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Russia, Belarus & Kazakhstan

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Bioequivalence Requirements in Various Global Jurisdictions

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 28))

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Abstract

The Customs Union of Belarus, Kazakhstan and Russia is a form of trade and economic integration of Belarus, Kazakhstan and Russia which provides a unified customs territory within the mutual trade in goods and does not apply customs duties and economic restrictions, except for special protective, antidumping and countervailing measures. The Republics of Belarus and Kazakhstan and the Russian Federation, in accordance with the Agreement of October 6, 2007, established the Commission of the Customs Union, a single permanent regulatory agency of the Customs Union. At present the Commission of the Customs Union is expected to sign the Agreement on common principles of the circulation of goods and services (which includes drug products). In connection with this Agreement which contains an approach to prepare a unified guidance for BE studies, a plan for document preparation has been approved (a Custom Union BE guidance was approved in May 2017).

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Authors and Affiliations

  1. Center of Pharmaceutical Analytics Ltd., 20, Nauchniy Proezd, Moscow, 117246, Russia

    I. E. Shohin, V. Yu. Medvedev & T. N. Komarov

  2. Center for Examinations and Tests in Health Service State Enterprise, 2a Tovarishesky Lane, Minsk, 220037, Republic of Belarus

    D. A. Rozhdestvenskiy

  3. Institute of Biochemical Technology and Nanotechnology Peoples’ Friendship University of Russia, 10-2, Miklukho-Maklaya St., Moscow, 117198, Russia

    D. Yu. Grebenkin

Authors
  1. I. E. Shohin
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  2. D. A. Rozhdestvenskiy
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  3. V. Yu. Medvedev
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  4. T. N. Komarov
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  5. D. Yu. Grebenkin
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Corresponding author

Correspondence to I. E. Shohin .

Editor information

Editors and Affiliations

  1. Faculty of Pharmacy, Rhodes University, Grahamstown, South Africa

    Isadore Kanfer

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© 2017 American Association of Pharmaceutical Scientists

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Shohin, I.E., Rozhdestvenskiy, D.A., Medvedev, V.Y., Komarov, T.N., Grebenkin, D.Y. (2017). Russia, Belarus & Kazakhstan. In: Kanfer, I. (eds) Bioequivalence Requirements in Various Global Jurisdictions. AAPS Advances in the Pharmaceutical Sciences Series, vol 28. Springer, Cham. https://doi.org/10.1007/978-3-319-68078-1_8

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