Resolution of the CMU No. 312 shortens the terms of registration in Ukraine of drugs registered by the competent authority of the USA, Switzerland, Japan, Australia, Canada or the EU.

In detail, the Resolution of the CMU No. 312 “On Amendments to the Procedure for State Registration (Re-registration) of Medicinal Products” can be found at the link .

This document was prepared by the Ministry of Economic Development and Trade of Ukraine (Ministry of Economic Development) on behalf of the Prime Minister and published for public discussion on the website ( link to the project ).

Despite the adoption of amendments to Resolution 376 of the Cabinet of Ministers of Ukraine and the introduction of a simplified registration (examination) procedure for all drugs registered in countries with a strict regulatory framework, it is important to remember that there are limitations at the legislative level in Article 9 of the Law of Ukraine “On Medicinal Products” .
This means that the Resolution will not be able to work until the adoption of amendments to the main Law. At the moment, the corresponding project is registered with the VRU – r. No. 4484.