News from the Eurasian Economic Union

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1 News from the Eurasian Economic Union Marina Volkova Director

2 New Board of the Eurasian Economic Commission (EEC) 2016 year Each EAEU member state have 2 representatives in the EEC Board Maintenance of the succession to the EEC (2 new Ministres) New Department of Internal Markets, Information Support, Information & Communication Technologies 2

The Board of the Eurasian Economic Commission 1 st February 2016 New Board of the EEC Viktor Khristenko

Macroeconomics Nurlan Aldabergenov Minister in charge of Competition and Antitrust Regulation Andrei Slepnev

Minister in charge of Technical Regulation Danial Akhmetov Minister in charge of Energy and Infrastructure

3 The Board of the Eurasian Economic Commission 1 st February 2016 New Board of the EEC Viktor Khristenko Chairman of the Board of the EEC Tatiana Valovaya Minister in charge of Development of Integration and Macroeconomics Nurlan Aldabergenov Minister in charge of Competition and Antitrust Regulation Andrei Slepnev Minister in charge of Trade Vladimir Goshin Minister in charge of Customs Cooperation Valery Koreshkov Minister in charge of Technical Regulation Danial Akhmetov Minister in charge of Energy and Infrastructure Sergey Sidorsky Minister in charge of Industry and Agribusiness Timur Suleimenov Minister in charge of Economy and Financial policy 3

Minister in charge of Development of Integration and Macroeconomics Nurlan

Danil Ibraev Minister in charge of Energy and Infrastructure Mukay

Minister in charge of Technical Regulation Veronika Nikishina Minister in

Agribusiness Timur Suleimenov Minister in charge of Economy and Financial

4 The Board of the Eurasian Economic Commission 1 st February 2016 New Board of the EEC Tigran Sargsyan Chairman of the Board of the EEC Tatiana Valovaya Minister in charge of Development of Integration and Macroeconomics Nurlan Aldabergenov Minister in charge of Competition and Antitrust Regulation Danil Ibraev Minister in charge of Energy and Infrastructure Mukay Kadyrkulov Minister in charge of Customs Cooperation Valery Koreshkov Minister in charge of Technical Regulation Veronika Nikishina Minister in charge of Trade Sergey Sidorsky Minister in charge of Industry and Agribusiness Timur Suleimenov Minister in charge of Economy and Financial policy Karine Minasyan Minister in charge of Internal Markets, Information Support, Info&Communication Technologies 4

5 Priorities for the New Board of the EEC Establishment of new Free Trade Zones International Cooperation Finalization of the EEU Customs Code and submission for approval to EAEU Member States The EEU Customs Code The Common Pharmaceutical Market General forms of Pharma Licenses and Certificates Application of the non-discrimination principle to different service sectors The Common Market for Services The Common Market for Excisable goods Unification of excise tax rates for tobacco and alcohol products Further discussions regarding parallel import Parallel import 5

6 Mutual trade in goods of EAEU Member States Mutual trade between the EAEU Member States* billions of US dollars $61 bn $45 bn -26% 57% Belorussia Russia 33% Kazakhstan Russia

7 External trade in goods of EAEU Member States Trade of the EAEU Member States with third countries* billions of US dollars 931 bn $ 874 bn $ -37% 579 bn $ * Resource: Analytical document of the EEC: the results of the mutual trade of the EEC in

8 Control measures on the movement of goods in the territory of the EAEU New procedure of statistical declaration in Russia in the mutual trade of the EAEU Member States Control over compliance with the requirements of the EAEU Technical Regulations Enhancing customs control over sanctioned goods and goods of Ukrainian origin in transit 8

9 Statistical Declaration in Russia New regulations in 2016 Fill out statistical forms New columns New data Additional Information, column 19, Customs Declaration, column 20; Information about documents confirming the compliance with the prohibitions and restrictions Responsibility for violation of the procedure of statistical declaration Increase of penalty rates New type of a violation From 3-5 thousand rubles up to thousand rubles; Added the case of declaration of the unreliable information New draft law about empowering customs authorities to impose of administrative sanctions for violation of the procedure for statistical declaration was adopted in the first reading on 25 March

10 EAEU: integration in pharmaceutical market (1 of 2) A common market of pharmaceuticals (Treaty On unified principles and rules of pharmaceuticals circulation within the EAEU of 23 December 2014, ratified by the Russian Federal Law No. 5-FZ of 31 January 2016) Creation of a common market of pharmaceuticals Adoption of unified rules of the marketing authorisation (registration) and expertise of pharmaceuticals Mutual recognition of the results of pre-clinical, clinical and other trials of pharmaceuticals Development of common pharmacopoeia of the EAEU Creation of the Unified Register of pharmaceuticals in the EAEU and common informational systems A similar Treaty of 23 December 2016 was also adopted and further ratified by Russia with respect to medical devices. 10

11 EAEU: integration in pharmaceutical market (2 of 2) When a common market of pharmaceuticals and a common market of medical devices would be created (current status of subordinate legal acts)? Pharmaceuticals registered before the abovementioned Treaty enters into force may be distributed on the territory of a respective member-state of the EAEU before their marketing authorisation expires (within a period up to 31 December 2025). For medical devices before the marketing authorisation expires (within a period up to 31 December 2021). It is possible to confirm the marketing authorisation of pharmaceuticals covered by registration certificates issued for a particular limited term under a national procedure. 11

Contacts Marina Volkova Director Customs Group +7 (495) 967 62 23 marina.volkova@ru.pwc.

12 Contacts Marina Volkova Director Customs Group +7 (495) This publication has been prepared for general guidance on matters of interest only, and does not constitute professional advice. You should not act upon the information contained in this publication without obtaining specific professional advice. No representation or warranty (express or implied) is given as to the accuracy or completeness of the information contained in this publication, and, to the extent permitted by law, Russia, its members, employees and agents do not accept or assume any liability, responsibility or duty of care for any consequences of you or anyone else acting, or refraining to act, in reliance on the information contained in this publication or for any decision based on it Russia. All rights reserved. Not for further distribution without the permission of Russia. " Russia" refers to IL member-firms operating in Russia. "" is the brand under which member firms of PricewaterhouseCoopers International Limited (IL) operate and provide services. Together, these firms form the network. Each firm in the network is a separate legal entity and does not act as agent of IL or any other member firm. IL does not provide any services to clients. IL is not responsible or liable for the acts or omissions of any of its member firms nor can it control the exercise of their professional judgment or bind them in any way.

The past year s key changes in the regulation of the pharma industry

www.pwc.ru The past year s key changes in the regulation of the pharma industry Andrey Odabashian, Senior Associate Maria Nevzorova, Associate Agenda Key changes in pharmaceutical regulations 1. Import