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 28. Registration Certificate for a Medicinal Product
Article 28. Registration Certificate for a Medicinal Product
1. A registration certificate for a medicinal product indicating dosage forms and dosage rates shall be issued for an unlimited period, except for registration certificates with a validity period of five years issued for the medicinal products to be registered in the Russian Federation for the first time.
2. Upon expiration of the period specified in Clause 1 of this article, a permanent registration certificate for the medicinal product shall be issued subject to confirmation of the state registration thereof.