We are delighted to share an important milestone in the continued development of KG Legal’s Data, AI & Cybersecurity Desk.

It has been a great honour to serve as the exclusive expert contributors for Poland to the OneTrust DataGuidance Privacy Overview – Poland, one of the world’s leading professional legal compliance resources relied upon by in-house counsel, privacy professionals, compliance officers, multinational organisations and technology companies operating across multiple jurisdictions.

Preparing this contribution was a long-term project that required several months of intensive legal analysis, research and editorial work. Our objective was not simply to describe the application of the GDPR in Poland. Instead, we sought to create a practical and comprehensive guide reflecting the significant transformation of the Polish regulatory landscape that has taken place in recent years as a result of new European legislation and its implementation into Polish law.

The publication therefore extends far beyond a traditional overview of Polish data protection law. It examines the interaction between privacy, digital regulation, cybersecurity and artificial intelligence, providing readers with practical guidance on the most important legal developments affecting organisations operating in Poland.

Our contribution discusses, among other things:

• the practical application of the GDPR within the Polish legal system;
• the powers and regulatory practice of the Polish supervisory authority for personal data protection;
• employee monitoring and workplace privacy;
• cookies, consent mechanisms and online tracking technologies;
• electronic communications and direct marketing requirements;
• international data transfers;
• personal data breaches and notification obligations;
• practical compliance with Polish privacy legislation;
• cybersecurity-related regulatory developments;
• the growing interaction between data protection and artificial intelligence governance.

A particularly important aspect of this work was addressing the rapidly evolving legislative environment. During the last few years, Poland has experienced substantial regulatory changes resulting from the implementation of numerous European legal instruments and the entry into force of directly applicable EU regulations that significantly affect organisations processing personal data.

Accordingly, the publication takes into account the practical implications of the evolving European digital regulatory framework, including the interaction between the GDPR and newer legal instruments governing digital services, artificial intelligence, cybersecurity and data governance. The analysis also reflects the impact of the AI regulatory framework, developments concerning data governance and electronic communications, as well as the increasingly interconnected compliance obligations facing businesses operating in today’s digital economy.

Rather than presenting legislation in isolation, the publication adopts a practical, compliance-oriented perspective. It combines:

• the GDPR and Polish implementing legislation;
• guidance issued by the European Data Protection Board (EDPB);
• the jurisprudence of the Court of Justice of the European Union;
• decisions and regulatory guidance published by the Polish Personal Data Protection Office (UODO);
• recent Polish legislative developments and market practice.

Our ambition was to create a resource that would assist both international and domestic organisations in navigating one of the fastest-changing areas of European regulation, where privacy law increasingly intersects with cybersecurity, AI governance, digital platforms, online communications and emerging technologies.

The contribution was prepared by Małgorzata Kiełtyka and Jakub Gładkowski, whose combined experience covers complex cross-border advisory work in data protection, artificial intelligence, life sciences, healthcare, technology law, cybersecurity, intellectual property and regulatory compliance.

https://www.dataguidance.com/experts-directory/Jakub_G%C5%82adkowski

https://www.dataguidance.com/experts-directory/Malgorzata_Kieltyka

For many years, Małgorzata Kiełtyka has advised international companies on GDPR compliance, healthcare regulation, AI governance, technology transactions and cross-border regulatory matters. Her practice combines strategic legal advice with practical implementation of compliance frameworks for multinational businesses operating in highly regulated sectors.

Jakub Gładkowski focuses on data protection, digital regulation, cybersecurity, intellectual property, IT law and emerging technologies. His practice includes advising innovative businesses on regulatory compliance, digital transformation projects and the implementation of European technology legislation affecting both public and private sector organisations.

Being entrusted with preparing Poland’s national contribution to OneTrust DataGuidance represents an important recognition of our team’s expertise and international standing. We are particularly proud that this publication reflects not only our experience in privacy law, but also our broader interdisciplinary approach, integrating data protection with AI regulation, cybersecurity, digital compliance and technology law.

We sincerely thank the editorial team at OneTrust DataGuidance for their confidence in our expertise and for the opportunity to contribute to a publication that supports legal and compliance professionals around the world.

For KG Legal, this publication marks another significant milestone in the continued growth of our Data, AI & Cybersecurity Desk and reinforces our commitment to delivering practical, business-oriented legal advice at the intersection of privacy, technology and innovation.

Artykuł A Major Milestone for KG Legal’s Data, AI & Cybersecurity Practice: Exclusive Poland Contribution to OneTrust DataGuidance pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

The Polish dietary supplements market is facing the most significant regulatory overhaul in years. The draft amendment to the Act on Food and Nutrition Safety and the Act on the State Sanitary Inspectorate introduces a series of far-reaching changes that will substantially alter the way supplements are notified, monitored, advertised, and supervised in Poland. While the reform does not formally introduce a pre-market authorization system, it undeniably strengthens the position of regulatory authorities and increases the compliance burden imposed on businesses operating in the sector.

The amendment, expected to enter into force six months after publication, reflects both domestic concerns regarding the rapid expansion of the supplements market and the broader European trend toward stricter food safety oversight. For manufacturers, importers, distributors, and marketing agencies, the proposed changes may require a complete reassessment of internal procedures, legal risk management, and commercial strategy.

The reform arrives at a time when the Polish dietary supplements market continues to expand at an exceptional pace. Poland has become one of the largest supplement consumers in the European Union, both in terms of total market value and per capita spending. According to market estimates, the sector exceeded PLN 7 billion in value in 2024 and is expected to continue growing steadily over the coming years. The scale of the market alone has become a challenge for regulators. Between 2017 and 2020, more than 62,000 supplement notifications were submitted to the Chief Sanitary Inspectorate (GIS), while the number of products listed in official registers exceeded 29,000.

At the same time, authorities increasingly pointed to systemic weaknesses in the existing framework. Under the current rules, a business may place a dietary supplement on the market immediately after submitting a notification to GIS, even if doubts exist regarding the product’s composition or classification. The authorities may initiate explanatory proceedings, but the product can still remain commercially available during the investigation. In practice, this system has often been criticized for providing insufficient preventive control and allowing potentially problematic products to circulate before any meaningful assessment takes place.

Another major concern involved the widespread use of aggressive advertising strategies. For years, the dietary supplements industry has been accused of blurring the line between supplements and medicinal products. Many advertisements indirectly suggested therapeutic effects or implied that supplements could substitute proper medical treatment or balanced nutrition. Regulators and pharmaceutical companies repeatedly argued that existing penalties were too low to deter large market participants from engaging in questionable promotional practices.

The lack of a centralized digital supervision system also contributed to inefficiencies. The notification process relied partly on outdated administrative mechanisms, resulting in difficulties with document verification, inconsistent communication, and lengthy proceedings. The new amendment seeks to address these concerns through digitalization, stricter procedural obligations, and substantially higher financial sanctions.

One of the most visible changes introduced by the reform is the mandatory use of the e-Sanepid platform for all supplement notifications. Until now, notifications could be submitted either electronically or in paper form, and businesses had some flexibility regarding the form and timing of submission. Under the new rules, however, the process becomes fully digitized. Notifications will only be accepted through the e-Sanepid system and will require either a qualified electronic signature or a trusted electronic profile.

This change may appear largely technical at first glance, but in reality it significantly increases the formalization of the entire notification process. For large companies with developed compliance departments, adapting to electronic communication systems is unlikely to create serious difficulties. Smaller businesses, however, may face operational and financial challenges connected with digital authentication tools, procedural monitoring, and document management requirements.

The amendment also changes the moment at which the notification obligation arises. Previously, the law referred both to products already introduced to the market and those merely intended for future introduction. The new wording removes the reference to “intended introduction,” meaning that the obligation will arise only once the product is actually being placed on the market. Although this clarification simplifies the legal interpretation of the obligation, it also narrows the flexibility businesses previously enjoyed when planning product launches.

Perhaps the most consequential aspect of the reform concerns explanatory proceedings and scientific opinions. Under the current framework, businesses could effectively delay proceedings indefinitely by postponing the submission of required scientific documentation. While the law imposed certain deadlines on the authorities themselves, it did not establish sufficiently strict obligations for the notifying entity. This created situations where proceedings remained unresolved for years, significantly limiting the effectiveness of supervision.

The amendment introduces a much stricter procedural regime. Once GIS requests a scientific opinion regarding a product’s classification or compliance, the business will have only 14 days to submit an application to a scientific institution or to the President of the Office for Registration of Medicinal Products. Furthermore, the scientific opinion itself must generally be issued within six months, with an absolute maximum period of twelve months in exceptional cases.

The most significant innovation is the introduction of a legal presumption against the entrepreneur. If the entity fails to submit the application for an opinion within the required 14-day period, the law will automatically presume that the proposed classification of the product is incorrect and that the product does not meet the requirements applicable to its category. In practical terms, procedural inactivity itself may lead to negative legal consequences.

This fundamentally changes the balance between businesses and regulatory authorities. Previously, delaying the process often worked in favor of companies by allowing products to remain on the market while proceedings continued. Under the new rules, inaction may immediately weaken the entrepreneur’s legal position. Businesses will therefore need to implement much stricter internal monitoring systems to ensure compliance with procedural deadlines.

The amendment additionally prohibits businesses from circumventing the procedure by repeatedly submitting notifications for identical products. Once proceedings are initiated, companies will no longer be able to submit another notification concerning a product with the same qualitative and quantitative composition. Similarly, withdrawing a notification will not allow the entrepreneur to restart the process with the same formula at a later stage. These restrictions are intended to eliminate procedural abuse and prevent companies from avoiding regulatory scrutiny through repeated filings.

Another major reform concerns transparency and the expansion of the public product register maintained within the SEPIS system. The current register already contains certain information regarding notified products, but the scope of publicly available data remains relatively limited. The new system significantly broadens the amount of information accessible to consumers and competitors alike.

Under the amendment, the register will include the product name, form of the product, qualitative composition, information regarding active substances, details concerning explanatory proceedings, and information about prohibited ingredients. Although quantitative composition data and certain identifying information regarding the reporting entity will remain confidential, the reform nevertheless represents a substantial increase in market transparency.

From the consumer protection perspective, this may be viewed as a positive development. Consumers will gain easier access to information about supplement composition and regulatory status, potentially allowing for more informed purchasing decisions. However, from the business perspective, the new transparency rules create considerable reputational risks. Information regarding ongoing explanatory proceedings may become publicly visible long before any final administrative decision is issued. As a result, companies may face reputational damage even in situations where no violation is ultimately confirmed.

The reform also updates the broader inspection framework to align Polish law with Regulation (EU) 2017/625 on official controls. Although the regulation has already been directly applicable across the European Union since 2019, several references in Polish legislation still pointed to repealed EU acts. The amendment therefore modernizes the legal terminology and adapts national provisions to the currently binding European framework.

Importantly, however, the changes do not significantly expand the substantive powers of sanitary authorities. The amendment primarily introduces terminological adjustments, extending references from “official food controls” to “official controls and other official activities.” Sanitary authorities will continue to possess extensive powers during inspections, including access to facilities, examination of production processes and documentation, and collection of samples for laboratory testing.

The reform does, however, expand the situations in which businesses must bear the costs of inspections and administrative activities. In addition to existing obligations related to violations, follow-up inspections, and border sanitary controls, businesses will now also be required to cover costs associated with official activities performed at their own request, such as the issuance of certain documents. While this change may appear relatively modest compared to other parts of the reform, it nevertheless contributes to the overall increase in operational costs for market participants.

One of the most controversial elements of the amendment concerns advertising and marketing practices. The reform significantly broadens the scope of administrative liability related to the promotion and presentation of dietary supplements. Previously, penalties focused primarily on incorrect product labeling. Under the new rules, liability will explicitly extend to advertising, online promotion, social media activities, and the overall presentation of products.

Most importantly, the amendment introduces severe sanctions for advertising or presenting a supplement before notifying GIS. This is likely to have a major impact on digital marketing strategies commonly used in the supplements industry. Influencer campaigns, online pre-launch promotions, teaser advertisements, and social media product announcements may all potentially fall within the scope of the new sanctions if conducted before formal notification.

The amendment also reinforces existing prohibitions against suggesting that a balanced diet cannot provide sufficient nutrients or implying medicinal properties of supplements. Although these prohibitions already existed under current law, the reform significantly strengthens enforcement mechanisms by attaching much higher financial penalties to violations.

Indeed, the increase in administrative penalties represents one of the most dramatic aspects of the reform. Under the current framework, the maximum administrative fine generally amounts to thirty times the average monthly salary. The amendment raises this threshold to one hundred times the average salary, increasing potential penalties by more than 330 percent.

Based on current economic indicators, maximum fines could exceed PLN 800,000. Such amounts are clearly intended to function as genuinely deterrent sanctions rather than symbolic administrative measures. For large corporations with extensive marketing operations, these penalties may significantly alter risk calculations related to aggressive advertising or borderline compliance practices.

For businesses operating in the supplements sector, the cumulative impact of these changes may be substantial. Compliance costs are likely to increase considerably. Companies may need to invest in legal advisory services, digital infrastructure, scientific assessments, employee training, and enhanced compliance monitoring systems. Marketing departments in particular will face increased scrutiny and will need to carefully verify advertising content before publication.

The reform may also contribute to market consolidation. Large, well-established companies are generally better positioned to absorb increased compliance costs and adapt to stricter regulatory requirements. Smaller businesses, startups, and niche supplement brands may struggle with the financial and administrative burden created by the new framework. As a result, the amendment could unintentionally reduce market diversity and strengthen the competitive position of major industry players.

From the perspective of public authorities, the reform aims to improve the efficiency and credibility of food safety supervision. Digitalization through e-Sanepid and SEPIS is expected to accelerate administrative processes, improve data analysis capabilities, and strengthen market oversight. The introduction of strict procedural deadlines should also reduce the risk of excessively lengthy proceedings and administrative disputes.

At the same time, the implementation of these systems will require significant investments in technological infrastructure and administrative capacity. The effectiveness of the reform will therefore depend not only on the wording of the legislation itself, but also on the practical ability of GIS and related institutions to manage the new digital environment efficiently.

Ultimately, the amendment does not formally transform dietary supplements into products requiring prior authorization before market entry. Businesses will still be able to introduce supplements through a notification-based system rather than a licensing procedure. Nevertheless, the practical reality of operating in the sector is likely to change considerably.

The reform substantially increases the procedural obligations imposed on businesses, strengthens enforcement tools available to authorities, raises financial exposure connected with non-compliance, and introduces far greater transparency into the market. While these changes may improve consumer protection and market oversight, they also create new operational and reputational risks for entrepreneurs.

For companies active in the supplements industry, the coming months may therefore become a critical period of preparation. Businesses that fail to adapt quickly to the new regulatory environment may face not only financial penalties, but also significant disruptions to their commercial operations and marketing strategies.

Artykuł Dietary Supplements Under Tightened Scrutiny: How the 2026 Reform Could Reshape the Polish Market pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Every drug introduced to the EU market must obtain a permit from the competent authority. In Poland, this is the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. EU regulations included in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, implemented into Polish law by the Act of 6 September 2001 – Pharmaceutical Law provide for several procedures enabling drug registration, one of which is the so-called well-established medicine procedure (WEU). This is a special procedure for obtaining marketing authorization for medicines containing active substances with well-established medical use, i.e., medicinal substances known and systematically used in the EU for at least 10 years. The most important difference with this procedure is that there is no need to submit new clinical and pre-clinical studies, and the application can be based on available scientific studies that confirm the effectiveness and safety of the substance.

Most often, this procedure applies to herbal medicines and medicines containing commonly used substances that were already in use before the introduction of the drug registration requirement – examples include medicines containing paracetamol or aspirin.

Administrative and documentation requirements

Article 10 paragraph 1 of the Pharmaceutical Law governs the general requirements of an application for marketing authorization for a medicinal product, which should include:

1. name and address of the responsible entity, manufacturer or importer;
2. name of the medicinal product;
3. detailed quantitative and qualitative data of the active substance or active substances and other substances relating to the medicinal product and their common names, and in their absence – chemical names;
4. the pharmaceutical form, strength and route of administration and shelf life of the medicinal product, as well as environmental data related to the destruction of the medicinal product, if necessary and resulting from the properties of the product.

Pursuant to paragraph 2, the application shall be accompanied by:

1. description of the manufacture of the medicinal product;
2. description of the control methods used in the manufacturing process;
3. written confirmation by the manufacturer of the medicinal product that it has verified, through an audit, compliance with the requirements of Good Manufacturing Practice by the manufacturer of the active substance at the place where it conducts its manufacturing activities;
4. information on special requirements for the storage of the medicinal product, its dispensing to patients and the disposal of the expired product, together with an assessment of the environmental risk associated with the medicinal product and a description of methods to reduce this risk;
5. results, summaries and research reports:
   1. pharmaceutical: physicochemical, biological or microbiological,
   1. non-clinical: pharmacological and toxicological,
   1. clinical

– together with a quality overall summary, a non-clinical overview and a non-clinical summary, and a clinical overview and a clinical summary;

• a summary description of the pharmacovigilance system used by the marketing authorisation holder, including:
  • a declaration by the marketing authorisation holder (submitted under penalty of perjury) that the marketing authorisation holder has the services of a qualified person responsible for monitoring the safety of medicinal products,
  • a list of the Member States of the European Union or the EFTA Member States in which the person referred to in point a resides and performs his or her duties,
  • a declaration by the marketing authorisation holder that it has the necessary resources to fulfil its obligations regarding the pharmacovigilance of medicinal products,
  • contact details of the person referred to in point a,
  • an indication of the place where the full description of the pharmacovigilance system for medicinal products referred to in Article 36g paragraph 1 point 4 is available for inspection;
• a risk management plan for the use of a medicinal product;
• in the case of clinical trials conducted outside the territory of the European Union Member States or EFTA Member States, a statement that the trials meet the ethical requirements set out in Regulation 536/2014;
• declarations signed by the experts preparing the overall quality summary, the non-clinical review and non-clinical data summary, and the clinical review and clinical summary that they possess the necessary technical or professional qualifications, as described in the attached curriculum vitae;
• Summary of Product Characteristics;
• templates of primary and secondary packaging presented in descriptive and graphic form, as well as a leaflet, along with a report on its readability;
• copies of all authorisations issued by the relevant authorities in the European Union Member States or EFTA Member States or third countries, Summaries of Product Characteristics, summaries of safety data, including data from periodic safety update reports and adverse reaction reports, where available, and copies of package leaflets, where applicable, and copies of all decisions refusing to grant an authorisation and the reasons for such decisions;
• a list of the European Union Member States and EFTA Member States where an application for a permit is being considered and, where applicable, details of any refusal to grant a permit in any country;
• a copy of the authorization to manufacture the medicinal product in the country of manufacture.

As can be seen, any entity wishing to market a medicinal product must have extensive documentation to ensure its safe use after marketing authorization. The template for applications submitted to the Polish Office was published in the Regulation of the Minister of Health of January 10, 2014, regarding the template for applications for marketing authorization for medicinal products (consolidated text: Journal of Laws of 2018, item 593).

With regard to the application submitted under the WEU procedure, significant differences are introduced by Article 16 of the Act, according to which the marketing authorisation holder is not obliged to present the results of non-clinical or clinical trials if:

• the active substance or substances of the medicinal product have a well-established medical use;
• in the territory of a Member State of the European Union or an EFTA Member State;
• for a period of at least 10 years, counting from the first systematic and documented use of this substance in a medicinal product and recognized efficacy and an acceptable level of safety.

In this case, the results of non-clinical or clinical studies are replaced or supplemented publications from the scientific literature, and the application must be accompanied by a justification prepared by an expert regarding the use of scientific literature in accordance with the requirements set out in Annex I.

The publications to be submitted must include the full scope of non-clinical and clinical trial results required for new medicinal products. Furthermore, the wording of Article 16 of the Act contradicts Article 10a of the Directive, which only refers to the replacement of scientific studies with publications, not to their replacement or supplementation.

Criteria for granting a permit

The above-mentioned conditions for applying the WEU procedure leave considerable room for interpretation and discretion in the issuance of marketing authorizations for medicinal products. Consequently, EU and national authorities have issued numerous guidelines on this topic.

Until March 30, 2007, detailed requirements for the WEU procedure were specified in the Regulation of the Minister of Health of January 16, 2003, regarding documentation of medicinal product test results, including veterinary medicinal products, and expert reports, which was repealed with the amendment to the Pharmaceutical Law. Currently, Polish regulations do not provide a binding interpretation of the concept of a substance with a well-established medical use.

The criteria for applying this concept can be found in Annex I to the Directive , according to which the following principles apply to demonstrate well-established medicinal use:

a/ The factors that should be taken into account in order to recognize the well-established medical use of the ingredients of medicinal products are as follows:

– how long a given substance has been used,

– the quantitative aspect of the use of a given substance,

– the degree of scientific interest in a given substance (as reflected in the published scientific literature) and

– consistency of scientific assessments.

b/ The documentation submitted by the applicant should cover all aspects of the safety and/or efficacy assessment and must include or refer to a review of the relevant literature, including pre- and post-marketing studies and published scientific literature on experience gained, in the form of epidemiological studies, and in particular comparative epidemiological studies. All documentation, both favorable and unfavorable, must be provided. In accordance with the provisions on “well-established medical use,” it is particularly necessary to clarify that “bibliographic references” to other sources of evidence (post-marketing studies, epidemiological studies, etc.), and not just data relating to tests and trials, can serve as valid evidence of the product’s safety and efficacy if the application satisfactorily explains and justifies the use of these sources of information.

c/ Particular attention must be paid to any missing information and an explanation must be provided as to why demonstration of an acceptable level of safety and/or efficacy can be supported despite the absence of some studies.

d/ Non-clinical and/or clinical reviews must clarify the relevance of any data submitted that relate to a product other than the product intended for marketing (so-called bridging data). A decision must be made as to whether the investigational product can be considered similar to the product for which marketing authorization has been applied for, despite existing differences.

e/ Post-marketing experience with other products containing the same ingredients is particularly important and the applicant should place special emphasis on this issue.

Furthermore, in July 2019, the European Commission issued guidance for applicants for marketing authorizations (Volume 2A, Chapter 1), which also addresses this procedure. The following indications follow from this guidance.

The Commission stressed that applications submitted under Article 10a of the Directive should not lower the level of safety and efficacy that a product with a well-established substance must also meet.

With respect to advanced therapy medicinal products (ATMPs), the Commission has determined that applications under this procedure are only permissible to the extent that the published scientific literature is relevant and sufficient to demonstrate the safety and efficacy profile of the medicinal product. Due to the specific nature of the ATMP manufacturing process, an application under this procedure will be admissible only exceptionally, provided that the manufacturing process for the product covered by the application is identical to the manufacturing process already described in the literature.

It is also worth noting that the term “medical use” does not necessarily mean use as an approved medical product, but evidence of the medicinal activity of a given substance must be provided. The 10-year period referred to in the regulations, in the case of a substance used in products authorised for marketing, does not have to cover the entire period during which a given country was a member of the EU or EFTA – this period also includes the years in which the product was authorised before the country joined the organisation in question.

The term “well-established use” refers to the use of a substance for a specific therapeutic purpose – if a well-known substance is to be used for a completely new therapeutic purpose for which no well-established use can be applied, it will not be possible to use this procedure.

It is the applicant’s responsibility to provide a detailed description of the strategy used to search for published literature and the rationale behind the selections made. The term “published” literature means that the text must be freely available in the public domain and published by a reputable, preferably peer-reviewed, source. Full texts of the research studies must be included in the application, along with any necessary translations.

European Medicines Agency (EMA) has also issued guidelines on this topic.

It is the applicant’s responsibility to demonstrate that the active substance contained in the medicinal product for which the application is submitted is identical to the substance described in the literature and to provide appropriate bridging data. Any studies submitted must support the efficacy and safety of the active substance.

The Agency stated that the applicant should submit a tabulated summary of data to support the assessment, including at least the following details:

• Comprehensive information on specific products (formulas that have been used in efficacy and safety studies reported in the literature)
• Justification for the studies and literature included to support the judgement that the product studied in the literature can be considered similar to the product for which marketing authorisation is being sought.
• Which of the attached literature is considered crucial to demonstrate the effectiveness and safety of a given substance for a specific therapeutic purpose?

For specific types of substances and products, EMA has also issued detailed guidance on the requirements for bridging data used to establish the well-established use of a specific substance.

Comparison of active substances in given products should be based on one or more of the following criteria:

• comparison of the qualitative and quantitative composition of the product;
• comparison of critical quality attributes;
• comparison of dissolution data;
• comparison of physicochemical properties;
• comparative in vitro release or permeation studies for a locally acting product;
• comparative bioavailability (PK) studies;
• clinical justification for the lack of comparative bioavailability studies.

Finally, it is worth emphasizing that if a medicinal product is authorized for the market under the WEU procedure, it may constitute a reference product when submitting applications for authorization to market equivalent products (as stated by the CJEU in its judgment of 23 October 2014 in case C-104/13).

Sources:

1. Act of 6 September 2001 – Pharmaceutical Law (consolidated text: Journal of Laws of 2025, item 750, as amended).
2. Pharmaceutical law. Commentary, 2nd edition, ed. M. Kondrat, Warsaw 2016.
3. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 2001, p. 67, as amended).
4. Annex I to the above-mentioned Directive
5. European Commission Guidelines for Applicants (Volume 2A: Marketing Authorisation Procedures. Chapter 1: Marketing Authorisations)
6. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-pharmacology-pharmacokinetics/clinical-pharmacology-pharmacokinetics-questions-answers#section-9-well-established-use-78013

Artykuł Well-established drugs – the procedure  of well established use pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.