On August 8 at session, government approved a decree “On Amendments to the procedure for the state registration (re-registration) of medicinal products”.
This document was adopted with the aim of bringing the procedure of state registration (re-registration) of drugs, approved by the Cabinet of Ministers of Ukraine dated May 26, 2005 № 376, according to the Law of Ukraine “On Amendments to Article 9 of the Law of Ukraine” On Medicines “on the simplification of the state registration of medicines “, adopted May 31, 2016 Supreme Council of Ukraine.
The adoption of this resolution will simplify the state registration of medicinal products registered by the competent authority of the United States of America, Switzerland, Japan, Australia, Canada, the European Union and reduce up to 10 days the period for acceptance decisions on drug registration or refusal of such registration.
The Ministry of Health of Ukraine worked out the necessary regulations to introduce this as soon as possible the simplified system.
Managing director, Ukraine