Medical Approval

Medicines, medical equipment and medical items are subject to registration with the State Register of the Ukrainian Healthcare Ministry.
Ukrainian exemption letters = explanatory letters on obligatory products certification in Ukraine

The exemption letter is a document stating that the products are not subject to statutory certification in Ukraine by the certification bodies. The letter specifies the contract number and invoice, as well as product quantity in a specific lot.

There are two types of exemption letters:
1. The exemption letter for trade purposes:
2. The exemption letter for customs, i.e. for customs clearance of cargos.
Generally, the contents of the letters is very similar, however the customs accept as a regulating document only those letters that were issued by accredited certification bodies as authorized by Gospotrebstandard of Ukraine, whereas the explanatory letter for trade purposes may be issued by any accredited certification body.

A special blank is not required for the exemption letter. It is executed on a letterhead blank of the certification body with affixed seal of such certification body. The exemption letter is valid for one year.