ГлавнаяDocumentsMedical product approval Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - Article 35. Repeated Presentation of a Medicinal Product, which Failed State Registration of Medicinal Products for State Registration of Medicinal Products
Article 35. Repeated Presentation of a Medicinal Product, which Failed State Registration of Medicinal Products for State Registration of Medicinal Products
Repeated presentation to the relevant authorized federal executive body of a medicinal product that failed state expert registration of medicinal products or was rejected for such registration, the composition of which medicinal product was changed, shall be considered as presentation of a new medicinal product for state registration regardless of whether its initial name was preserved or not.