Health ministry amends draft order to approve procedure for endorsing imported medicines registration documents

14:29, 01.11.2016 1 min read

Ukraine's Health Ministry has amended draft order facilitating registration of imported medicines.

The document has been posted on the ministry's website on Tuesday.

The new document specifies authorized agencies the websites of which the State Expert Center will use to check the fact of registration of medicines, in particular, U.S. Food and Drug Administration, Switzerland's Agency for Therapeutic Products (Swissmedic), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), Australia's Therapeutic Goods Administration, Canada's Health Ministry and European Medicines Agency.

According to the new document, medicines should be used as well as registered by relevant authorized agencies in these countries. .

The document lists reasons why the State Expert Center can decide not to register medicines – submission of an incomplete package of documents, revealing of incomplete or untrue information, non-conformity of the manufacturers' name, its address and location of production facilities mentioned in the registration application.