POLAND Law and Practice Contributed by: Marcin Tomasik, Tomasz Jaworski, Filip Gołba and Jakub Matusiak, Tomasik Jaworski Sp.p.
Tomasik Jaworski Sp.p. Al. Ujazdowskie 39/4 00-540 Warsaw Poland Tel: +22 625 10 81 Email: kancelaria@tjsp.pl Web: www.tomasikjaworski.com
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation Polish legislation regarding pharmaceuticals and med- ical devices is heavily influenced by EU legislation. The manufacturing, registration, distribution, market- ing and advertising of pharmaceuticals are regulated by the Pharmaceutical Law Act of 6 September 2001 and its executive regulations. Clinical trials of medici- nal 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 exec- utive 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 Prod- ucts Intended for Particular Nutritional Uses and Med- ical Devices of 12 May 2011 regulates reimbursement from public funds. Major amendments of this statute entered into force in November 2023 and, with fur- ther changes, in September 2025. A further extensive amendment package (SZNUR) was published for pub- lic 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, trans- port and storage of pharmaceuticals, among other matters. The Inspection is also responsible for over- seeing the advertising of those products, and for con- trolling the operations of pharmacies and wholesal- ers. The Chief Pharmaceutical Inspector is a central government administration authority operating within the centralised state administration. The Pharmaceu- tical Inspection is also comprised of regional phar- maceutical inspectors, but these are formally subor- dinate 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 prod- ucts and for key regulatory decisions relating to medi- cal 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 pharma- ceuticals and medical devices. 1.2 Challenging Decisions of Regulatory Bodies The procedure for challenging administrative deci- sions is generally similar for all regulated products, since all of the proceedings are at least partially reg- ulated by the Administrative Procedure Code of 14
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