scholarly journals Analysis of Noncompliances with Legislative Requirements in Pharmacovigilance Materials of Registration Dossiers

2021 ◽  
Vol 9 (4) ◽  
pp. 185-190
Author(s):  
E. O. Zhuravleva ◽  
N. Yu. Velts ◽  
G. V. Kutekhova
Keyword(s):  
Russian Federation ◽  
Marketing Authorisation ◽  
Pharmacovigilance System ◽  
System Management ◽  
Eurasian Economic Union ◽  
Marketing Authorisation Holder ◽  
The Russian Federation ◽  
Economic Union ◽  
Regular Training ◽  
Authorisation Holder

Since 1 January 2021 the authorisation of medicines in the Russian Federation has to be performed according to the Eurasian Economic Union (EAEU) procedure. The Pharmacovigilance System Master File (PSMF) is the main document describing the pharmacovigilance system of the marketing authorisation holder (MAH) or its authorised representative.  The aim of the study was to analyse noncompliances with the EAEU requirements, which were revealed during PSMF assessment.Materials and methods: the authors analysed 687 pharmacovigilance documents included in registration dossiers that were submitted for assessment from 1 January to 30 June, 2021.  Results: the authors identified and systematised the main noncompliances with the EAEU requirements in terms of presentation, content, completeness of each PSMF section. They analysed the frequency of noncompliances in PSMFs and identified the most frequent flaws of MAHs’ pharmacovigilance systems.Conclusions: the authors give recommendations for elimination of significant noncompliances identified during PSMF assessment, which may include: timely updating, maintenance, and revision of the documents in accordance with changes in legislation and any other significant changes, regular training of pharmacovigilance staff, etc. The results of this review will be useful for MAHs as the main participants of the marketing authorisation process who are directly involved in the pharmacovigilance system management at the pre- and post-authorisation stages, and will help them prevent potential mistakes when drawing up pharmacovigilance system documents.

scholarly journals Expert Evaluation of Pharmacovigilance System Documents Included in the Registration Dossier

2020 ◽  
Vol 8 (4) ◽  
pp. 191-197
Author(s):  
I. I. Snegireva ◽  
E. O. Zhuravleva ◽  
N. Yu. Velts
Keyword(s):  
Marketing Authorisation ◽  
Pharmacovigilance System ◽  
System Management ◽  
Eurasian Economic Union ◽  
Regulatory Submissions ◽  
Marketing Authorisation Holder ◽  
System Data ◽  
The Russian Federation ◽  
Registration Dossier ◽  
Authorisation Holder

The Russian Federation and the member states of the Eurasian Economic Union (EAEU) are working on the creation of a common pharmaceutical market. EAEU marketing authorisation may be granted to those pharmaceutical companies whose activities comply with the Good Pharmacovigilance Practice (GVP). The aim of the study was to analyse pharmacovigilance system documents submitted as part of registration dossiers of medicines and to identify problems that may arise during preparation of the pharmacovigilance system master file (PSMF). The authors analysed the PSMF, which makes part of the registration dossier, for compliance with the EAEU GVP requirements for submission, content, and completeness of all sections of the document. They identified the most common types of errors in PSMF preparation and analysed conditions when a PSMF is required or, alternatively, when a brief summary of the pharmacovigilance system of the marketing authorisation holder will suffice. The paper summarises specific aspects of incorporating pharmacovigilance system documents in regulatory submissions, as well as aspects of presenting pharmacovigilance system data when bringing the registration dossier in line with the EAEU requirements. This information may be useful for marketing authorisation holders who are the main stakeholders in the medicine authorisation process and who are directly involved in the pharmacovigilance system management during the authorisation and post-authorisation stages of the drug life-cycle.

scholarly journals Comparison of Approaches to Stability Testing of Medicines in the Russian Federation and the Eurasian Economic Union

2021 ◽  
Vol 11 (1) ◽  
pp. 16-23
Author(s):  
A. I. Belanova ◽  
E. L. Kovaleva ◽  
L. I. Mit’kina
Keyword(s):  
Medicinal Product ◽  
Russian Federation ◽  
Marketing Authorisation ◽  
Storage Conditions ◽  
Stability Testing ◽  
Medicinal Products ◽  
Regulatory Documents ◽  
Eurasian Economic Union ◽  
The Russian Federation ◽  
Economic Union

Stability testing gives necessary data on the effect of such factors as temperature, light, humidity, etc. on the medicinal product quality. The results of these studies help to select suitable primary and secondary packaging and to determine storage conditions and shelf life for the product. The aim of this study was to compare current requirements for stability testing of medicinal products in the Russian Federation and the Eurasian Economic Union (EAEU). The study covered stability testing of small-molecule medicines. The paper describes evolution of approaches to stability testing in the Russian Federation. It summarises the main differences in basic requirements for stability testing as stipulated in the State Pharmacopoeia of the Russian Federation (Ph. Rus.) XIII edition, Ph. Rus. XIV edition, and EAEU regulations. The study demonstrated that the Russian Federation lacks regulations containing specific requirements for stability testing performed to support variations to marketing authorisation documentation. The Ph. Rus. XIV edition does not specify the extent of stability testing to be performed after switching to another manufacturer of the active ingredient or introduction into operation of a new manufacturing site where the medicinal product will be produced. At the same time, the EAEU regulatory documents contain requirements for stability testing for each type of the most frequent variations to marketing authorisation documentation. The study demonstrated the continuing relevance of bringing the Russian regulations on stability testing in line with those of the EAEU.

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.

LEGAL REGULATION OF CRYPTOCURRENCY MINING

2020 ◽  
pp. 13-20
Author(s):  
Pavel Samolysov ◽  
◽  
◽  
Keyword(s):  
Russian Federation ◽  
Reliability And Validity ◽  
Legal Regulation ◽  
State Regulation ◽  
Entrepreneurial Activity ◽  
Mining Equipment ◽  
Social Phenomena ◽  
Eurasian Economic Union ◽  
The Russian Federation ◽  
Economic Union

Purpose and objectives: analysis of legal regulation of cryptocurrency mining in the Russian Federation and abroad, identification of problems and gaps in this area and development of proposals aimed at their resolution. Scientific significance: the article reveals the current state and established doctrinal approaches to the legal regulation of cryptocurrency mining in Russia. For the first time, the necessity of strengthening and developing state regulation of mining is substantiated. The main attention in the article is paid to the system of legal regulation of the process of creating cryptocurrencies in the territory of the Russian Federation, taking into account the law of the Eurasian Economic Union. Methods: a dialectical approach to the cognition of social phenomena, allowing them to be analyzed in their historical development and functioning in the context of a set of objective and subjective factors, which determined the choice of the following research methods: formal logical, comparative legal, sociological, which allowed the author to ensure the reliability and validity of the conclusions. Key findings: The legal vacuum in the regulation of mining acts as a serious inhibiting factor at the current stage of its improvement and often itself becomes an offense. At the same time, cryptocurrency mining is one of the new types of entrepreneurial activity, in connection with which in the near future it is necessary to introduce state regulation of cryptocurrency mining in the Russian Federation, for which it is necessary: to develop a law regulating the organization and implementation of the production of cryptocurrencies using cryptographic algorithms; to supplement the classifier of the main type of carried out economic activity with a new type of activity — mining; to create a unified electronic register of crypto farms operating on the territory of the Russian Federation; supplement the existing legislation of the Russian Federation and the Eurasian Economic Union with the norms regulating the import of mining equipment. Thus, the important results of the study are: the development of the problems posed, which for a long time remained outside the attention of specialists, as well as the significant novelty of the factual material introduced into circulation.

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 About the need to improve the requirements to labeling of food products in the Russian Federation and the Eurasian Economic Union

2019 ◽  
Vol 95 (2) ◽  
pp. 192-198 ◽  
Author(s):  
A. K. Baturin ◽  
O. V. Arnautov ◽  
Olga V. Bagryantseva ◽  
S. A. Khotimchenko ◽  
G. N. Shatrov
Keyword(s):  
Fatty Acids ◽  
Russian Federation ◽  
Nutritional Value ◽  
Food Products ◽  
International Standards ◽  
Chloride Salt ◽  
Positive Effects ◽  
Eurasian Economic Union ◽  
The Russian Federation ◽  
Economic Union

One of the major factors contributing to a healthy diet, proper selection of food consumers is the labeling of food products. In order to improve the requirements to labeling offood products in the Russian Federation and the Eurasian Economic Union and their harmonization with international standards and requirements of the European Union in the Technical regulations of the Customs Union "Food products are part of its labeling" (TR CU 022/2011) it should be amended as follows: 1. The list of indices of the nutritional value offood products referred to in their labeling, should be expanded by next positions: the amount of saturated fatty acids and trans fatty acids; carbohydrates, including mono- and disaccharides and the amount of added sugar; polyols; dietary fiber; added sodium chloride (salt). 2. To carry out the calculation of daily requirements of essential nutrients based on the human consumption of 2000 kcal per day, instead of 2500 kcal. 3. When setting the nutritional value offood products to envisage the application of the "color codes" indicating normal level of consumption by green, permissible - yellow, dangerously - in red. 4. In the text of the regulations Appendix, regulating the use in label offood to include information about the expected positive effects on the human body of the incoming (s) of the food product (s) ingredient (s) in case of systematic use of such a product in food rations.

Distinctive Features of the Object of Smuggling of Strategically Important Goods and Resources

2021 ◽  
pp. 225-230
Author(s):  
Vladislava K. Zaigraeva ◽  
Keyword(s):  
Public Relations ◽  
Russian Federation ◽  
Criminal Code ◽  
Public Security ◽  
International Treaties ◽  
Eurasian Economic Union ◽  
Legal Method ◽  
Economic Sphere ◽  
The Russian Federation ◽  
Economic Union

The aim of the study is to consider issues related to the definition of public danger and the object of smuggling of strategically important goods and resources as a crime under Article 226.1 of the Criminal Code of the Russian Federation, as well as the positions of individual researchers on these issues. The methodological basis of the research was formed by the general scientific theory of knowledge; the method of comparative analysis and the logical-legal method of cognition were also used. The latter was used for a more accurate understanding of the norms of Russian criminal legislation, their analysis, as well as for the interpretation of the main provisions reflected in the legal literature. As a result, the author questions the correctness of the placement of the smuggling of strategically important goods and resources in Chapter 24, Crimes Against Public Security, of Section IX, Crimes Against Public Security and Public Order: in cases of smuggling of strategically important goods and resources, the procedure for movement established in the international treaties and legislation of the Russian Federation always suffers directly, while, taking into account the possibility of further distribution of smuggled objects in the event of an untimely suppression of these objects' illegal movement, public security is only endangered but does not suffer directly. The legislator establishes the qualification of smuggling of strategically important goods and resources in large volumes as exceeding one million rubles, which confirms that the public danger of this crime is determined by economic indicators. The author proves that smuggling of strategically important goods and resources harms public relations in the economic sphere rather than public relations that ensure public security. The conclusion is formulated that the totality of social relations that ensure the normal functioning and development of the economy should be considered as the main generic object of this crime. The direct object of smuggling of strategically important goods and resources is the procedure established by the international treaties and legislation of the Russian Federation for moving strategically important goods and resources through the customs border of the Eurasian Economic Union or the state border of the Russian Federation with the member states of the Eurasian Economic Union. Criminal liability for smuggling of strategically important goods and resources is proposed to be provided for in a separate article, which should be placed in Section VIII, Crimes in the Economic Sphere, of the Criminal Code of the Russian Federation.

scholarly journals The Identity of the Russian Federation in the Framework of the Presidential Addresses to the Federal Assembly

2021 ◽  
Vol 14 (4) ◽  
pp. 63-69
Author(s):  
V. G. Tikhonov
Keyword(s):  
Russian Federation ◽  
Historical Development ◽  
Special Relationship ◽  
General Process ◽  
Eurasian Economic Union ◽  
Personal Nature ◽  
Subjective Factor ◽  
Russian President ◽  
The Russian Federation ◽  
Economic Union

The article is based on content and discourse analysis of the addresses of the President of the Russian Federation to the Federal Assembly dated 12/01/2016, 03/01/2018, 02/20/2019, 01/15/2020. The aim of research is to analyze the concept of identity in the framework of Presidential Addresses and changes in the concepts of identity in dynamics. The general tendencies of considering the term “identity” in the framework of determining the identity of the Russian Federation are derived. The special relationship between the identity of the Russian Federation and the integration of the Russian Federation into integration spaces is considered. The Vladimir Putin’s statements regarding the integration of the Russian Federation into the Eurasian Economic Union are evaluated, since the Russian Federation identity, in the opinion of the President, is inextricably linked with the formation of the “Eurasian identity of the Russian Federation”, which in turn determines the direct relationship between the identity of the Russian Federation and the integration of the Russian Federation into the Eurasian Economic Union. The article defines the subjective factor of the Russian President, which reflects the personal nature of the President’s orders and proposals. The dynamics of changes in the formation of the Russian Federation identity is reflected according to the addresses of the President of the Russian Federation to the Federal Assembly, and also on the basis of the dynamics of changes in the identity of the Russian Federation, the general process orientation of developing the Russian Federation identity is reflected. The article characterizes the permanent nature of the formation of the identity of Russia. Now, the identity of Russia is perceived as a special construct that reflects the special position of the Russian Federation, both in historical development and in the international arena.

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