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.
Regulations on the safety of food contact materials and limiting the impact of plastics on the environment
Regulation (EC) No 1935/2004 and Directive (EU) 2019/904 are two key pieces of legislation that aim to protect public health and the environment, focusing on materials and articles intended to come into contact with food and reducing the environmental impact of single-use plastic products.
