POLAND Trends and Developments Contributed by: Marta Sroka-Maleta, Andrzej Siwiec, Katarzyna Kroner and Maciej Adamczyk, DBS Law Firm
The Polish medical device sector is thus entering a phase of greater regulatory maturity. While the years 2021–2024 were a period of adaptation to the new legal regime, the coming years promise to be a time of verification and real compliance, at both EU and national levels. When discussing issues related to medical devices, it is important to note that work on a draft amend- ment to the Pharmaceutical Law began in the second half of 2025, following the CJEU judgment of 19 June 2025, in case C-200/2024, which ruled that the ban on advertising pharmacies, pharmacy points and their activities is contrary to European Union law. The medi- cal device market has raised concerns about the draft legislation’s continued ban on advertising non-phar- macy outlets, including publicly accessible stores, in relation to medical devices. The advertising of medical devices is subject to an autonomous and comprehensive legal regime, as set out in the Medical Devices Act. Considering that the majority of the medical device market is made up of entities other than pharmacies, including manufactur- ers, importers and specialty stores (such as medical or optical stores), as well as other publicly accessible stores, including drugstores, maintaining an additional restriction in the Pharmaceutical Law leads to unjusti- fied duplication of regulations, disruption of systemic consistency, and excessive regulation of economic activity in an area already detailed in a separate act. The final content of the amendments to the Pharma- ceutical Law will probably be known in the first half of this year. Deregulation of Pharmaceutical Laws Efforts are currently underway to deregulate certain areas of economic activity in Poland. This also covers some laws that are important for the pharmaceutical industry. The intention is not to relax the fundamen- tal safeguards, but rather to reduce formalism and administrative obstacles in certain areas, particularly where previous regulations hindered standard opera- tions or were out of step with current practice. • The Act of 4 June 2025 amending the Pharmaceu- tical Law eased the formal requirement for request- ing free medicinal product samples. According
to the new regulations, a healthcare professional authorised to issue prescriptions may now submit the request in document form, which under Polish legislation also covers e-mails. • Another deregulatory step involves removing part of the data set that had to be supplied to ZSMOPL (the national system for monitoring trade in medici- nal products). The obligation to report the planned place of delivery by the marketing authorisation holder (MAH) has been removed, thereby reduc- ing the operational reporting burden. The final wholesale delivery location is often not yet known at the time of reporting. However, the final delivery location is not important for monitoring product shortages. • In parallel, the Minister of Health Regulation on mail-order sales of medicinal products was amended. An explicit basis for ordering via other electronic means of communication beyond those previously listed was added, provided they enable the purchase of a medicinal product offered on the pharmacy website. This removes potential issues with using other means besides those enumerated in the Regulation. • The Act of 12 September 2025 amending the Pharmaceutical Law aims to adjust the require- ments to current standards and legislation. It updates the statutory descriptions of the qualifica- tion requirements for the Qualified Person (QP) and the Competent Person (CP) to reflect the current classification of academic disciplines. Details of how to evidence that the requirements are met are to be regulated in the Ministry of Health’s Regula- tions. Importantly, to ensure continuity and legal certainty, the same amendment contains a rule allowing individuals who were performing CP/QP duties on the date of entry into force to continue in those functions, provided they met the prior statu- tory requirements. The 2025 amendments to pharmaceutical legislation set out a pragmatic deregulatory trajectory, aiming to update and ease requirements that have no impact on product safety. This trend of deregulation and updat- ing the requirements in line with current practice may continue. However, it would be good practice for the legislator to include all amendments to the Pharma-
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