Noted for its ‘wide spectrum of expertise in pharmaceutical law‘, the team at Czyzewscy Kancelaria Adwokacka is adept at handling the gamut of regulatory issues relating to the registration and advertising of drugs, in addition to acting in post-registration proceedings. Praised by clients for being the ‘highest legal specialist with the deepest understanding‘, practice head Katarzyna Czyżewska regularly advises clients on the reimbursement, financing, and distribution of drugs and healthcare services, in addition to assisting with issues relating to clinical trials. Maciej Huzior left the firm.

Hailed as being ‘absolutely unique in the Polish market‘, Kieszkowska Rutkowska Kolasinski Kancelaria Prawna sp. j. acts for a diverse client base of healthcare providers, medical device producers, and biotech companies in the full range of sector-specific matters. Practice co-head Paulina Kieszkowska-Knapik advises a number of industry associations and pharmacies on distribution structures, co-operations between pharmacies and online platforms, and the reimbursement of orphan drugs and medical products. Fellow co-head Ewa Rutkowska assists both Polish and global corporates across the pharmaceutical and medical devices industries with public consultations, as well as acting in product liability disputes. Michał Chodorek is noted for his expansive expertise in drug development and manufacturing projects, in addition to regulations governing the division of IP rights to discoveries. Michał Tracz‘s primary areas of focus are food supplements and biocidal products, and he was promoted to partner in February 2023. Bartłomiej Sasin is another active team member.

Noted for its ‘unparalleled’ knowledge of Polish reimbursement rules, the team at Baker McKenzie Krzyzowski i Wspólnicy Sp.k. is well placed to advise clients on product distribution schemes and the transf of reimbursement approvals. ‘Skilled and bright’ team lead Juliusz Krzyżanowski is known for his expansive expertise in pricing and reimbursement issues within the pharmaceutical industry. Marcin Fiałka is particularly adept at handling matters involving pharmaceutical market regulations, dietary supplements, and medical devices, as well as advising on related data privacy procedures.

DLA Piper Giziński Kycia sp.k. houses an ‘outstanding‘ practice, known for its broad regulatory expertise in relevant distribution and advertising matters. The group also handles a variety of issues involving public procurement processes, and public education campaigns. ‘World-class regulatory lawyer’ Andrzej Balicki leads the team, maintaining a stellar reputation for advising on both domestic and EU regulatory frameworks governing the manufacturing and promotion of medical devices and pharmaceuticals. The ‘fantastic’ Jolanta Dąbrowicz regularly represents distributors and manufacturers of medical devices before the Main Pharmaceutical Inspectorate, the Main Sanitary Inspectorate, and the National Health Fund.

Domanski Zakrzewski Palinka‘s practice is known for handling a broad array of matters for clients, including M&A, research and development projects, and compliance issues. The group leverages its deep regulatory bench strength to advise clients on the manufacturing and promotion of pharmaceutical products. In December 2023, Mateusz Mądry arrived to head up the department; he brings in-house experience working at the Ministry of Health, the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products, and the European Medicines Agency to the group. In October 2024, Marcin Matczak departed the firm.

Jointly led by Marta Gadomska-Gołąb and Aleksandra Kunkiel-Kryńska, the team at Eversheds Sutherland Poland handles a broad array of issues involving the protection and transfer of patient data, and the advertising of medical devices. Gadomska-Gołąb has a great deal of expertise in matters concerning clinical trials and research and development projects within the healthcare sector, regularly advising on product safety and distribution, and medicinal product labelling. Kunkiel-Kryńska assists both Polish and international manufacturers, importers, and distributors with public procurement projects, as well as handling consumer claims.

The wide-ranging team at Kancelaria Tomasik Jaworski handles a vast range of issues on behalf of its diverse client base, including legislative proposals, licensing disputes, and public tender guidelines for in vitro medical devices. Marcin Tomasik and Tomasz Jaworski jointly lead the team;  the former handles a range of mandates concerning medical devices, while the latter’s primary areas of focus are public tenders, product liability cases, and relevant IP issues.

Kieltyka Gladkowski KG Legal maintains its stellar reputation for handling technology-related issues within the medical devices industry, regularly assisting distributors with EU and Polish marketing requirements, and bio-pharma companies with obtaining approval to market biosimilars in Poland. Dividing her time between Kraków and Warsaw, the ‘outstanding‘ Małgorzata Kiełtyka leads the team alongside the ‘excellent‘ Kazimierz Jakub Gładkowski. Kiełtyka is well placed to advise on a broad range of transactional and regulatory issues across the sector, including labelling and advertising, distribution channels, and entry procedures. Gładkowski has deep knowledge of issues related to clinical trials, frequently assisting clients with pharmacovigilance issues.

NGL Legal houses a ‘talented‘ team which assists its diverse client roster of medical device manufacturers and distributors, and companies in the aesthetic medicine industry, with the gamut of issues. The group regularly handles compliance and advertising matters. Practice head Agnieszka Majka has vast knowledge of product liability disputes and safety issues, in addition to the regulatory aspects of clinical trials and market surveillance. Medical device specialist Celina Bujalska is well versed in mandates involving the launch and registration of new products, as well as internal investigations. Since publication, Anna Wiktorow-Bojska has moved to WKB Lawyers.

Soltysinski Kawecki & Szlezak houses a team of ‘excellent specialists‘, who assist with the labelling of foodstuffs, handle public procurement disputes, and advise on the exploitation of regulatory niches. ‘Outstanding‘ practice co-head Ewa Skrzydło-Tefelska is noted for her knowledge of IP issues, including patent infringement actions and unfair competition cases, and regularly represents clients before the Supreme Administrative Court. ‘Very talented‘ co-head Jacek Myszko advises both international and domestic clients on the regulatory issues surrounding the wholesale distribution of medical devices and medicinal products, in addition to advising on clinical trial agreements.

CMS houses a broad team known for its expansive knowledge of relationships between medical representatives and healthcare professionals, regulatory inspections, and post-market responsibilities. Practice head Agnieszka Starzyńska is well versed in matters involving clinical trials and the placing of products on the market, in addition to the regulatory regime governing food supplements and cannabis. Katarzyna Łoś has broad expertise in the marketing, distribution, and development of products within the pharmaceutical and food industries.

Agata Bzymek-Waśniewska and Marta Sroka-Maleta jointly lead the team at DBS Law Firm; the former is noted for her broad expertise in sector-specific labour law issues, and promotional, logistics, and distribution issues within the pharmaceutical industry, while the latter is particularly active on mandates concerning changes to pharmaceutical, reimbursement and IP legislation. The ‘very well seasoned‘ group exhibits deep regulatory knowledge of orphan drugs and international drug launches. Andrzej Siwiec was promoted to partner in January 2023, and has extensive regulatory knowledge, advising on a range of market access and business development projects.

Praised for its ‘exceptional‘ industry knowledge, the team at Dentons regularly assists clients with the acquisition of wholesale and pharmacy trade licenses, as well as handling disputes concerning the withdrawal of licences. Adam Odojewski leads the team, and is noted for his deep knowledge of licensing issues within the pharmaceutical industry, and his regulatory expertise in the laws governing medicinal products and medical devices.

Fairfield maintains a diverse offering, with broad expertise in certification and pharmacovigilance-related issues within the medical devices industry. Practice co-head Oskar Luty has longstanding experience in matters relating to the advertising and reimbursement of medical devices, regularly advising on novel provisions of the Medical Devices Act. Fellow co-head Marcin Flak frequently assists clients with the implementation of distribution schemes and pharmaceutical inspections. Karol Korszuń, who completes the trio of practice heads, advises numerous manufacturers and market authorisation holders on public reimbursement and drug marketing issues. Oskar Platta is also recommended.

Kochanski & Partners‘ practice is noted for handling a broad array of mandates, including trade mark infringement actions and allegations, and proceedings concerning tenders. The team is also known for its medtech expertise, advising on medical records management and cloud-based IT solutions. Noted for his specialism in marketing and the formation of distribution systems, Krzysztof Zięba leads the team, and often assists clients with the negotiation of trade and distribution agreements, as well as acting in pharmaceutical product marketing disputes.

Osborne Clarke houses a broad practice known for handling a vast array of matters on behalf of clients from the healthcare and life sciences sectors, including appearances before the Polish Office of Public Tenders, advertising claims, and IP licensing schemes. The group is also noted for acting in trade mark infringement disputes and reimbursement proceedings before the Economic Commission of the Ministry of Health. Practice head Agnieszka Sztoldman has a great deal of experience in negotiating IP agreements, regularly advising clients on their IP portfolios in the context of M&A deals.

Hailed by clients as comprising ‘true enthusiasts who know medical law like no-one else‘, the Poznań-based team at Sowisło Topolewski Kancelaria Adwokatów i Radców Prawnych S.K.A. acts for hospitals in the full range of healthcare-related issues, including medical malpractice claims, the collaboration of Polish hospitals with foreign healthcare funders, and medical documentation management. Magdalena Cieślińska-Dopierała regularly handles disputes involving cases against the National Health Fund, and patient claims against medical entities involving the violation of patient rights and medical errors. ‘Undisputed specialist’ in labour and medical law Ewelina Jeglikowska regularly assists clients with administrative issues, and managerial contracts and remuneration systems, while Anna Piotrowska-Musioł primarily represents public healthcare facilities in disputes concerning the provision of healthcare services.

The ‘excellent‘ team at Taylor Wessing Poland is known for its extensive expertise in the regulations governing the advertising of medical devices on both an EU-wide and domestic level. The team also has a great deal of experience in handling the filing of trade marks and trade mark portfolio management. Issues surrounding the launching of clinical trials for medical devices are another area of strength. Przemysław Walasek leads the team with his exceptional knowledge of sector-specific IP, data protection, and technology issues. Bartosz Świdrak counts many major medical devices, food, and pharmaceutical companies among his core clients.

Wardynski & Partners‘ provides clients with a diverse offering, with the team’s workload involving data sharing initiatives, novel EU medical and in vitro devices regulations, and public-private partnerships. Practice head Joanna Krakowiak is a ‘top-notch specialist‘, who regularly assists clients with communication strategies and advertising campaigns. Having joined the practice from Fairfield in early 2023, Marcin Rytel maintains his strong focus on regulatory issues, particularly in relation to market authorisations, and public financing systems for regulated products.