The Ministry of Health of Russia has published a notification on the development of amendments to Federal Law No. 61 of 12.04.2010 “On circulation of medicinal products”, designed to synchronize it with regulatory acts of the Eurasian Economic Union.
The procedure for registration of the medicinal product will be corrected.
According to information published on the state web portal for draft normative and legal acts, pursuant to Article 7 of the Agreement on Uniform Principles and Rules for the circulation of medicinal products within the Eurasian Economic Union, the Rules for Registration and Expert Examination of Medicinal Products for Human Use have been approved. The Rules require submission of information on the existence of intellectual rights to a medicinal product protected by patents in force in the territory of a member state of the Eurasian Economic Union, when registering medicinal products.
Therefore, the Ministry of Health of the Russian Federation proposes amendments to the Federal Law “On circulation of medicinal products”, requiring that for the state registration of medicinal products for human use, the applicant should submit information on the existing protection of intellectual property rights for the claimed medicinal product, and also confirming that the registration of the medicinal product does not violate the rights of third parties to intellectual property.