We are delighted to share an important milestone in the continued development of KG Legal’s Data, AI & Cybersecurity Desk.
It has been a great honour to serve as the exclusive expert contributors for Poland to the OneTrust DataGuidance Privacy Overview – Poland, one of the world’s leading professional legal compliance resources relied upon by in-house counsel, privacy professionals, compliance officers, multinational organisations and technology companies operating across multiple jurisdictions.
The Polish dietary supplements market is facing the most significant regulatory overhaul in years. The draft amendment to the Act on Food and Nutrition Safety and the Act on the State Sanitary Inspectorate introduces a series of far-reaching changes that will substantially alter the way supplements are notified, monitored, advertised, and supervised in Poland. While the reform does not formally introduce a pre-market authorization system, it undeniably strengthens the position of regulatory authorities and increases the compliance burden imposed on businesses operating in the sector.
Every drug introduced to the EU market must obtain a permit from the competent authority. In Poland, this is the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. EU regulations included in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, implemented into Polish law by the Act of 6 September 2001 – Pharmaceutical Law provide for several procedures enabling drug registration, one of which is the so-called well-established medicine procedure (WEU). This is a special procedure for obtaining marketing authorization for medicines containing active substances with well-established medical use, i.e., medicinal substances known and systematically used in the EU for at least 10 years. The most important difference with this procedure is that there is no need to submit new clinical and pre-clinical studies, and the application can be based on available scientific studies that confirm the effectiveness and safety of the substance.
