New import laws spur hopes for reduced trial start-up time in Ukraine

Business development director for Ukraine firm Clinical Trail Logistics (CTL) Aleksey Mykheev told CPhI attendees that importing clinical investigational products now involves just two or three documents. Three years ago, the standard was 10.

He told Outsourcing-Pharma.com: “The legal system is being actively modernised. In 2012 customs legislation was significantly simplified and unified with European laws. As a result the number of customs procedures was reduced.”​

With the new possibility for an electronic submission, he added, the customs process is much simpler.

“The Ukraine regulatory authority is expecting start-up phase, including supply of initial investigational product sites will decrease to 45 days,”​ Mykheev added.

He also said that with the possibility of eliminated clinical logistics VAT on imports until 2013 because of further expected updates to customs procedure, the Ukraine is becoming an increasingly popular destination for clinical trials.

However ​

Mykheev said however a stumbling block for many sponsors and logistics firms is a lack of knowledge about a new requirement, which stipulates all suppliers must first sign an agreement with the local site before importing investigational product.

“It is very important for sponsors and logistics companies to know this,”​ he said.

He also said recent Ministry of Health (MoH) updates could delay the streamlines imports process significantly because it now requires written permission and a good manufacturing practice (GMP) certificate with each batch. Previously the documentation was only required per shipment.

When asked how expectations of 45-day start-up time can happen in the face of the new regulation, he admitted: “It’s difficult to say if it will happen because the updated regulations have only been affective for three months.”​

He added however that the local industry remains positive, and continues to expect significant growth over the next five years.