CATrialAuthorisation object

(2) Non-commercial studies
Non-commercial clinical studies are defined in Art 37ia Act on Pharmaceutical Law of 6 September 2001(Dz.U. 2008 nr 45 poz. 271).
If an owner of data from a clinical study is an academic institution or another institution with rights to issue scientific titles, researcher, patients organization, researchers organizations or another organization which aim is not gaining profits from clinical studies or manufacturing or circulating medicinal products, the study is a non-commercial clinical study. Data from a non-commercial study cannot be used for an approval of a medicinal product, for changes in current approval, nor for marketing purposes. Sponsors applying for a non-commercial study, must submit a statement that there are and will be no agreements for an approval of a medicinal product, for changes in current approval, or for marketing purposes. If there are any medicinal products obtained from a manufacturer or any other item free of expense or with reduced purchases cost, or any other type of support from them, the IEC and the President of URPL. The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) and URPL - English Information) have to be informed immediately.