Association of Clinical Trials Organizations (ACTO) - The answer of the Ministry of Finance

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Ministry of Finance of the Russian Federation

March 06, 2008 N 03-07-07/21
to N 5-ê of February 12, 2008

To the Association
of Ñlinical Trials organizations

Answering your appeal about VAT rate for medicines for clinical trials the Department of Tax and Customs Politics has to inform you:

According to the Federal law 85-FZ of May 17, 2007 «On introducing amendments to chapters 21, 26.1, 26.2 è 26.3 of Part Second of the Tax Code of the Russian Federation» VAT rate 10% shall be applied to all medicines including medicines for clinical trials.

According to the paragraph 4 of the article 164 of the Tax Code the code list of goods named in the article 164 for those VAT rate is 10% is to be approved by the Government of the Russian Federation.

As the Department of Federal Tax Incomes and Tax Regulation indicated, until the resolution of the Government is published, the decision on the possibility to apply VAT rate 10% to medicines for clinical trials may be made by customs based on the permission on the import of the lot of medicines issued by the Federal Service on Surveillance in Healthcare and Social Development according to the resolution of the Government of the Russian Federation # 438 of July 16, 2005 «On import and export of medicinal products for medical use».

The Ministry of Health and Social Development of the Russian Federation has prepared a project of the resolution of the Government of the Russian Federation that introduces the list of medical goods for those the VAT rate 10% shall be applied that includes medicines for clinical trials.

This project is being considered by the ministries and departments.

The Head of the Department Trunin I.