Encyclopedia
Post-registration clinical study of a medicinal product for medical use
Post-registration clinical study of a medicinal product - a clinical study of a medicinal product conducted by the manufacturer of the medicinal product, whose civil circulation is carried out after state registration, in order to collect additional data on its safety and efficacy, expand the indications for the use of this medicinal product, as well as identify adverse patient reactions to its action1;
Federal Law No. 61-FZ dated April 12, 2010 "On Circulation of Medicinal Products", as amended on April 12, 2010, Article 4 // RSFSR Gazette. 2010. No. 16. Art. 1815. ↩