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The Life Sciences & Healthcare industry is not free of criminal activity that may give rise to the companies’ liability for criminal offences. However, the corporate criminal liability in Poland is not effectively enforced now. The government presented its proposal to change that in the new draft law amending the Corporate Criminal Liability Act (the “draft”).

The adoption of the Regulation (EU) 2017/745 on medical devices (MDR) and the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) triggered changes in the medical devices law on the national level in Poland. The new Polish Medical Devices Act of 7 April 2022 (MDA) stipulates entirely new restrictions to advertising of medical devices (Articles 54-61) that were previously unknown to this industry sector and heavy sanctions for infringements of the new rules (Articles 103 and 104).

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NGL Legal offers full legal support for business. Our team understands the challenges our clients face and the business reality they are dealing with: they need flexible help and clear communication supporting their decision-making process with spot-on, tailor-made solutions.

At NGL Legal, we skillfully combine experience gained in Polish and international law firms and Big Four companies. We approach our clients’ matters with an open mind, searching for the best solutions and adjusting our actions to the specificity of a given organisation and its goals.

Our goal is to build long-term partnerships based on transparent cooperation and trust. We support our customers in the local and international markets using established partnerships. We recognise that clients often seek integrated services - we can provide that support. 

Our Products & Health team advises clients from life sciences, pharmaceutical and healthcare sector on all aspects of product law and regulatory advice, in the Polish office of one of the leading international law firms. We also offer full support in the area of product liability disputes and an advisor to health sector companies, and on internal investigations and compliance consulting for clients from this sector. The team supports clients from the life sciences, pharmaceutical and healthcare industry, including manufacturers, distributors and importers of medicinal products, medical devices, dietary supplements, cosmetics and food, as well as companies involved in clinical trials, and providers of products and services for the medical sector, including companies operating in the telemedicine and e-health industry.

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