Government submits amended draft bill on medicines to Parliament

05.05.2016 15:04

Ukrinform

At a meeting on May 5 the Cabinet of Ministers approved a new version of the draft law on amending the law on medicines and submitted the new document to the Verkhovna Rada.

The bill was represented by Vice Prime Minister, Economic Development and Trade Minister Stepan Kubiv.

According to Kubiv, the document proposes that the period in which the Health Ministry can adopt a decision on the registration of medicines can be reduced to 10 working days.

In addition, the bill envisages that state registration of medicines containing a medical substance that is not present in Ukraine’s state register of medicines, but registered by a competent agency of US, Switzerland, Australia, Canada or EU countries can be carried out under the simplified procedure. This means it requires a smaller list of documents, and the terms of examination are reduced to 20 days, while the Health Ministry can adopt a decision within a term of up to 7 days.\