Poland is an EU-member state and therefore the Polish legislative framework is shaped by legal acts adopted both on the EU and national level.

Chief legal act regulating medicinal products (both for human use and veterinary), which includes biologicals, is the act of 6 September 2001 Pharmaceutical law (Prawo farmaceutyczne “PF”), implementing the directive 2001/83/EC on the Community code relating to medicinal products for human use. PF regulates, among others, manufacturing, marketing, advertising, distribution (wholesale and retail) and prescribing of medicinal products. There are separate legal acts providing additional regulations regarding narcotics and reimbursement of medicinal products, medical devices and food for special medical purposes. In addition, there are executive regulations issued mostly by the Minister of Health that provide detailed technical and legal framework for activities related to handling medicinal products, e.g. GMP, GDP and regulation on advertising. Veterinary medicinal products are also regulated by Regulation (EU) 2019/6 on veterinary medicinal products (“VPR”).

Medical devices are regulated comprehensively by Regulation (EU) 2017/745 on medical devices (“MDR”) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”) and the Polish legal act supplementing those regulations, i.e. the act of 7 April 2022 on medical devices (Ustawa o wyrobach medycznych, “UWM”). Additionally, there are several executive regulations issued under UWM mostly by the Minister of Health that specify in detail issues like advertising medical devices, fees regarding registration of medical devices and reporting of serious incidents. Pursuant to intertemporal provisions of UWM, certain executive regulations issued under the previous act regulating medical devices (the act of 20 May 2010 on medical devices) still apply.

Similarly to medical devices, also food is regulated comprehensively by an EU-level regulation, i.e. Regulation (EC) No 178/2002 on the general principles and requirements of food law, further supplemented by EU regulations regarding i.a. food labelling, hygiene and health claims. On the national level, the act of 25 August 2006 on food and nutrition safety (Ustawa o bezpieczeństwie żywności i żywienia, “UBZ”) regulates food, and is supplemented by a number of executive regulations issued under UBZ mostly by Minister of Health.

Food supplements are regulated by UBZ and executive regulations issued by the Minister of Health under UBZ regarding composition and labelling of food supplements.

Medicinal Products

The regulatory process for human medicinal products during the R&D phase begins with the initiation of proceedings before the President of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (“URPL”), culminating in the issuance of a decision regarding the clinical trial authorization. In the Polish system, the ethical evaluation of clinical trials conducted by the Supreme Bioethics Committee is also crucial. The legal framework for clinical trials is detailed in response to question 7 of this chapter.

The marketing authorization of a medicinal product also requires an appropriate permit. The procedure for granting a marketing authorization is governed by Chapter II of the act of 6 September 2001 Pharmaceutical law (Prawo farmaceutyczne, “PF”). The President of the URPL issues the decision for marketing authorization of medicinal products, registered through the national procedure, mutual recognition procedure (MRP), and decentralized procedure (DCP). For products registered through the centralized procedure (CP), the authorization is issued by the European Commission, as regulated by Regulation (EC) No 726/2004.

Post-marketing surveillance activities and pharmacovigilance are regulated under the PF and are compliant with Directive 2001/83/EC. Patients have the right to directly report adverse drug reactions. Additionally, the Chief Pharmaceutical Inspectorate holds oversight responsibilities for the quality of medicinal products and can suspend or withdraw products from the market if they do not meet established quality standards.

Medical Devices

The regulations concerning medical devices are harmonized with EU law and outlined in the Regulation (EU) 2017/745 on medical devices (“MDR”) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”), as described in the chapter on Europe in this guide. Regarding clinical investigations of medical devices, applications for clinical trial authorization and amendments will eventually be submitted through the designated CI/PS module within the European database on medical devices (“EUDAMED”). Until this EUDAMED functionality is operational, applications should be submitted to the President of the URPL.

The main national regulations applicable to the regulatory process for food supplements in Poland are: act of 25 August 2006 on food and nutrition safety (Ustawa o bezpieczeństwie żywności i żywienia, “UBZ”) and Regulation of the Minister of Health on the composition and labeling of food supplements and Rozporządzenie Ministra Zdrowia w sprawie składu oraz oznakowania suplementów diety, as well as the European Union regulations covering that matter, in particular Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers and Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. The regulations include specifically the issues connected with:

• content of vitamins, minerals and other substances in food supplements; labelling and presentation of such products;
• notifying the Chief Sanitary Inspector about the introduction or intention to introduce a food supplement on the market for the first time.

According to the applicable regulations, food supplement is a foodstuff which purpose is to supplement a normal diet, being a concentrated source of vitamins or minerals or other substances with a nutritional or other physiological effect, single or combined, placed on the market in a form enabling dosing, in the form of: capsules, tablets, dragees and other similar forms, sachets with powder, ampoules with liquid, dropper bottles and other similar forms of liquids and powders intended for consumption in small, measured unit quantities, excluding products with the properties of a medicinal product within the meaning of the provisions of act of 6 September 2001 Pharmaceutical law (Prawo farmaceutyczne, “PF”) .

In order to introduce such a product to the market, there is an obligation to electronically notify the authority (Chief Sanitary Inspector) about such introduction. Such notification should include information listed in the regulations, including name of the product, its manufacturer, form, template of labelling, qualitative and quantitative composition, name and surname or name, address and tax identification number (NIP) of the entity notifying about the first introduction to the market.

The regulations cover proper labelling, presentation and advertisement of food supplements, including an obligation to directly indicate on the labelling that such product is a food supplement. In particular, the provided information must not attribute to any food the property of preventing, treating or curing a human disease, nor refer to such properties. All the claims used within the presentation of the products must comply with EU regulations on health and nutrition claims.

The products should comply with the necessary requirements indicated in the UBZ concerning its composition, quality and manufacturing or distribution process.

Industry requirements relating to food supplements are also being introduced – especially their presentation and advertising. As an example the Code implemented by The Polish Council for Supplements and Nutritional Foods (KRSiO) (Kodeks Dobrych Praktyk Reklamy Suplementów Diety).

The competent state district sanitary inspector, in an administrative decision, shall prohibit the introduction into the market or order the withdrawal from the market in the territory of Poland of a food supplement which does not meet the requirements specified for these foodstuffs in the UBZ.

Medicinal products

After a marketing authorization for a medicinal product is issued, pursuant to act of 6 September 2001 Pharmaceutical law (Prawo farmaceutyczne, “PF”) the marketing authorization holder (“MAH”) is obliged to fulfill certain legal obligations connected with the placing product on the market.

MAH is in particular obliged to inform the Chief Pharmaceutical Inspector about the first date of introduction of the medicinal product to the market and about the temporary or permanent suspension of trade in a medicinal product. MAH must also supply medicinal products only to authorized entities indicated in the PF, such as pharmaceutical wholesalers or hospital pharmacies, pharmaceutical stores, hospital pharmacy departments. The distribution and supply chain of the medicinal products should be in line with the specific regulations.

MAH is also obliged to establish, maintain and audit pharmacovigilance systems for the product, including appointment of a responsible person accountable for safety supervision and registry of reports of individual cases of adverse reactions. One of the requirements for the MAH is monitoring the safety of medicinal products and informing the authorities about any potential changes within the characteristics of the medicinal product and any previously unknown information that may require a change in the documentation covered by the application for marketing authorization. MAH should in general regularly update any information about the medicinal product.

In addition, specific rules should be adhered to as regards advertising medicinal products.

Medical devices

According to the act of 7 April 2022 on medical devices (Ustawa o wyrobach medycznych, “UWM”) certain entities are obliged to notify the authorities about any serious incidents regarding the medical devices, as after placing them on the market the medical devices are subject to vigilance compliance. Such notification should include inter alia information about the device, its manufacturer and importer, contact details. In case of infringements indicated in the UWM, the authority is entitled to issue an administrative decision on the withdrawal of such non-compliant medical devices from the market.

There are also specific obligations related to advertising medical devices.

Medicinal Products

1. The President of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (“URPL”): This authority is tasked with registering and regulating medicinal products and medical devices. It plays a crucial role in ensuring the safety of these products through pharmacovigilance and manages matters pertaining to clinical trials.
2. The Chief Pharmaceutical Inspector (“GIF”): This authority is primarily responsible for maintaining the quality of medicinal products available in the market. It conducts thorough inspections of manufacturing and distribution facilities, oversees pharmaceutical operations, and decides on the suspension or withdrawal of products failing to meet established standards. Furthermore, GIF is actively involved in combating illegal trade of medicinal products and provides educational resources regarding the safe usage of medicines.

Medical Devices

President of the URPL: This authority is also responsible for the registration and regulatory oversight of medical devices, ensuring compliance with applicable standards.

Food Supplements

The Chief Sanitary Inspector (“GIS“): This authority is responsible for the oversight and monitoring of food safety, including food supplements. This authority conducts sanitary inspections and enforces public health regulations, which encompass labeling and composition standards for food products.

The appeals against regulatory decisions concerning medicinal products, medical devices, and food supplements fall under the scope of administrative law and are subject to the appeal procedure outlined in the Polish Code of Administrative Procedure. The administrative process is two-tiered, allowing for appeals against any first-instance decision. An appeal must be filed within 14 days of receiving the decision.

While the core appeal procedures are consistent, there may be slight variations depending on the regulatory authority involved, such as Chief Pharmaceutical Inspector (“GIF”), the President of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (“URPL”), or the Chief Sanitary Inspector (“GIS”), due to specific regulations applicable to each. In the Polish system, if there is no higher authority in a given situation, the same authority acts as the second-instance body to consider the appeal. This is the case with regulatory decisions.

A final decision issued by the second-instance authority can be challenged before a Voivodship Administrative Court within 30 days. A ruling by the Voivodship Administrative Court can be further appealed to the Supreme Administrative Court.

Clinical trials regarding medicinal products for human use are regulated by the Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (“CTR”) and the act of 9 March 2023 on clinical trials on medicinal products for human use (“CTA”). Proceedings regarding clinical trials are conducted in front of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (the “URPL”). The sponsor of the clinical trial submits an application dossier (in Poland according to CTA substantial part of the accompanying documentation may be in English) to the intended Member States concerned electronically via Clinical Trials Information System (“CTIS”, https://euclinicaltrials.eu/). The President of the URPL performs scientific review of the application and approves or denies conducting clinical trials in the form of administrative decision, which can be appealed against (see response to question 6). Ethical review is conducted by the Supreme Bioethics Committee and may not be appealed against separately, only as an appeal against the decision denying the trials of the President of the Office. CTR provides detailed regulations regarding contents of the application and decision-making procedure and deadlines. Sponsor and investigator bear civil liability for clinical trials and are obliged to hold insurance coverage in this respect. The principal investigator has to be a person holding the right to practice the medical profession in Poland.

Clinical trials regarding medical devices are regulated by the Regulation (EU) 2017/745 on medical devices (“MDR”) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”) and supplementary also by the act of 7 April 2022 on medical devices (Ustawa o wyrobach medycznych, “UWM”). Proceedings regarding clinical trials are conducted in front of the President of the URPL, who approves or denies conducting clinical trials in the form of administrative decision, which can be appealed against (see response to question 6). The application for approval of clinical trials is submitted to the URPL electronically or on paper (until relevant European database on medical devices (EUDAMED) functionality becomes operational), only after the bioethics committee issues a positive opinion regarding such clinical trials. Negative opinions of the bioethics committee may be appealed against to the Appellate Bioethics Committee. Application and substantial part of accompanying documentation may be submitted in English. MDR, IVDR and UWM provide detailed regulations regarding contents of the application and decision-making procedure and deadlines. As a general rule sponsor and investigator are obliged to hold insurance coverage in respect to clinical trials.

Clinical trials of medicinal products and medical devices may be inspected by the President of the URPL in the context of their compliance with regulations.

Clinical trials regarding veterinary medicinal products are regulated by the act of 6 September 2001 Pharmaceutical law (Prawo farmaceutyczne) and Regulation (EU) 2019/6 on veterinary medicinal products.

Information regarding clinical trials of medicinal products approved under the Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use is accessible via the Clinical Trials Information System (“CTIS”) platform (https://euclinicaltrials.eu/). Clinical trial results should be reported to CTIS within one year of the end of the clinical trial, in order to be published. European Medicines Agency’s Policy 0070 (https://www.ema.europa.eu/en/documents/other/policy-70-european-medicines-agency-policy-publication-clinical-data-medicinal-products-human-use_en.pdf) facilitates the disclosure of clinical data provided by pharmaceutical companies as part of their marketing authorization applications within the EU’s centralized process (https://clinicaldata.ema.europa.eu/web/cdp/home).

There is also a publicly available database maintained by Employers’ Union of Innovative Pharmaceutical Companies INFARMA available at https://www.badaniaklinicznewpolsce.pl/baza-badan-klinicznych/#/, which shows clinical trials of companies associated in this organization.

Information regarding clinical trials of veterinary medicinal products is held at the Central Register of Clinical Trials, which is maintained by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

As regards medical devices, information on clinical trials will be published in the European database on medical devices (“EUDAMED”), as provided for by the Regulation (EU) 2017/745 on medical devices, to ensure transparency, as access to EUDAMED will be publicly available. The obligation to publish in EUDAMED shall apply six months after the date of publication by the European Commission of the notice that the relevant module in EUDAMED is operational, which will happen around 2026-2027.

The use of data from clinical trials in Poland is subject to the General Data Protection Regulation (EU) 2016/679 (“GDPR”) and the act of 10 May 2018 on personal data protection, in the event such data is personal data, i.e. when the natural person, who is a data subject, is identifiable. Generally, separate consent from a data subject is not required to use personal data in the course of a clinical trial protocol. Secondary uses of clinical trial data outside the clinical trial protocol for scientific purposes may require specific consent, depending on particular circumstances.

Under the act of 9 March 2023 on clinical trials on medicinal products for human use in certain cases it is permissible to restrict the application of some GDPR provisions if it is likely that the rights specified in those provisions will prevent or seriously impede the achievement of the objectives of the clinical trial as a scientific study, and if these limitations are necessary to achieve those objectives.

Databases are legally protected under the act of 4 February 1994 copyright law and the act of 27 July 2001 on protection of databases. Generally, the database producer has the exclusive and transferable right to extract and reutilize the data in whole or in substantial part, in terms of quality or quantity.

The digitization of the process of submitting applications for conducting clinical trials is already in effect (see answer to question 7 of this chapter).

Although a number of decentralized clinical trials is increasing in Poland, at the moment there are no major additional legislative initiatives on digitizing the process of conducting clinical trials in Poland.

Medicinal Products

In Poland, engaging in business activities related to the manufacturing of medicinal products requires obtaining a manufacturing authorization. This authorization is issued by the Chief Pharmaceutical Inspector (“GIF”). The GIF registers information about issued manufacturing authorizations in the European EudraGMDP database. The authorization is granted following the completion of proceedings and culminates in the issuance of an administrative decision.

Medical Devices

There are no uniform requirements for facilities manufacturing medical devices. The quality of manufacturing processes is indirectly regulated through the conformity assessment of the specific device and the manufacturer’s quality management system.

Food Supplements and Food

Food supplements are subject to regulations similar to those for food. The production of food or items intended to come into contact with food requires registration in the register of facilities subject to official control by the State Sanitary Inspection (Sanepid).

Medicinal products are introduced to the market by the Marketing Authorization Holder (“MAH”) or a third party (distributor) with the MAH’s approval and are primarily sold and supplied to wholesalers. Wholesaler, pursuant to article 72 point 3 of the act of 6 September 2001 Pharmaceutical law (Prawo farmaceutyczne, “PF”), is defined as any entity that procures, holds, supplies or exports medicinal products. The aforementioned entity is obliged to hold a wholesale distribution license. The distribution of medicinal products directly to end users (patients or healthcare professionals) is exclusive to pharmacies, except for those products that can be sold freely. The list of such medicinal products is stipulated under Regulation of Ministry of Health dated 21st December 2021 on the list of active substances contained in medicinal products that may be entered to the market in non-pharmacy market outlets and limited service pharmacies, and the criteria for classifying these products in individual lists.

Medical devices are brought to market by the manufacturer, or by the importer if the manufacturer is from outside of the EU/EEA region. Unlike medicinal products, the distribution of medical devices does not require government authorization or licensing. However, distributors must adhere to specific obligations to ensure that only compliant medical devices reach the market, as stipulated in particular under Article 10, 13 and 14 of the Regulation (EU) 2017/745 on medical devices.

The distribution of food supplements in Poland does not require obtaining official authorization or license. Nevertheless, in order to monitor products introduced to the market in the territory of Poland, an entity operating on the food market that introduces or intends to introduce food supplements to the market for the first time is obliged to notify the Chief Sanitary Inspector (Article 29 point 1.2 of the Food and Nutrition Safety Act).

In Poland, the reimbursement system is regulated by the Act of 12 May 2011 on the reimbursement of medicines, foods for special dietary purposes, and medical devices. The reimbursement covers medications that are listed in the official register of reimbursed medicines, published by the Minister of Health.

The reimbursement process begins with an application submitted to the Minister of Health. The application must include, among other things, the selling price, a proposed retail price, and justification containing data on the efficacy and safety of the drug. The Minister of Health assesses the viability of reimbursement based on a pharmacoeconomic analysis and the recommendation of the Transparency Council operating under the Agency for Health Technology Assessment and Tariff System (AOTMiT).

Medications can be reimbursed at different patient co-payment levels: a fixed charge, 50%, 30%, or available free of charge. The level of reimbursement depends on the allocation of the medication to the appropriate therapeutic category and its importance in treating a specific disease.

Medicinal products advertising activities are regulated mainly by the act of 6 September 2001 Pharmaceutical law (Prawo farmaceutyczne). The advertising of a medicinal product is any activity that involves providing information about or encouraging the use of a medicinal product with the aim of increasing: the number of prescriptions written and the supply, sale or consumption of medicinal products.

The above-mentioned legal act indicates a number of restrictions related to the advertising of medicinal products. The most important of these include:

• The advertising of a medicinal product cannot be misleading, should present a medicinal product objectively and should provide information on the rational use of the medicinal product.
• The advertising of a medicinal product cannot involve offering or promising any benefits either directly or indirectly in exchange for purchasing a medicinal product or providing proof that a medicinal product was purchased.
• The advertising of a medicinal product cannot be directed at children or contain any element directed at them.
• The advertising of a medicinal product which refers to a full advertisement, apart from its invented name and international non-proprietary name, may contain only a trademark that contains no references to therapeutic indications, pharmaceutical form, dose, advertising slogan or other advertising content.

What is more, specific requirements related to conditions and forms of advertising medicinal products, the necessary data that the advertisement must contain, as well as the method of conveying the advertisement, are regulated by Regulation of Ministry of Health dated 21 November 2008 on advertising of medicinal products.

Advertisement of medical devices is generally regulated by the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (in particular Article 7 in both regulations) as well as the Polish legal act supplementing those regulations, i.e. the act of 7 April 2022 on medical devices (Ustawa o wyrobach medycznych, “UWM”). The advertisement of a medical device directed to the public must be formulated in a manner that is understandable to a layperson. This requirement also applies to medical and scientific terminology, as well as the citation of scientific studies, opinions, literature, or scientific reports, and other materials aimed at users other than laypersons. UWM also contains several restrictions connected with advertisement activities.

Food supplements’ advertisement (and legal restrictions) are mainly connected with proper formulation of so-called health claims. Such claims were regulated in particular by Health Claims Regulation (EC) No. 1924/2006. Several requirements regarding labeling and advertising food supplements are also indicated in Article 27 point 5 and 6 of act of 25 August 2006 on food and nutrition safety.

Act of 30 June 2000 Industrial Property Law regulates patents and trademarks for medicinal products, medical devices as well as food supplements. What is more, the patent protection related to medicinal products can be extended in time bearing in mind provisions of the aforementioned Act, which implements provisions of the Regulation (EC) No 469/2009 (Supplementary Protection Certificate – SPC). The protection extension period can reach up to five years.

Authorized entity can register trademark for medicinal products, medical devices and/or food supplements as:

• National (Polish) trademark – the procedure is conducted by The Patent Office of the Republic of Poland;
• European Union trademark – the procedure is conducted by European Union Intellectual Property Office (EUIPO) which follows the provisions of the Trademark Regulation (EU) 2017/1001; or
• Global trademark – the procedure is conducted by The Patent Office of the Republic of Poland.

If an entity exclusively authorized to use a patented medicinal product or medical device learns that the rights to their patent have been violated, regardless of the form of such violation, they may pursue their claims in civil proceedings based on the provisions of Article 283 et seq. of the Act of 30 June 2000 Industrial Property Law. The regulations do not provide for any separate procedure for pursuing claims related to patent infringement, indicating that such cases are considered under the general principles provided for in the Code of Civil Procedure.

As part of the rights of the person entitled to patent rights, this person may, among others, demand the cessation of activities threatening to violate the law, the withdrawal from sale of products owned by the infringer, award this products to the entitled person as part of the amount of compensation awarded to this person or their destruction.

It should be noted that the time limit for pursuing aforementioned claims is limited. Claims in this respect are subject to a limitation period of 3 years, which means that filing a lawsuit after that period may end in its dismissal if the defendant raises the defense of the limitation period.

On the EU level, the European Medicines Agency issued Guidelines on the acceptability of names for human medicinal products processed through the centralized procedure (https://www.ema.europa.eu/en/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure-scientific-guideline). This document sets out requirements and recommendations for developing an invented name for the medicinal product.

Bearing in mind Polish legislation, the act of 6 September 2001 Pharmaceutical law (Prawo farmaceutyczne) stipulates (i.a) that the name of a medicinal product may be a proprietary name that does not allow for confusion with a generic name, or a generic or scientific name. What is more, the advertisement of a medicinal product cannot be misleading.

Moreover, regarding the use of appropriate naming for medicinal products (which also affects the trademarks), the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued a communication dated 24 September 2019, concerning guidelines for the naming of medicinal products intended for human use.

Medicinal products

Marketing authorization holder (“MAH”) is generally responsible for the registration, safety, efficacy and quality of the medicinal product, as well as for providing regulatory authorities with all necessary information and documents. Additionally, it is MAH’s obligation to monitor adverse effects of medicinal products already placed on the market and to report them to the appropriate authorities.

The compliance with the applicable regulations and standards is being monitored by the pharmaceutical inspection authorities (i.a. Chief Pharmaceutical Inspectorate).

Medical devices

The manufacturer bears the primary responsibility for ensuring that the medical device complies with all legal requirements. They must ensure that the device is safe and performs the declared functions. The manufacturer is also responsible for developing the technical documentation, the declaration of conformity and implementing a quality management system.

Importers and distributors also have specific duties, although not as extensive as those imposed on the manufacturer. They must, among other things, ensure that the product complies with regulations and verify whether the manufacturer fulfills their obligations. They are required to keep documentation and cooperate with authorities in the event of proceedings.

The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products has the right to inspect medical devices on the market and to intervene in case of non-compliance.

Food supplements

Under the current legal provisions, the manufacturer or entrepreneur introducing a food supplement to the market is fully responsible for the health quality of the food, its labelling and presentation. The specific regulations covering non-compliance with the legal requirements are covered by the national legislation.

Especially such obligations are connected with the safety of the product (connected with its quality, specification and product composition). Additionally, it is required to comply with the regulations on the labelling of the products and providing necessary information for the consumers.

Notwithstanding the foregoing, the general provisions regarding product safety and civil liability for damages or defects of the products apply.

Medicinal products

For medicinal products the act of 6 September 2001 Pharmaceutical law (Prawo farmaceutyczne, “PF”) covers the rules on penalties connected with the infringement of the applicable regulations.

According to those provisions there is a wide range of infringements, which can be subject to criminal liability of natural persons, which includes among others placing on the market or storing without authorization, manufacturing, supplying or making available counterfeit medicinal products, as well as undertaking or carrying out business activities without necessary permission. The criminal sanctions for the indicated acts are possibly fines, restriction of liberty or imprisonment.

Additionally, there are administrative fines specified for indicated infringements – such as violating the regulations related to the export or sale of medicinal products abroad, which may be imposed on entrepreneurs, and therefore also on legal entities.

Depending on the sanctions, they are enforced through administrative or criminal proceedings.

Medical devices

The act of 7 April 2022 on medical devices (Ustawa o wyrobach medycznych) covers the rules on penalties connected with the infringement of applicable regulations connected with the medical devices. Such sanctions regard the administrative fines for manufacturers, importers and distributors for non-compliance with the requirements, in particular the obligations imposed by the requirements of the Regulation (EU) 2017/745 on medical devices (“MDR”) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”).

Such sanctions can also be specifically connected with the advertisement of the medical devices – for using misleading texts and symbols and for violating advertising rules of products indicated in the MDR and IVDR, as well as national legislation.

Foods and food supplements

Criminal provisions and financial penalties are regulated by the provisions of act of 25 August 2006 on food and nutrition safety (Ustawa o bezpieczeństwie żywności i żywienia). According to the applicable regulations, the various cases of non-compliance with the requirements of the foods law can result in the financial and criminal sanctions – e.g. in case of manufacturing or placing on the market a spoiled or adulterated foodstuff, which shall be subject to a fine, the penalty of restriction of liberty or imprisonment of up to one year.

Notwithstanding the above, civil matters concerning the specified categories of products may be processed through civil proceedings, as well as general criminal sanctions regardless of the product’s legal classification.

In recent years, the Polish healthcare system has been experiencing progressive digitization of processes, the benefits of which are also accessible to patients. As a result, there are many legal acts within the Polish and EU legal framework regulating the general principles, such as those related to health applications, as well as dedicated legislation implementing the functioning of specific tools. The most important legal acts in this area include:

1. The Act of 28 April 2011 on the Information System in Healthcare – this act defines the organization and operational principles of the information system in healthcare. It specifies the obligations of entities processing health data, the rules governing databases, and describes the IT systems supporting the information system such as IKP (Internetowe Konto Pacjenta).
2. Regulation (EU) 2017/745 on medical devices (“MDR”) – for other (commercial) medical/healthcare applications it should be noted that it can be classified as medical devices of class I, IIa or IIb. Therefore, in some circumstances aforementioned applications can be subjected to MDR regulations.
3. Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonized rules on artificial intelligence (“AI Act”) – in the situation when such medical/healthcare application uses artificial intelligence, such application’s functionalities and overall operating should be governed by aforementioned EU regulation. At the time being Polish Parliament is in the process of creating national legislation in this respect.

In Poland, there are legal provisions and measures in place to ensure the continuity of supply for medicinal products. The key regulations in this area include:

1. Pharmaceutical Law

Under the act of 6 September 2001 Pharmaceutical law (Prawo farmaceutyczne, “PF”), manufacturers, wholesalers, and pharmacies are required to ensure a steady supply of medicines to meet patient needs. These regulations mandate the monitoring of stock levels and the implementation of measures to prevent shortages.

2. System for Monitoring Medicine Availability

Poland has established a system to track the availability of medicines, known as the Integrated System for Monitoring the Circulation of Medicinal Products (Zintegrowany System Monitorowania Obrotu Produktami Leczniczymi, “ZSMOPL”). This system enables the rapid identification and resolution of supply shortages. Pharmaceutical companies are required to report data on the availability of their products.

3. Regulatory Interventions

In instances where significant shortages of essential medicinal products arise, regulatory authorities are empowered to intervene, facilitating their import to address patient needs.

In Poland, there are several industry organizations whose aim is to ensure ethical marketing practices for medicinal products, medical devices, and food supplements. The most important regulations in this area include:

1. Code of Good Practices – this document sets standards for: the promotion and advertising of medicinal products, the organization of symposia, congresses and other scientific meetings, the administration of research and the collaboration with representatives of medical professions and patients’ organizations. The content of this code (implemented in Poland by INFARMA) is based on the Code of the European Federation of Pharmaceutical Industries and Associations (EFPIA);
2. Medicines for Europe Code of Conduct – this document sets out a framework of principles and standards that promote trust, responsible behavior and respect between pharmaceutical companies and the healthcare community, including healthcare professionals, healthcare organizations, patients and patients organizations.
3. Code of Good Practice for Advertising Food Supplements – the code regulates the principles of advertising food supplements by entities operating on the food supplements market.
4. MedTech Europe Code of Ethical Business Practice – this document (implemented in Poland by POLMED) sets out the minimum standards appropriate to the various types of activities such as: organizing medical educational events, making arrangements with healthcare professionals, as well as conducting medical research.

1. Judgment of the Supreme Administrative Court regarding pharmacy advertisement (29 October 2024, II GSK 831/21)

According to the judgement, understanding of the “advertising” term must be interpreted rigorously, since the provision of the law clearly indicates that the location of the pharmacy and its hours of operation do not constitute advertising. The rigor of this understanding must always relate to the potential or actual economic benefits that may be associated with the information provided and relating to the pharmacy’s operations, particularly the sale of products offered by the pharmacy.

2. Action brought on 13 March 2024 – European Commission v Republic of Poland (Case C-200/24) (C/2024/3062)

On 13March 2024, the European Commission filed a complaint with the Court of Justice of the European Union in Luxembourg against Poland regarding pharmaceutical law provisions that prohibit the advertising of pharmacies or pharmaceutical outlets and their activities.

The indicated prohibition is introduced into the act of 6 September 2001 Pharmaceutical law (Prawo farmaceutyczne) in 2012.

According to the presented arguments, the Commission asserts that that prohibition infringes Article 8(1) of Directive 2000/31, since it covers any form of electronic commercial communication, including via a website created by a pharmacist working in a pharmacy or a pharmaceutical outlet. It was also indicated that the prohibition restricts freedom of establishment and freedom to provide services beyond what is necessary to achieve the objective of public health protection in the Republic of Poland.

3. Judgment of the Constitutional Tribunal regarding the Pharmaceutical Law novelization (18 September 2024, K 15/23)

According to the judgment, the Apteka dla Aptekarza 2.0 (“ADA 2.0.”) regulation (regarding the issues of pharmacies’ ownership structure) was introduced in a manner inconsistent with the Polish Constitution. As per the proposed changes, a prohibition was to be introduced on taking control over an entity operating a pharmacy by individuals other than pharmacists or companies with their participation, as well as by entities that already directly or indirectly operate a specific number of pharmacies.

However, as indicated in the judgement – the Constitutional Tribunal in this case did not substantively assess the constitutionality of the changes proposed in the pharmaceutical law, but considered the violation of the legislative procedure as outlined by the Constitution. It should be noted that in this case, the provisions amending the pharmaceutical law were found to be unconstitutional. Due to complicated political situation in Poland this judgment is not legally effective.

The Polish public health system has undergone substantial digitalization over the past few years. Starting from January 2020, prescriptions for prescription-only medicinal products are only issued electronically, allowing the patient to fill their e-prescription via a dedicated application – Internetowe Konto Pacjenta (“IKP”). Within the IKP functionalities, patients have also the opportunity to (i.a.) view and receive electronic health documentation, follow the dosage of medicinal products prescribed by the specialist, view the treatment history of a family member, as well as receive referral for medical investigation in electronic form.

Moreover, according to the latest announcements made by the Ministry of Health, some new solutions are planned to be introduced in 2025 and following years, including those based on the use of artificial intelligence:

The Intelligent Services Platform is intended to deliver specialists with medical services supported by AI algorithms. The platform will use the resources of the e-Health Center and external services. One of the first applications will be imaging diagnostics supported by artificial intelligence.

The Ministry of Health is also planning implementation of the Medical Documentation Digitization Center. Its main task will be digitizing medical documentation (current and archived) collected by health facilities. The system will also facilitate the storage and exchange of information between medical facilities.

The use of artificial intelligence in the healthcare and life sciences sector will be also governed by implementation of Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence adopted within the EU.

In 2025 it is planned to introduce a significant amendment of the Act of 12 May 2011 on the reimbursement of medicines, foods for special dietary purposes, and medical devices.

In the first half of 2025, Poland holds the presidency of the European Union. Some of the main objectives of the Polish presidency are:

• pharmaceutical security, including the revision of pharmaceutical legislation and the introduction of the Critical Medicines Act;
• the digital transformation of healthcare – plans include building the regulatory and institutional architecture, as well as developing new standards and e-health principles within the European Union. The outcomes of these efforts will be the next steps in the form of delegated acts and standards that will implement the architecture of the European Health Data Space.