The Procedure for Importation of Unregistered Medicines, Standardized Samples, and Reagents into Ukraine, Including for Taxation at a Reduced Fee of Medicines, Imported into Ukraine for Conduction of Clinical Studies, Was Amended

Clinical Trials

On April 03, 2015 as of the date of publishing the Order of the Ministry of Healthcare of Ukraine “On Amendments to the Order of the Ministry of Healthcare of Ukraine of April 26, 2011 No 237” of 18.12.2014 No 967 became effective the amendments to the Procedure for Importation into Ukraine of Unregistered Medicines, Standardized Samples, and Reagents (hereinafter – the “Procedure for Importation”) approved by the Order of the Ministry of Healthcare of Ukraine of 26.04.2011 No 237.

As a result, as of April 03, 2015 the number of cases when unregistered medicine may be imported into the territory of Ukraine without sales rights is increased.From now onward unregistered medicines may be imported into the territory of Ukraine furthermore:

for medical maintenance (medical use) of military servants and rank and file personnel and commanding officers, which carry out tasks whilst ATO, and state of emergency, special term by the separate Decision of the Ministry of Healthcare of Ukraine upon availability of documents confirming registration and use of medicines in such states, and
treatment of rare (orphan) diseases by the Decision of the Ministry of Healthcare of Ukraine. This provision relates only to the medicines developed exclusively for the treatment of rare (orphan) diseases, which were duly admitted for use in the territory of the USA and EU-member States regardless whether they are registered as medicines by relevant authorities of the USA or EU.

Import of the above-mentioned medicines unregistered in Ukraine may be carried out by the separate Decision of the Ministry of Healthcare of Ukraine upon availability of the list of documents applicable also in instances of natural calamity, catastrophe, epidemic disease, namely:

application to the Ministry of Healthcare of Ukraine, central or local executive authorities, which provide information about medicines: title, manufacturer, product description, dosage, total amount of packages, batch number, expiration date;
copies of documents confirming registration of medicines, imported into Ukraine, in the country of origin;
copies of quality certificate issued by manufacturer on each batch with indication of final expiration date (not less than 6 months by the time of medicines` arrival);
instruction for use of medicine accompanied by Ukrainian translation.

Essential amendments were also introduced to the Procedure for Importation of Unregistered Medicines for Clinical Studies.

Formerly, the Procedure established the necessity of obtaining a notification of possibility for importation of unregistered medicines, standardized samples, and reagents into customs territory of Ukraine. In order to import unregistered medicines, designed for conduction of clinical studies, documents had to be filed to the Ministry of Healthcare of Ukraine by the list essentially analogous to the list envisaged for unregistered medicines that were imported for ensuing state registration. Particularly, the list of documents specifically included: letter of acknowledgement of state enterprises “State Expert Center of the Ministry of Healthcare if Ukraine”, copy of a quality certificate and invoice, and document, causing the most lamenting, – copy of a decision on approval of clinical studies program and its conduction.

It is to be recalled, that neither prior nor after the amendments by the Order of the Ministry of Healthcare of Ukraine of 18.12.2014 No 966 to the Procedure for Conduction of Clinical Studies of Medicines and Analysis of Clinical Studies Materials and Model Regulation on Ethics Commission, approved by the Order of the Ministry of Healthcare of Ukraine of 23.09.2009 No 690 (hereinafter – the “Procedure for Clinical Studies”) an approval document under the name of “decision on approval of clinical studies program and its conduction” has not existed. Unfortunately, customs authorities were taking the provision of the Procedure for Importation literally and regardless of the express provision of paragraph 2 subsection в) section 193.1 Article 193 of the Tax Code of Ukraine instead of preferential taxation at the rate of 7% VAT were applying 20% VAT rate.

Amendments to the Procedure were introduced specifically to resolve this stalemate. Hence, as of April 03, 2015 unregistered medicines for conduction of clinical studies may be imported into the territory of Ukraine upon availability of only one document, which is expressly provided for in the Procedure for Conduction of Clinical Studies, - the decision of the Ministry of Healthcare of Ukraine on conduction of clinical studies.