The CE marking was introduced as part of the harmonization of product marking processes within the EU. It is intended to replace all existing conformity markings. The marking itself indicates that the product meets the requirements of the applicable regulations. It is affixed to products intended for introduction into the EEA and Turkish markets, regardless of where they were manufactured.

Main regulations

The main acts that regulate the CE marking of products and the conformity testing that must accompany this process are: Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (consolidated text: OJ L 218, 2008, p. 30, as amended) as well as Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (consolidated text: OJ L 218, 2008, p. 82).

CE marking

Although the mark is generally believed to be an abbreviation of the French expression “Conformité Européenne”, no EU legal act provides such an expansion of this abbreviation.

The appearance and method of affixing the CE marking are specified in Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 and Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008, stating that it consists of the initials “CE” presented in the form specified in the regulation. Unless other regulations specify a different height, it shall be at least 5 mm. In all cases, the proportions of the mark must be maintained. It must be affixed so that it is visible, legible, and indelible from the product. The CE marking is followed by the identification number of the notified body, if it was involved in the production control phase. If the CE marking cannot be affixed to the product, it should be affixed to the packaging or accompanying documentation.

Declaration of Conformity

Union harmonisation legislation requires the manufacturer to draw up and sign an EU declaration of conformity before placing the product on the market.

The manufacturer or its authorized representative established within the EU is required to draw up and sign an EU declaration of conformity as part of the conformity assessment procedure provided for in Union harmonisation legislation. The EU declaration of conformity is a document stating that the product complies with all relevant requirements of the applicable legislation.

By drawing up and signing the EU declaration of conformity, the manufacturer takes responsibility for the product’s compliance with the regulations.

The EU declaration of conformity must be continuously updated and kept for ten years from the date the product is placed on the market, unless a different period is specified by law.

According to the model declaration in Decision No 768/2008/EC of 9 July 2008, the declaration should include:

1. unique product identifier,

2. name and address of the manufacturer or authorized representative issuing the declaration,

3. a statement that the declaration is issued under the sole responsibility of the manufacturer,

4. Subject of the declaration (product identifier enabling the reconstruction of its history. Where appropriate, it may include a photo),

5. all relevant provisions of Union harmonisation legislation that the product must comply with, referenced standards or other technical specifications (such as national standards and technical specifications) in a precise, complete and clearly defined manner,

6. Where applicable, name and number of the notified body that issued the certificate,

7. Additional information,

8. Date of issue of the declaration, signature and position or equivalent designation of the authorized person,

Modules

The mark itself is intended to indicate that the product meets the requirements specified in the law. The product is marked with it by the manufacturer, either independently or with the participation of a national authority (conformity assessment body, notified body). For this purpose, the manufacturer assesses conformity using modules (described in the Commission Notice Blue Guide – Implementation of EU product regulations 2022 (i.e. OJ EU C. of 2022 No. 247, p. 1) and Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008). The modules refer to both the design and production phases. Conformity assessments can be performed using one or two modules. Assessment modules can refer to one of the phases (e.g. only to the production phase), or to both. If a module refers to only one phase, the assessment consists of two modules, while if it refers to both phases, the assessment consists of one.

There are eight modules in total, but with the addition of variants, their number increases to 16 (A, A1, A2, B, C, C1, C2, D, D1, E, E1, F, F1, G, H, H1). Each subsequent module contains further requirements, along with increasing risks posed by the product. In the “least demanding” module, A, the manufacturer only prepares technical documentation and takes all necessary measures to ensure the production process ensures compliance of manufactured products with the technical documentation, and then affixes the marking to the product. In the highest module, H1, the manufacturer must have an approved quality assurance system (approved by a notified body) for design, production, and inspection and testing of finished products. It is also subject to supervision by a notified body. The notified body may also pay unannounced visits to the manufacturer, during which it may conduct or commission product tests.

Entities involved in conformity assessment

At the outset, it is worth noting that regardless of whether a notified body is involved in the conformity assessment procedure or not, the conformity assessment is the manufacturer’s responsibility, and the declaration of conformity is made under his sole responsibility.

There are three possibilities for the involvement of other entities in the conformity assessment procedure:

– No involvement of external entities. In such a case (and this usually applies to products that the legislator has deemed not to pose such a risk that the manufacturer cannot be entrusted with the independent conformity assessment), the manufacturer prepares the declaration itself (along with the appropriate tests and technical documentation), and conducts the tests, inspections, and guarantees compliance during production.

– Conformity assessment is carried out using an accredited in-house body, i.e., a part of the manufacturer. However, this body cannot perform any tasks other than conformity assessment. It must be independent of commercial, design, and manufacturing entities and must possess the same level of technical competence and impartiality as external assessment bodies. They may conduct assessments within the scope of modules A1, A2, C1, or C2.

– Conducting the assessment with the involvement of an external entity. If the legislator deems such intervention necessary, an external conformity assessment body will participate in the conformity assessment. This body must be impartial and fully independent of the organization or the product it assesses. It must not engage in any activities that might compromise its independence, and it must not have user or other interests in the product being assessed.

Member States are responsible for designating conformity assessment bodies. They must designate bodies (within their jurisdiction) that have the appropriate competence to assess product conformity.

Even though in-house bodies cannot be notified (i.e. they cannot be external conformity assessment bodies), they must demonstrate at least the same level of technical competence as external bodies through accreditation.

Notified bodies

Conformity assessment bodies (referred to as notified bodies in EU legislation) are entities designated by Member States. Appointed notified bodies must then be notified to the European Commission.

They play roles in the conformity assessment process, responsible for activities such as calibration, testing, certification, and inspection. To qualify as a notified body, a body must be a legal entity established in a Member State, but it may operate or employ personnel outside a Member State or even outside the EU.

The bodies must be accredited, which means that the relevant national accreditation body must confirm that the conformity assessment body meets the requirements set by the harmonised standards and any additional requirements for carrying out specific conformity assessment tasks.

Member States may designate a maximum of one national accreditation body. However, they may choose not to designate such a body and instead have accreditation performed in their territory by an accreditation body from another Member State. In both cases (designation or non-designation), Member States are required to notify the European Commission.

Notified bodies are subject to oversight by national notifying authorities and must keep them informed about their activities (including, for example, availability of resources, performance of conformity assessments, subcontracting of work, and conflicts of interest). They must provide, directly or through another body (e.g., a national accreditation body), all information concerning the proper implementation of the conditions under which they were notified, upon request, both to their notifying authorities and to the Commission.

The notifying authority is responsible for the activities of notified bodies. It must remain capable of ensuring monitoring. If such monitoring is not possible, the notifying authority must withdraw or limit the scope of the notification to the extent necessary.

It’s also worth mentioning that the independence requirement (which also means that notified bodies “are and must remain” third parties independent of their clients) does not mean that only state bodies can become notified bodies. On the contrary, both state and private entities can apply for this status, provided their independence, impartiality, and reliability are guaranteed, and they constitute independent legal entities with appropriate rights and obligations.

Product labeling requirement

The CE marking is not required for every product, only for those for which legislation requires it. Currently, these include toys, electrical products, machinery, personal protective equipment, and cranes. It is prohibited to affix the CE marking to products that are not covered by the CE marking regulations.

Changes in the law

There have been no significant recent changes to the legislation governing the CE marking. However, sector-specific regulations necessarily influence the use of the mark. Such as Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) (OJ EU L 2024, item 2847, as amended) or Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904 and repealing Directive 94/62/EC (OJ EU L 2025, item item 40) and acts requiring CE marking of products such as Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) Text with EEA relevance (OJ L 1689, 2024).

In its Annex I, Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 lists Union harmonisation legislation.

In summary, the purpose of the CE marking is to signal that a product meets the requirements of the applicable regulations. It is affixed to the product by the manufacturer, either independently or with the involvement of accredited internal bodies or a notified body, following the conformity assessment module(s) appropriate for the level of risk posed by the product, and under their own responsibility.

CE Marking – what really stands behind those two letters?

CE marking is more than just a symbol on a product – it’s a legal declaration that the product complies with all applicable EU requirements and can be placed on the EEA and Turkish markets, regardless of where it was manufactured.

It is the result of a structured conformity assessment process defined in EU harmonisation legislation (including Regulation (EC) No 765/2008 and Decision No 768/2008/EC). Depending on the level of risk, this process may involve the manufacturer alone, internal accredited bodies, or independent notified bodies.

By affixing the CE mark, the manufacturer takes full responsibility for product compliance. In parallel, an EU Declaration of Conformity must be issued, maintained, and kept up to date, confirming that all relevant legal requirements have been met.

The system is built on risk-based modules – from basic self-assessment to highly controlled certification schemes involving external oversight. This ensures proportional control while maintaining product safety and market access across the EU.

In short: CE marking is not a quality label – it is a regulatory passport for products entering the European market.

#CEMarking #EUCompliance #RegulatoryAffairs #ProductCompliance #ConformityAssessment #CECertification #EURegulation #MarketAccess #ProductSafety #NotifiedBody #TechnicalDocumentation #QualityAssurance #ManufacturingCompliance #IndustrialCompliance #LegalMetrology #EUlaw #ProductTesting #DeclarationOfConformity #RiskAssessment #HarmonisedStandards #BlueGuide #RegulatoryCompliance #EngineeringCompliance #SupplyChainCompliance #ProductRegulations #ComplianceManagement

Artykuł CE marking pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Resignation from the management board of a limited liability company is permissible at any time, regardless of the term of office. Therefore, a sole management board member is not obligated to serve until the end of their term and may terminate their position earlier either through their own resignation or through dismissal by the relevant body. Each of these options leads to the expiry of their mandate, but they differ significantly in terms of procedure and practical consequences.

Legal nature of resignation

Resignation from the management board constitutes a unilateral legal act. Its effectiveness does not depend on the consent or any action of the shareholder or the company. This is based on Article 202 § 5 of the Commercial Companies Code, which refers to the provisions of the Civil Code on termination of an assignment. The mandate holder may terminate the assignment at any time, and the declaration becomes effective upon the addressee having had the opportunity to become familiar with its content, as stipulated in Article 61 § 1 of the Civil Code. Therefore, the mandate expires by operation of law at the time specified by law, not only upon entry in the National Court Register. An entry in the register is solely declaratory in nature, confirming the existing legal status, but does not create it. Its absence does not affect the effectiveness of the resignation, although it may cause practical difficulties in relations with contractors and institutions.

Special procedure for the resignation of the sole member of the management board of a limited liability company

Article 201 § 2 of the Commercial Companies Code allows for the management board of a limited liability company to consist of one person. This is a dispositive provision, meaning that the company agreement may provide otherwise and, for example, require a larger number of management board members. Therefore, before taking any action, the content of the specific company agreement in this regard should be verified.

If the sole member of the management board resigns, no management board seat would be filled after their departure. The legislature anticipated this situation by introducing a separate procedure in Article 202 § 6 of the Commercial Companies Code. According to this procedure, the resignation is submitted to the shareholders, convening a shareholders’ meeting. The resignation statement should be included in the invitation to the meeting or delivered to the shareholders together with the notice of its convening. The meeting is convened by registered mail, courier, or email (if the shareholder has previously consented in writing), sent at least two weeks before the shareholders’ meeting. The procedure in such a case should be as follows:

1/ The member of the management board shall submit a declaration of resignation to the shareholders, and not to another body of the company, e.g. the supervisory board (if established in the company’s articles of association) or to a commercial proxy, if one has been appointed in the company.

2/ At the same time, it convenes a shareholders’ meeting two weeks before the planned meeting, attaching the text of the resignation declaration to the invitation.

3/ The resignation becomes effective on the day following the date for which the meeting was convened. This occurs regardless of whether the meeting actually takes place or whether the shareholders adopt any resolutions.

4/ The effectiveness of the resignation does not depend on the shareholder’s participation in the meeting, the adoption of the resolution or the consent to the resignation.

5/ A subsequent entry in the National Court Register is of a declaratory nature and confirms the existing situation, but does not condition the effectiveness of the resignation.

Who is the proper addressee of the declaration of resignation?

A resignation declaration must be submitted to the shareholders, as they are the entities authorized to appoint and dismiss management board members. It cannot be submitted to the company as a whole, to the sole proxy (if appointed), as this is not the entity authorized to receive such declarations on behalf of the shareholder or the shareholders’ meeting. Ineffective submission of the declaration, for example, to the wrong addressee, has no legal consequences. In such a case, the management board member’s mandate does not expire, and the person formally remains on the management board.

The company with one shareholder

In the case of a single-member company, i.e., one in which all shares are held by a single shareholder, convening a shareholders’ meeting is formal. A physical meeting is not required. It is sufficient for the sole shareholder to receive notice of the meeting along with the content of the resignation declaration, as, pursuant to Article 156 of the Commercial Companies Code, in a single-member company, the powers of the shareholders’ meeting are exercised independently by the sole shareholder. Therefore, there is no need to organize a formal meeting, as delivering the declaration in a manner that allows for review of its content is sufficient. However, for evidentiary purposes, it is recommended to document this action in writing. Proper delivery of the declaration to the shareholder is crucial. In practice, it is recommended to deliver it in a manner that allows for proof of this fact, e.g., by registered mail with acknowledgment of receipt, courier, or electronic means with acknowledgment of receipt. Proper delivery is a necessary condition for assessing the effectiveness of the resignation and its effective date.

The procedure is as follows:

1/ The member of the management board sends a declaration of resignation to the shareholder when convening the shareholders’ meeting;

2/ Because the company has a single shareholder, there is no need to formally convene a shareholders’ meeting. The sole shareholder exercises the powers of the shareholders’ meeting independently.

3/ The resignation becomes effective on the day following the day for which the meeting was called, even though it does not have to be formally held.

4/ A subsequent entry in the National Court Register is of a declaratory nature and confirms the existing situation, but does not condition the effectiveness of the resignation.

Can a company function after the resignation of the sole member of the management board?

The resignation of the sole member of the management board leads to a situation in which no mandate on the management board is filled. This situation is referred to in legal doctrine as a “hull body.” A company without a management board, and therefore a representative body, generally cannot effectively enter into contracts, incur obligations, or sign documents requiring management board representation. However, Polish law permits a company to temporarily operate without a management board, provided that an independent commercial proxy is present. Commercial power of attorney does not automatically expire upon the dismissal or resignation of the management board, as Article 109 § 7 of the Civil Code enumerates the instances in which commercial power of attorney expires, and the absence of a management board is not one of them. This view is also reflected in the case law of the Supreme Court and in rulings of the Supreme Administrative Court, for example, in judgment V CZ 26/16.

An independent commercial proxy may, therefore, temporarily represent the company and manage its day-to-day affairs. However, this situation should be purely temporary. A commercial proxy acts within a limited scope; for example, they cannot sign the company’s financial statements, which can result in serious consequences for failing to submit financial statements for the financial year, such as dissolution of the company without liquidation proceedings if the financial statements are not submitted for two consecutive years. They also cannot grant a special power of attorney for actions that require it (sale or encumbrance of real estate, sale of an enterprise), as these actions are reserved by law exclusively for the management board. Such company representation may also pose a risk of suspension of proceedings, as common courts have varying views on this issue, with some courts suspending proceedings ex officio under Article 174 § 1 item 2 of the Code of Civil Procedure, considering the lack of a management board to be a deficiency that prevents the company from operating, as evidenced by opposing rulings by the District Court in Bydgoszcz, case file VIII Gz 218/19, and the Court of Appeal in Poznań, case file III AUz207/22. Moreover, a long-term lack of management may negatively impact the company’s credibility in the eyes of business partners, who may refuse to enter into contracts with a company represented solely by an independent proxy, fearing for the entity’s stability.

Deletion of a management board member by the registry court and vacancy in the management board

The registry court will remove a management board member from the National Court Register (KRS) based on a submitted application, even if the company does not yet have a new management board. As mentioned earlier, an entry in the National Court Register is declaratory in nature, and the removal of a management board member by the registry court is not a necessary condition for the expiry of their mandate due to resignation. In such a situation, the court cannot refuse to remove a management board member unless the company is in arrears with its financial statements. However, pursuant to Article 24, Section 1a, if the court finds that there is nobody authorized to represent the company or that the body’s composition is deficient, the court may set a deadline and summon the shareholders to appoint or elect this body, subject to a fine. This initiates enforcement proceedings, in which the court may impose a fine of up to PLN 10,000 on the company’s shareholders, which may be imposed multiple times up to a total of PLN 1 million. If new management board members are elected, any unpaid fines will be waived. The court may also, as a last resort, waive or discontinue the compulsory decision and initiate proceedings to dissolve the company without liquidation proceedings, provided that the company has no transferable assets or does not conduct actual business.

Cancellation as an alternative to resignation

Besides resignation, another way for a management board member to terminate their position is through dismissal by an authorized body. In a limited liability company, this is generally the shareholders’ meeting, although this authority may be delegated to another body in the company agreement. In a company with a single shareholder, dismissal occurs by a shareholder resolution without convening a formal meeting. This immediately terminates the management board member’s mandate.

Sources:

P. Pinior, Resignation of a member of a corporate body, ABC.

A. Krokowski, K. Wielgus, Resignation from the mandate by a member of the management board of a limited liability company after the amendment of November 9, 2018, Rejent 2020, No. 5, pp. 65-100.

D. Marciniak, Resignation of the sole member of the management board of a capital company, PPH 2019, no. 12, pp. 52-58.

M. Dumkiewicz [in:] Commercial Companies Code . Updated commentary, Gdańsk 2026.

Resignation of the sole member of the management board in a Polish limited liability company (sp. z o.o.) is possible at any time, but the procedure is more formalized than in the case of an ordinary board member.

Under Article 202 § 6 of the Commercial Companies Code, the last remaining board member must submit the resignation to the shareholders while simultaneously convening a shareholders’ meeting. The resignation becomes effective on the day following the date for which the meeting was convened — regardless of whether the meeting actually takes place.

Importantly:
• resignation is a unilateral legal act,
• KRS entry is only declaratory,
• incorrect delivery of the resignation may render it ineffective,
• a company may temporarily function without a management board if a commercial proxy (prokurent) has been appointed, although this creates significant practical and legal risks.

The issue remains highly relevant in practice, especially in single-shareholder companies and entities facing governance disputes.

#CorporateLaw #Poland #CompanyLaw #ManagementBoard #Resignation #SpZoo #CommercialLaw #KRS #Governance #PolishLaw

Artykuł Resignation of the sole member of the management board of a limited liability company in Poland pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Labor law, as it regulates one of the key aspects of life, which is performing work in order to obtain funds ensuring a decent living, is one of the most important branches of law. As such, it must be constantly amended to adapt to the dynamically changing reality of life.

Information obligations

An important aspect of entering into an employment relationship is the level of knowledge the applicant has about the future job and its conditions. This allows for a conscious entry into a legal relationship with the employer. New regulations, introduced under the Act of 4 June 2025 amending the Labor Code (Journal of Laws, item 807), come into effect on Christmas Eve. They will require employers to provide information on all remuneration components, regardless of their name and nature, as well as other work-related benefits granted to employees in cash or otherwise. The initial amount or range of remuneration will also be required. All amounts must be based on objective, neutral criteria, particularly with respect to gender. Another mandatory information that employees will be required to receive is information on the provisions of the collective bargaining agreement or remuneration regulations, if such optional documents have been adopted at the workplace.

The information outlined above will need to be included in the job advertisement. However, failure to do so will not, as yet, entail any consequences. If this information was missing from the advertisement, the employer will be obligated to inform the candidate of its content before the interview. If it is not provided even then, the employee will ultimately be required to know it before signing the contract.

As for job advertisements themselves, they will be required to be gender-neutral. As for the recruitment process, the law will mandate that it be conducted in a non-discriminatory manner.

In addition to this information, the candidate will also be granted the right not to disclose their salary for their current position and all previous positions. This right is intended to protect against potential manipulation and pressure regarding remuneration, as this is a key issue.

Counting towards the period of employment

Another change, introduced by the Act of 26 September 2025 amending the Labor Code and certain other acts (Journal of Laws, item 1423), will concern the calculation of employment period. This period is important because of the benefits granted after achieving a certain length of service. These include, for example, increased leave entitlement.

According to the new regulations, the period of service in uniformed services and special services, including the military, currently included in these regulations, will be included in the employment period. Officers of the Marshal’s Guard and the Customs and Tax Service will be added to the list. This is undoubtedly a nod to officers who, after a period of service to ensure the proper functioning of the Polish government, leave for civilian life and have previously experienced worse treatment than their colleagues in other services.

The new regulations also include non-agricultural activities as employment, meaning, to simplify matters, such as running a business or practicing a freelance profession, and collaboration therein, as well as the performance of a mandate contract or other service contract if the provisions on mandate apply, i.e., so-called innominate contracts. The period of performance of an agency contract will also be considered a period of employment, as well as collaboration in the performance of this contract, mandate contracts, and the aforementioned other service contracts.

The cooperating person referred to in this text is considered to be the spouse, one’s own children, children of the other spouse and adopted children, parents, stepmother and stepfather, and adoptive parents if they live with them in a common household and cooperate in conducting the specified activity.

Another group whose activities are counted towards the employment period is membership in agricultural production cooperatives and agricultural circles. I believe this is intended to provide these individuals with some security for the future, particularly the opportunity to change jobs or retrain. For the above-mentioned periods to count towards employment, these individuals must be covered by social security (pension and disability insurance) during their periods, pursuant to separate regulations.

The new regulations will also introduce significant benefits for entrepreneurs who use the so-called “start-up relief” by counting the period of use of this entitlement towards their employment period. Their collaborators will have this period counted towards their employment period if they have opted to pay pension and disability insurance contributions, which is not mandatory for spouses.

The period of employment will also include the period during which the person suspended their business activity to provide personal care for the child. The same applies to a collaborator who suspended their professional activity to provide care for the child. This is a significant relief for parents.

A major facilitation, also important in the context of the EU principle of free movement of workers, will be the inclusion of the time spent working on a basis other than an employment contract towards the period of employment.

The period of employment required from candidates for specific positions in recruitment for vacant positions initiated and not completed before the date of entry into force of this Act by an employer that is not a public finance sector entity is not included in the calculation of the period of employment required from candidates for specific positions in recruitment for vacant positions initiated and not completed before the date of entry into force of this Act.

Including the period of employment with a specific employer

The method for calculating employment time with a specific employer will also change. This is important, for example, in determining the notice period for an employment relationship. Periods of non-agricultural business activity, performance of a mandate contract or other service contract are included in the employee’s employment period with a given employer. The provisions regarding mandate contracts, performance of agency contracts, being a collaborator with the aforementioned, being a member of an agricultural production cooperative, being a member of a cooperative of agricultural circles, performing activities covered by the start-up tax relief, or performing paid work on a basis other than an employment relationship abroad apply accordingly.

If the periods described above overlap, the most favorable, i.e. the longest, one is taken into account.

The periods referred to in non-agricultural activities, cooperation with an entrepreneur covered by the “start-up relief”, suspension of non-agricultural activities and cooperation in conducting such activities for the purpose of childcare are confirmed by a certificate issued by the Social Insurance Institution on the payment of contributions for retirement, disability or accident insurance for a given period on a given basis.

The periods of performance of a contract of mandate or other contract for the provision of services if the provisions on commission apply to it, an agency contract and cooperation in the performance of these contracts are confirmed by a certificate issued by the Social Insurance Institution on the coverage of pension and disability insurance.

The periods of entrepreneurial coverage under the “start-up relief” are confirmed by a certificate issued by the Social Insurance Institution on registration for health insurance

An application for issuing a certificate by the Social Insurance Institution is submitted by the person whose periods of employment are to be included in the employment period, in electronic form using an information profile created in the IT system provided by the Social Insurance Institution.

Artykuł Changes in labor law in Poland in 2026 pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Previous amendments to the Tobacco Act

The Polish Act on the Protection of Health against the Consequences of Using Tobacco and Tobacco Products (Journal of Laws 1996, No. 10, item 55, as amended) has undergone several significant changes in recent years.

On March 31, 2025, a law introducing a ban on the sale of heated tobacco products with a characteristic aroma was signed. It is worth mentioning that Commission Delegated Directive (EU) 2022/2100 of 29 June 2022 amending Directive 2014/40/EU of the European Parliament and of the Council as regards the abolition of certain exemptions for heated tobacco products (OJ L 283, 2022, p. 4), which required EU Member States to introduce such a ban, waited almost 3 years for implementation.

At the time of the act’s signing, work was underway on two further draft bills. The first of these had already been submitted and adopted as the Act of 21 May 2025 amending the Act on the Protection of Health against the Effects of Using Tobacco and Tobacco Products (Journal of Laws of 2025, item 799).

It introduces new definitions, among others:

• electronic cigarettes – as products that can be used for consuming nicotine-free vapor through a mouthpiece, or all components of such a product, including cartridges, tanks, and devices without a cartridge or tank. Electronic cigarettes can be disposable, refillable using a refill container or tank, or rechargeable using disposable cartridges.
• spare containers – as vessels with liquid containing nicotine that can be used to refill an electronic cigarette, or a vessel with liquid not containing nicotine that is intended for use in electronic cigarettes.
• nicotine pouches – as all products for oral use, except those intended for inhalation, containing no tobacco but nicotine, mixed or unmixed with other ingredients, which are portioned into pouches or available in pouches
• smoking electronic cigarettes – as the consumption of nicotine-containing vapour or nicotine-free vapour released by an electronic cigarette.

A ban on the sale of nicotine and nicotine-free electronic cigarettes to children and adolescents under 18 years of age, a ban on the sale of nicotine pouches in vending machines and remotely, and an extension of the advertising and promotion ban to include nicotine-free e-cigarette liquids and the maximum nicotine content in nicotine pouches were also introduced.

In addition to fulfilling the law’s goal of protecting public health and combating addiction, it was intended to close loopholes in the current legal framework, which allowed nicotine-free products (e.g., e-cigarette liquids) to be purchased even by minors. Furthermore, the ban on remote sales of nicotine pouches is intended to limit their availability and, consequently, reduce consumption.

Work is currently underway on the second of the announced bills.

Another amendment to the anti-smoking law

Another bill is currently being planned to introduce a ban on the sale of disposable electronic cigarettes, a ban on the sale of flavored nicotine pouches, greater control over e-cigarettes and new rules for the sale of other nicotine products (e.g. tablets).

The draft bill has been posted on the Government Legislation Center website and is currently in public consultation. Numerous entities have already expressed their views on the bill, including the American Chamber of Commerce in Poland, the Polish Chamber of Commerce, and several private individuals.

The draft amendment to the Anti-Smoking Act, designated as UD213 in the RPL list, provides for a ban on the sale of disposable electronic cigarettes and any products containing nicotine that are not tobacco products or related products – i.e. electronic cigarettes, refill containers, herbal products for smoking and nicotine pouches, with exemptions resulting from pharmaceutical law, the EU regulation on medical devices and EU food law (the latter exclusion is justified by the fact that some plants of the nightshade family (e.g. potato, tomato, pepper, eggplant) contain nicotine or its derivatives. Therefore, it was necessary to exclude from the aforementioned ban the placing on the market of food and foodstuffs in which the nicotine content results from its natural occurrence in the above-mentioned plants.

It also grants the State Sanitary Inspection and the Trade Inspection the authority to verify compliance with technical requirements by electronic cigarettes or refill containers on the market.

The President of the Bureau for Chemical Substances will have the right to request laboratory testing of the composition or emissions of electronic cigarettes or refill containers at the expense of the entity from which the sample was collected. Samples will be collected by the appropriate State Sanitary Inspectorate or, at the request of the President of the Bureau for Chemical Substances, by the manufacturer, importer, or distributor of electronic cigarettes.

The bill also includes a ban on the sale of nicotine pouches with a scent and taste other than tobacco.

As well as the requirement to inform about all ingredients used on the packaging of nicotine pouches and the prohibition of including elements relating to taste, smell or flavourings on them.

Justification

According to the bill’s authors, the bill aims to limit the availability of electronic cigarettes and nicotine pouches. This is intended to reduce their consumption and, consequently, reduce the health and safety risks they pose. This stems from research by the World Health Organization (WHO), which has shown that attractive scents and flavors increase the risk of addiction and attract young people to these products. For many, e-cigarettes are their first exposure to smoking. Even those who smoke e-cigarettes without nicotine are at risk, as they are more likely to later switch to nicotine-based products.

According to data from the Chemicals Bureau, in the period from 2018 to 2023 there was a significant increase in the number of notifications of electronic cigarettes and refill containers to the EU- CEG system from 2,575 in 2018 to as many as 12,772 in 2023. This is an increase of almost 400%.

The law is in line with European trends. Regulations banning disposable cigarettes are being introduced in countries such as France, Belgium, and the Netherlands.

The justification also highlighted the existence of a large number of nicotine-containing products on the market. In the bill’s opinion, only those specified in the act (such as cigarettes, electronic cigarettes, and novel products) should be allowed to be placed on the market. Other nicotine-containing products (such as gum, tablets, nasal and oral sprays, and nicotine-containing beverages) should be available only as a means of reducing the physiological and psychological effects of smoking cessation. Their removal from certain markets is also justified by their particularly addictive nature for certain groups, such as children, adolescents, non-smokers, and pregnant and breastfeeding women.

The possibility introduced into the Act for the Trade Inspection and the State Sanitary Inspection to verify the compliance of electronic cigarettes and refill containers with technical requirements is intended to enable these bodies to effectively supervise the composition of the liquid used in these products.

The improvement of supervision is also aimed at granting the President of the Bureau for Chemical Substances the right to commission tests on the composition of liquids for electronic cigarettes and tests on emissions from electronic cigarettes at the expense of the entity providing the samples.

Artykuł Revolutionary changes in tobacco law in Poland pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

The defendant, as a party in Polish civil proceedings, is a subject of rights and obligations. Their role in achieving the goal of each proceedings — the issuance of a just judgment that concludes the case—is indispensable. As the subject of the lawsuit, they respond to the opposing party’s arguments, thus assisting the court in fulfilling its task of fairly resolving the dispute. The defendant offers the justice system their perspective, which is essential because the justice system’s clear duty is to hear both sides; otherwise, it would be impossible to speak of a fair trial in which citizens have the opportunity and right to defend their rights and interests. Far from being a passive recipient of allegations, they are an active participant in the process, influencing the shape and course of the entire procedure and its outcome through the exercise of their rights. It should also be noted that the defendant’s overall rights and obligations constitute the principle of equality of parties in civil proceedings, which precludes denying one party access to necessary legal tools, for example, by excluding the possibility of appointing a legal representative or the ability to submit evidentiary motions. These rights extend beyond court proceedings and also include the use of amicable dispute resolution methods, such as mediation. Mediation naturally serves to avoid lengthy and costly litigation by reaching a settlement that is at least partially satisfactory to both parties. However, court proceedings, similarly, cannot limit the rights of one party at the expense of the other. The purpose of this study is to review the defendant’s rights in both arbitration and pre-trial proceedings, as well as in selected areas of court proceedings (hearings).

Defendant’s rights related to mediation and amicable dispute resolution

As noted in the legal literature, the most important feature (principle) of mediation proceedings is their voluntary nature. A party cannot be forced to participate in mediation, continue it, or reach a settlement, even if they have previously entered into a mediation agreement. This also gives them the right to terminate mediation by submitting a declaration of non-consent to mediation – as provided for in Article 183 (10) § 2 of the Code of Civil Procedure. It is also worth noting the flexibility of mediation proceedings, which, as provided in Article 183 (1) § 4, can be conducted before the initiation of the proceedings or, with the consent of the parties, during the hearing. This regulation clearly illustrates the principle of equal rights, as mediation will never occur without the consent of both parties. Parties also have the right to participate in an informational meeting on amicable dispute resolution methods, particularly with information relating to mediation proceedings. Therefore, it is appropriate to agree that courts, when referring parties to mediation and simultaneously seeking their consent, should also explain the essence of mediation. Courts may, for example, use their authority to inform the parties about what mediation is, as well as its advantages and possible benefits for the parties. Information meetings serve to provide knowledge about mediation proceedings and to equalize opportunities for both parties in order to counteract any information imbalance that may arise between them.

Parties can also shape the course of mediation proceedings, primarily by appointing a mediator. Importantly, this provision further emphasizes the balance between the parties in civil proceedings, as the other party must receive a copy of the mediation application, which the mediator receives. The parties may unanimously select someone from the pool of permanent mediators or select someone who is not a permanent mediator but meets the requirements of Article 183 (2) of the Code of Civil Procedure – i.e., a natural person with full legal capacity and full public rights who is not an active judge. Furthermore, both the plaintiff and the defendant have a say in the mediation period. Pursuant to Article 183 (10) of the Code of Civil Procedure, the deadline for extending mediation may be extended, which requires one of two conditions: a unanimous request from the parties or other compelling reasons, if this would favor an amicable resolution of the matter.

From the defendant’s perspective, a key guarantee is the so-called confidentiality principle of mediation, set out in Article 183 § 4 of the Code of Civil Procedure. This principle is primarily expressed by the fact that mediation proceedings are not public. None of the participants, including the mediator, may disclose information obtained during mediation or report on its progress. Participants may be released from this obligation only with the consent of the parties. The obligation of confidentiality by the mediator and other parties to maintain the confidentiality of facts learned in connection with the mediation continues regardless of the results achieved during the proceedings. The sanction for violating this obligation is the ineffectiveness of invoking the indicated proposals and statements during court or arbitration proceedings – Article 183 § 4 of the Code of Civil Procedure.

Defendant’s rights in preparatory proceedings

The preparatory proceedings are a crucial stage before the actual hearing, during which the court attempts to reach a preliminary resolution of the dispute, aiming to limit its scope or even conclude it without the need for further hearings. This stage involves the parties to the proceedings and their attorneys, who have the right and obligation to co-determine the course of the proceedings. Pursuant to Article 205 § 7 of the Code of Civil Procedure, a party’s participation in the preparatory hearing may be limited at the request of the party or its attorney. If the circumstances of the case indicate that the attorney’s presence alone will be sufficient to achieve the hearing’s objectives, the Presiding Judge may exempt the party from the obligation to appear in person. The defendant also has the right to influence the date and course of the proceedings. Pursuant to §§ 2 and 3 of Article 205 § 7 of the Code of Civil Procedure, the parties may, upon mutual request, adjourn the preparatory hearing for a specified period, not exceeding three months, and may exercise this option twice. This provision allows the parties to adequately prepare for the hearing and attempt to resolve the dispute amicably during this time. Additionally, the court may adjourn the preparatory hearing ex officio, particularly if it has referred the parties to mediation. The hearing is then adjourned until the mediation is completed or, importantly, until it is terminated, which the defendant has the right to influence independently by expressing their disagreement with further participation in mediation.

During the proceedings, the defendant has the right to present allegations and evidence in support of his or her own motions, as well as to rebut the opposing party’s allegations and motions. This right remains in effect until the court approves the draft trial schedule or prepares a trial schedule. In exceptional circumstances, the defendant may present new allegations or evidence even after the deadline, provided, however, that the defendant demonstrates that it was impossible to present them earlier or that the need to present them arose only during the proceedings. In such cases, the court is obligated to consider the new evidence and allegations and cannot ignore them. This regulation protects the defendant’s procedural rights, providing him with a real opportunity to defend himself and shape the evidence, and also guarantees that no important circumstances will be omitted during the proceedings, which is the foundation of a fair trial.

The defendant’s rights related to participation in the hearing

A fundamental right of a party in civil proceedings, including the defendant, is the right to seek the appointment of a court-appointed attorney or legal counsel. This right is available to parties unable to cover the costs of private legal assistance on their own, partially guaranteeing their right to a fair defense of their interests. It should be emphasized that this right is optional, as reflected in the use of the word “may” in Article 117 § 1 of the Code of Civil Procedure. According to this provision, this right is available to individuals exempt from court fees in whole or in part, as well as non-exempt individuals who submit an appropriate declaration that they cannot bear the costs of an attorney’s fee without detriment to the necessary support of themselves and their family. It is also worth noting that this right also applies to legal entities and other organizational units with legal capacity, as indicated in Article 117 § 1 of the Code of Civil Procedure. Thus, the legislator provides legal protection not only to natural persons, but also to other entities participating in the process who may need legal support at the state’s expense.

The 2019 amendment to Article 162 § 1 of the Code of Civil Procedure grants both parties the right to bring to the court’s attention any violations of procedural provisions. These violations are noted in the transcript of the hearing at the request of a party, but can be raised no later than the next session. Pursuant to Supreme Court judgment II CSKP 2317/22, objections submitted to the transcript do not require the court to indicate the procedural provisions violated to be effective. This is justified by the fact that the regulation does not require citing specific procedural provisions and by the fact that parties are often not represented by a professional attorney, which can happen because a power of attorney granted ex officio is optional, as indicated above.

Another important right of the defendant is the ability to justify their failure to appear in response to a summons or court notification due to their own illness, as well as the illness of their legal representatives, attorneys, witnesses, or other participants in the proceedings. Pursuant to Article 214 § 1 of the Code of Civil Procedure, this justification requires the presentation of a medical certificate confirming the inability to appear at the scheduled hearing. Such a certificate should be issued by a court-appointed physician, guaranteeing the reliability and objectivity of the assessment of the absent person’s health. This provision aims to protect the rights of the parties and participants in the proceedings by ensuring they can participate in the proceedings without endangering their health. At the same time, it serves to maintain the proper course of proceedings, as a failure to appear justified by a medical certificate does not result in negative procedural consequences for the party. This ensures that a party unable to participate in a hearing or session due to illness is not automatically deemed inadmissible, and their procedural rights remain intact.

A judgment issued in the defendant’s absence will not be considered a default judgment if the defendant has previously requested a hearing in their absence or has provided explanations, both orally and in writing, during the proceedings. Pursuant to Article 340 § 2 of the Code of Civil Procedure, the court cannot issue a default judgment against a defendant who has actively participated in the proceedings by providing explanations or has expressed a willingness to participate. This avoids situations in which a judgment is issued without considering the defendant’s position, which is contrary to the principle of equality of arms and the right to a fair trial. As explained in the case law, a written explanation submitted by the defendant (Article 340), contesting – in whole or in part – the request submitted in the lawsuit, precludes the issuance of a default judgment, regardless of the validity of the allegations contained in that explanation and the evidence presented therein. However, the fact that a party has undertaken preparatory activities, e.g., submitting a power of attorney, a request to adjourn the hearing or to grant a deadline for filing a response to the claim, or obliging the plaintiff to specify or justify the claims in the claim, does not constitute evidence of participation in the case. A default judgment cannot be issued against a defendant who has filed an application for exemption from court fees in whole or in part and for the appointment of an ex officio attorney, because such applications, which do not directly concern the defendant’s position on the claims filed against him, include the defendant’s intention to participate in the hearing in the sense that he wishes to defend himself in the proceedings, which should be considered a decisive negative premise in the context of issuing a default judgment.

The defendant’s position in civil proceedings has been shaped to guarantee them effective participation in the resolution of the dispute. The legislature has provided the defendant not only with the ability to defend themselves against the plaintiff’s claim but also with influence over the conduct of the proceedings, their pace, and their scope. These rights include the ability to refuse participation in mediation, to submit evidentiary motions and procedural objections, as well as the right to retain the assistance of a professional attorney or to appeal a default judgment. The above considerations are summarized in the diagram below, which concisely presents the defendant’s key rights at each stage of civil proceedings – from mediation and pre-trial proceedings to the trial.

List of defendant’s rights

1.         The right to participate or not to participate in mediation (Art. 205 § 2 of the Code of Civil Procedure; (Art. 183 § 8 § 2 of the Code of Civil Procedure); Art. 183 § 1 of the Code of Civil Procedure).

2.         Participation in an information meeting on amicable dispute resolution methods, in particular mediation (Article 183 § 8 § 4 of the Code of Civil Procedure).

3.         Lack of transparency of mediation proceedings (Art. 183 § 4, paragraph 1 of the Code of Civil Procedure)

4.         Possibility of extending the mediation deadline (Article 183 10 § 1 of the Code of Civil Procedure)

5.         Possibility of postponing preparatory proceedings twice (Article 205 7 § 3 of the Code of Civil Procedure)

6.         Possibility of terminating mediation (Article 183 10 § 1 of the Code of Civil Procedure; Article 183 1 § 1 and 2 of the Code of Civil Procedure)

7.         Possibility of conducting mediation with the consent of the parties also during the course of the case (Article 183 1 § 4 of the Code of Civil Procedure)

8.         Principle of confidentiality in mediation – The mediator and other persons participating in the mediation proceedings are obligated to maintain the confidentiality of any facts they have learned in connection with the mediation. The parties may release the mediator and other persons participating in the mediation proceedings from this obligation (Article 183 § 4 § 2 and 3 of the Code of Civil Procedure).

9.         The right of the parties to appoint a mediator (183 6 § 2 of the Code of Civil Procedure)

10.       The right to extend mediation upon the parties’ joint request or for other important reasons, if this will facilitate an amicable resolution of the matter. (Article 183 10 § 1 of the Code of Civil Procedure)

11.       Adjournment of the preparatory session when there are prospects of an amicable settlement of the dispute or when there is a need to clarify circumstances relevant to the resolution of the case or in the event of a justified failure to appear by a party, as well as at the joint request of the parties, for an indefinite period of time not longer than 3 months (Article 205 7 § 2 of the Code of Civil Procedure)

12.       The right to be released by the presiding judge from the obligation to appear at the preparatory hearing if the circumstances of the case indicate that the participation of the attorney will be sufficient (Article 205 § 1 of the Code of Civil Procedure)

13.       The right to cite allegations and evidence to support one’s motions or to refute the opposing party’s motions and allegations until the hearing schedule is approved. Claims and evidence submitted after the hearing schedule is approved will be disregarded unless the party substantiates that their submission was impossible or that the need to submit them arose later (Article 205 12 § 1 and 2 of the Code of Civil Procedure).

14.       The right to draw the court’s attention to procedural violations by requesting that an objection be entered into the minutes. Objections may be raised no later than the next hearing (Article 162 § 1 of the Code of Civil Procedure).

15.       Justification for failure to appear due to illness of the parties, their legal representatives, attorneys, witnesses and other participants in the proceedings, requiring a certificate confirming the inability to appear in response to a summons or notification from the court, issued by a court-appointed physician (Article 214 1 § 1 of the Code of Civil Procedure)

16.       A judgment issued in the defendant’s absence will not be issued by default if the defendant requested a hearing to be held in his presence or has already provided explanations in the case orally or in writing (Article 340 § 2 of the Code of Civil Procedure)

17.       A party (also a legal person) may request the appointment of a legal representative (Article 117, paragraphs 1, 2 and 3 of the Code of Civil Procedure)

18.       Representation is not mandatory (Article 117 § 1 of the Code of Civil Procedure).

Artykuł Defendant’s rights in Polish civil procedure pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

A family foundation is a relatively new institution in Polish law, introduced two years ago by the Act of January 26, 2023, on Family Foundations. The ability to establish such an entity was introduced primarily to enable entrepreneurs to secure the succession of their businesses in an undivided form, as well as to ensure the implementation of their own vision for managing them even longer after the founder’s death. Only a natural person with full legal capacity can be the founder of a family foundation. They can establish the foundation and designate its beneficiaries—themselves, relatives, or public benefit organizations—in their will or deed of incorporation. Both deeds should be executed by a notary. Unlike an Anglo-Saxon trust, a family foundation is not a legal relationship but a separate legal entity. Upon establishment, it acquires legal capacity and becomes a so-called “imperfect legal person.”

Tax benefits

Some use foundations to reduce, or rather optimize, their tax liabilities. According to the Corporate Income Tax Act, a foundation is exempt from, among other things, corporate income tax (CIT) if it conducts business activities. However, permissible business activities are defined by the framework set forth in Article 5 of the Family Foundation Act. Permitted forms of activity include:

– disposal of property, unless the property was acquired solely for the purpose of further disposal;

– renting, leasing or making property available for use on another basis;

– joining commercial companies, investment funds, cooperatives and entities of a similar nature, having their registered office in the country or abroad, as well as participating in these companies, funds, cooperatives and entities;

– acquisition and sale of securities, derivative instruments and rights of a similar nature (and others).

Establishment of the Family Foundation

According to the law, the establishment of a family foundation requires:

1) submitting a declaration of establishment of a family foundation in the founding act or in the will;

The documents should be in the form of a notarial deed.

2) establishing a statute that

*mandatory includes:

-name of the family foundation;

-seat of the family foundation;

-detailed purpose of the family foundation;

– the beneficiary or the method of defining it and the scope of the beneficiary’s rights;

– rules for maintaining the list of beneficiaries;

– rules, including detailed procedures, for waiving rights by the beneficiary;

-duration of the family foundation, if specified;

-value of the founding fund;

– the principles of appointment and dismissal, as well as the rights and obligations of members of the bodies of a family foundation, as well as the principles of representation of the family foundation by the management board or by other bodies of the family foundation in cases specified in the Act;

– entity authorized to approve the activities of the management board of a family foundation in the organization;

-principles of amending the statute;

– the allocation of the property of a family foundation after its dissolution, including the designation of the beneficiary entitled to the property in connection with the dissolution of the family foundation.

*may additionally contain:

– principles of cooperation or collaboration between the bodies of a family foundation;

– detailed circumstances of the dissolution of the family foundation;

– guidelines for investing the assets of a family foundation;

-provide for the establishment of a field unit or field units.

3) preparing an inventory of property which includes:

– Property rights contributed by the founder or persons other than the founder to the family foundation, with the indication of the person contributing the property and the specification of the type and value of each of the contributed property components, in the amount determined according to the condition and prices at the time of their contribution and their tax value,

-determination of the proportions used to determine the PIT exemption

– a list of property contributed to the family foundation to cover the founding fund.

4) establishing the bodies of the family foundation required by law or the statute;

– the Act enumerates: the management board, the supervisory board and the meeting of beneficiaries.

– The management board is appointed, unless the statute provides otherwise, by the founder and, after his death, by the supervisory board. In the absence of a supervisory board, the election is made by the meeting of beneficiaries. The management board’s duties include:

• managing the affairs of the family foundation and representing it;
• realization of the goals of the family foundation specified in the statute;
• taking actions related to ensuring the financial liquidity and solvency of the family foundation;
• creating, maintaining and updating the list of beneficiaries in accordance with the provisions of the Act and the principles contained in the statute;
• informing the beneficiary about the benefit he or she is entitled to;
• fulfillment of the benefit to which the beneficiary is entitled.

– A supervisory board is not mandatory if there are 25 or fewer beneficiaries. Unless the statute provides otherwise, the appointment and dismissal of supervisory board members is made by the founder, and after the founder’s death, by the meeting of beneficiaries.

5) contribution of the founding fund

 before entering the family foundation register in the case of establishing a family foundation in the founding act, or contributing the founding fund within two years from the date of entering the family foundation in the family foundation register in the case of establishing a family foundation in a will;

– the founding capital is specified in the statute, but cannot be lower than PLN 100,000

– the sole person obliged to contribute assets to cover the founding fund is the founder.

– property contributed to the founding fund cannot be returned.

– A foundation account may be established outside the territory of the Republic of Poland . This is not subject to restrictions in the European Union. Outside the EU, using such an account will constitute foreign exchange transactions and therefore require a foreign exchange permit from the President of the National Bank of Poland or a director authorized by him.

6) entry into the register of family foundations.

-The register of family foundations is maintained by the District Court in Piotrków Trybunalski, hereinafter referred to as the “registry court”.

-the proceedings are generally conducted in accordance with the provisions on non-contentious proceedings,

– the application for entry is submitted by submitting the foundation to the register by the founder or the board in the case of a foundation established in a will

-The application should include

• name of the family foundation, its registered office and address;
• the amount of the founding fund of the family foundation;
• names and surnames, PESEL numbers of the management board members, and in the absence of an obligation to have such a number – date of birth, and their addresses for correspondence, as well as the manner of representing the family foundation;
• names and surnames, PESEL numbers of the members of the supervisory board, and in the absence of an obligation to have such a number – date of birth, and their addresses for correspondence, if a supervisory board is established in the family foundation, if a board has been established at all;
• names and surnames, PESEL numbers of beneficiaries who are natural persons who are members of the group of beneficiaries, and in the absence of an obligation to have such a number – date of birth, and their addresses for service, and in the case of the beneficiary being an entity other than a natural person – name or company name and REGON identification number, and if the entity is registered in the National Court Register – also its number in that register;
• name, surname and correspondence address of the founder, if the founder is entitled to appoint the management board;
• duration of the family foundation, if specified.

-The following must be attached to the registration of a family foundation in the register of family foundations:

– the foundation’s founding act or the protocol of opening and announcing the will in which the foundation was established;

-statute

– a declaration by the founder about contributing property to cover the founding fund, and in the case of establishing a family foundation in a will – a declaration by the members of the management board that the founding fund will be contributed within two years from the date of entering the foundation in the register;

– proof of establishment of the foundation’s bodies, specifying their composition, if the composition of the family foundation’s bodies does not result from its statute

– consent to serve as a member of a family foundation body.

The notification is subject to the payment of a fee of PLN 500 in accordance with Article 64 a of the Act of 28 July 2005 on court costs in civil cases ( i.e. Journal of Laws of 2025, item 1228, as amended ).

*Before entry in the register, a company does not have legal personality, so its obligations are the responsibility of the founder or his or her representative. This responsibility ceases upon approval of their actions by a resolution of the management board.

Artykuł What is a family foundation under Polish law? pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

What essentially is GLP?

The problem of regulating diligence clauses in employment contracts in the laboratory industry is essential on the basis of Polish and EU law. These issues shall also consider the general consequences of breaching employee obligations in the form of the so-called Good Laboratory Practice (GLP) principles.

For some time in the business turnover we can observe the practice of including in employment contracts clauses concerning professionalism and professional diligence in the actions of future employees. As a rule, the clause at issue imposes an obligation on the employee to perform their tasks in a professional manner, adequate to their position and in accordance with standard operating procedures. In addition, all actions of the prospective employee must conform to the recommendations and directives of the supervisor and comply with the applicable law.

The laboratory industry is no exception in this area. It imposes an obligation on employees and contractors to act not only diligently but also based on the principles of Good Laboratory Practice. These principles have been in place since 1978 and regulate issues such as quality assurance in drug testing and development, the prevention of pharmaceutical scandals, and ensuring performance standards for laboratory areas. In addition, the principles regulate such key issues as staffing, space requirements and the quality of equipment and inspection processes for laboratory areas.

Polish GLP regulation and the consequences of violating it

On the grounds of domestic legislation, the issue of GLP is regulated in the Regulation of the Minister of Health of 3 August 2021 on Good Laboratory Practice and the performance of research in accordance with its scope. Annex I to the Regulation defines the standards of work required of the manager of a research center, the study director or members of the research staff. Attention should be paid to the last two categories, since the work standards specified for them determine the scope of diligence to which the employee may be obligated in a contractual clause. According to section 2(6) of the Annex to the said Regulation, the members of staff should be knowledgeable about the GLP of the specific research being conducted. They are required to act on the basis of the study plan and instructions contained in the documents, and to accurately record data obtained from the studies. Each employee should take care of his/her own safety and that of the environment, and report any deterioration of his/her health to his/her supervisor for the purpose of the possible removal from the study. Additional responsibilities are placed on the study supervisor as the person responsible for coordinating the team. These include, but are not limited to: overseeing the study and ensuring that it is conducted with care and accuracy; including cooperation with quality assurance programme officer, accepting the plan and standard operational procedures, and ensuring that adequate copies of the plan are available for the team to rely on when conducting the study. 

Employee actions are subject to constant scrutiny – any deviation from work standards and failure to follow GLP principles is documented and reported to the study director, according to the Regulation. This may result in various employment law consequences for the employee, such as reprimand, disciplinary responsibility, or even termination of employment contract. The detailed rules of an employee’s liability for a breach of due diligence are always defined in an individual contract constructed for them. It is worth mentioning, however, that omissions of individual employees may negatively influence the outcome of an inspection of the entire testing unit by the Inspector of Chemical Substances – the body appointed to inspect testing units at the national level.

European solutions

The basis of the Regulation of the Polish Minister of Health is to be found in the EU legal acts, which have been implemented into Polish law. Therefore, it should not be surprising that the regulations contained in the acts (created before the regulation) do not differ significantly from those adopted in the Regulation. The first of them, Directive 2004/10/EC of the European Parliament and the UE Council from 11February 2004 in Article 1 imposes on Member States the obligation to ensure that laboratories conducting tests on chemical products act in accordance with the principles of the GLP act and the Directive of 1967 on the classification, labelling and packaging of dangerous substances (67/548/EEC). Annex I of the 2004 Directive defines GLP as a quality system that relates to the organizational process and conditions under which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, archived and reported. It has been determined that the purpose of the establishment of the GLP is to take care of the quality and conditions under which non-clinical safety studies for health and the environment are carried out for the registration or authorisation of products such as pharmaceuticals, pesticides, veterinary products, industrial chemicals or food additives.

Key issue is the regulation set out in Section II, para. 1.4. of the abovementioned act, which constitutes the duties of research personnel. It imposes on personnel the obligation to know the GLP principles applicable to their participation in study being conducted. It orders the personnel to act on the basis of instructions included in study documents, as well as to maintain health protection measures in order to care for the environment and their own safety. They should also record the raw data swiftly and thoroughly. The duties of the study director set forth in this act are similar to those of the Regulation of the Polish Ministry of Health, namely such a director is responsible for supervising the diligent performance of personnel, approves study programs and instructions, and certifies that qualified personnel, familiar with GLP principles and the study plan undertake their duties.

The issue of control of research units, and consequently – their employees and their compliance with GLP principles, was regulated in Directive 2004/9/EC of the European Parliament and the EU Council of 11February 2004. It stipulates that Member States shall appoint national inspection authorities to supervise the operation of entities in accordance with the principles of professional diligence. If irregularities are detected in the implementation of GLP principles in a given unit, and employees show ignorance in the application of its principles, there will entail negative consequences (ranging from questioning the validity of the tests carried out by the unit to its removal or undertaking legal action). These consequences do not preclude additional action by the national authority, based on the specific rules of a given Member State.

It should not come as a surprise that employers in the laboratory sector are striving to enforce the highest possible degree of professionalism, accuracy and attention to professional duties from their employees – the specificity of the described branch requires the highest possible diligence in performing tasks and marginalization of mistakes, which may have serious consequences in the environmental and health dimension. EU and Polish regulations enable employers to effectively implement these obligations in the contract, with individual sanctions for failure to do so.

Artykuł DUE DILIGENCE CLAUSES IN LABORATORY EMPLOYMENT AGREEMENTS AND THE LEGAL CONSEQUENCES OF VIOLATING THEM VS. GOOD LABORATORY PRACTICE pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Artificial intelligence (AI) is currently finding widespread use in healthcare. A prime example is the Polish National Health Fund (NFZ) initiative, which utilizes AI to analyze patient data stored in the Fund’s databases. This data is then analyzed with the support of machine learning tools to make strategic decisions regarding the health of Poles. This approach will certainly simplify the work of doctors by searching for and analyzing the desired information, undoubtedly reducing their workload. However, such a solution may raise several issues and legal requirements related to regulations regarding the protection and processing of personal data.

What is personal data?

The most common definition of personal data is contained in the EU Regulation 2016/679 (GDPR), according to which personal data is any information about an identified or identifiable natural person. This includes direct identification (e.g., name and surname) or certain factors allowing indirect identification (e.g., job description or nationality). This concept is expanded by the Polish Act on the Protection of Personal Data Processed in Connection with the Prevention and Combating of Crime of December 14, 2018, by applying it directly to health. Health data here means personal data relating to the physical or mental health of an individual, including data on the use of healthcare services that reveal information about their health.

Patients’ rights

A number of patient rights are listed in the EU Regulation 2025/327 (Regulation on the European Health Data Space). The fundamental right is the right of individuals to access their electronically collected data (especially “priority data,” e.g., electronic prescriptions or imaging test results), which should be granted immediately after data is registered in the system. Individuals can also add their own information to their data already visible in the system and correct it. Furthermore, patients can grant access or request the transfer of their data to another provider. Access to healthcare professionals can also be restricted (however, in such cases, the patient should also be informed of the potential impact of such action on the quality of care provided). In this case, institutions collecting patient data should be aware of these rights, because if they are not respected, the patient could file a complaint (provided, however, that the rights or interests of the individual are adversely affected) and demand appropriate compensation.

The EU GDPR also provides similar rights, which additionally provides for one crucial privilege: the right to object. According to this regulation, an individual may object at any time to the processing of their data, including in connection with the performance of healthcare tasks, for reasons relating to their particular situation. In such a case, the data may no longer be processed unless the controller demonstrates compelling and legitimate grounds for further processing. Under the regulation, a patient could also request the deletion of their personal data if, for example, they are no longer necessary for the purpose for which they were collected or if they were processed unlawfully. Furthermore, the regulation also provides for the possibility of imposing an administrative fine of up to €20 million for a controller’s violation of guaranteed rights. Furthermore, Article 79 of the GDPR grants the right to an effective judicial remedy if the individual (patient) believes that the processing of their personal data violated the law.

Obligations of entities storing and processing data

Pursuant to Article 24 of the GDPR, the data controller is obligated to implement appropriate technical and organizational measures to ensure data processing is carried out in compliance with legal provisions and the rights and freedoms of others. The controller must also review and update these measures as necessary. In the case of AI-based patient data processing, the obligation specified in this article to design the measures described above is also crucial, ensuring that only information necessary to protect the patient’s life and health is processed by default. In the event of a personal data breach, the controller should (within 72 hours of becoming aware of the breach) notify the relevant supervisory authority of the personal data breach. However, the controller is not obligated to do so if the likelihood of a breach affecting the rights and freedoms of natural persons is low. If the risk of a breach is high, the controller should also notify the affected individual. Furthermore, before processing begins, even using new technologies (including AI), if it may result in a high future risk to the rights and freedoms of natural persons, it will be necessary to assess the impact of the planned processing on personal data protection. If such an assessment indeed reveals a high risk, and if the controller fails to implement any measures to mitigate it, the controller must contact the relevant supervisory authority (in Poland, the President of the Personal Data Protection Office [President of the UODO]), which then provides the controller with a written recommendation and may also temporarily restrict or prohibit processing or issue a warning to the controller. General obligations, according to which personal data must be processed lawfully and fairly, in a transparent manner, and limited to what is necessary for the purposes for which they are processed, are also important.

In this situation, Regulation 2024/1689 (“AI Act”) also provides an interesting requirement. According to Article 4 thereof, healthcare entities using AI systems to make strategic decisions about patients are responsible for maintaining an appropriate level of AI competence among their staff, taking into account the purpose of using the system and the persons for whom the systems are to be used.

Requirements for the AI systems themselves

The basic requirements that AI systems used for data processing would have to meet are set out in the aforementioned AI Act. This document explicitly classifies AI systems as “high-risk systems”, and therefore, the requirements set out in the act apply to them. Primarily, this requires maintaining appropriate documentation for the system: technical documentation regarding the quality management system (including data acquisition, collection, analysis, and labeling) and an EU declaration of conformity confirming the system’s compliance with the requirements set out in the regulation. Furthermore, this documentation should be kept at the disposal of the competent national authorities for 10 years after the system’s commissioning. Such systems should also meet transparency requirements, meaning they should be designed to facilitate proper use and interpretation of their actions (they should also have clear operating instructions). They must also have an appropriate oversight system that allows for human oversight of the AI if necessary, especially if its operation were to get out of control and harm others. Finally, AI systems are also subject to certain formal requirements, such as undergoing a pre-market conformity assessment and registering in a dedicated EU database for high-risk AI systems. It is also important to remember that high-risk AI systems are subject to general CE marking regulations. Once placed on the market, suppliers are required to establish a post-market monitoring system for AI systems to ensure their legal compliance.

The issue of non-personal data

It is also worth raising the issue of non-personal data, for example, in the context of a situation where a hospital, in order to decide on the appropriate medication for a patient, requests information about certain medications from a pharmacy. A public sector body may request such information only to the extent that the lack of this data would prevent it from performing its public interest tasks or when the body has no other available means of obtaining such data. A request for this purpose should be submitted (specifying, in particular, the purpose for which the information is requested). However, the data subject who received it may refuse to provide it if they have no control over the requested information or if a similar request for the same purpose has already been submitted by another public sector body. Once the requested information is in the possession of the requester, they must not use it in a manner inconsistent with the purpose for which the data was provided. They must ensure measures to protect its confidentiality or integrity, and they must delete the data as soon as it is no longer needed for the specified purpose. They are also prohibited from using the information obtained to improve a competitive product or from disclosing any information in this regard to third parties. It is also important to bear in mind the right of a public sector body to share the data received with individuals or organisations for the purposes of scientific research or analyses consistent with the purpose for which the data was requested, or with national statistical offices (e.g. the Central Statistical Office). It is important here that these organisations do not have a commercial nature or are not related to entities that do.

The status in Poland

As mentioned above, Poland has established a special supervisory authority for personal data protection, the President of the Personal Data Protection Office (UODO), acting with the assistance of the Office for Personal Data Protection. Among other things, this authority is responsible for consultations on data processing that poses a significant risk of violating the rights of others. It also conducts proceedings in cases of violations of personal data protection regulations and establishes a plan for monitoring compliance with these regulations.

It is also worth remembering the regulations of the Polish Act on Patients’ Rights and the Patient Ombudsman. It stipulates that patients have the right to access medical records concerning their health and the services provided to them. The entity storing this documentation is obligated to disclose the data contained therein only to the patient themselves or an authorized person (or, for example, to a university or research institute for scientific purposes, but without any data allowing for the identification of the individual). Furthermore, the entity providing services is obligated to retain medical records only for a specified period (generally 20 years), after which they should be destroyed in a way that prevents the identification of the patient to whom they pertained. The Act on the Healthcare Information System also limits access to these records to medical professionals and physicians.

Also important are the provisions of the Act on the computerization of the activities of entities carrying out public activities, under which an entity maintaining a public register (i.e. any type of records used to carry out public tasks based on the relevant provisions) should provide another public entity with access to the data in its possession to the extent necessary to carry out public tasks.

It is also important to remember the Polish Code of Medical Ethics, which, in Article 14, requires physicians to inform patients about the benefits and risks associated with proposed diagnostic procedures and, where appropriate, about the possibility of using other methods. Furthermore, according to Article 12, the use of AI in treatment may only occur after the following conditions are met: informing the patient that artificial intelligence will be used in the diagnosis or therapeutic process; obtaining the patient’s informed consent to the use of artificial intelligence in the diagnostic or therapeutic process; and using AI algorithms that are approved for medical use and have the appropriate certifications. However, the final decision always rests with the physician.

A government draft legislation is currently being prepared, which will be designed to adapt the national legal system to the requirements imposed by the AI Act. The government’s proposals primarily envisage the establishment of the Artificial Intelligence Development and Security Commission, which will oversee the AI market within the scope specified in Article 2 of Regulation 2024/1689. The second main body will be the President of the Personal Data Protection Office (UODO) that will oversee high-risk AI systems, including those related to healthcare.

Summary

Processing personal data for healthcare purposes, additionally supported by artificial intelligence, is undoubtedly a convenient and practical solution, but it is associated with a number of legal obligations intended to ensure the security of the data used (e.g., using the acquired data only for a strictly defined purpose), the security of patients themselves (e.g., the obligation to inform the patient of the intention to use artificial intelligence in the treatment process), or simply related to formalities (e.g., the requirement to register the artificial intelligence system in an EU database). Currently, EU regulations are much more detailed in this matter.

Artykuł National Healthcare and the processing of personal data by means of AI pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

The Act of 21 February 2019 (Journal of Laws of 2025, item 259) established a new state institution in the medical sector – the Medical Research Agency. According to Article 1, Section 7 of this Act, the Agency’s objective is to support innovative activities in healthcare, with particular emphasis on the development of non-commercial clinical trials and research experiments. One of its tasks is to support the biomedical sector by financing scientific research and development, as well as strengthening the national capacity to conduct non-commercial clinical trials. Between 2019 and 2021, the Agency contracted research projects worth approximately PLN 1 billion – 50% of the projects concerned specialization projects in oncology and cardiology, which accounted for 67% of the research budget. More importantly, the Agency was tasked with designing the Government Biomedical Sector Development Plan for 2022–2031, for which a PLN 2 billion budget was secured, originating from two sources: the National Recovery Plan and funds from the Medical Research Agency, subsidized by the Ministry of Health. Biomedicine is a field of medicine that utilizes the achievements of biological, biochemical, biophysical, and biotechnological sciences and is widely used in the early diagnosis and treatment of diseases. It utilizes innovative technologies and research results on a large scale. The global biomedical market is experiencing steady growth. Poland aspires to become a leader in this field in Eastern Europe, a goal that cannot be achieved without a unified strategy, hence the decision to create the Plan.

Diagnosis of the Polish biomedical sector

The Medical Research Agency began creating the plan by preparing a diagnosis of the Polish biomedical market, dividing it into several sectors:

• Drug manufacturing sector (pharmaceutical);

• Medical device and equipment manufacturers sector;

• Biotechnology sector;

• Start -up sector.

Pharma sector is undoubtedly the most developed in Poland in the biomedical field. According to 2019 data, domestic drug manufacturers supply patients with 48% of all reimbursed drugs, but this only generates 28% of the total reimbursement from the National Health Fund. The pharmaceutical industry generated approximately 0.8% of GDP in 2019, while in 2022 it was 0.67%. However, this decline in percentage does not reflect the actual contribution of the drug manufacturing sector to GDP, which increased from PLN 16.7 billion to PLN 20.66 billion during the same period, reflecting overall economic growth. The pharmaceutical industry directly or indirectly provides approximately 100,000 jobs, and in 2019, 36% of companies collaborated with scientists and universities. Significantly, the majority of drug production financing (75%) comes from internal funds.

Turning to the medical device and equipment manufacturing sector, this is the most dynamically developing area – in 2018, the Polish market was valued at $2.5 billion (a 40% increase over 2017), and in 2020, it reached approximately $4.7 billion. However, the picture emerging from these rather promising figures is significantly marred by the fact that domestic manufacturers only account for 15% of this market, with as much as 60% of revenue generated from device exports. The main categories of medical devices offered by Polish companies include rehabilitation equipment, orthopedic equipment and prostheses, medical and veterinary instruments, hospital furniture, operating room and intensive care equipment, diagnostic devices (ultrasound machines, X-ray machines), and disposable equipment.

The biotechnology sector is by far the least developed – in 2019, only 181 companies were involved in biotechnology, half of which employed fewer than 50 people. Importantly, however, 63% of companies conduct R&D (research and development) activities, which involves conducting their own scientific research and then using its results to develop new products and implement innovative technologies. The most important part of the biotechnology market is red biotechnology, i.e., related to healthcare and diagnostics. It is based on gene therapies, regenerative medicine, and the creation of biopharmaceuticals using living organisms. According to forecasts, the Polish medical biotechnology market is expected to grow at an average annual rate of 3.4% between 2021 and 2027, reaching a value of $4.8 billion. However, this will still be a small share compared to other countries of similar size (for example, in Spain, the market value is twice as large). The largest segments of the Polish red biotechnology market are vaccines, blood products, and recombinant gene therapies. According to forecasts, the fastest-growing sectors in Poland between 2021 and 2027 will be personalized medicine (6% CAGR) and recombinant gene therapies (5.8% CAGR).

The start-up segment also plays a minor role in the Polish biomedical market. They specialize in bioinformatics and IT applications in healthcare. Importantly, these companies are characterized by a wide variety of medical specialties, with cardiology and psychology accounting for the largest share. Over half of healthcare startups finance their development with grants from the National Centre for Research and Development (NCBR), and 30% receive support from the Polish Agency for Enterprise Development (PARP). The remainder consists of own funds, revenues, and customer contributions. Interestingly, start-ups primarily collaborate with individual scientists, not research centers such as universities, and Academic Business Incubators (ABIs) play no role in financing startups specializing in biomedicine.

While biomedical research is subsidized, the Medical Research Agency, the National Centre for Research and Development, and the National Science Centre spent over PLN 4.2 billion on research and development between 2014 and 2021. However, this doesn’t translate into Poland’s innovation in biomedicine compared to Europe. According to the European Research Index, Poland’s research and innovation intensity index, which measures total domestic research and development expenditure as a percentage of GDP, is 1%, compared to the EU average of 2.1%. Research conducted by the Medical Research Agency (ABM) shows that entrepreneurs identify numerous obstacles to the development of the biomedical market and its innovation, including:

• Legal and administrative – entrepreneurs’ opinions indicate that administrative procedures (reimbursement, tenders) are long and complicated, and legal solutions are inadequate and slow down or even block decision-making, operational and investment processes in enterprises;

• Financial – limited access to financial resources for research and development, inappropriate financing to the specific nature of the business and high costs of operation and development;

• Infrastructure – limited access to research infrastructure, insufficient national know-how and lack of systemic education for the needs of the sector;

• the lack of a comprehensive development strategy for the biomedical sector, which translates into a lack of coordination between individual ministries, as well as the lack of a mechanism to support the domestic production of drugs and medical devices necessary to ensure drug safety.

It follows that the development of the biomedical sector in Poland requires the creation of a supportive system with clearly defined development goals, involving entities conducting scientific research and development (such as universities, research institutes, biotechnology enterprises, start-ups, and scale -ups). In the field of biomedical innovation, we are observing an unprecedented alliance of information technology and computational technologies with biological sciences (e.g., the use of artificial intelligence to model processes at the genome level). The Polish system should adapt to changes in technological development in biomedicine, respond to needs, and remove obstacles to innovation – this role was intended to be fulfilled by the “Biomedical Sector Development Plan for 2022-2031,” completed in 2022.

Biomedical sector development plan for 2022-2031 – planned changes and investments

ABM conducted an analysis of the market situation and market indicators, and also used recommendations from stakeholders in the biomedical sector in the country, which allowed for the definition of priorities towards which the development of the sector should be directed (so-called development domains):

• targeted/personalized medicine developed in the context of gene and cell therapies, immunotherapy and vaccines, small molecule and biological drugs supported by bioinformatics tools and pharmacogenomics;

• biological drugs, innovative methods of producing APIs (active drug substances) and innovative solutions in the field of generic drugs;

• translational medicine, clinical research and solutions supporting treatment effectiveness in the context of patient data and treatment management, legal and governance infrastructure for VBM/EBM (evidence-based medicine that uses the best available scientific evidence, physician clinical experience and patient preferences to make decisions);

• diagnostic, therapeutic and treatment and rehabilitation support tools in the context of patient data and treatment management, legal and management infrastructure for VBM/EBM and the application of bioinformatics solutions.

Key areas related to the health needs of both Polish society and the healthcare system have also been identified – the Plan focuses on research development and protection, primarily in areas such as:

• oncology, in particular: malignant tumors of the trachea, bronchi and lungs, female breast and prostate;

• cardiology, in particular: ischemic heart disease, atherosclerosis and cerebrovascular disease;

• respiratory diseases, in particular: influenza, pneumonia, COPD and asthma;

• infectious diseases;

• metabolic diseases, especially diabetes;

• neurology and psychiatry, in particular depression and dementia.

The Plan therefore takes into account both the market and economic aspects (directional priorities – development domains) as well as the development needs of the healthcare system. It is also intended to address the problems identified by biomedical entrepreneurs, as outlined above. The actions planned for implementation within the Plan are aimed at implementing the so-called “escape forward” scenario – achieving a strong position in one of the biomedical niches and building R&D potential that will spill over into other areas of the economy. In theory, this will allow for the achievement of easily noticeable development effects with a relatively small funding stream. By 2031, the Plan’s authors aim for Poland to become a leader in the biomedical sector in Central and Eastern Europe, leading to the development of the first innovative Polish drug, and leading Poland from a fragmented and inefficient biomedical sector to a Polish Medical Valley.

To achieve its goals, the Agency has identified four areas of development and the actions that must be taken in each. These are:

• Management system;

• Innovative therapies and medicines of the future;

• Medical Devices and Digital Health;

• Developing the sector’s potential.

• Management system – at the initial stage, the most important thing is to properly support the development of innovations during the research phase and the consistent commercialization of emerging medical and technological solutions. The role of the ABM is to ensure coordination, information flow, and actions taken by establishing and launching a monitoring and coordination center for biomedical sector projects in the Republic of Poland, as well as by mapping and verifying biomedical projects in the Republic of Poland with the help of a coordination and monitoring committee – for now, this is only theoretical, as neither has been established to date.

However, at the initiative of the ABM, there was established Health Innovation Hub – this entity is intended to be a place for the exchange of experiences, the flow of ideas, and the establishment and shaping of appropriate relationships between economic, public, and scientific entities collaborating within the biomedical sector. As part of its activities, Health Innovation Hub will review and recommend innovative research and implementation projects conducted by individual partners and their consortia.

Innovative therapies and medicines of the future – the Plan places a strong emphasis on scientific development and the creation of innovative solutions in the field of targeted/personalized medicine – creating medicinal products based on nucleic acids, cell therapy, and protein products, as well as strengthening the pharmaceutical and biotechnology sectors. The challenge currently faced by European countries, including Poland, is drug safety, which should be ensured not only by securing supply chains in crisis situations, but primarily through the development and domestic production of active substances, the development of new pharmaceutical forms of authorized drugs, biosimilars, and innovative solutions in the field of generic drugs. The goal is to implement at least 40 projects that advance to at least Phase I of clinical trials. PLN 750 million (37.5% of the budget) has been allocated to this area, of which PLN 650 million from state funds and PLN 100 million from the National Treatment Programme (KPO).

Medical Devices and Digital Health – the development of telemedicine will be particularly dynamic in the areas of primary care and clinical trials. This involves the development of digital analytical platforms that collect patient health data and analyze it based on AI algorithms, including machine learning. The use of artificial intelligence for disease detection, diagnosis, and treatment is intended to improve the efficiency of the healthcare system – shortening patient treatment times, increasing treatment efficacy, and lowering costs. Development in this area would also involve the development of new diagnostic methods, increasing the accuracy and speed of diagnosis at an acceptable market cost, particularly in oncology and infectious diseases. It is assumed that at least 51 projects will be implemented, reaching at least the MVP/ scale -up phase – creating a minimum viable product and establishing a successful business model. PLN 524.5 million (26.23% of the budget) has been allocated to this area, of which PLN 364 million from state funds and PLN 160 million from the National Health Fund (KPO).

Developing the sector’s potential – at the time the Plan was created, the biomedical innovation system was fragmented, with individual entities focusing solely on tasks within their own areas of activity. Integrating individual areas requires a strong link between the various stages of development, as well as a shift in the ethos of strategic collaboration and thinking in terms of measurable end results (such as patient health and well-being, treatment costs, social costs and impacts, and the economy). In short, in order to develop, the biomedical sector must define the effects it wants to achieve and, to this end, create links between the individual stages of the “chain.” To this end, the plan will create financial instruments for R&D companies, such as grants for companies implementing projects at early TRL levels (a scale used to assess the maturity and technological readiness of a project or technology), acceleration programs for companies supporting start-ups at early TRL, grants for companies with identified technological solutions, and grants for Technology Transfer Centers to support start-up development. The development of a network of Clinical Research Support Centers is also planned. In this area, it is assumed that at least 55 projects will be implemented and 40 new Clinical Research Support Centers (CWBK) will be created, an IT platform for the Polish Clinical Research Network (PSBK), an IT platform for the Polish Clinical Research Network (PSBK), a Polish-language clinical trial search engine will be launched, and awareness and acceptance of clinical trials will be raised. PLN 702.6 million (35.13% of the total) has been allocated to this area. budget), of which PLN 4 million from state funds and PLN 698.6 million from KPO.

Funding will largely be allocated through a competitive process. The Medical Research Agency website features a dedicated “Competitions” tab, which provides access to all current applications (currently one) and completed applications, of which 25 have been completed since 2019.

Sources:

1. Annex to resolution No. 141/2022 of the Council of Ministers of 21 June 2022 – GOVERNMENTAL DEVELOPMENT PLAN FOR THE BIOMEDICAL SECTOR FOR 2022–2031;

2. Polish Agency for Enterprise Development – The Medical Devices and Pharma Sector in Poland Report 2024.

Artykuł POLISH BIOMEDICAL SECTOR DEVELOPMENT PLAN FOR 2022-2031 pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Publication date: August 31, 2025

On August 28, 2025, the Polish Act of June 25, 2025, on the national cybersecurity certification scheme, entered into force, implementing Regulation (EU) 2019/881 of the European Parliament and of the Council of April 17, 2019, on ENISA (the European Union Agency for Cybersecurity) and cybersecurity certification in information and communication technologies and repealing Regulation (EU) No 526/2013 ( Cybersecurity Act ) (OJ L 151, 7.06.2019, p. 15 and OJ L 2025/37, 15.01.2025).

Regulation 2019/881 established a European cybersecurity certification framework, introducing the possibility of creating European certification schemes and common rules for obtaining certificates. Recital 69 of the aforementioned Regulation states: “It is therefore necessary to adopt a common approach and establish a European cybersecurity certification framework, specifying the main horizontal requirements for the European cybersecurity certification schemes to be developed and enabling the recognition and use in all Member States of European cybersecurity certificates and EU statements of conformity for ICT products, ICT services or ICT processes. […] This European cybersecurity certification framework should have a two-fold objective. Firstly, it should help to increase trust in ICT products, services and processes certified under European cybersecurity certification schemes. Secondly, it should help to avoid the proliferation of conflicting or overlapping national cybersecurity schemes, thereby reducing costs for undertakings operating in the digital single market.” Recital 70 further states: “The European cybersecurity certification framework should be established in a harmonised manner across Member States in order to prevent certification shopping practices due to differences in the levels of requirements in different Member States.”

Unification of certificates in the European Union?

Each certificate issued under a specific European cybersecurity program, as referred to in Article 2, point 9 of Regulation 2019/881, will be automatically recognized throughout the European Union. As indicated in the Council of Ministers’ justification for the adoption of the Act, Regulation 2019/881 requires all EU Member States to establish a national cybersecurity certification authority, which will oversee the market and monitor the correctness of certification activities. To implement the Regulation’s provisions, it was also necessary to introduce a procedure for the accreditation of entities authorized to issue certificates into the Polish legal system. The Act also provides for the introduction of a national cybersecurity certification scheme in areas not covered by European cybersecurity certification programs.

Pursuant to Article 1 of the Act on the National Cybersecurity Certification System, the Act specifies the organisation of the national cybersecurity certification system and the tasks and responsibilities of the entities comprising this system, including the method of supervising the activities of the entities comprising this system, controlling the activities of these entities and coordinating their activities.

The complex relationship between European and national certificates

The relationship between these models (the European and Polish certification systems), or between the Act on the National Cybersecurity Certification System and Regulation 2019/881, appears in some respects rather complicated, incomprehensible, or even chaotic. The problem with this provision appears to lie in the parallel operation of the national and European systems.

Under the Regulation, Poland will issue a European cybersecurity certificate as defined in Article 2, point 11 of Regulation 2019/881, a definition to which the Act on the National Cybersecurity Certification System refers. In addition to the European cybersecurity certification scheme (Article 2, point 9) and the related European cybersecurity certificate (Article 2, point 11), Regulation 2019/881 provides for a national cybersecurity certification scheme (Article 2, point 10).

The Act on the national cybersecurity certification system, specifically in Article 2, point 12, additionally mentions a national certificate defined as:

 a document confirming that a given ICT product, a given ICT service, a given ICT process, a given managed security service, a given cybersecurity management system or a given natural person has been assessed for compliance with the detailed requirements specified in the national diagram cybersecurity certification.

The concept of a national cybersecurity certification scheme is interesting because it is a way to expand the national cybersecurity certification program defined in Regulation 2019/881. A national cybersecurity certification program can only apply to ICT products, services, and processes, as well as managed security services. However, this definition leaves Member States without the basis to issue certificates covering individuals (e.g., cybersecurity experts) or security management systems under national certification programs.

For this reason, the Polish legislator created the concept of a national cybersecurity certification scheme in Article 2, point 13, which reads as follows: “national cybersecurity certification scheme – a national cybersecurity certification program referred to in Article 2, point 10 of Regulation 2019/881 and a comprehensive set of regulations adopted by a national cybersecurity certification authority, applicable to the certification of cybersecurity management systems or natural persons in the field of cybersecurity.”

What is the national cybersecurity certification system?

As indicated in Art. 3, paragraph 1: “The national cybersecurity certification scheme is a set of entities referred to in paragraph 2 and procedures related to certification […] under European cybersecurity certification schemes or national cybersecurity certification schemes and procedures for the certification of cybersecurity certification schemes or natural persons under national cybersecurity certification schemes […]”, and also in paragraph 2: “The national cybersecurity certification scheme includes: 1) the minister responsible for digitalization; 2) the Polish Centre for Accreditation; 3) conformity assessment bodies; 4) suppliers who subject their products, services, ICT processes or managed security services to a conformity assessment under a given European cybersecurity certification scheme or a given national cybersecurity certification scheme; 5) natural persons who subject their knowledge and practical skills to a conformity assessment under a given national cybersecurity certification scheme; 6) entities that subject the cybersecurity management systems they use to a conformity assessment under a given national cybersecurity certification scheme.”

The relationship between national cybersecurity certification schemes and European cybersecurity certification schemes is also governed by Article 57(1) of Regulation 2019/881. It states that: “national cybersecurity certification schemes and related procedures for ICT products, ICT services, ICT processes and managed security services that are covered by a European cybersecurity certification scheme shall cease to have effect on the date specified in the implementing act adopted pursuant to Article 49(7). National cybersecurity certification schemes and related procedures for ICT products, ICT services, ICT processes and managed security services that are not covered by a European cybersecurity certification scheme shall continue to exist.”

The distinction between a national certificate and a national cybersecurity certificate was outlined in the Council of Ministers’ justification for the act as follows: a national certificate will be issued for a product, service, ICT process, or managed security service, a security management system that ensures the availability, authenticity, integrity, or confidentiality of stored, transmitted, or processed data, or provided functions or services, at a level appropriate to potential cyberthreats, and minimizes known risks related to cyberthreats.

Therefore, possession of such a certificate will guarantee an adequate level of protection. In turn, a national cybersecurity certificate may be issued to an individual who possesses the knowledge and practical skills necessary to effectively perform cybersecurity tasks. Its holders will be able to stand out in the job market, and potential employers, including public institutions, will have proof of their competence.

Framework for the national cybersecurity certification system

Article 6 of the Act on the National Cybersecurity Certification System specifies that a product, service, ICT process, managed security service, cybersecurity management system, or an individual’s cybersecurity knowledge and practical skills may be subject to a compliance assessment in accordance with a given national cybersecurity certification scheme. Article 7 of the Act on the National Cybersecurity System specifies the requirements for issuing a national certificate.

These requirements include ensuring the availability, authenticity, integrity, or confidentiality of processed data or provided functions or services at a level appropriate to potential cyberthreats, and minimizing known risks related to cyberthreats. In the case of individuals, a national certificate may be issued to an individual who possesses the knowledge and practical skills necessary to perform cybersecurity tasks.

Methods for verifying whether the requirements are aligned with the appropriate cybersecurity certification scheme include: examination of technical documentation, audits, testing of specific properties, or performance analyses. In the case of individuals, competence will be verified through a knowledge and practical skills test (Article 8 of the Act on the National Cybersecurity Certification System). A national certificate may be issued for a period of no less than two years and no longer than five years. According to the justification for the act, this is due to the fact that cybersecurity is a rapidly evolving field, meaning that a certificate issued in the past may not necessarily correspond to the level of competence currently required. However, its validity must be sufficiently long to ensure the certificate continues to function and remains relevant in the market. The certificate’s validity can be extended (Article 10 of the Act on the National Cybersecurity System).

Obtaining a national certificate also entails certain obligations on the part of its holder, including reporting obligations to the conformity assessment body, as further specified in Article 12 of the Act on the National Cybersecurity Certification System. The act stipulates that technical documentation regarding the subject of certification must be retained for a period of 10 years following the certificate’s expiry. This is necessary for monitoring and, if necessary, auditing the proper functioning of conformity assessment bodies (Article 14 of the Act on the National Cybersecurity Certification System).

Creating national cybersecurity certification schemes

Pursuant to Art. 15 of the Act on the national cybersecurity certification system: The minister responsible for digitalization may specify, by regulation, a national cybersecurity certification scheme for selected ICT products, ICT services, ICT processes, managed security services, cybersecurity management systems or individuals, containing:

1) detailed requirements for ICT products, ICT services, ICT processes, managed security services, cybersecurity management systems subject to conformity assessment or individuals whose knowledge and practical skills in the field of cybersecurity are subject to conformity assessment;

2) detailed methods used to demonstrate that an ICT product, ICT service, ICT process, managed security service, cybersecurity management system or individual meets the requirements referred to in point 1;

3) detailed conditions for issuing, maintaining and extending the validity of national certificates;

4) detailed method of monitoring the compliance of ICT products, ICT services, ICT processes, managed security services, cybersecurity management systems or individuals with the requirements referred to in point 1, including mechanisms for demonstrating compliance with these requirements;

5) the detailed scope of technical documentation relating to certification and the method of storing and destroying this documentation;

6) the period of storing technical documentation relating to certification;

7) the period for which the national certificate is issued; 8) the template of the national certificate.

Accreditation and conformity assessment

Conformity assessment is performed by a conformity assessment body accredited to a given European cybersecurity certification program or national cybersecurity certification scheme. To assess the conformity of products, services, processes, managed services related to the security of cybersecurity management systems, and individuals, interested entities will need to obtain accreditation from the Polish Centre for Accreditation (PCA). The Polish Centre for Accreditation will inform the minister responsible for digitalization, no later than 14 days from the date of accreditation, of the granting of accreditation to a given European cybersecurity certification program or national cybersecurity certification scheme, as well as of any refusal, suspension, or limitation of the scope of accreditation to a conformity assessment body no later than 14 days from the date of the relevant decision. The Polish Centre for Accreditation supervises, within the scope of accreditation granted, conformity assessment bodies in the area covered by a given European cybersecurity certification scheme or a given national cybersecurity certification scheme, taking into account the requirements referred to in Art. 22 sec. 4 of the Act of 13 April 2016 on conformity assessment and market surveillance systems and the requirements specified in: 1) the annex to Regulation 2019/881, 2) European cybersecurity certification schemes, 3) national cybersecurity certification schemes (Art. 16 and 17 of the Act on the national cybersecurity certification scheme).

Assessment of compliance with the requirements of the European cybersecurity certification program

An ICT product, service, process, or managed security service (which therefore has a narrower scope) may be subject to a conformity assessment in accordance with a given European cybersecurity certification scheme based on an agreement between the provider and the conformity assessment body. The conformity assessment in question refers to one of the assurance levels specified in Article 52 of Regulation 2019/881. This agreement specifies, in particular, the ICT product, ICT service, ICT process, or managed security service to be subject to a conformity assessment, the scope of certification, the European cybersecurity certification scheme under which the European certificate is to be issued, the assurance level to which the certificate is to refer, the obligations of the parties related to certification, and the obligations related to the protection of information provided to the conformity assessment body, in particular the method of protecting trade secrets and other confidential information, including trade secrets, as well as the protection of intellectual property rights (Article 5 of the Act on the National Cybersecurity Certification System).

Article 49(7) of Regulation 2019/881 states that the Commission, on the basis of a scheme proposal prepared by ENISA, may adopt implementing acts establishing a European cybersecurity certification scheme for ICT products, ICT services, ICT processes and managed security services that meets the relevant requirements set out in Articles 51, 51a, 52 and 54. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 66(1) and in paragraph 8 that “ENISA shall evaluate each adopted European cybersecurity certification scheme at least every 5 years, taking into account feedback received from stakeholders. Where necessary, the Commission or the ECCG may request ENISA to initiate the process of developing a revised scheme proposal in accordance with Article 48 and this Article.

Currently, one European cybersecurity certification scheme has been adopted, i.e. the European Cybersecurity Certification – the Scheme on Common Criteria (EUCC), effective from February 2025, applies to ICT products (hardware, software, components) and is based on the Common Criteria standard (ISO/IEC 15408). Such a certificate issued in Poland will be recognized throughout the EU. Other programs are in the preparation phase, including the European Cybersecurity program. Certification Scheme for Cloud Services (EUCS) for cloud services.

The role of the minister

The national cybersecurity certification authority, referred to in Article 58 of Regulation 2019/881, is the Minister responsible for computerization (Article 4 of the Act on the National Cybersecurity System). As part of the responsibilities imposed on the national government administration authority responsible for cybersecurity, the minister will conduct a number of administrative proceedings, including: granting consent to the issuance of European certificates referring to the “high” level; issuing authorizations to conduct conformity assessments where the certification program specifies specific requirements for assessment bodies; 3) withdrawing and limiting authorizations to conduct conformity assessments where the certification program specifies specific requirements for conformity assessment bodies; withdrawing a certificate referring to the “high” assurance level issued in contravention of the provisions of Regulation 2019/88 or the Act or in contravention of the provisions of the certification program; and imposing fines.

As part of the certification programs being developed by the European Cybersecurity Agency (ENISA), a procedure for introducing changes to the assessment methodology used by a conformity assessment body has emerged. Such an exception to the standard certification procedure requires the consent of the competent authority for cybersecurity. Therefore, it was necessary to establish an appropriate procedure in national legislation. Article 21, Section 1 of the Act on the National Cybersecurity Certification Scheme states: “If a given European cybersecurity certification program provides for the possibility of introducing changes to the assessment methodology to be used by a conformity assessment body, that body may submit a request to the minister responsible for digitalization to introduce changes to that methodology. The request shall include proposed changes to the assessment methodology to be used by the conformity assessment body, along with a justification.”

Artykuł New provisions on cybersecurity certification in Poland pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.