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EAEU common market of pharmaceuticals and opportunities€¦ · pharmaceutical ingredients (APIs),...

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EAEU common market of pharmaceuticals and opportunities Alex Stolarsky, Partner, Rechtsanwalt Legal, Compliance, Tax & Interim Management Diana Movsesyan, Head of Pharma Competence Center, legal counsel Almaty, 2019
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Page 1: EAEU common market of pharmaceuticals and opportunities€¦ · pharmaceutical ingredients (APIs), vaccines Development of various applications and software for clinical studies,

EAEU common market of

pharmaceuticals and opportunities

Alex Stolarsky, Partner, Rechtsanwalt

Legal, Compliance, Tax & Interim Management

Diana Movsesyan, Head of Pharma Competence Center, legal counsel

Almaty, 2019

Page 2: EAEU common market of pharmaceuticals and opportunities€¦ · pharmaceutical ingredients (APIs), vaccines Development of various applications and software for clinical studies,

2

Agenda

market entry | accounting | ERP | import | legal | tax

EAEU common market of pharmaceuticals

EAEU: opportunities

Pharma Competence Center EEU: who we

are?

Armenia: legal and business environment

Page 3: EAEU common market of pharmaceuticals and opportunities€¦ · pharmaceutical ingredients (APIs), vaccines Development of various applications and software for clinical studies,

3

EAEU common market

of pharmaceuticals (1/3)

market entry | accounting | ERP | import | legal | tax

Unified registry of pharmaceuticals

Unified policy and approach to QC

system of circulation, efficacy and safety of

pharmaceuticals

Harmonization of state pharmacopeias

pre-clinical and clinical trials mutual

recognition

mutual recognition of pharmaceuticals

registered in one of the MS

EEU

Common

Pharma

Market

Page 4: EAEU common market of pharmaceuticals and opportunities€¦ · pharmaceutical ingredients (APIs), vaccines Development of various applications and software for clinical studies,

EAEU: common market

of pharmaceuticals(2/3)

4 market entry | accounting | ERP | import | legal | tax

http://www.eurasiancommission.org/en/Page

s/ses.aspx

Page 5: EAEU common market of pharmaceuticals and opportunities€¦ · pharmaceutical ingredients (APIs), vaccines Development of various applications and software for clinical studies,

EAEU: common market

of pharmaceuticals(3/3) RU BY KZ AM KY TOTAL

GDP per

capita $10,610 $5,760 $8,840 $4,604 $1,220 -

Pharma

Market $24bn $0.8 bn $1.2bn $0.1bn $0.3bn $26.4

Doing

business (2019)

31 37 28 41 70 -

Population 147m 10m 18m 3m 6m 184m

5 market entry | accounting | ERP | import | legal | tax

Page 6: EAEU common market of pharmaceuticals and opportunities€¦ · pharmaceutical ingredients (APIs), vaccines Development of various applications and software for clinical studies,

EAEU: opportunities

6 market entry | accounting | ERP | import | legal | tax

Manufacturing of new drugs, generics, active

pharmaceutical ingredients (APIs),

vaccines

Development of various applications

and software for clinical studies, patient

data

Biopharmaceuticals production

Preparation and packing of medicinal

herbs

Founding of new or collaboration with existing CROs,

research institutions Common

pharma market

without internal

borders

Page 7: EAEU common market of pharmaceuticals and opportunities€¦ · pharmaceutical ingredients (APIs), vaccines Development of various applications and software for clinical studies,

7

Pharma Competence Center EEU composed

of specialists with extensive industry

knowledge starts running at SCHNEIDER

GROUP in response to creation of the common

market of pharmaceuticals.

Pharma Competence Center

EEU: who we are? (1/2)

market entry | accounting | ERP | import | legal | tax

Page 8: EAEU common market of pharmaceuticals and opportunities€¦ · pharmaceutical ingredients (APIs), vaccines Development of various applications and software for clinical studies,

Pharma Competence Center

EEU: who we are?(2/2)

We support our clients and partners to tap the EEU

pharmaceuticals market without additional costs and time wasting

at all stages, from planning to full operation and lead them to

success.

We work closely with state bodies and regulatory authorities to

coordinate and facilitate the entry of our partners and clients to

pharmaceuticals markets of the EEU.

8 market entry | accounting | ERP | import | legal | tax

Page 9: EAEU common market of pharmaceuticals and opportunities€¦ · pharmaceutical ingredients (APIs), vaccines Development of various applications and software for clinical studies,

9 market entry | accounting | ERP | import | legal | tax

Armenia: legal and business

environment

Company registration

•Approx. 4 days*

•No state duty required

•No minimum capital requirements*

•Easy and user-friendly e-governance services

International agreements

•DTT with 46 countries, FTA with several countries

•GSP+ (EU & UK), GSP (Canada, Japan, Norway, Switzerland, USA)

•EU-Armenia Comprehensive and Enhanced Partnership Agreement (CEPA)

other

•+3 Free Economic Zones

•Legislative protection of foreign investments from changes in legislation

Page 10: EAEU common market of pharmaceuticals and opportunities€¦ · pharmaceutical ingredients (APIs), vaccines Development of various applications and software for clinical studies,

SCHNEIDER GROUP

Pharma Competence Center

10

Partner, Rechtsanwalt

Legal, Compliance, Tax & Interim

Management [email protected]

Pharma Competence

Center EEU, Legal Counsel [email protected]

market entry | accounting | ERP | import | legal | tax

Page 11: EAEU common market of pharmaceuticals and opportunities€¦ · pharmaceutical ingredients (APIs), vaccines Development of various applications and software for clinical studies,

11 выход на рынок | бухгалтерия | ERP | импорт | право | налоги

Felix Paytyan

Head of office

[email protected]

The exclusive right to the content of this presentation including the rights of translation, reproduction, transmittal, distribution and usage of the presentation and

parts of it, in any way, as well as the rights to the company’s logo and name SCHNEIDER GROUP, in existing and future publications in printed or electronic form,

and the ability to confer rights to a third party belong to SCHNEIDER GROUP.

The reproduction, alteration, transmittal or any distribution or usage of this presentation or parts of it, as well as of the company’s logo or name SCHNEIDER

GROUP in any way, need the written permission of SCHNEIDER GROUP in advance and shall be accompanied with the link to the SCHNEIDER GROUP website

and reference to the copyright permission. © SCHNEIDER GROUP www.schneider-group.com

Page 12: EAEU common market of pharmaceuticals and opportunities€¦ · pharmaceutical ingredients (APIs), vaccines Development of various applications and software for clinical studies,

www.schneider-group.com

armenia

belarus

germany

kazakhstan

poland

russia

uzbekistan

ukraine

market entry | accounting | ERP | import | legal | tax


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