Polish legislation regarding pharmaceuticals and medical devices is heavily influenced by EU legislation.

The manufacturing, registration, distribution, marketing and advertising of pharmaceuticals are regulated by the Pharmaceutical Law Act of 6 September 2001 and its executive regulations. Clinical trials of medicinal products for human use are governed primarily by Regulation 536/2014, and at a national level by the Clinical Trials of Medicinal Products for Human Use Act of 9 March 2023, which supplements Regulation 536/2014 in the areas left to member states.

The Medical Devices Act of 7 April 2022 and its executive regulations deal with the regulation of medical devices, including safety and quality. Polish law has been aligned with the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR).

The Act on Reimbursement of Medicines, Food Products Intended for Particular Nutritional Uses and Medical Devices of 12 May 2011 regulates reimbursement from public funds. Major amendments of this statute entered into force in November 2023 and, with further changes, in September 2025. A further extensive amendment package (SZNUR) was published for public consultation in May 2025.

The key regulatory authority for medicinal products is the Pharmaceutical Inspection, which is led by the Chief Pharmaceutical Inspector (GIF) and supervises the quality, manufacture, import, distribution, transport and storage of pharmaceuticals, among other matters. The Inspection is also responsible for overseeing the advertising of those products, and for controlling the operations of pharmacies and wholesalers. The Chief Pharmaceutical Inspector is a central government administration authority operating within the centralised state administration. The Pharmaceutical Inspection is also comprised of regional pharmaceutical inspectors, but these are formally subordinate to voivodes (regional governors in charge of governmental administration) rather than to the Chief Pharmaceutical Inspector. In practice, this results in a dual subordination model (substantive supervision by the Chief Pharmaceutical Inspector, organisational subordination within the voivodeship administration).

The President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) is the regulatory body responsible for the registration and authorisation of medicinal products and for key regulatory decisions relating to medical devices, including their classification and safety. Under the Medical Devices Act, supervision over the advertising of medical devices (including IVDs) is also exercised by the President of the URPL. The Ministry of Health decides on the reimbursement of pharmaceuticals and medical devices.

The procedure for challenging administrative decisions is generally similar for all regulated products, since all of the proceedings are at least partially regulated by the Administrative Procedure Code of 14 June 1960. As a rule, there is always a legal remedy. Typically, an appeal against a first-instance administrative decision is filed within 14 days.

Decisions made by local branches of the authorities can be challenged by appealing to the main authority (eg, a decision of the Regional Pharmaceutical Inspector can be appealed to the Chief Pharmaceutical Inspector), and the final decision is subject to judicial review by the administrative courts. In general, the administrative appeal is free of charge and not subject to any specific formal requirements other than the explicit disagreement of the party. The judicial review is subject to a fee, which differs depending on the type of decision that is being questioned. A complaint to the voivodeship administrative court is generally filed within 30 days of service of the final decision.

It is not possible to appeal against decisions made by the central authorities, such as the Chief Pharmaceutical Inspector. The party may file a motion for the decision to be reconsidered or proceed directly to a judicial review by the administrative courts.

In principle, the regulations mentioned in 1.1 Legislation and Regulation apply to all categories of medicines. However, certain categories are subject to additional or stricter rules (eg, dispensing, advertising and controlled-substance restrictions).

Medical devices and in vitro diagnostic medical devices are regulated separately at the level of EU law, but in national law they are regulated by a single statute. Within the MDR/IVDR framework, devices are risk-classified, and the class determines, among other matters, the conformity-assessment route (including whether a notified body must be involved) and certain post-market obligations.

Clinical trials of medicinal products and studies involving medical devices are regulated under different EU frameworks, although both are harmonised at EU level. Medicinal products are governed primarily by Regulation 536/2014, while medical devices are covered by the MDR/IVDR framework (clinical investigations under the MDR and performance studies under the IVDR), supplemented by Polish implementing legislation. On a national level, clinical trials of pharmaceuticals are regulated by the Clinical Trials of Medicinal Products for Human Use Act of 9 March 2023, while clinical investigations/performance studies relating to medical devices and in vitro diagnostic medical devices are regulated by the Medical Devices Act (Articles 31 to 47).

The provisions of the Clinical Trials of Medicinal Products for Human Use Act clarify the rules of procedure for issuing a clinical trial authorisation set forth in Regulation 536/2014.

A clinical trial can be started after a decision from the President of the URPL to issue a clinical trial permit (subject to the possibility of “so-called” implied consent in cases specified by Regulation No 536/2014) has been obtained and a bioethical committee has issued a positive opinion on the study. The application for permission is submitted through the Clinical Trials Information System (CTIS). As a rule, it is possible to submit documentation in English or Polish (with the exception of certain elements which the law provides must be in Polish). In practice, the CTIS dossier is typically prepared in English for the co-ordinated assessment, while participant-facing and local/site documents (informed consent, recruitment materials and certain contracts/insurance confirmations) are commonly required in Polish for the national/ethics assessment.

The rules for the payment of the application fee are determined in Article 58 of the Act. The amount of the fee depends on the phase of the clinical trial. In the case of a commercial phase I-III clinical trial, the fee is PLN30,000 when Poland acts as the reporting member state and PLN25,000 when Poland does not act as the reporting member state (with separate amounts provided for Phase IV trials and certain other application types). Proof of payment must be attached in CTIS.

Clinical trials for medical devices are required for higher-risk devices. The provisions of the Medical Devices Act detail the rules set by the MDR for applying for a clinical trial permit and the rules set by the IVDR for applying for a performance study permit. Under the MDR/IVDR, the route depends on the type of study and the device status.

Under EU MDR rules as applied in Poland, a regulatory inconsistency emerges for clinical investigations of CE-marked medical devices. Even when a device is used strictly within its intended purpose and the investigation involves no additional invasive or burdensome procedures (Article 82 of the MDR), a full administrative authorisation is still required.

For medicinal products, information on clinical trials authorised under the Clinical Trials Regulation (CTR) is publicly available via the CTIS public portal, and sponsors must upload summary results and a layperson summary to CTIS (with limited deferral possibilities in specific circumstances). The Employers’ Association of Innovative Pharmaceutical Companies (INFARMA, which is a member of the European Federation of Pharmaceutical Industries and Associations) represents pharmaceutical companies engaged in research and development activities in Poland, and has voluntarily established a publicly available database of ongoing clinical trials conducted by its members (ie, pharmaceutical manufacturers). Such industry-driven listings are supplementary and do not replace the CTR/CTIS transparency framework. For medical devices, transparency is structured around MDR/IVDR reporting and database obligations (the European Database on Medical Devices, or EUDAMED), and the clinical investigations/performance studies module remains under development.

There is no specific restriction against using online tools to support clinical trials. However, online tools must be used in a way that complies with the CTR/MDR/IVDR requirements (including participant information, consent processes, safety reporting and data integrity), Good Clinical Practice and applicable data protection law (GDPR and the Polish Act of 10 May 2018 on personal data protection). Recruitment materials and methods (including online recruitment) typically require ethics review and approval as part of the national CTR process.

Sponsors and clinical investigators have to ensure that any online tools used to recruit or monitor study participants comply with the GDPR, the Polish data protection implementing act, and clinical trial/device study requirements, including having appropriate technical and organisational measures in place.

Clinical trial datasets will typically constitute personal data and, insofar as they include data concerning health or genetic data, they will usually be classified as special category data under Article 9 of the GDPR. As a rule, sponsors or other controllers should ensure appropriate pseudonymisation and separation of direct identifiers, and define clear controller and processor roles.

Data obtained from the conduct of a non-commercial clinical trial may not be used for marketing purposes, nor for the purpose of obtaining a marketing authorisation for a medicinal product or making changes to the granted authorisation, except for changes to the marketing authorisation for a medicinal product with respect to the safety of the medicinal product’s use.

Processing performed to run the trial, ensure subject safety, meet regulatory obligations and maintain the trial master file/archiving is generally treated as being necessary for clinical trial compliance and oversight. Any further scientific use outside the approved protocol (secondary research) typically requires a separate legal assessment under the GDPR and may require additional safeguards or approvals, depending on the scope and identifiability of the dataset.

Transfers to third parties/affiliates are possible if properly structured. International transfers outside the EEA require GDPR Chapter V safeguards to be in place.

The provisions of the Clinical Trials of Medicinal Products for Human Use Act do not specify additional technical obligations for the maintenance of databases obtained in the course of a clinical trial. The provisions of Regulation No 536/2014 and the GDPR apply. In addition, the Polish Act of 10 May 2018 applies as the national GDPR-supplementing framework.

In practice, trial stakeholders often maintain separate datasets/records for different purposes, including:

• a database of clinical trial participants;
• a database of research team members; and
• a database of persons reporting adverse events.

It is the responsibility of these entities to implement technical and organisational measures to protect the processed information and personal data from unauthorised or unlawful access, disclosure, dissemination, alteration, destruction or accidental loss, especially in the case of processing involving transmission over a network. Depending on scale and risk, additional GDPR obligations may be triggered.

The provisions of the Pharmaceutical Law Act shall apply to a product that simultaneously meets the criteria of a medicinal product and the criteria of another type of product, in particular a dietary supplement, a cosmetic product or a medical device, as defined by separate regulations.

In practice, the key substantive criterion for the medicine v medical device borderline is the product’s principal intended mode of action: pharmacological, immunological or metabolic action points towards a medicinal product, whereas a primarily physical/mechanical mode of action points towards a medical device (with possible ancillary pharmacological action not changing the primary classification).

Product qualification is carried out by the manufacturer, in accordance with the statutory definitions of a medical device and pharmaceutical. Competent authorities may intervene if they consider the classification incorrect, and they may require relabelling/reclassification or take enforcement steps if a product is placed on the market under an incorrect regulatory regime. However, the competences of authorities in this respect are not clearly defined or demarcated, which sometimes leads to delays in decisions. In borderline cases, classification practice is additionally shaped by EU-level guidance and case law. Depending on the product type, the relevant Polish authorities may include the URPL for medicinal products/medical devices and sanitary authorities for food/dietary supplement aspects.

Biological medicinal products may fall under different authorisation routes depending on their type. The EU centralised procedure (Regulation (EC) No 726/2004) is mandatory for specific categories, including products derived from biotechnology, orphan medicines and certain other categories listed in EU rules. Where the centralised procedure applies, the marketing authorisation is granted at EU level (European Commission, after EMA assessment).

The marketing authorisation is issued for five years and may be renewed indefinitely, at the request of the marketing authorisation holder. An application for an extension should be made at least nine months before the expiry date of the authorisation. Following renewal, the authorisation is typically extended for an indefinite period; in exceptional cases (where justified by safety considerations), the authority may renew for a further five years.

The President of the URPL is obliged to revoke a marketing authorisation if any of the circumstances described in Article 33 of the Pharmaceutical Law Act occur, including:

• an unexpected serious adverse reaction;
• the pharmaceutical does not have the declared therapeutic efficacy; or
• the risk of using it is found to be disproportionate to its therapeutic effect.

The President of the URPL can suspend a marketing authorisation when the circumstances described above do not pose a direct threat to public health.

The marketing authorisation expires if the marketing authorisation holder does not actually place the medicinal product on the market within three years of receiving the authorisation. The “sunset clause” also applies where the product is not placed on the market for three consecutive years after having initially been placed on the market. In both cases, the authorisation expires by operation of law, subject to a possible URPL decision (on request) that it does not expire, where justified by public health or exceptional circumstances.

In general, there is no “marketing authorisation” for medical devices. Placing on the market is based on compliance with MDR/IVDR (including conformity assessment, CE marking where required, and post-market obligations), supplemented by Polish requirements under the Medical Devices Act, including registration obligations in EUDAMED and the requirement for distributors to register with the list maintained by the President of the URPL. However, the following are prohibited:

• placing on the market and putting into service/using a medical device whose expiry date or date of safe use specified by the manufacturer has passed (eg, the shelf life date indicated on the packaging or in the instructions for use);
• placing on the market a medical device whose certificate of conformity (issued by a notified body) has expired, been withdrawn or been suspended;
• making available to laypersons (for self-use) most in vitro diagnostic (IVD) devices other than devices for self-testing, sample containers or general laboratory products;
• making available to laypersons IVD devices not intended for self-testing (including most devices intended for near-patient/professional use), unless they meet the IVDR requirements applicable to self-testing devices;
• placing on the market a product that was not originally a medical device under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR), but that has been modified by an entity other than the original manufacturer in such a way that its intended purpose and mode of action now meet the definition of a medical device or IVD, unless that entity places it on the market under its own name, registered trade name or trade mark; and
• placing on the market in the territory of Poland medical devices, systems or procedure packs that are not intended for use in that territory (eg, national versions with instructions for use only in another language or with a different intended purpose).

Breach of the above prohibitions may result in the President of the URPL issuing an administrative decision ordering the withdrawal from the market or withdrawal from use of the medical devices, products, systems or procedure packs concerned, where this is justified by the need to protect public health or patient safety. An administrative fine of up to PLN250,000 may also be imposed.

In addition, the Medical Devices Act provides for a system of administrative fines that, depending on the infringement, may reach up to PLN5 million for misleading information contrary to MDR/IVDR, for example, or up to PLN2 million for certain advertising infringements. Other infringements carry lower (but still material) penalty caps.

The national procedure for obtaining a marketing authorisation is as follows.

• The applicant should submit an application for a marketing authorisation for the medicinal product to the President of the URPL.
• The President of the URPL formally verifies the application and attached documentation.
• If formal deficiencies are found, the President of the URPL calls for the application to be supplemented within at least seven days, under pain of leaving the application unprocessed.
• If there are substantive comments on the submitted documentation, the President of the URPL calls on the applicant to submit supplements and clarifications.
• Proceedings for the issuance of a marketing authorisation for a medicinal product should be completed within no more than 210 days of the application being submitted.
• If it is necessary to supplement the documents or to submit explanations, the President of the URPL shall issue a decision to suspend the deadline.

Fees for marketing authorisation applications and post-authorisation procedures are set in secondary legislation and depend on the procedure route and product type. In practice, the amounts can range up to tens of thousands of złoty for some cases. The procedure for a variation of a marketing authorisation is governed by Commission Regulation No 1234/2008 of 24 November 2008 and the Pharmaceutical Law Act (Article 31). The change procedure depends on the type of change. Changes are made by the President of the URPL at the request of the marketing authorisation holder.

If there is a change of marketing authorisation holder, the President of the URPL shall issue a new authorisation on the basis of the application of the person assuming the rights and obligations of the existing marketing authorisation holder. The decision issued in favour of the new marketing authorisation holder shall come into force no later than six months after it is issued.

The requirements that have to be satisfied before medical devices can be placed on the market are contained primarily in the MDR and the IVDR. In addition, Polish national requirements apply under the Medical Devices Act and URPL guidance.

Local registration procedures must be carried out by manufacturers of custom-made medical devices, their authorised representatives as well as importers, who are obliged to submit an application for registration of the conducted activity to the President of the URPL before placing that device on the market. The obligation concerns entities that have their place of residence or registered office within the territory of Poland.

The following products are approved for sale without a marketing authorisation:

• magistral formulas;
• official formulas;
• radiopharmaceutical products prepared at the time of use in authorised medical entities, from authorised generators, kits, radionuclides and precursors, in accordance with the manufacturer’s instructions, and radionuclides in the form of sealed radiation sources;
• blood and plasma in full composition or blood cells of human or animal origin, excluding plasma processed by an industrial process;
• pharmaceutical raw materials not intended for the preparation of prescription and pharmacy pharmaceuticals;
• immunological veterinary medicinal products made from pathogens or antigens derived from animals on a farm and intended for the treatment of animals on that farm; and
• advanced therapy medicinal products (hospital exceptions).

Polish law does not operate a single, standalone “compassionate use programme” label comparable to some jurisdictions. However, patient access to non-authorised medicines may occur via specific legal mechanisms – in particular, named-patient or target import (import docelowy) under Article 4 of the Pharmaceutical Law Act and, separately from authorisation, certain emergency access/reimbursement pathways. Any medicinal products imported from abroad are allowed to be marketed without the need for authorisation if their use is necessary to save the life or health of a patient, provided that the medicinal product is authorised in the country from which it is imported and has a current marketing authorisation. Article 4 also provides for temporary placing on the market in exceptional emergency situations (eg, disaster/serious threat), subject to the statutory prerequisites.

In accordance with Article 59(1) of the MDR, the competent authority (ie, the President of the URPL in Poland) may, upon receiving a duly justified request, allow the placing on the market or putting into service in the territory of the member state concerned of a specific device for which the relevant procedures referred to in the relevant provisions of the MDR have not been carried out, if the use of which is in the interest of public health or the safety or health of patients.

The following obligations may be imposed in the marketing authorisation:

• to take measures, within the framework of the risk management system for the use of the medicinal product, to ensure the safe use of the medicinal product;
• to conduct post-authorisation safety studies;
• to record or report adverse reactions;
• to use an appropriate system for the supervision of the safe use of medicinal products;
• to conduct post-authorisation efficacy studies where doubts have arisen regarding certain aspects of this medicinal product’s efficacy that can only be clarified after it is placed on the market; and
• to provide information on the safety and efficacy of the medicinal product in question resulting from scientific and technical progress and the expansion of knowledge about that medicinal product.

In addition, as a matter of routine EU/Polish pharmacovigilance requirements, the marketing authorisation holder must operate a pharmacovigilance system (including a qualified person responsible for pharmacovigilance, appropriate reporting, and compliance with risk management obligations), and submit periodic safety documentation where applicable.

With regard to medical devices, each manufacturer analyses all complaints about the device, as well as cases of error in use and misuse. The analysis depends on risk management, ergonomics, design validation, and corrective and preventative actions. The manufacturer shall make the results of the analysis available at the request of the President of the URPL and the notified body involved in the conformity assessment of the device. The manufacturer assesses the risks associated with the devices affected by the medical incident and, based on this assessment, decides whether corrective actions are necessary and to what extent. The manufacturer shall describe the corrective action in the Field Safety Corrective Action Report. The corrective action must be communicated to customers via a Field Safety Notice.

The manufacturer initiates an investigation into the reported medical incident and decides whether said incident meets the criteria for reporting to the President of the URPL. This description should be read as part of the broader MDR/IVDR post-market surveillance and vigilance framework (including incident reporting and field safety corrective actions), supplemented by Polish enforcement powers and administrative penalties under the Medical Devices Act.

Third parties have access only to information on medicinal product authorisation published by the URPL (ie, the authorisation itself, the Summary of Product Characteristics, and the Patient Information Leaflet). As a rule, the URPL publishes the product information set (SmPC, PIL) for authorised products. Risk Management Plans are obligatory in the dossier, but they are not generally disclosed in full.

Other documents are available on request but only to entities that can substantiate their legal interest (eg, violation of rights), and subject to the protection of proprietary information. There are no specific regulations allowing disclosure of the process of applying for the marketing authorisation. Ending (ongoing) marketing authorisation procedures are not publicly transparent as to their file contents.

In the case of medical devices, it is possible to obtain public information on information contained in safety notes and certificates of conformity, and on the issuance, amendment, supplementation, suspension and withdrawal of certificates of conformity.

For medicinal products, Poland does not provide a separate “national fast-track” marketing authorisation route. Accelerated pathways are primarily available at EU level (in particular, within the centralised procedure). Under the EU framework, eligible medicines may benefit from accelerated assessment (typically 150 evaluation days instead of 210) and, in certain cases (unmet medical need/public health emergencies), from conditional marketing authorisation with specific post-authorisation obligations.

The regulations concerning the placing on the market of medical devices are contained in the IVDR/MDR. No accelerated procedures are provided for at the national level but the President of the URPL, acting as the competent authority within the meaning of Article 59(1) of the MDR/Article 54(1) of the IVDR, may issue a decision authorising the placing on the market or putting into service in the territory of the country of a specific medical device in respect of which no conformity assessment has been carried out, where the use of that device is in the interest of public health or patient safety or health.

Poland participates in EU authorisation pathways based on recognition of another member state’s scientific assessment, in particular the mutual recognition procedure (MRP) and the decentralised procedure (DCP), which are grounded in reliance on an assessment led by a reference member state. Authorisations from non-EU jurisdictions (eg, FDA approvals) do not, as such, trigger an expedited Polish reliance authorisation pathway outside these EU procedures.

Regarding medical devices, there is no need or space for regulatory reliance laws on a local level. Poland is a member of the EU, so the regulatory framework for medical devices is mostly aligned with EU law. Medical devices are placed on the Polish market and across the entire EU based on CE marking obtained via conformity assessment. The President of the URPL (the Polish competent authority) does not perform any pre-market assessment based on foreign (non-EU) authorisations. The URPL’s role is limited to market surveillance, registration of certain economic operators (eg, distributors, custom-made manufacturers), notifications and enforcement.

While mutual recognition agreements may exist in conformity assessment areas, under the MDR/IVDR there is no practical mechanism whereby third-country authorisations replace the EU conformity assessment/CE marking. By way of example, the EU–Switzerland MRA chapter on medical devices has not been updated for the MDR/IVDR, so Switzerland has been treated as a third country for medical devices since May 2021 (and for IVDs since May 2022).

Undertaking the business of manufacturing pharmaceuticals requires a manufacturer’s licence, issued by the Chief Pharmaceutical Inspector. The manufacturing of a medicinal product is any activity leading to the creation of a medicinal product, including the purchase and receipt at the manufacturing site by the manufacturer of materials used for production and their release for subsequent manufacturing stages, including packaging or repackaging and storage and distribution of manufactured medicinal products covered by the application for a manufacturing authorisation, as well as control activities related to these activities.

An applicant for a manufacturer’s licence should submit an application containing, among other things, the type and pharmaceutical form of the medicinal product, the place of manufacture of the medicinal product, and a determination of the scope of manufacture of the medicinal product.

The model application is specified in the Regulation of the Minister of Health of 29 April 2019 on the model application for granting or amending the authorisation to manufacture or import medicinal products.

The permit is issued for an indefinite period of time.

The manufacture of active pharmaceutical ingredients is subject to registration in the National Register of Manufacturers, Importers and Distributors of Active Pharmaceutical Ingredients.

The manufacture of medical devices does not require a special licence. Medical device manufacturers must comply with MDR/IVDR requirements (including conformity assessment where applicable), and the President of the URPL acts primarily as the competent authority for market surveillance and enforcement under the Medical Devices Act/MDR/IVDR.

Undertaking the business of operating a pharmaceutical wholesaler requires a licence from the Chief Pharmaceutical Inspector. Wholesale distribution covers activities such as the acquisition, storage, supply and export of medicinal products conducted in the course of wholesale distribution. An applicant for a licence should submit an application that includes:

• a definition of the scope of the wholesale business;
• the date on which the intended activity is to be undertaken;
• the name of the person responsible for the operation of the wholesale business; and
• for pharmacists, the number of the professional licence, or the PESEL number in the case of other individuals (PESEL is the Polish acronym for “Universal Electronic System for Registration of the Population”).

The following items should be submitted with the application:

• relevant declarations, including a declaration from the responsible person that they undertake this function as of the date the wholesale business started;
• an opinion of the competent district pharmacy chamber regarding the responsible person, if they are a member of the pharmacy chamber;
• a description of the procedures for effective withholding or withdrawal of the medicinal product or veterinary medicinal product from the market and from distributors;
• a document confirming the legal title to the premises intended for the business;
• a technical description including illustrations concerning the premises intended for the business, prepared by an authorised person; and
• an opinion on the suitability of the premises.

The model of the application is specified in the Regulation of the Minister of Health dated 29 April 2019 on the model of the application for a licence to operate a pharmaceutical wholesaler.

A wholesaler engaged in the wholesale distribution of medicines must:

• have adequate facilities to carry out this activity;
• employ a qualified person;
• have a description of the procedure for the effective cessation of distribution or withdrawal of a drug from the market; and
• comply with the more specific obligations set forth in the Pharmaceutical Law Act.

A wholesale licence is issued for an indefinite period of time, unless the applicant has applied for a fixed-term licence. The fee for granting a licence to operate a pharmaceutical wholesaler is PLN6,756 (approximately EUR1,600).

On 1 February 2026, GIF introduced a new online application for reporting and updating lists of transport means used by pharmaceutical wholesalers and by entities holding manufacturing or import authorisations. The previous email channel was discontinued.

In Poland, the list of distributors of medical devices is maintained by the President of the URPL.

The registration obligation applies to entities that have their registered office or place of residence in the territory of the Republic of Poland and act as a distributor (within the meaning of the MDR/IVDR) and make medical devices available on the Polish market.

The distributor must first obtain an access code and password. After obtaining access, the distributor must enter, among other data, the Basic UDI-DI and the manufacturer’s details, and must register each device/system/procedure pack brought into Poland for the first time within seven days from bringing the first device into Poland. Registration of distributors in the list has been mandatory since 1 July 2024.

The Pharmaceutical Law Act divides pharmaceuticals into the following categories:

• available without prescription (over-the-counter, or OTC);
• available on prescription only (Rp);
• available on prescription only, for restricted use (Rpz);
• available on prescription only, containing narcotic drugs or psychotropic substances specified in separate regulations (Rpw); and
• for hospital use only (Lz).

In accordance with the Pharmaceutical Law Act, the import of medicinal products takes place only if such products are brought in from a territory outside the European Economic Area (EEA). If a medicinal product is delivered to Poland from another country within the EEA, such delivery is deemed to be wholesale of medicinal products, rather than being qualified as an import. Export and parallel import are also classified as instances of wholesale.

In addition, for certain products facing potential shortages in Poland (as listed by the Minister of Health), a specific export/sale outside Poland notification regime applies. The business entity must report the intent to export or sell outside Poland, and the Chief Pharmaceutical Inspector may object within 30 days. If there is no objection, the entity must still report the fact of export/sale within seven days.

Similarly, the Medical Devices Act defines an importer by reference to the MDR and the IVDR, under which the importer is an entity that places a medical device from a third country on the EU market.

Articles 38 to 51a of the Pharmaceutical Law Act govern the import of medicinal products. The import of medical devices is regulated primarily in the MDR and the IVDR, although important provisions might be found in the Medical Devices Act as well. The main obligations for an importer are contained in Articles 13 and 16 of these two Regulations.

For medicinal products (including investigational medicinal products), the GIF issues manufacturing/import authorisations and supervises compliance, including GMP inspections. For medical devices, the President of the URPL acts as the competent authority for market surveillance/enforcement under the Medical Devices Act/MDR/IVDR. Where an importer is established in Poland, registration steps (including obtaining a Polish-issued SRN based on EUDAMED actor registration) are handled with the URPL.

For medicinal products, the importer of record (for commercial import from outside the EEA) must in practice be an entity holding a valid authorisation for the import of medicinal products (as part of manufacturing/import authorisation), issued by the Chief Pharmaceutical Inspector. This also applies to the import of investigational medicinal products. Separate Polish rules on incompatibilities apply at the retail level. A pharmacy licence is refused if the applicant holds (or has applied for) an authorisation to manufacture or import medicinal products, or conducts wholesale distribution, among other grounds.

Any person, natural or legal, can act as an importer of record of pharmaceuticals. However, an importer of pharmaceuticals cannot apply for a licence to run a pharmacy.

Any person, natural or legal, whose place of residence or headquarters, respectively, is in the EU can act as an importer of record of medical devices. If the importer is established in Poland, Polish law requires prior registration in the relevant MDR/IVDR electronic system (EUDAMED), as well as an application to the President of the URPL for the issuance of a Single Registration Number (SRN).

The importation of medicines requires a licence from the Chief Pharmaceutical Inspector, even if the pharmaceuticals are only intended to be imported for the purpose of further exporting them outside the EEA. It is likewise compulsory for the import of investigational medicinal products, for example.

An application for a licence should specify which medicinal products are going to be imported. An importer can only import medicines that are covered by a licence. The Pharmaceutical Law Act also allows imports on the basis of an agreement with another importer.

Information on importers is publicly available in the Register of Manufacturers and Importers of Medicinal Products provided by the Chief Pharmaceutical Inspector.

Licensed importers of a medicinal product are not exempt from civil or criminal liability in relation to the use of the medicinal product.

The import of medical devices will require registration with EUDAMED prior to a device being placed on the market. After filing with the register, the importer should apply to the President of the URPL for an SRN. EUDAMED’s first four modules (including actor registration and UDI/devices registration) become mandatory EU-wide from 28 May 2026, following the Commission’s functionality notice and a six-month transition period. Custom-made devices are generally excluded from the UDI/devices registration module, but economic operator (actor) registration/SRN obligations may still apply, depending on the operator’s role.

Parallel import is allowed (it is an instance of wholesale trade) as required by EU law, especially the standards related to the single market. However, this requires a licence for a particular medicinal product to be obtained from the President of the URPL. The licence is valid for five years, although it is possible to extend it for a further five years.

In order for the parallel import of the medicinal product to be allowed, the medicines in question have to have:

• the same active substances;
• at least the same indications up to level 3 of the Anatomical Therapeutic Chemical (ATC) code;
• the same strength;
• the same route of administration; and
• the same form or a similar form that does not result in therapeutic differences.

The medicinal product subject to parallel import has to be properly repackaged in order to satisfy all the demands of the Pharmaceutical Law Act. Generally, if such repackaging is necessary, it is a legal requirement and the trade mark holder cannot object to it. This should be read in line with EU trade mark exhaustion/repackaging principles. Repackaging is permissible where necessary to market the product in the importing member state and where the established conditions protecting the trade mark holder’s legitimate interests are met (eg, no adverse effect on product condition, proper presentation, and prior notice).

For medical devices, non-tariff requirements are driven by MDR/IVDR compliance (conformity assessment/CE marking, documentation, labelling/IFU requirements, etc), while at the border importers established in Poland may also need to provide specified compliance documents in customs procedures, as required by Polish Medical Devices Act provisions linked to the EU Customs Code.

Poland is a member state of the EU and thereby is part of the European single market comprised of all EU member states and three countries of the European Free Trade Association (EFTA) that chose to be part of the EEA: Iceland, Liechtenstein and Norway. Poland is also a member of the EU Customs Union. The EU itself is a party to an array of free trade agreements with third countries, which thus have an impact on Poland.

Poland is also a member of the World Trade Organization (WTO) and the Organisation for Economic Co-operation and Development (OECD).

Following the aggression of the Russian Federation against Ukraine in 2022, sanctions have been imposed on the import and export of certain goods to and from Russia and Belarus. Poland applies EU sanctions and has also adopted a national law that allows the application of further sanctions on Polish entities and their related companies that deal with Russian/Belarussian entities that support the aggression. The trading of pharmaceuticals and medical devices has not been expressly excluded from these national regulations. Sanctions compliance is counterparty- and goods-specific. While pharmaceuticals/medical devices are not typically the primary target category, restrictions may apply depending on the sanctioned person/entity, financing/logistics and export-control classifications.

As a rule, statutory price control applies to products covered by a reimbursement decision (reimbursed medicines, certain medical devices and foodstuffs intended for particular nutritional uses ); the prices of non-reimbursed products are generally market-based. Key pieces of legislation in this respect are the Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices and the Act of 27 August 2004 on the Healthcare Services Financed from Public Funds. In accordance with the former, the following products may be publicly reimbursed:

• medicinal products, medical devices and foodstuffs intended for particular nutritional uses that are reimbursed in the “pharmacy” category (dispensed in pharmacies);
• medicinal products and foodstuffs intended for particular nutritional uses available within a drug programme;
• medicinal products available within chemotherapy; and
• medicinal products, medical devices and foodstuffs intended for particular nutritional uses available for use within the provision of publicly funded services other than those listed above.

If a product is reimbursed, its price is fixed by the reimbursement decision and reflected in the ministerial reimbursement announcement (obwieszczenie). For reimbursed products, official prices and margins are fixed (in particular, the official retail price must be applied in pharmacies). Official prices are uniform nationwide. The official wholesale margin is 6% of the official net selling price, with statutory caps (in particular, a cap of PLN150 for products reimbursed in pharmacies, and PLN2,000 for products reimbursed in drug programmes/chemotherapy). The official retail margin is calculated according to statutory rules (price brackets) and depends, inter alia, on the limit base in the relevant limit group. For providers (hospitals/clinics) purchasing reimbursed products to deliver publicly financed guaranteed services, the Reimbursement Act sets maximum purchase prices linked to the official net selling price plus no more than the official wholesale margin.

For a product to be publicly reimbursed, the marketing authorisation holder has to apply for inclusion in the public reimbursement system.

The 2023 amendment of the Reimbursement Act envisages special incentives for products manufactured in Poland. Available preferences include expedited processing of the application, exemption from price negotiations with the Economic Commission or a prolonged term of reimbursement. Official net selling prices and other reimbursement conditions are set by an individual decision of the Minister of Health. Negotiations with the Economic Commission are a key element of the process in practice. The decisions are then reflected in the ministerial reimbursement announcement (obwieszczenie), which specifies reimbursement categories, co-payment levels and official prices, among other matters.

Medicinal products, medical devices or foodstuffs intended for particular nutritional uses are assigned to reimbursement limit groups (internal reference pricing). Medicines with the same international name or with a different international name but similar therapeutic effects and similar mechanisms of action should be classified in a single group. Medical devices or foodstuffs intended for particular nutritional uses are classified in a single group if they have the same or similar reimbursement indications or uses and similar efficacy.

The net disposal price of the first equivalent on the list may not be higher than 75% of the net selling price of the presentation with the lowest cost per defined daily dose, calculated according to the net selling price of the only counterpart reimbursed in a given indication. In the case of subsequent counterparts, the net disposal price may not be higher than the price of the counterpart determining the basis of the financing limit or the cheapest counterpart if the basis for the limit in the limit group is a drug that is not equivalent to the subject of the application.

After the market exclusivity expires, the new net disposal price cannot be higher than 75% of the product’s price during the previous decision period, subject to the statutory mechanism.

External reference pricing is a formal part of the reimbursement application and pricing framework. As a rule, the applicant must submit information on the minimum and maximum net prices (and reimbursement status) of the product in EU/EFTA countries over the preceding year and, where not publicly funded, the market price information.

Moreover, in the course of the negotiations, the Economic Commission typically uses this international price information as one of the inputs when negotiating and assessing price competitiveness and budget impact. The Economic Commission can also consider rebates, discounts or price agreements in these countries.

Usually, it is expected that the price will be among the lowest in the EEA member states. An applicant must provide the prices of a product, together with information on the reimbursement status of the product (level of reimbursement, conditions, restrictions, existence of risk-sharing schemes, for which indications it is reimbursed) in all EEA member states.

Polish public health funding includes reimbursement of medicinal products, medical devices and foodstuffs intended for particular nutritional uses that are provided to patients in publicly funded establishments and purchased by them in pharmacies and pharmacy outlets. With regard to medicinal products purchased in pharmacies and pharmacy outlets, virtually only prescription medicines are reimbursed; although the law has allowed the possibility of reimbursing OTC medicines, this possibility has never been used. Moreover, the planned amendment to the Reimbursement Act provides for the discontinuation of this option.

The levels of reimbursement are as follows.

• 100% reimbursement (free of charge) – products with proven efficacy in the treatment of malignant cancer, psychotic disorders, mental disability and development disorders, or contagious diseases posing a special epidemic risk for the population. Also, as a rule, products reimbursed within drug programmes and chemotherapy are provided to patients free of charge.
• Lump sum (PLN3.20):
1. products that must be administered for more than 30 days and whose monthly administration cost for the service recipient would, in the case of a payment level of 30% of the financing limit, exceed 5% of the minimum wage; and
2. products that must be administered for no more than 30 days and whose cost for the service recipient would, in the case of a payment level of 50% of the financing limit, exceed 30% of the minimum wage for work.
• Partial reimbursement – 50% of the financing limit, for products that must be administered for not more than 30 days.
• Partial reimbursement – 70% of the financing limit, for other products.

These patient payment amounts are reduced by 10% if the medicine is made in Poland or if an active substance made in Poland was used in its manufacture. If both of these conditions are met, the payment is reduced by 15%.

In addition, a broad category of products are available in pharmacies free of charge to senior citizens (65+), minors (18-) and pregnant women.

Medical devices are publicly funded in several ways.

• Prescribed medical devices available in pharmacies are covered by the Minister of Health’s reimbursement decisions and published in its reimbursement list. This category consists of devices that do not require personalisation for every patient – eg, diagnostic strips for blood glucose monitoring and special types of dressings. The pricing of this device group is regulated under the same statutory official price/margin framework as reimbursed medicines.
• Medical devices supplied on the instructions of an authorised healthcare professional are included in the Minister of Health’s regulation, which indicates, for example, the device’s public fund financing limit, the patient’s own share in the limit and the criteria on which devices are granted. There are no negotiation procedures; conditions apply to every device and are set formally. This group consists of devices that require personalisation (eg, infusion sets for a personal insulin pump, lenses, prostheses, adult diapers and wheelchairs).
• Medical devices provided in an inpatient setting are financed from the public fund as part of the medical procedure and are supplied to patients free of charge. These devices are procured by hospitals and clinics in public procurements.

Health technology assessment (including clinical and/or economic evidence and budget impact) is a core component of the reimbursement process, with the scope of required analyses depending on whether there is a reimbursed equivalent in the given indication, among other factors. The reimbursement decision has to be made on the basis of scientific evidence. The applicant marketing authorisation holder has to prove the product’s cost-effectiveness compared to the alternative therapeutic substance that is already reimbursed from public funds. The Agency for Health Technology Assessment and its advisory body, the Transparency Council, play a crucial role in the assessment process.

As of 16 February 2026, Poland continues to use the statutory cost-effectiveness threshold expressed as three times GDP per capita. The current published value is PLN244,821 per quality-adjusted life year.

The Minister of Health issues an individual administrative decision on the reimbursement of a product, taking into account the statutory criteria for setting the net selling prices and reimbursement conditions, including:

• the stance of the Economic Commission;
• the recommendations of the President of the Agency for Health Technology Assessment and Tariff System (AOTMiT);
• the significance of the clinical condition to which the reimbursement application relates;
• clinical and practical efficacy;
• safety;
• the relationship between health benefits and administration risk;
• the cost to health effects ratio of the previously reimbursed products compared to that covered by the application;
• price competitiveness;
• the impact on the expenses of the entity obliged to finance healthcare services from public funds and on service recipients;
• the existence of alternative medical technology and its clinical efficacy and safety;
• the map of health needs developed by the Minister to identify priority health needs and challenges for the organisation of the healthcare system and to ensure sustainable and co-ordinated spending of public funds;
• the threshold cost of gaining an additional quality-adjusted life year; and
• commitment to continuity of supply.

While dispensing reimbursed medicinal products, medical devices or foodstuffs intended for particular nutritional uses, pharmacy staff (pharmacists and pharmacy technicians) should inform a patient about the availability of an affordable and publicly reimbursed equivalent whose retail price does not exceed the price of the prescribed product and the financing limit. In the case of medicines, the equivalent has to share its international name, dosage and indication with the prescribed product, and must have a pharmaceutical form that cannot give rise to therapeutic differences. The pharmacy is obliged to display this information on its premises.

Pharmacy staff are also obliged to issue an equivalent to patients who make such requests. Upon the patient’s request, the pharmacy may also dispense another reimbursed equivalent even if its retail price is equal to or higher than the prescribed reimbursed product (subject to statutory conditions). Dispensing a non-reimbursed equivalent is possible upon the patient’s request, but it is not part of the mandatory cheaper reimbursed equivalent substitution duty and is paid by the patient in full.

These rules also apply to pharmacy outlets.