The limits of trade in medicinal products in Poland are strictly defined by legal regulations. The main source regulating the sale of medicines is the Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws of 2024, item 686, as amended) (hereinafter referred to as “Pharmaceutical Law”). Art. 2, point 32 of the aforementioned Act states that a medicinal product is a substance or mixture of substances presented as having properties for the prevention or treatment of diseases occurring in humans or animals or administered for the purpose of making a diagnosis or for the purpose of restoring, improving or modifying the physiological functions of the body through pharmacological, immunological or metabolic action. Pharmaceutical Law presents principles that define the rules of trade in such products.
Retail trade in medicinal products takes place, among others, in public pharmacies, pharmacy points and, in accordance with art. 71, in non-pharmacy trade outlets. However, the legislator has significantly limited the scope in which they can sell medicinal products. They can dispense medicines without a doctor’s prescription, excluding veterinary medicinal products. Non-pharmacy trade outlets include – herbal and medical stores, specialist medical supply stores and general stores. In the category of general stores, it is necessary to distinguish grocery stores, stores at petrol stations and drugstores.
On the basis of art. 71 sec. 3 points 1 and 2 of the Pharmaceutical Law Act, the Regulation of the Minister of Health of 21 December 2021 was issued on the list of active substances included in medicinal products that may be admitted to trading in non-pharmacy trade outlets and pharmacy outlets, and the criteria for classifying these products into individual lists (Journal of Laws of 2023, item 2533). Individual annexes attached to this regulation specify the criteria for medicinal products that may be admitted to trading in specific non-pharmacy trade outlets and pharmacy outlets. Annex No. 1 limits sales in pharmacy outlets to products that are dispensed without a prescription (OTC) or with a prescription (Rp). They must also meet the conditions specified in the first point of this annex. Annex No. 3 specifies the scope of medicinal products that may be sold in general stores and specialist medical supply stores. Only medicinal products with the availability category available without a prescription – OTC are permitted for circulation, and the active substances included in the medicinal products are permitted for circulation in the territory of the Republic of Poland in medicinal products dispensed in pharmacies without a prescription for a period of at least 5 years.
In addition, the range of people who can issue medicinal products has also been limited. Although the regulations do not impose particularly stringent regulations on entrepreneurs running non-pharmacy trade outlets, there is an obligation to meet the requirements regarding the qualifications of the employee issuing the goods. Based on the Regulation of the Minister of Health of 2 February 2009 on the qualifications of people issuing medicinal products in non-pharmacy trade outlets, as well as the requirements that should be met by the premises and equipment of these outlets and pharmacy outlets (Journal of Laws No. 21, item 118), the issue of qualifications of people issuing goods has been regulated. In accordance with paragraph 2 of this Regulation, people issuing medicines must have knowledge of the use of the medicinal products sold, as well as know how to store the sold product. People issuing medicinal products in herbal and medical stores must have a professional title of either a master of pharmacy, a doctor, a nurse, or a pharmaceutical technician or equivalent qualifications. If they do not have a professional title, they must at least have secondary education and knowledge in the field acquired as part of a course in herbal commodities science or they must have qualifications recognised under separate regulations in the case of citizens of Member States of the European Union, the Swiss Confederation or Member States of the European Free Trade Agreement (EFTA).
The aforementioned Regulation of the Minister of Health of 2 February 2009 also specifies requirements for the premises and equipment of non-pharmacy trade outlets. Sales in general stores have been limited by the requirement to ensure appropriate storage conditions for medicinal products, so as to guarantee their proper quality specified by the responsible entity or pharmacopoeia, with particular attention to the temperature and humidity range and protection against direct access by children. The requirements for herbal and medical stores are consistent with the requirements for pharmacy outlets.
Pharmaceutical law does not specify any special requirements for commencing the sale of medicinal products in non-pharmacy outlets. It should therefore be assumed that in such a situation it is not required to obtain a permit or even notify the pharmaceutical inspection. They are not obliged to keep records related to the trade in medicinal products. The regulations regarding the trade in medicinal products in such outlets are less restrictive compared to pharmacies, which may lead to certain imperfections in the supervision of this market segment. Due to the lack of the obligation to obtain a permit, these outlets can offer medicines without major formalities, which creates a risk of uncontrolled access to medicinal products. In addition, the lack of the obligation to keep detailed records of transactions makes it more difficult to monitor the flow of products and ensure their appropriate control. As a result, there is no full transparency regarding the trade in medicines in such outlets, which may encourage their improper use by consumers. It is worth noting that in such conditions it is easier to violate the regulations regarding the sale of medicines, especially those that require special caution, such as painkillers, anti-inflammatory drugs or preparations containing addictive substances. The lack of appropriate control procedures in these facilities may also lead to improper storage, which consequently affects the quality and safety of medicinal products available to consumers.
Non-pharmacy trade facilities and their activities related to medicinal products or medical devices are subject to the advertising ban pursuant to art. 94a par. 1a of the Pharmaceutical Law, and the supervision of compliance with the provisions of the Act is exercised by the Provincial Pharmaceutical Inspector. The advertising ban is intended to protect consumers from unfair practices and prevent the improper use of medicines, which could result from their excessive promotion. Advertising medicinal products may mislead patients by suggesting that they are safe or effective in cases where their use is not recommended or may pose a risk to health. In the event of a violation of the regulations, the Provincial Pharmaceutical Inspector shall order, by way of a decision, the cessation of such advertising, and in the event of its further violation, may impose additional sanctions. The Inspector also has the right to impose financial penalties on entities that do not comply with the ban. Moreover, in the case of serious violations, it is possible to suspend the activity of the facility, and also to submit a notification to the prosecutor’s office in the event of a suspicion of committing a crime. In this way, the authorities try to ensure that the circulation of medicines and medical devices is carried out in accordance with safety principles, minimizing the risk of inappropriate use of these products. Supervision of compliance with the regulations is therefore crucial to maintaining high standards in the circulation of medicinal products and ensuring their appropriate use in society.
Recently, however, it has been noticed that Polish legislation does not guarantee full control over the improper use of OTC drugs. According to the findings of the Supreme Audit Office, minors have too easy access to purchasing OTC drugs. At self-service checkouts, there is no control over who and in what quantities purchases a medicinal product. In December 2024, the Supreme Pharmaceutical Council submitted a motion to consider introducing new legal standards aimed at correcting the regulations. Among the proposed changes, one can distinguish, among others, the desire to introduce the National Register of Out-of-Pharmacy Trade Facilities maintained by the Chief Pharmaceutical Inspector in the IT system. For entry into the National Register of Out-of-Pharmacy Trade Facilities, the Chief Pharmaceutical Inspector would charge a fee of 50% of the minimum wage for work specified on the basis of the provisions on the minimum wage for work that constitutes budget income, while out-of-pharmacy trade facilities operating in the territory of the Republic of Poland would be subject to control by provincial pharmaceutical inspectors, and already operating facilities conducting retail trade in medicinal products on the date of entry into force of the new provisions would be required to submit an application for entry into the National Register of Out-of-Pharmacy Trade Facilities within 3 months of the date of entry into force of the act. In addition, it was proposed to keep records of all transactions concerning medicinal products, as well as the obligation to dispose of the services of a pharmacist who will conduct, at least once a month, control of the storage and dispensation of medicinal products in accordance with the applicable provisions, will suspend or withdraw medicinal products from trade and use after obtaining a decision from the competent authority, and will supervise the keeping of records of all transactions concerning medicinal products purchased and sold. The pharmacist referred to above could provide the above services in no more than ten non-pharmacy trade outlets. It was also recommended to introduce compulsory initial, and no less than once a year, periodic training in non-pharmacy trade for persons involved in the storage and dispensing of medicinal products. The definition of a framework training program for these persons would be the responsibility of the minister responsible for health by way of a regulation. Among the proposed changes, it is also worth mentioning the introduction of a ban on dispensing medicinal products to persons under 16 years of age. By March 2025, none of these proposals had been introduced into the Polish legislature. However, it is worth paying attention to the existing regulations regarding intermediaries in the trade of medicinal products. Intermediaries are required to obtain an entry in the National Register of Intermediaries in the Trade of Medicinal Products, kept by the Chief Pharmaceutical Inspector.
Currently, there is no register of general stores selling OTC drugs available on the websites of the Chief Pharmaceutical Inspectorate (GIF), the Ministry of Health and the Supreme Pharmaceutical Chamber. According to information from the Ministry of Health, retail trade in medicinal products is mainly conducted by general pharmacies and pharmacy points, which operate on the basis of permits issued by provincial pharmaceutical inspectors. Based on these permits, the locally competent Pharmaceutical Inspector maintains the National Register of Permits to Run General Pharmacies, Pharmacy Points and the Register of Granted Consents to Run Hospital and Institutional Pharmacies – referred to in short as the Pharmacy Register. However, it should be noted that the lack of a register of general stores selling OTC drugs may affect the control and safety of trade in distributed medicinal products.
At present, neither in Poland nor in the European Union there is a clear legal norm requiring the separation of the medicinal assortment on shelves in general stores. However, this does not mean that medicinal products can be mixed with other goods. Paragraph 8 of the Regulation of the Minister of Health of 2 February 2009 on the qualifications of persons dispensing medicinal products in non-pharmacy trade facilities, as well as the requirements that should be met by the premises and equipment of these facilities and pharmacy points states that Non-pharmacy trade facilities referred to in § 2 must ensure the storage of medicinal products in a manner that guarantees the maintenance of their proper quality specified by the responsible entity or pharmacopoeia, with particular consideration of the temperature and humidity range and protection against direct access by children. Taking into account the above regulation, it should be noted that it is recommended that medicines sold without a prescription be separated from products intended for underage customers. This then means that medicines should not be mixed with sweets on the shelves. However, it is worth paying attention to the general product safety regulations that apply in the European Union. Although they do not directly refer to the arrangement of medicinal products on shelves, they impose on entrepreneurs the obligation to ensure that all products introduced to the market are safe for consumers.
In Polish law, issues related to the sale of medicines, dietary supplements and medical devices in general stores are regulated by various legal acts, but there is no uniform act that would describe how such facilities should look in terms of offering these products. In accordance with Article 68 of the Pharmaceutical Law, retail trade in medicinal products is conducted mainly by general pharmacies and pharmacy points, and to a significantly limited extent by non-pharmacy trade outlets. Currently, the only recommendation regarding the display of the range of over-the-counter medicines in general stores requires that medicinal products be protected from direct access by children and in conditions ensuring their quality and safety. In the previously applicable Regulation of the Minister of Health of 10 January 2003 on the qualifications of persons dispensing medicinal products in non-pharmacy trade outlets, as well as requirements that should be met by the premises and equipment of these facilities and pharmacy points (Journal of Laws No. 23, item 196) in par. 7, the obligation to allocate a place exclusively for the sale of medicinal products was formulated, and the medicines themselves should be stored in separate cabinets or shelves in a way that ensures their separation from the rest of the assortment and ensures that their proper quality is maintained. It is generally believed that the obligation to allocate a place for the sale of medicinal products does not mean that it must be closed with a counter. Market practice also shows that cabinets or shelves intended for storing these products can be located on the dispatch area of a general store, allowing customers free access to them. In addition, it is also practiced to display shelves with OTC medicines right next to the cash registers (as emergency products), which in theory should make it easier for the customer to consult the cashier.
A dietary supplement within the meaning of the Act of 25 August 2006 on food and nutrition safety (Journal of Laws of 2023, item 1448) is a foodstuff whose 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 complex, placed on the market in a form enabling dosing. In accordance with the above-mentioned Act, there is an obligation to notify the Chief Inspector of the introduction or intention to introduce dietary supplements to the market for the first time (Article 29). The only restrictions relating to the sale of these products concern the method of their packaging. In accordance with the Regulation of the Minister of Health of 9 October 2007 on the composition and labelling of dietary supplements (Journal of Laws of 2023, item 79), Dietary supplements placed on the market are marked by placing the following information on the packaging:
The label, presentation or advertising of dietary supplements must not contain statements stating or implying that a balanced and varied diet cannot provide sufficient amounts of nutrients for the body.
Medical devices are tools, devices, equipment, software or other items used for diagnostic or therapeutic purposes. The regulations regarding their sale are not precisely defined in a single legal act. The most important assumption is that such products will be offered in a way that does not mislead the consumer as to their purpose and properties.
The State Trade Inspection (Polish: PIH) supervises the quality and safety of products offered to consumers. These products also include medicines, dietary supplements and medical devices. PIH operates under the Act of 15 December 2000 on the Trade Inspection (Journal of Laws of 2025, item 229). It controls, among other things, the correctness of product labelling, compliance with the declared composition and compliance with the provisions on advertising and presentation of these products. On this basis, it can also be assumed that it also supervises the way goods are displayed in a general store, including checking whether the range of OTC medicines is set in a way that ensures safety for children.
In Poland, there have been many situations in which the services had reservations about the legality of citizens’ actions. For example, it is worth paying attention to the case concerning the possibility of selling medicines from a motor vehicle – a mobile store. In case file reference VI SA/ Wa 2691/20, the administrative court considered the issue of the legality of selling medicines from a motor vehicle that served as a mobile store. This store planned to sell over-the-counter (OTC) medicines in various locations, using the vehicle that was to act as a point of sale. The plaintiff filed a motion for an interpretation of the regulations on pharmaceutical trade in the context of conducting business in a mobile form. The fundamental question was whether such a method of sale complies with the provisions of the Pharmaceutical Law, which impose requirements on pharmacies and non-pharmacy trade outlets regarding a permanent location. Public administration bodies expressed doubts about the legality of such activity, indicating that the regulations require that a place of sale for medicinal products has a specific location. Law representatives emphasized that the sale of medicines requires appropriate storage conditions, control over trade and pharmaceutical supervision, which may be difficult to ensure in a mobile point of sale. In addition, the law requires that the sale of medicines take place in a specific location, and not in a mobile manner, which makes it difficult to ensure supervision. In turn, supporters of this form of sale argued that the innovative approach could improve the availability of medicines in areas with limited access to stationary points of sale. The administrative court found that the provisions of the applicable law do not provide for such a form of sale of medicines, and its introduction would require a change in the regulations. Ultimately, the court confirmed that mobile sale of medicines is not permitted under the applicable regulations. This case became an important precedent in the discussion on modern forms of trade in medicinal products in Poland.
Another example of punishment in respect of the described services is case with file reference number II GSK 541/19, which concerned the issue of legality of economic activity consisting in the sale of dietary supplements. In this case, the subject of the dispute was a decision concerning the introduction of dietary supplements to the market, in particular the sale of products that were not properly labelled or met safety requirements. An inspection carried out by the Sanitary Inspection authorities showed that the entrepreneur had introduced dietary supplements to the market that had not been properly reported to the register, which constituted a violation of the law. These supplements, although sold as health-supporting agents, did not meet the requirements for food products, especially in terms of declarations regarding their health properties. As a result of the inspection activities carried out, an administrative penalty was imposed on the entrepreneur. The case went to the administrative court, which was to decide whether the penalty imposed was in accordance with the applicable regulations. The court found that the entrepreneur had indeed violated the regulations on food safety, including the introduction of dietary supplements without proper notification. The court also found that the supervisory authorities had grounds to impose a penalty, taking into account the gravity of the violation. As a result of this ruling, the entrepreneur was required to adapt its operations to the provisions of the law. The court emphasized that compliance with food safety rules and appropriate labeling of dietary supplements are key to protecting consumer health. This ruling also aimed to clarify how the obligations of entrepreneurs should be understood in the context of regulations on dietary supplements.
In 2019, the Chief Pharmaceutical Inspectorate (GIF) took a number of actions in connection with the growing number of medicine vending machines and their compliance with applicable laws. GIF began inspections of medicine vending machines located in public places, such as shopping malls, train stations or petrol stations. The inspection showed that some of these devices sold over-the-counter medicines in a manner inconsistent with the law. The main concerns were the lack of pharmaceutical supervision over the sale of medicines and the improper storage of some medicinal products. As a result of the inspection, it turned out that the medicine vending machines did not meet the requirements for storing medicines in appropriate conditions, e.g. in terms of temperature. In addition, medicines were sold in such machines without consulting a pharmacist, which posed a risk to consumer health. GIF withdrew several such medicine vending machines from circulation, imposing administrative penalties on their owners. In response to these events, GIF intensified its activities to ensure that all medicine vending machines operated in accordance with applicable regulations. Attention was drawn to the need to improve regulations regarding the sale of medicines in vending machines in order to increase control over patient safety. During the year, the Chief Pharmaceutical Inspectorate also developed guidelines regarding the legality of such sales. In the case of medicine vending machines that did not meet the requirements, the pharmaceutical inspection made decisions to liquidate them. GIF representatives emphasized that the aim of these actions was not only to punish illegal practices, but also to ensure the health safety of citizens. In turn, entrepreneurs running medicine vending machines were required to adapt their points of sale to the provisions of the law. The year 2019 became a turning point in the discussion on the future of medicine vending machines in Poland.
Although Poland has strict regulations on advertising dietary supplements, many entrepreneurs still use illegal marketing practices. As mentioned above, dietary supplements cannot be advertised in a way that suggests they have medicinal properties. Common violations include using the images of doctors and pharmacists in advertisements. It is also illegal to include the names of diseases that supplements are supposed to treat in advertising messages. The State Sanitary Inspectorate and the Office of Competition and Consumer Protection (UOKiK) may impose financial penalties on companies that violate the regulations on advertising supplements as part of their inspections. Penalties for violating these regulations range from PLN 10,000 to even PLN 1 million. The purpose of these regulations is to provide consumers with reliable information and prevent them from being misled about the properties of dietary supplements.
In summary, regulations on the trade of medicinal products in Poland, especially those relating to non-pharmacy trade outlets, constitute an important element of the healthcare system. On the one hand, these regulations aim to ensure the safety of users of medicinal products, as well as control over their sale, on the other hand – they still leave some gaps that may affect the effectiveness of supervision. Limiting the scope of medicinal products that can be sold outside pharmacies is a step towards protecting consumers from their improper use. Nevertheless, in practice, there are noticeable imperfections in the supervision of the trade in OTC medicines, which leads to the risk of their improper use, especially among younger users.
Proposals for changes in Polish legislation, such as the introduction of the National Register of Non-Pharmacy Trade Facilities or transaction record requirements, are aimed at increasing control over this market segment. The introduction of new legal regulations could certainly improve the safety of trade in medicinal products, as well as minimize the risk of their illegal and irresponsible issuance. On the other hand, there is a need for broader regulation of issues related to the display of medicinal products in general stores, in order to minimize the risk of their inappropriate storage and easy access by children.
In the face of dynamic changes in the pharmaceutical market and the growing demand for easy access to medicines, it is necessary to continue monitoring and improving the regulatory system to ensure user safety and compliance with the principles of responsible trade in medicinal products. Therefore, in addition to introducing new legal standards, education and responsibility of all participants in the pharmaceutical market, both sellers and consumers, remain an important element.
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