Grounds for refusal of state registration of a medicinal product – definition and meaning of "Grounds for refusal of state registration of a medicinal product"

The basis for refusing state registration of a medicinal product - the basis for refusing state registration of a medicinal product is the decision of the relevant authorized federal executive body that the efficacy of the medicinal product being registered is not confirmed by the obtained data or that the risk of harm to human or animal health resulting from taking the medicinal product exceeds its effectiveness in use¹.

Federal Law No. 61-FZ dated April 12, 2010 "On Circulation of Medicinal Products", as amended on April 12, 2010, Article 27 // RSFSR. 2010. No. 16. Art. 1815. ↩