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Association of Clinical Trials Organizations (ACTO)
non-commercial organization of the companies/ legal entities and clinical research community engaged in clinical trials in Russia.

Home Page  >  Good taxation practice (VAT rate 10%)   >  ACTO request




¹ __14-k__ of May, 20 2008
  To First Vice-Premier
Shuvalov I.



Dear Igor Ivanovich!


On behalf of ACTO’s members we are appealing to you with the following demand.

January 1, 2008 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» came into effect.

According to the amendments introduced by the Federal law 85-FZ to the second paragraph of the fourth subparagraph of the article 164 of the Tax Code, VAT rate 10% can be applied to all medicines including medicines for clinical trials.

According to the answer of Federal Customs Service of February 28, 2008 ¹ 05-17/7531, prepared on behalf of the Government of January 31, 2008 ¹ P12-2680, 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 ¹ 438 of July 16, 2005 «On import and export of medicinal products for medical use».

Now customs apply VAT rate 10% to medicines for clinical trials but refuse applying it if there is placebo in the lot.

Placebo is an imitation of the investigational product that is inert. Placebo is used in clinical trials conducted with blinding to make the results of the trial valid. Placebo should not differ from the investigational product that is active that is why it has the same package. By importing the lot for placebo controlled studies the whole number of medicines is indicated without specifying the number of investigational products and placebo.

The cost of the lot including placebo is evaluating by customs by the cost of investigational product, because the cost of placebo in the lot is insignificant in comparance with to the cost of active medicines.

In the same time customs refuses to apply VAT rate 10% to the lots including placebo as well as active medicines.

But according to the Rules of clinical practice approved by the Ministry of Health and Social Development June 16, 2003, the definition of the investigational product includes active medicine as well as placebo.

We are demanding you to help us and charge the Federal Customs Service to clarify the possibility of application of VAT rate 10% to the lots of medicines for clinical trials including placebo.


Regards,
Executive Director
Zavidova S.




 
   
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