance of inconsistency with EU law.

The current legislative status is such that the draft has not yet been promulgated in the Journal of Laws; the government schedule assumed submission to the Council of Ministers in Q4 2025, but the works have been prolonged — the draft is after consultations and the opinion of the Legislative Council and awaits further governmental/parliamentary steps.

So how to act?

What are the permissible directions for conducting pharmacy advertising in a state of legal uncertainty:

a. Informing about opening hours, location, available pharmaceutical services (e.g., medication reviews, elements of pharmaceutical care) — in an objective and neutral manner.

b. Educational and preventive communication (pro-health content), without elements of sales pressure.

And which techniques are prohibited or limited based on examples from the draft Act, but also on the basis of other existing provisions concerning the protection of competition and consumers:

a. Prohibition of offering benefits in exchange for purchase (discount, free item, coupons) with regard to medicines and other assortment available in the pharmacy (which should be verified due to the variability of the draft);

b. Prohibition of comparative advertising (“cheapest”, “better than X”).

c. Prohibition of directing messages to children and using their image/voice.

d. Prohibition of using the image and voice of publicly known persons, scientists and persons with medical education (including actors playing medical professionals).

e. Prohibition of suggesting a health threat in the absence of purchase (“frightening” the patient).

f. Prohibition of misleading, exerting pressure, violating professional secrecy and principles of ethics.

The existing provisions have been considered inconsistent with EU law, and there are no new provisions yet. So how to conduct advertising during the transitional period? Here is a checklist for pharmacies for the “transitional period”:

1. Communication audit — it is worth resigning from messages that may be considered sales pressure or comparative advertising; it is advisable to focus on neutral information and education.
2. Online channels — a good solution is to prepare a publication policy (website, social media, newsletter) compliant with the requirements of neutrality and objectivity, which will also be consistent with the guidelines of the CJEU judgment.
3. Pharmaceutical services — we also recommend organizing the offer and description of services so that the messages are factual, without sales-oriented “call-to-action”.
4. Cooperation with manufacturers — it is advisable to ensure separation of roles and responsibilities in campaigns, as we have different advertising regimes: different for medicinal products, different for medical devices, different for dietary supplements.
5. Internal procedures — training for staff and checklists for approval of materials in the spirit of compliance, taking into account the principles of professional ethics of the pharmacist, are recommended.

Summary

The CJEU, in its judgment of 19 June 2025, unequivocally ruled that the general ban on pharmacy advertising in force in Poland is contrary to EU law, which opened the way to the necessary amendment of the provisions. The processed draft (UD291) assumes the abolition of the existing ban and the introduction of strictly regulated frameworks for conducting promotional activities, while at the same time providing for stricter financial sanctions and precise limitations on advertising techniques. Although the Legislative Council supported the direction of changes, it indicated the need to clarify key definitions and ensure greater proportionality of the envisaged penalties. The upcoming reconciliation conference suggests that the final shape of the regulation may still evolve, which requires market participants to exercise particular vigilance and flexibility in planning communication strategies.

In view of these dynamic legislative changes, our Law Firm offers full support in auditing and reviewing advertising projects, ensuring their compliance both with the current case law and with the forthcoming statutory requirements. We are ready to comprehensively assess promotional activities conducted directly by pharmacies, as well as by entities cooperating with them, including IT solution providers and business partners. Our advisory services include verification of the admissibility of forms of communication and substantive support in the process of adapting operational models to new legal standards, which allows minimizing the risk of exposure to severe sanctions while fully utilizing the emerging market opportunities.

We invite you to contact us: office@ajlaw.pl

For exhibitors, this is not only a chance to win a prestigious title, but above all a powerful marketing tool that builds trust among business partners and consumers alike.

In this edition, participants will compete in three key categories reflecting the full value chain of the nutraceutical sector:

Dietary Supplements – for finished products distinguished by their composition, dosage form, and effectiveness.

Raw Materials – a category dedicated to innovative components with documented efficacy.

Technologies & Innovations – a space for modern production and logistics solutions, as well as innovative approaches to R&D.

The composition of the Competition Jury guarantees substantive evaluation and the highest ethical standards. We are pleased to announce that Dr. Joanna Uchańska will once again serve on the Jury – Partner at AJ LAW Uchańska Diskau Attorneys-at-Law and Vice-President of the Management Board of the National Council of Supplements and Nutrients. Her many years of experience in food and pharmaceutical law ensure that the awarded projects will be not only innovative, but also fully transparent from a legislative perspective.

NutraFood Poland is much more than an exhibition – it is an international networking hub connecting opinion leaders, manufacturers, and distributors from around the world.

The event offers a unique opportunity to:

1. Portfolio Optimization: Build competitive advantage by establishing relationships with new suppliers and implementing future-proof solutions.
2. Exposure to International Markets: Gain direct access to unique raw materials and products that often debut on the Polish market during the trade fair.
3. Knowledge Transfer: Participate in discussion panels and lectures led by top industry experts.

The trade fair will take place on April 14–16, 2026, at EXPO XII Warsaw.

More information and the competition rules are available on the organizer’s website.

As part of the event program, Attorney-at-law Edyta Oleszczuk-Romańska from AJ LAW will deliver an expert presentation on 12 March 2026, in the thematic session from 09:15 to 10:30 – New challenges for quality and safety – MICRO-NANO PLASTICS and other substances. Her lecture, entitled “Law versus microplastics – regulatory standards, challenges for business, an opportunity for innovation,” will address the practical consequences of upcoming legal changes for entrepreneurs, with particular emphasis on obligations related to packaging design, placing products on the market, and compliance with new legal requirements. The presentation will focus on real regulatory risks, possible implementation scenarios, and recommended actions that will help companies prepare for the “packaging revolution” and avoid costly mistakes.

AJ LAW’s participation in the Pack4Future FORUM aligns with the firm’s mission to support businesses in safely and consciously adapting to the dynamically changing regulations of food and packaging law. The partnership with the event and the expert presence of Attorney Edyta Oleszczuk-Romańska highlight the firm’s commitment to dialogue with the industry and to providing practical legal knowledge tailored to current market needs. Of course, we simply could not miss this event.

See you in Łódź!

Dear Clients and Partners,

The upcoming Christmas season is a moment to slow down, look back, and appreciate what we have achieved together. For the AJ LAW team, this past year has been a time of intense work and important decisions. Every meeting and every entrusted matter has reinforced our belief that the trust you place in us is the greatest value of our work.

We sincerely thank you for every step we have taken together, for inspiring conversations, and for allowing us to become part of your story — both professional and personal.

In this special time, we wish you peace, health, and joy in the company of your loved ones. May the coming days be full of light, and may the New Year bring new perspectives, wise decisions, and the feeling that law — like people — can be close, understandable, and fair.

Merry Christmas and best wishes for a successful 2026!

The AJ LAW Team

💡 Are you looking for a place where your ideas matter and law becomes a tool for turning dreams into reality?

At our law firm, we don’t just support clients in their most important matters — we create a space where you can also grow, work creatively, and gain experience through real projects.

We are AJ LAW — Aleksandra Diskau and Joanna Uchańska. We run our law firm side by side in Kraków, the city where we graduated and have lived and worked for years. AJ LAW is now a team of several people. What do we do? We accompany our clients in their everyday matters, business ventures, and the realization of their dreams and goals, taking care of the legal side of their activities.

Our main area of expertise is the Life Science and Healthcare sectors, including medical, pharmaceutical, food, beauty, biotechnology, and chemical industries. We also provide legal services in intellectual property, protection of personal rights, and protection against unfair competition. Schedule a meeting with us and get to know us better!

🔍 Who are we looking for?

Someone who:

• Has an educational background in administration, management, marketing, accounting, or similar fields
• Can work with documents, deadlines, and a team
• Wants to grow and isn’t afraid of challenges

✨ What will you do?

🔹 Organize office life — from correspondence to business trips, from case calendars to coordinating with technical services
🔹 Support our lawyers in client matters — prepare short administrative letters, communicate with offices and courts
🔹 Create content for our social media and website — creativity is welcome!
🔹 Participate in projects, trainings, and educational events — grow with us!
🔹 Manage documentation, invoices, time tracking, and leave records
🔹 Monitor the current status of court and administrative cases
🔹 Prepare simple letters for the team

🎯 Our requirements:

• Accuracy, good organization, independence
• Ability to work under time pressure
• Commitment to professional growth and improvement

🌟 Nice to have:

• Completed bachelor’s or master’s degree
• Experience in social media and graphic design
• Knowledge of English
• Familiarity with Microsoft tools and social media platforms

🎁 What we offer:

• Real opportunities for professional development — grow with us!
• Flexible cooperation or employment: contract of mandate or employment contract | Part-time or ¾ time (depending on availability)
• Independence, decision-making, and space for your ideas
• Participation in interesting projects and initiatives
• Office in the heart of Kraków — 5 minutes from Wawel Castle on foot (faster by bike)
• Possibility of partial remote work
• A dynamic work environment — every day is different with us! Truly!

✨ Our motto:
Make your dreams come true, legally!

📩 Interested? Send us your CV to office@ajlaw.pl along with a few words about yourself — we’re waiting for you!

Kraków + possibility of remote work | Salary and form of cooperation: to be determined

💡 Are you looking for a place where your ideas matter and law becomes a tool for making dreams come true?

In our law firm, we not only support clients in their most important matters — we create a space where you can also grow, work creatively, and gain experience through real projects.

We are AJ LAW — more precisely, Aleksandra Diskau and Joanna Uchańska. We run our law firm side by side in Kraków — the city where we graduated and have lived and worked for years. AJ LAW is now a team of several people. What do we do? We accompany our clients in their everyday matters, business ventures, and the realization of their dreams and goals, taking care of the legal side of their activities.

Nasz główny profil działalności to branże z obszaru Life Science i Healthcare, czyli: branża medyczna, farmaceutyczna, spożywcza, beauty, biotechnologiczna i chemiczna. Świadczymy także obsługę prawną w zakresie własności intelektualnej, ochrony dóbr osobistych i ochrony przed nieuczciwą konkurencją. Umów się z nami i poznaj nas bliżej!

🔍 Who are we looking for?

A person who:

• has a legal education (or is in the 4th/5th year of law studies), possibly administrative,
• knows civil, administrative, and EU law, and wants to develop in the life sciences field,
• can work with documents, deadlines, and a team,
• wants to grow and is not afraid of challenges.

✨ What will you be doing?

🔹 Organize office operations — from correspondence to business trips, from case calendars to coordinating with technical services.
🔹 Support our lawyers in client matters — prepare documents, analyses, and communicate with offices and courts.
🔹 Create content for our social media and website — creativity is welcome!
🔹 Participate in projects, training sessions, and educational events — grow together with us!
🔹 Manage documentation, invoices, time tracking, and leave records.
🔹 Monitor changes in regulations and prepare simple analyses for the team.

🎯 Our requirements:

• Attention to detail, good organization, independence
• Ability to work under time pressure
• Commitment to growth and professional development

🌟 Preferred::

• Status as a trainee attorney-at-law or advocate
• Experience in social media and graphic design
• Knowledge of English
• Proficiency in Microsoft environment programs and social media platforms

🎁 What do we offer?

• Real opportunities for professional growth — grow with us!Flexible cooperation or employment options: contract of mandate or employment contract | part-time or ¾ time (depending on availability)Independence, decision-making, and space for your ideasParticipation in interesting projects and initiativesOffice in the heart of Kraków — 5 minutes from Wawel on foot (faster by bike)Possibility of partial remote workDynamic work environment — every day is different here! Really!

✨The slogan that defines us:

Make your dreams come true, legally!

📩Interested? Send us your CV to office@ajlaw.pl along with a few words about yourself — we’re waiting for you!

The resolutions include, among other things, lists of prohibited substances such as yohimbine, DMAA, SARMs, or ibutamoren, which are not allowed to be used in food supplements. They also specify the maximum recommended levels of vitamins and minerals—for example, vitamin D is limited to 2000 IU for adults up to the age of 75 and 4000 IU for those above that age, while vitamin B6 has been limited to 6 mg per day starting in 2024. Additionally, the resolutions contain labeling and warning recommendations, such as the requirement to inform consumers that the product should not be consumed by individuals taking anticoagulants containing vitamin K antagonists (e.g., warfarin and acenocoumarol) in the case of supplements containing vitamin K.

In practice, many questions arise regarding the nature of these resolutions—whether they constitute law, customary practice, or scientific guidelines with significant authority, and what real impact they have on ongoing proceedings. It is important to understand who considers them and why, and whether they should be taken into account in research and development processes, the design and launch of new products, updates to quantitative and qualitative compositions, internal systems, product withdrawals from the market, packaging design, as well as advertising, marketing, and educational campaigns.

In the context of administrative and judicial proceedings, questions arise about the type of arguments that should be used before the Chief Sanitary Inspectorate (GIS) in explanatory proceedings concerning the status of a product, before the Provincial Sanitary Inspectorates (PPIS) in control proceedings—both those conducted in parallel with GIS proceedings and those following their conclusion—as well as during court proceedings. There is also consideration of the possibility of challenging the resolutions—either globally or on a case-by-case basis, in relation to specific substances or products, and the scientific literature on which the resolutions are based. The question arises whether it is possible to demand their update in light of the latest scientific knowledge.

Additional concerns relate to products placed on the market from outside the EU, as well as those distributed in Poland but first introduced in another EU country, which do not comply with the resolutions. It is also important to consider how one can influence the content and application of the resolutions—both in specific proceedings and through changing the perception of the industry, conducting product research, publishing scientific papers, engaging in educational and promotional activities, or participating in industry organizations.

New Resolution on Tablet Splitting

On May 7, 2025, the Team for Food Supplements issued Resolution No. 1/2025, in which it expressed an opinion on establishing requirements in cases where the labeling of a food supplement includes instructions for use involving tablet splitting.

The resolution was issued pursuant to Article 9(2b)(1) of the Act on the State Sanitary Inspection. It sets out the conditions that must be met for information about the possibility of tablet splitting to be included on the packaging of a food supplement. In particular:

1. Tablet splitting is permitted, provided that the entire tablet does not exceed the maximum daily amounts of individual substances.
2. The manufacturer or responsible entity must ensure that each portion resulting from splitting the tablet contains the appropriate, declared amount of vitamins, minerals, or other substances with nutritional or physiological effects.
3. The tablet must have an appropriate score line that allows consumers to split it evenly and easily. The product should be in a form that facilitates such division.
4. The product labeling should include precise instructions regarding both the recommended portion for consumption and the method of tablet splitting.

The resolution entered into force on the date it was adopted, although it was published on June 2, 2025.

Resolution No. 1/2025 of the Team for Food Supplements, dated May 7, 2025, carries significant practical and regulatory implications for food supplement manufacturers, distributors, and supervisory authorities.

The resolution may influence the standardization of labeling practices for supplements that allow tablet splitting. It introduces criteria for the admissibility of information about tablet splitting on the labeling of food supplements. Until now, there have been no precise guidelines in this area, which has led to inconsistent market practices. However, the proposed guidelines may raise concerns in relation to actual practice, particularly regarding the condition that tablet splitting is permitted only if the entire tablet does not exceed the maximum daily amounts of individual substances.

The resolution may have implications for the liability of manufacturers and importers.

Manufacturers should:

• Ensure uniform composition in each part of the tablet after splitting,
• Provide an appropriate physical form of the tablet (e.g., a score line),
• Develop precise instructions for splitting and dosing.

Failure to meet these conditions may result in the labeling being challenged by supervisory authorities, and in extreme cases — the product being withdrawn from the market.

What is also important is that this undoubtedly contributes to strengthening consumer protection.

The purpose of the resolution is to increase the safety of food supplement use by consumers. Splitting tablets without appropriate information may lead to:

• Incorrect dosing,
• Uneven intake of substances,
• Improper use by elderly individuals.

The new guidelines aim to prevent this by promoting clarity and reliability in labeling.

Moreover, the resolution is practically significant for the course of inspections conducted by authorities. Although the resolution does not have the force of law, it represents the official position of the advisory body to the State Sanitary Inspection. In practice, it may be used by:

• Voivodeship Sanitary and Epidemiological Stations,
• Chief Sanitary Inspectorate,
• And in some cases, also by the Chief Pharmaceutical Inspectorate (GIF), if the product raises classification concerns.

It is worth considering, in the daily practice of running a business, the need to update documentation, processes, production practices, as well as labeling and packaging.

Companies that have so far used labeling related to tablet splitting will need to:

• Verify compliance with the new guidelines,
• Update labels and leaflets,
• Adjust quality and technological documentation.

If you have any questions regarding the resolutions of the Team for Food Supplements or other concerns related to labeling, marking, communication, advertising, and promotion of your products, please feel free to contact us at: office@ajlaw.pl and juchanska@ajlaw.pl.

What are entrepreneurs’ personal rights?

Entrepreneurs’ personal rights are non-material values that are crucial for a company’s operations and its position in the market. According to Article 23 of the Polish Civil Code, personal rights include, among others: health, freedom, dignity, name, image, and the secrecy of correspondence. In the context of entrepreneurs, this list also includes:

• The good name and reputation of the company – essential for building trust among clients and business partners.
• The company name – protected against unlawful use by competitors.
• Trade secrets – covering confidential information related to the company’s operations.
• Trademarks and other identifiers of the company – protected against unfair competition.

The protection of entrepreneurs’ personal rights is based on Article 43 of the Polish Civil Code, which states that the provisions concerning the protection of personal rights of natural persons also apply to legal persons.

Legal basis for mediation in civil cases

Mediation in civil cases, including those concerning the protection of entrepreneurs’ personal rights, is regulated by the Polish Code of Civil Procedure (KPC). According to Article 183¹ of the KPC, mediation may be conducted either on the basis of an agreement between the parties or by referral from the court. For entrepreneurs, mediation can serve as a valuable tool to resolve conflicts without the need for lengthy court proceedings.

Additionally, mediation is supported by the Act on Out-of-Court Consumer Dispute Resolution and the provisions concerning the protection of personal rights contained in the Civil Code (CC). Mediation can be an effective tool for pursuing claims related to the violation of a company’s reputation, name, or trade secrets.

Course of Mediation

Mediation consists of several stages:

1. Contacting the mediator – the parties express their willingness to mediate, agree on the terms, and select a mediator.
2. Preliminary meeting – the mediator meets with the parties, explains the rules of mediation, and outlines the process.
3. Negotiations – the parties present their positions, and the mediator assists in working out a compromise.
4. Conclusion of a settlement – if the parties reach an agreement, a settlement is drafted, which may be approved by the court.

Role of the Mediator

The mediator is a neutral party who helps the participants reach an agreement. They do not make decisions but support the parties in their negotiations. A mediator must be a person with full legal capacity and listed on the register of mediators maintained by regional courts. The mediator is required to maintain impartiality and confidentiality.

Significance of the Settlement

A settlement reached through mediation has legal force and can be approved by the court. Once approved, the settlement becomes enforceable, meaning that if it is not fulfilled, claims can be pursued through enforcement proceedings.

Examples of Case Law

In Polish case law, there are examples where mediation could have played a significant role in protecting entrepreneurs’ personal rights. One such case was heard by the Court of Appeal in Białystok (Case No. I ACa 439/2013), which concerned the violation of an entrepreneur’s good name through the publication of false information in the media. The court emphasized that violating an entrepreneur’s personal rights may result in the obligation to issue a public apology and provide compensation. This case illustrates how mediation could have offered a less confrontational and more efficient path to resolution, potentially avoiding a lengthy court process.

Another important ruling is the resolution of the Supreme Court of October 3, 2023 (Case No. III CZP 22/23), in which the Court held that a legal person may claim compensation for non-material harm under Article 448 of the Civil Code. This decision confirms that entrepreneurs can effectively seek protection of their personal rights in the event of a violation, including the right to claim non-pecuniary damages for harm suffered.

Summary

Mediation in cases concerning the protection of entrepreneurs’ personal rights is an effective tool that enables quick, efficient, and less costly conflict resolution. Thanks to legal regulations and court rulings, mediation is becoming an increasingly popular method of dispute resolution, allowing entrepreneurs to protect their reputation and good name without the need for lengthy court proceedings.