scholarly journals Differences between the European and Eurasian Good Pharmacovigilance Practices

2021 ◽  
Vol 9 (2) ◽  
pp. 75-84
Author(s):  
A. V. Matveev ◽  
A. E. Krasheninnikov ◽  
E. A. Matveeva ◽  
B. K. Romanov
Keyword(s):  
Marketing Authorisation ◽  
European Medicines Agency ◽  
The European Union ◽  
Current Version ◽  
Eurasian Economic Union ◽  
Expert Analysis ◽  
The Russian Federation ◽  
Economic Union ◽  
Systems Effectiveness ◽  
The Eu

Good pharmacovigilance practices (GVP) of the Eurasian Economic Union (EAEU) were prepared based on the GVP of the European Medicines Agency that have been in force in the European Union (EU) since 2012. The EAEU GVP have been in force in the Russian Federation and the other EAEU member states since 2016. It is important to identify potential differences between the current regulations in order to harmonise requirements for the pharmacovigilance systems in the EU and EAEU. The aim of the study was to analyse and compare GVP requirements in the EU and EAEU. The analysis helped to identify differences in the structure and contents of GVP sections, the definitions of terms (EU GVP definitions are more detailed and supported by examples, subsections, and references to other documents). Moreover, supplements and annexes to the EU GVP contain figures, templates, examples, algorithms, and tables, which are missing in the EAEU GVP. Expert analysis of these differences as applied to assessment of the pharmacovigilance systems’ effectiveness, and practical activities of marketing authorisation holders, medicine developers, and regulatory authorities, demonstrated that the two GVPs are sufficiently harmonised and have very few differences. However, the number of differences between the documents increases, as changes are made to the EU GVP. A more comprehensive harmonisation of the EAEU GVP with the current version of the EU GVP will make it possible to develop and use uniform pharmacovigilance documents in the EU and EAEU, and will facilitate the introduction of EAEU medicines into the global pharmaceutical market.

Towards an Enhanced Institutional Structure of the Eurasian Economic Union

2020 ◽  
Vol 152 ◽  
pp. 102-111
Author(s):  
Igor V. Pilipenko ◽  
Keyword(s):  
Decision Making ◽  
European Union ◽  
Institutional Structure ◽  
Governance Structures ◽  
The European Union ◽  
Integration Process ◽  
Eurasian Economic Union ◽  
Economic Commission ◽  
Economic Union ◽  
The Eu

This article considers how to enhance the institutional structure of the Eurasian Economic Union (EAEU) in order to enable timely decision-making and implementation of governance decisions in the interests of Eurasian integration deepening. We compare the governance structures of the EAEU and the European Union (EU) using the author’s technique and through the lens of theories of neofunctionalism and intergovernmentalism elaborated with respect to the EU. We propose to determine a major driver of the integration process at this stage (the College of the Eurasian Economic Commission or the EAEU member states), to reduce the number of decision-making bodies within the current institutional structure of the EAEU, and to divide clearly authority and competence of remaining bodies to exclude legal controversies in the EAEU.

scholarly journals Nothern European Lessons for Eurasian Integration

2021 ◽  
Vol 1 (1) ◽  
pp. 79-91
Author(s):  
L. S. Voronkov
Keyword(s):  
European Union ◽  
Regional Integration ◽  
Nordic Countries ◽  
The Other ◽  
Northern Europe ◽  
The European Union ◽  
Economic Relations ◽  
Eurasian Economic Union ◽  
Economic Union ◽  
The Eu

The paper is dedicated to the differences between the classical instruments for regulating interstate political and trade-economic relations from those used in the development of regional integration processes. Traditionally, the Eurasian Economic Union is compared with the European Union, considering the EU as a close example to follow in the development of integration processes. At the same time, there exist the other models of integration. The author proposes to pay attention to the other models of integration and based on the analysis of documents, reveals the experience of Northern Europe, which demonstrates effective cooperation without infringing on the sovereignty of the participants. The author examines the features of the integration experience of the Nordic countries in relation to the possibility of using its elements in the modern integration practice of the Eurasian Economic Union.

Digitalization features of integration associations (on the example of the EU and the EAEU)

2021 ◽  
Vol 23 (1) ◽  
pp. 46-50
Author(s):  
IGOR PANKRATOV ◽  
Keyword(s):  
Digital Transformation ◽  
The European Union ◽  
Common Information ◽  
Eurasian Economic Union ◽  
Common Information Space ◽  
Economic Union ◽  
Business Entities ◽  
Industry Structures ◽  
Theoretical Foundations ◽  
The Eu

The article provides and analyzes the theoretical foundations and practices of digitalization of integration associations on the example of the European Union and the Eurasian Economic Union. Studying the program documents on digitalization (digital agendas), the authors identified the features and risks of the digital transformation of various integration associations. The article describes the digitalization of integration associations as a concept and logic of interaction between citizens, business entities, industry structures, government bodies of countries participating in an integration association in a common information space. These ideas are expressed in the form of explicit algorithms, specifications, and standards unified for each participating country and implemented in the form of integrated information systems of B2B, B2G, G2G formats with a single coordination and monitoring center.

scholarly journals Responsibilities of the Marketing Authorisation Holders in Respect of GMP Compliance (Review)

2020 ◽  
Vol 9 (4) ◽  
pp. 164-170
Author(s):  
A. P. Meshkovskiy ◽  
N. V. Pyatigorskaya ◽  
Z. I. Aladysheva ◽  
V. V. Beregovykh ◽  
A. M. Pyatigorskiy ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Marketing Authorisation ◽  
Good Manufacturing Practice ◽  
European Medicines Agency ◽  
The European Union ◽  
Related Quality ◽  
Ultimate Responsibility ◽  
Control Procedures ◽  
National Competent Authorities ◽  
The Eu

Introduction. The article is focused on differences in quality assurance-related obligations and responsibilities between Marketing Authorisation Holders (MAHs) and manufacturing authorisation holder (manufacturers) in pharmaceutical industry. In case of outsourcing and technical agreements there is a need to differentiate responsibilities related to quality assurance between the above mentioned categories.Text. The guidelines for the pharmaceutical sector of the European Union (EU) provide guidance on the responsibilities of the MAHs in relation to the GMP rules, which are scattered throughout the various chapters of the GMP and its appendices. In addition, certain provisions on this topic are contained in the EU directives. With this in mind the European Medicines Agency (EMA) issued in January 2020 a draft Reflection paper on Good manufacturing practice and Marketing Authorisation Holders. The draft clarifies that while certain activities of an MAH may be delegated to the manufacturer, MAH retains ultimate responsibility for the performance of a medicinal product, its safety, quality and efficacy. The important obligation of MAH in this context is to facilitate GMP compliance by establishing a robust two-way communication system with national competent authorities, manufacturing sites, Qualified Persons (QPs) certifying batches before release, and other interested parties. The MAH ought to communicate to manufacturing personnel, normally through QPs, production processes and related quality control procedures, including subsequent variations, described in registration dossiers.Conclusion. A general one conclusion: in view of rapid developments in the EU GMP Guide, the Eurasian Economic Union GMP requirements ought to be updated. In respect of specific responsibilities of MAH pertaining to GMP compliance the EMA draft Reflection paper merits attention as a guidance regarding separation of obligations and responsibilities between MAH and personnel of manufacturing sights.

The Beijing–Minsk Partnership and Belarus’s Role in China’s Economic Relations with the European Union

China Report ◽  
2021 ◽  
Vol 57 (1) ◽  
pp. 79-94
Author(s):  
Anthony V. Rinna
Keyword(s):  
European Union ◽  
Eastern European ◽  
The European Union ◽  
Economic Relations ◽  
Eurasian Economic Union ◽  
Belt And Road ◽  
Economic Union ◽  
The Republic ◽  
The Relationship ◽  
The Eu

China’s deepening ties with the Republic of Belarus, combined with the latter’s geographic position between the EU and Russia (the veritable leader of the Eurasian Economic Union), stands to potentially benefit China’s bid to deepen economic cooperation with the European Union. More specifically, enhanced collaboration between Beijing and Minsk helps the PRC develop relations with the Eurasian Economic Union (essential to China’s ambitions to augment cooperation with Europe) while simultaneously providing a geographic avenue for China into the central and eastern European regions of the EU for the Belt and Road Initiative (BRI). Nevertheless, the degree to which Beijing’s stronger relations with Minsk will serve Chinese interests in connecting with Europe will depend in large on whether or not Belarus and the EU can overcome significant differences in their relationship, as well as whether the relationship between the European Union and the Eurasian Economic Union (as a partner of the BRI) takes on a cooperative or a competitive nature.

scholarly journals Buy national campaigns promotionin the EU and EAEU countries

2022 ◽  
Vol 7 (4) ◽  
pp. 41-54
Author(s):  
K. N. Elikbaev ◽  
G. V. Podbiralina
Keyword(s):  
National Policy ◽  
Soft Law ◽  
The European Union ◽  
Member States ◽  
Model Code ◽  
Eurasian Economic Union ◽  
Retail Chains ◽  
Economic Union ◽  
National Campaigns ◽  
The Eu

It is determined in the article that the promotion of the “Buy National” policy is of a protectionist nature and often may not comply with international trade rules, including within the framework of integration associations. It was determined that this approach of the states participating in integration associations (the EAEU is no exception) is a certain brake on the development of integration processes. As a result of the analysis of studies on this issue, it was revealed that consumers in certain countries support the policy “Buy national, but their purchasing habits are not fundamentally changed. The study analyzes individual ways of using the Buy National campaigns in the countries of the European Union and the Eurasian Economic Union and shows that countries are actively using this policy, explaining these measures by supporting the national economy, but such actions threaten the development of integration. Based on the results obtained, possible recommendations for cooperation of the EAEU member states have been developed for an equal representation of goods from the five countries in retail facilities. In particular, it was proposed to develop and adopt a model code of good practices for retail chains as norms of "soft" law, enshrining in it the principle of non-discrimination towards goods from the EAEU member states.

The Eurasian Economic Union: Problems and Prospects

2018 ◽  
pp. 722-749 ◽  
Author(s):  
Seljan Verdiyeva
Keyword(s):  
Decision Making ◽  
European Union ◽  
Russian Federation ◽  
Kyrgyz Republic ◽  
The European Union ◽  
Eurasian Economic Union ◽  
Economic Council ◽  
The Russian Federation ◽  
Economic Union ◽  
Eurasian Region

Abstract On 29 May 2014, during the meeting of Supreme Eurasian Economic Council, the Presidents of Russia, Belarus and Kazakhstan signed the Treaty on the Eurasian Economic Union (EAEU). Presently, the EAEU consists of the Russian Federation, Belarus, Kazakhstan, Armenia and the Kyrgyz Republic. Nonetheless, the EAEU is lobbying for an ambitious plan of enlargement and is aiming to expand across the entire Eurasian region. The EAEU claims to be the second union after the European Union with the deepest integration aspirations, containing similar institutions and decision-making approaches. This article argues that there are a number of challenges for the effective functioning of EAEU and that its Member States are not yet fully committed to liberalization in practice, contrary to the aspirations they are advocating.

scholarly journals Administrative regulation measures for foreign trade in the European union (on the example of the Republic of Poland) and in the Eurasian economic union (on the example of the Russian Federation)

2019 ◽  
pp. 101-105 ◽  
Author(s):  
V. A. Kardanov ◽  
V. N. Kulik
Keyword(s):  
European Union ◽  
Foreign Trade ◽  
Russian Federation ◽  
Main Task ◽  
The European Union ◽  
Goods And Services ◽  
Eurasian Economic Union ◽  
The Russian Federation ◽  
Economic Union ◽  
The Republic

The European Union is the largest trading partner for the Eurasian Economic Union. The multi-integration of the Eurasian Economic Union with foreign countries practically guarantees a positive result. The issues, related with non-tariff measures regulating foreign trade, have been considered in the article. For the countries of the Eurasian Economic Union and the Russian Federation in particular, in the near future, the main task should be step-by-step standardization and elimination of almost all non-tariff barriers to trade, as these values significantly aggravate the counter-trade in goods and services and hinder further integration. And this concerns, above all, the development towards the European Union.

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