To undergo the state registration procedure for a medicinal product, it is necessary to:
1. Compile a registration dossier for the medicinal product in accordance with the provisions set out in Annex 6 to the Procedure for conducting expert evaluation of registration materials, approved by MoH order No. 426 of August 26, 2005, as amended by MoH order No. 460 of 23.07.2015.
Regulatory references: http://zakon5.rada.gov.ua/laws/show/z1210-15
2. Submit an application for state registration of a medicinal product to the Ministry of Health's administrative services center "Single Window". The application form for state registration of an API is defined by MoH order No. 707 dated 30.10.2015.
3. Submit registration materials to the State Expert Center of the MoH for expert evaluation of these materials in accordance with the requirements governed by Article 9 of the Law of Ukraine "On Medicinal Products" in the procedure approved by Cabinet of Ministers of Ukraine resolution No. 376 dated 26.05.2005.
