Ukraine. Simplified Registration Procedure for Medicines Against Rare and Socially Dangerous Diseases

On 3 June 2014 the Verkhovna Rada of Ukraine approved in the first reading the Law of Ukraine “On amendments to the Law of Ukraine “On medicines” with regard to the improvement of access to medicines for treatment of socially dangerous and severe diseases” (the “Law”).

According to the Law, the medicines for treatment of tuberculosis, HIV/AIDS, viral hepatitis, severe oncological and rare (orphan) diseases shall be registered under the simplified procedure within 7 days from the application submission provided they are registered with the US or the EU authorities.

The Law also suggests adding the medicines for treatment of rare diseases which are permitted for use in the USA and the EU to the list of unregistered medicines which can be imported Ukraine regardless of whether they are registered in the respective countries.

Upon the workup, the Law will be submitted for the voting in the second reading.

Source: KPMG-Ukraine