KIEŁTYKA GŁADKOWSKI KG LEGAL participated in the conference “Longevity Biotech: Investing in a healthier future”. As part of its life science specialisation, our biotech and pharma lawyers offer comprehensive legal services to its clients in many areas of law, including extensive legal services to companies operating in the longevity biotech sector and biotech companies engaged in life extension and human health. Within this specialism our law firm offers assistance in respect of trademark protection and patent issues, regulatory law, certification, contractual, and litigation and arbitration issues. At KG Legal, we know that a key role in the biotechnology sector is innovation and responsiveness to changing market needs. Therefore, we offer our clients a proactive approach, flexibility and efficiency in action. All these qualities of our firm make us recognized as one of the leading law firms in Poland and the world, especially in the field of cross-border specialization and knowledge.
Under EU Law, namely Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (hereinafter “GDPR”) and the pending entry into application of Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directive 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (hereinafter “AIA”), the use of sensitive data (including medical data) for AI training would only be possible after obtaining consent, in cases specified by law, or when using anonymized data. AIA is not a lex specialis vis-à-vis the GDPR, so when using personally identifiable data, using data for AI model training requires meeting the requirements of both acts.
The purpose of an inspection of the pharmacovigilance system for medicinal products intended for human use (pharmacovigilance inspection) is to verify how the marketing authorization holder for medicinal products is fulfilling its obligations regarding the pharmacovigilance system imposed by Polish and European Union law.
Laughing gas, or nitrous oxide (N2O), is legal in Poland and used exclusively for medical purposes by authorized entities such as hospitals and private clinics. Its medical uses include anesthesia during dental, surgical, and gynecological procedures, as well as pain management. In medicine, nitrous oxide is considered a medical device or medicinal product, depending on its use and form. In medical practice, it is a medicinal gas used under the supervision of qualified personnel, meaning its sale and use are strictly regulated. In Poland, nitrous oxide is available in pharmacies and pharmaceutical wholesalers, but only by prescription and to medical entities.
