In the past few years Ukraine has become recognised worldwide for a variety of reasons, but how has the nation's burgeoning clinical trials sector been affected by domestic and world events? Nataliia Lanetska, business development manager at SMO-Group, a provider of first-class logistics services for clinical trials, looks at the evolution of an industry.
In one of its previous articles, SMO-Group described the benefits of conducting clinical trials in Ukraine, outlining the government's interest in integration into the EU, and its desire to simplify and review regulation and customs procedures. Significant progress has been made towards these objectives and it is proud to share the first changes to the import procedures of investigational medicinal products (IMPs) and clinical trial supplies (CTS).
It started in April 2015 with the amendments to MOH Order # 690, which have changed the whole study approval process. The question is: has it really simplified things or has the process been made more laborious?
Today, all the documents are submitted to a single contact point at the State Expert Centre (SEC) of the Ministry of Health (MOH). This is where the documents are initially reviewed.
The SEC reviews and communicates the results of its evaluation to the MOH for its subsequent review and approval.
Upon approval by the MOH, a study approval order is issued, which then serves as the foundation for issuing a 'decision', again by the MOH.
The timelines for study approval review were reduced to 55 days instead of 60, although there were some delays concerning 'decision' issuance at the beginning, due to initial implementation of the new set of rules.
Additionally, the confirmation letter (umbrella licence) and notification letter (single import permit) have been omitted and are no longer required. Previously, 20-25 days passed before the start of the study due to delays in obtaining import permits and licences.
The MOH Order #690 changed Ukraine's tax code threshold and additional legislative acts led to a decrease in the VAT rate from 20 to 7%.
There were a significant number of announcements about the new VAT rate that should have been applied to IMPs and CTS during import to Ukraine. However, it took some time for all the legislative acts to be created and implemented.
SMO-Group has identified that the format of the first study approval orders will require a comparison with the customs requirements. One of those requirements was that the detailed information of all comparators, non-investigational medicinal products (NIMPs) and CTS used in a study were fully presented in the submitted documents for approval.
Declaring that information assists with the transparency of documentation and minimises disputes at customs when applying a 7% rate of import VAT.
There have already been a number of successful cases when the new 7% rate was applied at customs during import of IMPs and CTS.
The changes that have occurred during the past year represent a tremendous step forward in building a favourable environment for the clinical trials industry in Ukraine.
SMO-Group is ready to provide comprehensive expert regulatory and legislative support, and to present questions for the further development clinical trial regulation in Ukraine.