Well-established drugs – the procedure of well established use
Publication date: January 21, 2026
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.
