scholarly journals COMPARISON OF REQUIREMENTS OF ANNEX 1 TO THE RULES OF GOOD MANUFACTURING PRACTICE OF THE EURASIAN ECONOMIC UNION AND REQUIREMENTS OF THE DRAFT ANNEX 1 GMP PIC/S

2020 ◽  
Vol 2 (2) ◽  
pp. 8-19
Author(s):  
Anna V. Basevich ◽  
Irina E. Kaukhova ◽  
Artemy A. Kodash ◽  
Tatyana A. Bitkina ◽  
Elena M. Smirnova ◽  
...  
Keyword(s):  
International Organizations ◽  
Action Plan ◽  
Good Manufacturing Practice ◽  
Organizational Level ◽  
Pharmaceutical Companies ◽  
Current Version ◽  
Regulatory Requirements ◽  
Eurasian Economic Union ◽  
Organizational Work ◽  
Economic Union

This article provides an overview on draft GMP EC Annex 1 revision progress and, as a consequence, the GMP PIC/S. The role and position of Russia in the pharmaceutical market, its inclusion in international organizations involved in the regulation of the production and circulation of drugs has been indicated. The interconnection between economic integration processes, changes in international regulatory requirements and national legislation has been demonstrated. The article shows how changes in the laws governing the pharmaceutical industry entail changes in the organization of manufacturing or in the approach to the manufacturing process at the organizational level and/or lead to material expenses to eliminate incompliance. Keeping track of possible future changes in legislation allows to pre-build a plan for eliminating incompliance. When analyzing the changes in the Draft Appendix 1 regarding the current version of Appendix 1, it has been revealed that the documents have significant differences. To eliminate significant incompliances with a number of paragraphs of the draft Appendix 1, it is necessary to make changes not only in the operating procedures, but also in the planning solutions of production sites. Based on the results of the work carried out, it has been established that the introduction of the draft Annex 1 GMP PIC/S and its implementation in the GMP EAEU requirements will lead to incompliance at existing pharmaceutical enterprises, the elimination of which requires a lot of organizational work. Significant changes at the existing enterprise are required in accordance with 14 points of the draft. This article presents clauses 5.9, clause 5.21, clause 8.7, clause 8.16, clause 8.29, clause 9.17, clause 9.33 - this is due to that most of these requirements are absent in the current valid requirements of GMP EAEU and Russian GMP rules. The comparison made is an occasion for pharmaceutical companies to conduct internal audits for compliance with the requirements of the draft GMP PIC/S Annex 1 in order to preventively identify incompliances and develop an action plan to address them.

«Soft law» in the law of the Eurasian Ec onomic Union: place and possibility of challenging

2020 ◽  
Vol 9 ◽  
pp. 35-42
Author(s):  
P.P. Myslivsky ◽  
◽  
I.N. Shchurova
Keyword(s):  
International Law ◽  
International Organizations ◽  
Soft Law ◽  
Binding Force ◽  
Eurasian Economic Union ◽  
Economic Commission ◽  
Economic Union ◽  
The Law

In international law, there are sources that do not formally have binding force, but may indicate the emergence of the opinio juris of states, as well as emerging practice. The Eurasian Economic Union also issues acts that are not formally binding: they are adopted by the Eurasian Economic Commission in the form of recommendations. In addition, the Union takes into account the recommendatory acts of other international organizations. At present, the practice of the EAEU Court indicates that this body takes into account “soft law” in the course of argumentation, but proceeds from the impossibility of challenging acts that are recommendations of the EEC. The authors give ways to establish the possibility of challenging the EEC recommendations in the EAEU Court.

scholarly journals Problems of the preliminary customs informing system and the introduction of the Single Window at the sea check points of the Russian Federation

2018 ◽  
Vol 239 ◽  
pp. 04004 ◽  
Author(s):  
Svetlana Maydanova ◽  
Igor Ilin
Keyword(s):  
Developing Countries ◽  
International Trade ◽  
Russian Federation ◽  
International Organizations ◽  
International Standards ◽  
Eurasian Economic Union ◽  
Check Points ◽  
The Russian Federation ◽  
Economic Union ◽  
National Governments

The Single Window concept in the international trade and logistics has been explored by international organizations and national governments over the last two decades. International standards and recommendations, government decisions on this approach are widespread today in both developed and developing countries. Similar decisions and legal acts were implemented during the last ten years by the Russian Federation, as a member of the Eurasian Economic Union. This article provides overview of the following coherent stage – the implementation of preliminary customs informing system at sea check points of the RF with concerns of the Single Window introduction.

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.

scholarly journals The Impact of Regionalization on Eurasian Integration: Economic and Political Factors

2020 ◽  
Vol 14 (3) ◽  
pp. 39-51
Author(s):  
K. Shatila ◽  
M. Alozian
Keyword(s):  
International Organizations ◽  
Regional Integration ◽  
Legal Aspects ◽  
Economic Factors ◽  
Political Factors ◽  
Eurasian Economic Union ◽  
Security Treaty ◽  
Peace And Security ◽  
Economic Union ◽  
The Impact

This article discusses the legal aspects of regional integration processes in Eurasia. It argues that these processes are driven by both political and economic factors, which in particular include the desire on the international stage of a number of post-Soviet nations for regional peace and security as well as to create a greater and more effective economic system. It is often claimed that in the sense of two different yet strongly linked international organizations - with the same similar composition - the Collective Security Treaty Organisation (CSTO) and the EurAsEC, officially turning into the Eurasian Economic Union, unitedited Eurasia is hierarchical. The article then provides the history to CSTO and EurAsEC and discusses how they are to be combined. It also discusses the structural structure of these relationships and describes their goals, values, and main collaboration zones. Finally, the paper contains closing remarks aimed at highlighting problems and assessing opportunities for incorporation processes in Eurasia.

scholarly journals IMPLEMENTATION OF INTERNATIONAL COMMITMENTS UNDERTAKEN MEMBER STATES WITHIN THE FRAMEWORK OF THE EURASIAN ECONOMIC UNION

2017 ◽  
Vol 3 (3) ◽  
pp. 109-118
Author(s):  
Андрей Морозов ◽  
Andrey Morozov
Keyword(s):  
International Organizations ◽  
Structural Method ◽  
Legal Analysis ◽  
International Treaties ◽  
Member States ◽  
Eurasian Economic Union ◽  
Legal Method ◽  
Logical Method ◽  
International Obligations ◽  
Economic Union

The article explores the issues related to the fulfillment of international obligations accepted by the member states within the framework of the Eurasian Economic Union, on the basis of an analysis of international legal and domestic legal acts. The purpose of the article is to develop scientifically grounded recommendations and proposals on improving the legal mechanisms for the fulfillment by Member States of international obligations arising from international legal acts operating within the framework of the Eurasian Economic Union. Tasks of the article: analysis of the provisions of the Treaty on the Eurasian Economic Union of May 29, 2014, concerning the application and implementation of decisions adopted by the bodies of the Eurasian Economic Union; an analysis of the regulatory legal acts of the member states of the Eurasian Economic Union affecting the implementation of international obligations arising from international treaties and decisions of international organizations; comparative legal analysis of the provisions of the constitutions of the member states of the Eurasian Economic Union on the place of international treaties in national legal systems; development of proposals on the improvement of legal mechanisms for the implementation of international obligations adopted within the framework of the Eurasian Economic Union. Among the methods used in the preparation of the article, it is necessary to distinguish the dialectical method, the philosophical method, the formal logical method, the system-structural method, the historical method, the formal legal method, the method of interpreting the law, the comparative legal method, the method of expert appraisal, the method Legal modeling and forecasting. In the article, based on the results of the study of international legal acts, legislative and by-laws of the member states of the Eurasian Economic Union, as well as scientific developments, proposals were made to improve the legislation of the Russian Federation in the field of fulfilling international obligations, the source of which are decisions of international organizations, including the Eurasian Economic Union.

scholarly journals The Role of the Country’s Status in the EAEU

2021 ◽  
Vol 15 (3) ◽  
pp. 125-134
Author(s):  
A. A. Seryogina ◽  
V. E. Bogomolova ◽  
A. S. Harlanov
Keyword(s):  
Foreign Policy ◽  
Research Methods ◽  
International Organizations ◽  
Theoretical Research ◽  
Modern World ◽  
Eurasian Economic Union ◽  
Economic Union ◽  
The Difference

Integration associations in the modern world. Depending on the foreign economic and foreign policy priorities of the country, its status in the integration associations is designated. In the course of writing this article, based on empirical and theoretical research methods, it was possible to determine the difference between the types of participation of countries in international organizations, highlight the main reasons for countries to obtain observer status with the Eurasian Economic Union, and also analyze the prospects for expanding the integration association.

scholarly journals PROBLEMS OF MAKING QUALITY ASSURANCE DOCUMENTATION

2021 ◽  
Vol 93 (3) ◽  
pp. 5-13
Author(s):  
E. L. Alexandrova
Keyword(s):  
Quality Assurance ◽  
Quality Management System ◽  
Quality System ◽  
International Standards ◽  
Regulatory Requirements ◽  
Eurasian Economic Union ◽  
Pharmacy Organization ◽  
Pharmaceutical Quality System ◽  
Economic Union ◽  
The Republic

The article is devoted to the development of quality system documents for the pharmacy organization. The legislation of the Republic of Belarus, as well as the Eurasian Economic Union, requires the development and maintenance of the quality assurance system, the quality management system, the pharmaceutical quality system in a pharmacy organization, a distributor or manufacturer of medicinal products. The article presents the comparative analysis of regulatory requirements as well as approaches of the international standards ISO series to the construction of the quality systems and processes documentation. Such documents as the Quality Manual or its equivalent, Standard Operating Procedures (SOP) and Process Instructions are the most difficult to develop. The distribution of responsibility for processes within the organization is difficult to understand. On the example of RUE «BELPHARMATSIYA» it is shown how the processes in the pharmacy organization can be documented and responsibility for their implementation can be stated. The functioning of the quality system depends on the clarity of the documentation structure and its development and circulation organization. It is the responsibility of the organization authorities to maintain effective functioning of this system.

scholarly journals Approaches to Clinical Development of Combination Medicines in the Russian Federation and the Eurasian Economic Union in view of the Requirements of the Current Legislation

2019 ◽  
Vol 9 (1) ◽  
pp. 14-27
Author(s):  
A. V. Dobrovolskiy
Keyword(s):  
Russian Federation ◽  
Clinical Studies ◽  
Clinical Development ◽  
Drug Combinations ◽  
Sufficient Information ◽  
Regulatory Requirements ◽  
Eurasian Economic Union ◽  
Fixed Drug ◽  
The Russian Federation ◽  
Economic Union

In recent years, there has been an increasing interest in the development of combination medicines (fixed drug combinations) containing two or more active ingredients in a single dosage form. Therefore, there is an urgent need to develop an optimal programme of pre-authorisation clinical trials for combination medicines. The aim of the paper was to summarise modern science-based approaches to clinical development of combination medicines and identify possible ways of their practical implementation, taking into account the requirements of the current legislation. The author reviewed scientific publications devoted to creation of fixed drug combinations and analysed the regulatory documents defining regulatory requirements for pre-authorisation clinical studies of medicines in the Eurasian Economic Union, the Russian Federation, and other countries. Based on the results of the analysis the author described the general regulatory requirements for planning clinical studies of combination medicines for the purpose of their subsequent authorisation in the Russian Federation (via the national procedure) and the Eurasian Economic Union (via the centralized procedure). The pre-authorisation clinical development programme should be designed individually for each combination medicine. The selection of an optimal clinical trial strategy will make it possible to obtain sufficient information on the efficacy and safety of a combination medicine for its subsequent authorisation. 

Reforming and Integrating Pension Systems in the Eurasian Economic Union

2019 ◽  
Vol 2019 (5) ◽  
pp. 40-64
Author(s):  
Egor Zabolotskii
Keyword(s):  
Member State ◽  
Financial Market ◽  
International Organizations ◽  
Theoretical Framework ◽  
Pension Funds ◽  
Member States ◽  
Pension Systems ◽  
Eurasian Economic Union ◽  
Economic Commission ◽  
Economic Union

In recent years the Eurasian Economic Commission (EEC) pursues a policy aimed at improving cooperation among the Eurasian Economic Union (EEU) member states in pension area. Creation of a single financial market, to which pension funds are also parties, is expected to be completed in the EEU by 2025. The purpose of this paper is to make recommendations for further reforms of the EEU pension systems and their possible integration. The scope of the study refers to existing arrangements in pension area among the EEU member states and their pension systems. The theoretical framework of research relates to works of national and international organizations and scientists in pension area as well as relevant normative legal acts and agreements between the EEU member states. The results of the study can be used by EEC and member state executive authorities for further cooperation in pension area.

Regional Integration in Eurasia: The Legal and Political Framework

2016 ◽  
Vol 41 (2) ◽  
pp. 157-194 ◽  
Author(s):  
Zhenis Kembayev
Keyword(s):  
International Organizations ◽  
Regional Integration ◽  
Institutional Framework ◽  
Economic Factors ◽  
Collective Security ◽  
Economic Space ◽  
Eurasian Economic Union ◽  
Security Treaty ◽  
Peace And Security ◽  
Economic Union

This article examines the legal and political aspects of regional integration processes in Eurasia since the end of the Soviet era. It contends that both political and economic factors are driving these processes, including the desire of a number of post-Soviet countries to consolidate regional peace and security and, also, to create a larger and more effective economic space, thus increasing these countries’ power and international influence. It also argues that the formation of a united Eurasia is being conducted in the framework of two separate but closely connected—with almost identical membership—international organizations: the Collective Security Treaty Organization (csto) and the Eurasian Economic Union (eaeu). This article provides some background to the csto and the eaeu and explains their consolidating factors. It also examines the institutional framework of these groupings and expounds on their purposes, principles, and major areas of cooperation. It argues that these two organizations, in combination, constitute a single de facto structure that, for discussion purposes in this article, is referred to as the Eurasian alliance. Finally, the article attempts to illustrate problems and to assess prospects related to integration processes in Eurasia.

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