In Ukraine, the State Service of Ukraine for Medicines and Drugs Control (SMDC) is the primary regulatory authority overseeing the pharmaceutical sector. The SMDC is responsible for issuing licenses for the production, import, wholesale, and retail trade of medicinal products. Importers must comply with the Licensing Conditions approved by the Cabinet of Ministers of Ukraine, which include maintaining a pharmaceutical quality system that incorporates applicable Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) elements. (dls.gov.ua)
Key legislation governing pharmaceutical imports includes the Law of Ukraine on Medicinal Products and the Law of Ukraine on Licensing of Certain Types of Economic Activity. These laws establish the framework for the registration, importation, and distribution of medicinal products, ensuring that imported medicines meet the required quality and safety standards.
The marketing authorization pathway for Indian generics involves obtaining a marketing authorization from the SMDC, which requires compliance with Ukrainian regulatory standards, including GMP certification and quality control procedures. Additionally, parallel importation of medicines is permitted under specific conditions, allowing for the import of medicines identical or similar to those registered in Ukraine from countries such as the EU, Iceland, Liechtenstein, and Norway. (cms.law)
