The purpose of an inspection of the pharmacovigilance system for medicinal products intended for human use (pharmacovigilance inspection) is to verify how the marketing authorization holder for medicinal products is fulfilling its obligations regarding the pharmacovigilance system imposed by Polish and European Union law.

Inspection Basis

Inspections of the pharmacovigilance system are conducted by inspectors from the Department of the Inspection of Medicinal Products and Medical Devices, authorized by the President of the Office. Inspectors are authorized to:

– inspect the marketing authorization holder (MAH) regarding the pharmacovigilance system

– request documentation related to ensuring the functioning of the pharmacovigilance system

– request clarification regarding ensuring the functioning of the pharmacovigilance system

Inspection Process

The inspection of the pharmacovigilance system consists of, among other things:

– verification of the pharmacovigilance system documentation

– interviews with responsible employees, including the QPPV

– checking databases

– insight into the organizational procedures

Inspection

The inspection begins with an opening meeting, which serves to introduce the inspection team and define the purpose and scope of the inspection.

The team will need a room/office where they can interview relevant employees and review documentation.

On the last day of the inspection, during a closing meeting, the inspection team presents their observations and describes any discrepancies in the functioning of the pharmacovigilance system.

What information do inspectors expect from the entity subject to inspection?

Before commencing the inspection, the marketing authorization holder (MAH) is requested to submit a copy of the full description of the Pharmacovigilance Management System (PSMF).

In addition, the MAH should provide inspectors with access to documentation regarding, among other things:

– standard operating procedures, work instructions,

– source documentation for individual case reports (ICSRs),

– periodic safety update reports (PSURs),

– risk management plans for the use of the medicinal product,

Inspection Report

The results of the inspection are presented in an inspection report, which is prepared within 30 days of the inspection completion date. The report is then submitted to the President of the Office for approval. The approved report is forwarded to the MAH.

Types of Inspections:

Routine inspection – conducted after prior notification to the MAH, sent no later than 30 days before the planned inspection.

Targeted inspections are conducted after prior notification to the responsible entity, sent no later than 14 days prior to the planned inspection.

Unannounced inspections are conducted when there is a suspicion that a system malfunction poses a threat to patient life.

It is worth pointing out that apart from Article 24a of Pharmaceutical Law, Chapter 2 of the Act also applies (Article 36b-36z). The Pharmaceutical Law Act regulates pharmacovigilance, in a scope much broader than the inspection itself. The said chapter defines the tasks of the President of Office for the Registration of Medicinal Products, situations in which the Act imposes the obligation to report adverse reactions to the President of the Office, the patient’s right to report adverse reactions, and, among others, the obligations of the marketing authorization holder (MAH) who has obtained a marketing authorization (MAH – Marketing Authorization Holder), which include, for example, maintaining a pharmacovigilance system, appointing a person responsible for safety surveillance and reporting his/her data to the President of the Office, collecting, registering and reporting adverse reactions to medicinal products, presenting, at each request of the President of the Office, within 7 days, a copy of the full description of the safety surveillance system for medicinal products, conducting regular audits, and cooperating with the EMA.

Control under European law:

Significant changes have occurred with the publication of Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025, amending Implementing Regulation (EU) No 520/2012 on activities related to pharmacovigilance. The changes are of various nature, including, among others, reducing the administrative obligations regarding the pharmacovigilance system master file. Implementing Regulation (EU) No 520/2012 specifies, among other things, the content of the pharmacovigilance system master file. To avoid unnecessary administrative burden for applicants and competent authorities, only significant deviations from pharmacovigilance procedures, their impact and their management until the issue is resolved should be documented in the pharmacovigilance system master file, which in particular implies an amendment to Article 4(3).

The same Implementing Regulation introduced new requirements for subcontracting arrangements (added Article 6(3) and (4) and Article 13(1a) of Regulation 520/2012). The marketing authorisation holder may subcontract certain pharmacovigilance system tasks to third parties. However, the main MAH retains full responsibility for the completeness and accuracy of the pharmacovigilance system master file and that the marketing authorisation holder shall draw up a list of existing subcontracting arrangements between himself and third parties. The marketing authorisation holder shall include the following elements in subcontracting agreements: (a) a clear description of the roles and responsibilities of third parties to whom pharmacovigilance activities are subcontracted; (b) a provision obliging third parties to exchange safety data with the marketing authorisation holder and, where appropriate, the method for exchanging safety data; (c) arrangements for the third-party inspection and audit process; (d) a provision obliging third parties to agree to be audited by or on behalf of the marketing authorisation holder and to be inspected by the competent authorities.

Article 13 of the Regulation addresses the auditing requirements imposed by the European legislator on marketing authorization holders. The new wording states in paragraph 1 that: Marketing authorization holders shall conduct risk-based audits of the quality system at regular intervals to ensure its compliance with the requirements set out in Articles 8, 10, 11, and 12 and to determine its effectiveness. Audits, taken individually or in combination, shall cover all pharmacovigilance activities during a designated period and shall verify their compliance with the policies, processes, and procedures defined within the quality system. Audits shall be carried out by persons who are not directly involved in, or responsible for, the matters or procedures being audited. The added paragraph 1a provides that any third party subcontracted to perform all or part of the pharmacovigilance tasks on behalf of marketing authorisation holders or in collaboration with them shall be subject to an audit by or on behalf of the marketing authorisation holders, taking into account the risks associated with subcontracting, and may be subject to an inspection by the competent authorities, even if the subcontracting agreement does not yet include the obligation under Article 6(3).

In addition to audits at regular intervals, audits must be carried out when necessary, including corrective actions and a follow-up audit for non-compliance (Article 13(2)).

The periodic safety update report, in accordance with Article 34 of Commission Implementing Regulation No. 520/2012, contains the results of assessments of the effectiveness of risk minimization activities relevant to the risk-benefit assessment, and from February 2026, will also include information on the implementation of risk minimization measures and the results of the assessment of the effectiveness of the actions taken (Article 34, paragraph 3, new wording).

Another new obligation on the part of MAHs (marketing authorization holders) is to post information on post-authorization safety studies in the EMA electronic register (Article 36, paragraph 5, new wording).

All the changes mentioned above come into force on February 12, 2026; however, the obligation to actively use the EudraVigilance database is different. The amended Article 18, paragraphs 2 and 3 of Regulation 520/2012 obliges MAHs to monitor, but also to use data from the EudraVigiliance database in combination with data from other sources. This obligation has already entered into force, on 12 August 2025, unlike other amendments.

Recital 5 of Commission Implementing Regulation (EU) 2025/1466 explains: “The Eudravigilance database is a system for managing and analysing information on adverse reactions to medicines authorised or undergoing clinical trials. The European Medicines Agency (“the Agency”) and national competent authorities continuously monitor the data in the Eudravigilance database. Marketing authorisation holders also have access to the database to the extent necessary to fulfil their pharmacovigilance obligations. Based on the experience of marketing authorization holders in monitoring data in the Eudravigilance system, the requirements for marketing authorization holders should be clarified, including requirements for approving signals and notifying them to the Agency and national competent authorities. Recital 7 states: “Individual cases of suspected adverse reactions to a medicinal product shall be reported to the Eudravigilance database. Such reports should contain as much information as possible, and to partially standardize them, minimum reporting requirements should be applied to all cases.”

Additionally, Regulation 520/2012 also regulates other issues. Chapter I specifies the pharmacovigilance system master file in terms of structure, content of the system master file and the content of the annex to the system master file. It also introduces rules for system maintenance and specifies the format of documents included in the pharmacovigilance system master file. Chapter II, in turn, specifies the minimum requirements for quality systems for pharmacovigilance activities conducted by marketing authorization holders (the regulations specify the activities covered by the quality system, the requirements that marketing authorization holders must meet in terms of human resources management, e.g., appropriately qualified staff, and the obligation to implement quality procedures and processes to ensure data monitoring, risk minimization, and prevention.

The regulations also specify how data should be recorded and stored, as well as the principles and obligation to conduct audits). The following chapters cover: minimum requirements for data monitoring in the Eudravigilance database, terminology (according to recital 12, the use of terminology, formats, and standards at international level should facilitate the interoperability of systems used for pharmacovigilance activities and avoid duplication of coding of activities concerning the same information. It should also enable easier exchange of information between regulatory authorities at international level), the submission of reports on suspected adverse drug reactions, risk management plans, and periodic safety update reports.

The marketing authorisation holder shall submit the study protocol, the abstract of the final study report and the final study report submitted in accordance with Articles 107n and 107p of Directive 2001/83/EC in English, except for studies conducted in only one Member State and required pursuant to Article 22a of Directive 2001/83/EC. For such studies, the marketing authorisation holder shall submit an English translation of the title and abstract of the study protocol and an English translation of the summary of the final study report.

The marketing authorisation holder shall ensure that all information relating to the trial is recorded and stored in a manner that allows for accurate reporting, assessment and verification of information, and ensures the confidentiality of data relating to trial participants. The marketing authorisation holder shall ensure that the analytical dataset and statistical programmes used to generate the data included in the final trial report are stored electronically and made available for audit and inspection purposes.

When analysing the pharmacovigilance control system, one cannot ignore the so-called soft law, of which the EMA guidelines stand out in particular, such as the Guidelines on Good Pharmacovigilance Practices (GVP) – Module VIII: Post- authorisation safety studies. At this point, the current, applicable version of the GVP Module VIII rev. 3 guidelines has been in force since 2017. The purpose of this document is to ensure a uniform approach in the EU to the design and supervision of PASS (Post- authorization Safety Studies) and to support the relevant authorities (in Poland, this is the President of the office, mentioned earlier) and marketing authorization holders (MAHs). Due to the recent adoption of Implementing Regulation 2025/1466, the adoption of new guidelines, the so-called GVP Module VIII rev. 4, is expected in the near future.

Due to the importance of both Polish and European regulations, and due to the high importance of the guidelines published by the EMA, on May 29, 2025, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued information on studies on the safety and efficacy of the use of a medicinal product conducted after the issuance of authorization – PASS and PAES. It includes, among other things, that: A study on the safety of the use of a medicinal product conducted after the issuance of authorization (Post- authorization safety study (PASS) may be undertaken by the marketing authorisation holder voluntarily or as a result of an obligation imposed by the President of the Office, if there are concerns about the risk associated with the use of a medicinal product or if it is necessary to assess the effectiveness of the measures taken to reduce this risk. If the study will be conducted exclusively in the territory of the Republic of Poland, the marketing authorisation holder shall submit the study protocol to the President of the Office, who shall assess it. Protocols of studies to be conducted in more than one EU Member State should be submitted to the Pharmacovigilance Risk Assessment Committee, which assesses the appropriateness of the proposed protocol. The principles for preparing study protocols and their conduct are included in Commission Implementing Regulation (EU) No 520/2012, Guideline on good pharmacovigilance practices (GVP), Module VIII – Post- authorisation safety studies. It was also indicated that the marketing authorisation holder should register the conducted study in the electronic register maintained by the European Medicines Agency (EMA).

Artykuł Current status of pharmacovigilance in Poland under Polish and EU provisions pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Alternative investment companies are a specific form of investment activity introduced into the Polish legal system within the framework of the provisions on investment funds, and specifically in the context of managing alternative investment funds. These regulations are contained in the Act of 27 May 2004 on investment funds and the Act of 22 July 2005 on the management of alternative investment funds, Journal of Laws 2024.1034. AIICs are therefore a specific form of asset management that creates the possibility of investing in alternative assets, such as real estate, private equity, raw materials or debt, while maintaining high flexibility in terms of investment strategies.

Legal Basis for Alternative Investment Companies

Alternative investment companies are regulated in the Polish legal system by the aforementioned acts on investment funds and on the management of alternative investment funds. In particular, their functioning is associated with the appropriate transformation of the legal form of investment funds, which can operate as capital companies. This means that Alternative Investment Companies are joint-stock companies or limited liability companies that can invest in a wide range of alternative assets.

Pursuant to Article 8a of the Act, alternative investment companies may conduct business in two forms, namely as:

– limited liability companies, joint-stock companies or European companies;

– limited partnerships or limited joint-stock partnerships in which the sole general partner is a limited liability company, joint-stock company or European company.

Key Features of Alternative Investment Companies

Legal form: According to the Investment Funds Act, alternative investment companies may take the form of a joint-stock company or a limited liability company. This means that investors acquire shares or stocks in such companies, which then invest these funds in accordance with a specific investment strategy.

Investment scope: Alternative investment companies, in accordance with the Act on the Management of Alternative Investment Funds, have the ability to invest in a wide range of assets, including:

– Real estate,

– Unlisted companies (private equity),

– Raw materials (e.g. gold, oil),

– Debt instruments (e.g. investments in corporate debt),

– Derivatives and other non-standard assets.

The Investment Funds Act provides great flexibility in the selection of investment instruments, which allows for the implementation of more complex investment strategies.

In accordance with Article 8b of the Act of 27 May 2004 on Investment Funds and the Act of 22 July 2005 on the Management of Alternative Investment Funds (AIF), Journal of Laws 2024, item 1034,

Alternative investment companies are managed by a so-called investment fund manager, which in the case of alternative investment company plays a role equivalent to the management board of an investment fund. In managing this fund, it is important that the people responsible for investment decisions have the appropriate qualifications and experience, and also comply with the requirements related to capital market regulations. Fund managers have an obligation of transparency, responsibility and compliance with legal regulations.

Participant Restrictions: In the case of alternative investment companies, as in other investment funds, there are specific regulations regarding the group of investors. According to the Act on the Management of Alternative Investment Funds, alternative investment companies are intended mainly for professional investors who meet certain criteria, such as the minimum investment value or the status of a professional investor (e.g. financial institutions, wealthy individual investors). Such funds are not aimed at the general public.

According to art. 8c of the Act, an investor in an alternative investment company is an entity that holds participation rights in an alternative investment company and meets the criteria of a professional client. The criteria of a professional client shall not apply if the alternative investment company has obtained the authorization referred to in art. 5 sec. 1 of the Regulation 2015/760 on European long-term investment funds, OJ EU.L.2015.123.98 of 2015.05.19.

The participation rights of an alternative investment company are, respectively, a share in the company and a stock.

In the case of a limited partnership and a limited joint-stock partnership, participation in a company is understood as all the rights and obligations of a partner in the company.

An entity meeting the criteria of a professional client may make a contribution to an alternative investment company in exchange for participation rights in that company.

The subject of a contribution to an alternative investment company operating in the form of a limited partnership may not be an inalienable right or the provision of work or services.

The alternative investment company manager who manages an alternative investment company investing assets in shares of companies admitted to trading on a regulated market shall prepare and publish an engagement policy that describes how the engagement of shareholders of such companies is taken into account by the alternative investment company in its investment strategy. The manager of an alternative investment company shall prepare and publish an annual report on the implementation of the policy. The report shall include in particular:

– general description of voting procedure;

– description of the most important votes;

– description of the method of using the services of a shareholder voting advisor, referred to in Article 4 § 1 item 16 of the Commercial Companies Code, Journal of Laws 2000 No. 94 item 1037.

An alternative investment company may be marketed among:

– professional clients;

– retail clients – in the event that it has obtained the authorisation referred to in Article 5 paragraph 1 of Regulation 2015/760.

The manager of an alternative investment company is obliged to notify the Commission in writing of the intention to introduce an alternative investment company to trading in the territory of the Republic of Poland.

Capital

Initial capital for conducting business activity:

– in respect to externally managed alternative investment company – amounts to at least the equivalent of EUR 125,000 expressed in PLN,

– in respect to internally managed alternative investment company – amounts to at least the equivalent of EUR 300,000 expressed in PLN;

– using the average exchange rate announced by the National Bank of Poland on the last business day preceding the date of submission of the application for a permit to perform business activity by the manager of the alternative investment company.

Initial capital shall be understood as the sum of the share capital in the amount in which it was paid up together with the issue premium, undistributed profits from previous years, as well as the net profit in the process of approval, provided that this profit results from the financial statements audited by a statutory auditor, and the reserve capital, reduced by the uncovered loss from previous years.

Benefits and Challenges of Alternative Investment Companies

Benefits

Flexibility in asset selection – Alternative investment companies have the ability to invest in a wider range of assets than traditional investment funds. This includes the ability to invest in real estate, private equity, venture capital or commodities, which allows for greater diversification of the investment portfolio.

Tax benefits – the Investment Funds Act provides tax preferences for alternative investment companies, which means that profits earned by these companies may be exempt from income tax, provided that the company meets certain conditions regarding the investment structure and activities.

Access to Niche Markets – Alternative investment companies can invest in assets that are hard to access or non-traditional in traditional markets, giving investors the opportunity to participate in profitable but riskier markets.

Challenges

Higher risk – Due to their flexibility in asset selection, alternative investment companies often invest in riskier assets, which is associated with a higher potential return, but also with greater risk. Risk can also result from the illiquidity of some of the assets in which these companies invest.

Lack of liquidity – Many of the investments of alternative investment companies (e.g. real estate and private equity) are illiquid. This means that investors may have difficulty selling their holdings in the short term, which may limit their ability to exit their investment if necessary.

Regulatory Complexity – Managing alternative investment funds involves meeting specific regulatory requirements, both domestic and EU.

Summary

Alternative investment companies are an attractive form of investment that offers great flexibility in terms of asset selection and investment strategies. Based on the provisions of the Act on Investment Funds and on the Management of Alternative Investment Funds, alternative investment companies can invest in a wide range of alternative assets, which allows for the implementation of complex investment strategies, but at the same time involves higher risk. For this reason, alternative investment companies are mainly aimed at professional investors and require extensive experience in investing.

Artykuł Alternative Investment Companies – practical comments pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

On January 15, 2024, there will be held the event KRAKÓW: City – space for business. Synergy for the reconstruction of Ukraine. The event is organized by the Polis-Ukrainian Chamber of Commerce within the framework of the social campaign “Partnership and Employment” and the project “Work for Reconstruction of Entrepreneurship in Ukraine.” The event will provide a unique platform for diverse professionals, thought leaders, and stakeholders to come together and discuss critical issues surrounding urban development, business opportunities, and collaborative efforts for the reconstruction of Ukraine. The conference will cover a wide range of topics such as urban planning, sustainable development, and the role of businesses in contributing to the reconstruction efforts in Ukraine. Renowned experts and speakers will share valuable insights, best practices, and innovative ideas, fostering a rich exchange of knowledge and experience. Participation in the Conference will be an enriching experience. The insights we will gain and connections made will undoubtedly contribute to our professional growth. The event will be participated by Weronika Mazurek on behalf of KIELTYKA GLADKOWSKI KG LEGAL.

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Artykuł <strong>KIELTYKA GLADKOWSKI KG LEGAL TAKES PART IN THE EVENT “KRAKÓW: City – space for business. Synergy for the reconstruction of Ukraine”, January 15, 2024</strong> pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

KIELTYKA GLADKOWSKI KG LEGAL takes part in the project “Systemic Design and Sustainable Healthcare for MedTech Manufacturing (SysteMA)”. One of elements of the project is led by the Life Science Cluster in Krakow and the MedSilesia cluster. The latter became involved in activities to raise awareness and knowledge in the field of the circular economy.

The research is part of the EIT Manufacturing project SysteMA (Systemic Design and Sustainable Healthcare for MedTech Manufacturing), which focuses on the role of MedTech manufacturing towards the environmental, social, and economic sustainability of healthcare systems. The project aims to create online training courses on this topic, providing EU companies with actionable skills to improve the sustainability of their products and processes and seize new market opportunities.

The aim of the research is to define the sustainability knowledge and actions that EU MedTech companies have already undertaken. This will allow project partners to define effective training paths according to the actual state of the sector.

The demand for green procurement, sustainable products/services, and higher environmental standards, is set to increase dramatically. However, companies, especially SMEs, have few tools to fill the knowledge gaps on sustainable healthcare issues. The training programme aims to address this need by offering learning paths tailored according to the starting level and the sustainability goals that professionals and students in the MedTech industry aim to acquire.

The action is carried out as part of the project “Systemic Design and Sustainable Healthcare for MedTech Manufacturing (SysteMA)”, in which, apart from the Life Science Cluster, there participate the University of Technology in Turin (ITALY) – Project Leader and partners: Bioindustry Park Silvano Fumero SpA (ITALY), TEM at Lund University / Nordic Center for Sustainable Healthcare (SWEDEN), Stryker (IRELAND); GVS Group – (ITALY).

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Artykuł <strong>KIELTYKA GLADKOWSKI KG LEGAL IS INVOLVED IN THE PROJECT “SYSTEMIC DESIGN AND </strong>KIELTYKA GLADKOWSKI KG LEGAL IS INVOLVED IN THE PROJECT “SYSTEMIC DESIGN AND SUSTAINABLE HEALTHCARE FOR MEDTECH MANUFACTURING (SYSTEMA)”<strong> FOR MEDTECH MANUFACTURING (SYSTEMA)”</strong> pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

On November 17, 2021, Pracuj.pl group, a leader in the digital recruitment market, operating in Poland, offering services to support the recruitment, retention and development of employees has published a prospectus with a view to conducting an initial public offering of the Company’s shares and their admission to trading on the main market of the Warsaw Stock Exchange. The offer covered up to 22,380,626 existing shares with each share having a nominal value of PLN 5 – representing 32.86% of the share capital. The maximum price has been set at PLN 82 per share.

Book building

Before the sale of shares takes place, the company conducts book-building, which is a key process in determining the share issue price. The book of demand thus involves the collection of non-binding information from potential institutional investors on their interest in acquiring the securities in question. The key stage affecting book building is the acceptance of subscriptions from potential investors, and on the basis of the interest in the offer the company determines the issue price and the final number of shares.

Subscription for shares

The method of subscribing to a share experiences differences depending on the category of investor – individual or institutional. In the case of an individual investor, the first requirement is to have a securities account open with the investment firm with which he intends to place such a subscription. Subsequently, subscriptions for shares must be made on subscription forms available at customer service points of investment firms, by fax, by telephone or by other electronic means. Retail Investors will place subscriptions at the maximum price, indicating the number of offered shares they intend to purchase.

As far as institutional investors are concerned, the entire subscription process starts once the book-building is completed. Then, after a discretionary selection by the responsible entities, invitations to subscribe are sent to investors, which entitle them to subscribe for a specific number of shares at a specific price. They are made in writing, on a special form made available by the relevant brokerage house.

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However, the shareholder of the share thus acquired will not be the literal owner of the share, as this right accrues to the majority shareholder of the company upon completion of the offer, as this is a public offer of existing shares to which current shareholders are entitled. Nevertheless, shareholders have rights attached to their shares under the Companies Act and other laws. This matter may also be regulated by a special agreement entered into by the shareholders.

Role of the prospectus

The prospectus is, in a sense, an offer made to potential investors, by outlining the financial benefits of the investment, is intended to encourage new shareholders to put their capital into the company. Taking Pracuj Group’s prospectus as an example, it presents the amounts of dividends paid in the past and the current dividend policy, which indicates that at least 50% of net profit will be distributed to shareholders. Moreover, a large part of the prospectus is devoted to the company’s financial results, its development plans and usually optimistic financial forecasts, which are supposed to convince as many investors as possible, that this is a profitable venture.

KIELTYKA GLADKOWSKI KG LEGAL advises on current basis individual and corporate investors at all stages of investment process in Poland, with a particular emphasis on cross border shareholding structures.

Bibliography:

1. https://grupapracuj.pl/oferta-publiczna ,

2. Prospekt Grupa Pracuj S.A., online: https://grupapracuj.pl/wp-content/uploads/2021/11/Prospekt-spolki-Grupa-Pracuj-SA.pdf .

Artykuł <strong>Foreign individual investors in the prospectus of shares of the e-commerce industry – principles of investing in securities in Poland</strong> pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

On August 24, 2018, the Polish Ministry of Finance published a draft act amending the act on personal income tax, the act on corporate income tax. One of the proposed changes was the introduction of preferential taxation of income from intellectual property rights (the so-called “IP Box” or “Innovation Box” relief).

Innovation Box – IP Box allowances – were introduced to the Polish Personal Income Tax Act (“PIT”) and to the corporate income tax (“CIT”) as a preferential form of taxation (preferential taxation of earned income) for entrepreneurs obtaining income from commercialization of intellectual property rights. Qualified intellectual property rights are obtained after submitting an application to the appropriate body – then it is possible to take advantage of this relief.

IP Box has been implemented in other countries, including: the Netherlands, Great Britain, Ireland, Luxembourg.

The mechanism used in these countries consists in taxing income from intellectual property rights with a reduced tax rate (e.g. in Great Britain – 10%) or exempting part of tax revenues (e.g. 80% in Luxembourg). IP Box Relief is available to increase one’s company’s knowledge resources or to protect intellectual property. It can also be used by those who want to register an industrial design as part of research and development.

Regulations on preferential taxation of intellectual property rights should be consistent with the OECD guidelines under the Base Erosion and Profit Shifting (BEPS) initiative.

The subject of taxation covered by the IP Box

The preferential rate of income tax – 5% of the tax base – will be applicable to income from qualifying intellectual property rights created, developed or improved by the taxpayer as part of its R&D activities. The basis for granting the IP Box tax relief is the fulfillment of several conditions. More precisely, it is possible in the case of using knowledge resources and research and development works related to: rights to an invention (patents), additional protection rights for an invention, utility model rights, rights from registration of an industrial design, rights from registration of integrated circuit topography, additional protection rights for a patent for a medicinal product or plant protection product, legal protection of plant varieties, creating new applications, rights from registration of a medicinal or veterinary product, rights from registration of new plant varieties and animal breeds, rights to a computer program.

The above rights must be legally protected on the basis of the provisions of separate acts or ratified international agreements to which Poland is a party or other international agreements to which the European Union is a party. The draft also allows for the appropriate application of its provisions on qualified intellectual property rights to persons waiting for these rights (additional protection right), provided that the taxpayer submits an application to the competent authority.

Conducting research and development activities – qualified intellectual property right

The IP Box relief applies to those intellectual property rights that are created, developed or improved by the taxpayer as part of R&D activities. It is indicated that the application of the relief is permissible if the taxpayer is the owner, co-owner, user or has the right to use the above-mentioned intellectual property rights. The Innovation Box tax relief may also be used in the event that the taxpayer acquires the results of research and development, provided that he then incurs costs related to the development or improvement of the acquired right.

Tax rate, income tax in the field of IP Box – Polish Ministry of Finance

The tax rate on qualified income earned by the taxpayer from the intellectual property rights discussed above will be 5% of the tax base. Accordingly, the tax base will be calculated as the sum of revenues from qualifying intellectual property rights in a given tax year.

Income (loss) for the purposes of claiming IP Box relief – income calculation

Income / loss on qualifying intellectual property rights includes income / loss from: fees or commissions resulting from a license for a qualified intellectual property right, sale of qualifying intellectual property rights, qualifying intellectual property rights included in the selling price of products or services, compensation for infringement of qualifying intellectual property rights, if obtained in court proceedings, including arbitration proceedings.

Losses on qualifying intellectual property rights incurred in a given tax year will reduce income from the same qualifying intellectual property right or the same type of product or service or the same group of products or services in which the intellectual property right has been used for 5 consecutive tax years.

What is the period of application of the IP Box relief to the qualified intellectual property right?

The taxpayer has the right to benefit from the tax relief for the entire period of legal protection of the entitled intellectual property rights. In the case of property components subject to the application / registration procedure (waiting to obtain a qualified intellectual property right), the taxpayer has the right to benefit from tax preferences from the moment of submitting the application for registration (however, the taxpayer will be obliged to refund the amount in the event of withdrawal of the application, refusal of registration or rejection of the application).

Qualified intellectual property rights – criteria to be met in order to obtain relief

The Polish IP Box tax relief is available from January 1, 2019. This is a preferential CIT / PIT rate of 5% on the taxpayer’s income from commercialization of qualifying intellectual property rights. In order to use the IP Box, 4 basic criteria must be met:

a) to conduct research and development activities;

b) to cover the results of R&D activities with legal protection in accordance with the list of authorized intellectual property rights. Qualified intellectual property rights are, inter alia, patents, utility models, industrial designs, the right to register an integrated circuit design, an additional protection certificate for a patent for a medicinal product or plant protection product, copyrights to computer programs;

c) to identify the costs of R&D activities carried out, which led to the entrepreneur obtaining a qualified intellectual property right (the key is to keep detailed accounting records);

d) to identify the commercialization of qualifying intellectual property rights, e.g. by selling or levying royalties on qualifying intellectual property rights.

IP Box and R&D relief

The IP Box relief and R&D complement each other. The first one includes a preferential tax rate on income from the commercialization of intellectual property rights. They have to be created, developed or improved through the research and development activities carried out by the enterprise. R&D tax relief reduces the tax base for conducting R&D activity.

To qualify for the IP Box tax credit, one must engage in R&D

The IP Box tax relief consists in taxing at the preferential tax rate only income obtained from qualifying intellectual property rights that have been produced, developed or improved by the taxpayer as part of his research and development activities. Therefore, one cannot claim the IP Box tax credit without doing R&D.

Artykuł IP BOX TAX RELIEF IN POLAND pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

According to analyses, 2021 a record year in terms of the number and value of investments in Poland. From the beginning of the last year, 402 investment support decisions were issued. By analogy, in the same period last year this was a difference of 56%. The value of investments in 2021 was approximately 17.3 billion PLN, which is an increase of 14% compared to the whole of 2020.

Since the beginning of the Polish Investment Zone (which is an instrument thanks to which one can obtain tax relief for the realization of a new investment, which can be used throughout Poland, regardless of the size of the company. Such support is granted to companies from the industrial and modern services sector), 1209 decisions on investment support have already been issued. 2021 declarations accounted for 33% of the total and were declarations of over 9500 new workplaces.

Which countries do investors come from?

Foreign investors come mainly from Germany, the United States and South Korea. There are also investors from countries such as the Netherlands or Luxembourg, among others.

These include representatives of the automotive industry (including manufacturers of batteries for electric cars). There are many shared service centres. A significant proportion of foreign investors in Poland are from the so-called clean energy areas. An example of this are American companies, such as Westinghouse, which cooperate precisely in this area.

Interministerial Team for Investments of Significant Importance to the Polish Economy

The legal basis for the Team’s activities is Regulation No. 38 of the PRM of 1 June 2015 on the appointment of the Interministerial Team for Investments of Significant Importance for the Polish Economy. M.P. 2015 item 520.

The Team consists of: Secretary of State or Undersecretary in the Ministry responsible for economy (chairman), one representative at the rank of Secretary or Undersecretary of State designated by the Minister in charge of the government administration department, Representative of the Chancellery of the Council of Ministers, Representative of the President of the Office of Competition and Consumer Protection.

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The main tasks of the Team include:

• Analysis of investment projects from the point of view of their impact on the Polish economy on its innovativeness and competitiveness;
• Assessment of investment projects presented by the Polish Information and Foreign Investment Agency from the point of view of whether it is justified to provide support.

The Team is the body that decides on the granting of financial support in the form of grants to companies in Poland. Grants have recently been decided for 12 companies, half of which are Polish.

The value of the grants ranges from several hundred thousand PLN to several tens of millions of PLN. The value depends primarily on the value of the investor’s outlay.

The potential of the Polish labour market for foreign investors

The main advantage of the Polish labour market for foreign investors is its geographical location. Other advantages include relative economic stability and educated and creative employees. There have also been recent changes in Polish law relating to the facilitation of the employment of foreigners. The most recent act extends the period of work with a statement to two years and speeds up the issuance of permits for strategic industries.

Poland is also competitive on the foreign investment market in terms of investment conditions and location.

Sources:

https://biznes.gazetaprawna.pl/artykuly/8299899,piechowiak-inwestycje-zagraniczne-w-polsce-2021.html | gazetaprawna.pl

https://www.gov.pl/web/rozwoj-technologia/miedzyresortowy-zespol-do-spraw-inwestycji-o-istotnym-znaczeniu-dla-gospodarki-polskiej | gov.pl

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The Convention on the Civil Aspects of International Child Abduction, signed at The Hague on 25 October 1980, known as the Hague Convention of 1980, is an international agreement of which Poland is a party. It was concluded in order to ensure the immediate return of children wrongfully abducted or detained in one of the States, which are parties to that agreement and to ensure the respect for custody and visitation rights specified by the legislation of those States. Pursuant to Article 569¹ of the Code of Civil Procedure, the local jurisdiction for applications under the Hague Convention of 1980 is the regional court in the locality of the court of appeal with jurisdiction over the place of residence or stay of the child. The time limit for the court to give its decision is 6 weeks from the date of the application. Abduction of a child according to the Convention must be unlawful in order for an application to be brought successfully to the central authority of the State in which the child is present. This authority, according to the Convention, is competent to hear the application.

The application may be submitted to the central authority of the State where the child has permanent residence or directly to the authority of the State where the child is present. In Poland the central authority competent to examine the application is the Polish Minister of Justice. The court which adjudicates the case issues a decision on return or refusal to return the child. In such litigation, the parties to the proceedings must be represented by an advocate or a legal advisor. The decision of the regional court may be appealed to the Court of Appeal in Warsaw, which is the only second instance court for cases under the Hague Convention of 1980. A cassation appeal to the Supreme Court is available against the decision of this court, which may be filed only by the General Prosecutor, the Ombudsman for Children and the Ombudsman for Civil Rights. Pursuant to Article 577 of the Code of Civil Procedure, the court may change even a final decision if the good of the person concerned by the proceedings so requires (vide Resolution of the Supreme Court of 22 November 2017, case files number III CZP 78/17, OSNC 2018/5/51). According to the current law, under Article 578 of the Code of Civil Procedure, the decisions of the Guardianship Court are effective and enforceable upon their announcement or, if there was no announcement, upon their issuance. This means that the moment a judgment is valid, it also becomes enforceable, even if a cassation appeal has been filed to the Supreme Court (the cassation appeal does not stop the enforceability of the judgment).

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Proposed amendments to the current Polish legislation

According to the draft amendments to the Code of Civil Procedure adopted by the Polish Council of Ministers, if a cassation appeal against a decision of a court of second instance is announced or if such an appeal is filed, the forced take-back of a child will be prevented by suspending the immediate enforceability of the court decision. The enforceability of the final decision will be ex officio obligatorily suspended by the court until the cassation appeal is examined. The General Prosecutor, Children’s Rights Ombudsman or Civil Rights Ombudsman, after filing a request for suspending the enforceability of a decision within 2 weeks from its becoming final and binding, will be able to file a cassation appeal to the Supreme Court within 2 months from the date of its becoming final and binding. The enforceability of the order will therefore be suspended until the cassation appeal is examined. If such a cassation appeal is not filed, then the suspension of the enforceability of the decision will cease. The situation is similar in the event of filing an extraordinary complaint. According to the authors of the draft, in the current legal status there are situations in which a final decision ordering the surrender of a child is executed while the Supreme Court is considering a cassation appeal or when it has not yet been filed. Such a complaint then becomes pointless, because the court decision has already been enforced. According to the drafters, such changes are to contribute, above all, to securing the good of the child and ensuring its safety.

Sources:

1. The Act of 17 November 1964 – Code of Civil Procedure,
2. Convention on the Civil Aspects of International Child Abduction, signed at The Hague on 25 October 1980,
3. https://www.prawo.pl/prawnicy-sady/przekazanie-dziecka-nowe-prawo-pozwoli-ignorowac-wyrok-sadu,513355.html

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Refugees from Ukraine are starting to enter Polish labor market, which is suffering from a labor deficit. Employment agencies speak of a real boom in their services. There is already a recorded interest of 60% higher level in work enquiries comparing to the same period last year.

The most wanted are construction workers, highly specialized workers, such as welders, locksmiths, carpenters, workers for the production and operation of machinery. There is also great demand in services, trade, tourism and gastronomy, transport, logistics, e-commerce and accounting. Demand is therefore similar to the year before, but the deficit increased. This is due to the fact that the Polish economy is recovering from the pandemic.

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According to the HR agencies in Poland, the number of job candidates from Ukraine is also growing fast. The most booming regions in Poland are Poznań and Wielkopolska, Silesia and Lower Silesia where the unemployment rate is low and the demand for workers is high.

Employers in Poland are serious about creating jobs, especially for women and sanctions against Russia are already taking effect. New orders arrive in Poland, including those from the automotive sector. There are increased job offers in the production of car upholstery and in the field of electric harnesses. New jobs will also be created in the hotel and gastronomic sector when the season will be about to start. Other sectors actively seeking for employees from Ukraine are printing sector, wind turbines sector and beauty sector. There are also needed translators, electricians and IT specialists.

On March 4, 2022, the EU Council adopted a directive introducing temporary protection in connection with the mass influx of people fleeing Ukraine as a result of the war. It gives the right of legal residence and access to the labor market throughout the Union for all citizens of Ukraine and third countries leaving this country after February 24.

KIELTYKA GLADKOWSKI provides comprehensive legal assistance in all aspects of hiring foreign employees and choosing the proper legal frames for employment relations.

Artykuł <strong>Poland records big demand for Ukrainian workers</strong> pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

The EU has provided EUR 450 million (USD 503 million) for weapons, including air defence systems, anti-tank weapons, ammunition and other military equipment for the Ukrainian Armed Forces. A further EUR 50 million will be provided for fuel, bulletproof vests, helmets and first aid kits.

Since the EU Treaties do not allow the use of the EU budget for military purposes, the Community is introducing an instrument called the “European Peace Fund”, which allows the provision of military aid of up to EUR 5 billion.

The United States is also increasing its supplies and is providing an additional USD 350 million (EUR 313 million) in military aid, including Javelin anti-tank missiles, Stinger anti-aircraft missiles, small arms and ammunition.

FIGHTING JETS

Ukraine’s military pilots aren’t trained to fly U.S. jet fighters and would be far more equipped to handle MiG-29 or Su planes that are currently used by former Soviet-bloc NATO members Poland, Bulgaria and Slovakia.

Ukrainian pilots would be able to fly MiGs right away, but Poland isn’t eager to lose significant amounts of its air force without replacements. U.S.-made F-16s are becoming the mainstay of Poland’s air force as it modernizes its military.

US – POLISH DEAL

According to other Western media, including Bloomberg and NBC News, President Joe Biden’s government is holding talks with Poland.

– We are working with the Poles on this matter and consulting with the rest of our NATO allies. We are also working on the possibility of filling Poland’s cavities if it decides to relocate planes to Ukraine – reports NBC News, citing a White House source.

On Sunday, Foreign Minister Antony Blinken said that the United States is giving the “green light” to NATO countries if they decide to deliver fighter jets to Ukraine.

POLISH DEFENCE SECTOR

Russia has warned that supporting Ukraine’s air force would be seen in Moscow as participating in the conflict and open up suppliers to possible retaliation. Official comment from NATO and European Union member Poland has been only to confirm continuing talks on the subject.

Earlier, Polish President had also said that sending planes would be tantamount to interfering in the conflict. Similarly, the experts note that dispatching such aircraft is not an easy process: in addition to repainting, they would also require the dismantling of NATO instruments.

SOURCES:

https://www.rp.pl/dyplomacja/art35813161-usa-szukaja-sposobu-na-dostarczenie-ukrainie-mysliwcow-przez-polske

https://www.wsj.com/livecoverage/russia-ukraine-latest-news-2022-03-04/card/blinken-says-u-s-is-eyeing-ways-for-poland-to-supply-jets-to-ukraine-iTsOmhIZTv60jZBqpS5I

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