scholarly journals MODERN REQUIREMENTS TO INDUSTRIAL PRODUCTION AND PHARMACEUTICAL MANUFACTURE OF INFUSION MEDICINAL PREPARATIONS IN THE RUSSIAN FEDERATION: SIMILARITIES AND DIFFERENCES

2018 ◽  
Vol 6 (3) ◽  
pp. 214-228
Author(s):  
R. A. Gachenko ◽  
A. B. Goryachev

The quantitative reduction of the manufacturing pharmaceutical organizations significantly lowers public accessibility to medicinal preparations manufactured by pharmacies. The aim of this research has is the analysis of the normative legal standards regulating the industrial production and the pharmaceutical manufacture of infusion medicinal preparations in the territory of the Russian Federation. Materials and methods: The research has been carried out by the analysis of the current legislative and normative acts by means of documentary observation and content analysis. Results and discussion. Hereby the review has been done of the main acts along with normativelegal documentation regulating the industrial production and the pharmaceutical  manufacture of infusion medicines such as federal laws, regulations of the Government of the Russian Federation, the State Pharmacopeia (Editions XI and XIII), orders of the Ministry of Health of the Russian Federation, etc. It has been established that in the Russian Federation there has been developed and currently functioning the system of mandatory requirements to industrial production and quality control of infusion medicinal preparations produced by manufacturing enterprises. At the same time, despite the restrictions on the pharmaceutical manufacture of the aseptic medicines registered in the Russian Federation, the pharmaceutical organizations implement manufacture of the medicines which are not produced industrially. That makes it possible to provide an individual dosage of ingredients and take into account patients’ individual characteristics. The normative legal regulation system for the pharmaceutical manufacture significantly differs from the similar system for the industrial production. The scientific discussion on the implementation of the international Rules of Good Manufacturing Practices (GMP) into pharmaceutical activities has not arrived at a unanimous organizational and technological opinion because of essentially different purposes, a diverse range of the undertaken tasks and dissimilar economic opportunities of pharmaceutical organizations and manufacturing enterprises. Conclusion: The currently existing normative legal regulation system for the industrial production and the pharmaceutical manufacture of infusion medicines in the Russian Federation is aimed at providing the national health services’ needs of necessary remedies for infusion therapy. At the same time, the pharmaceutical manufacture does not oppose the industrial production, but quite the contrary, expands public accessibility to such preparations for treatment in emergency or urgent cases and also during routine treatment of patients.

Author(s):  
M.N. Tarsheva

Legal procedures in a state governed by the rule of law are a kind of guarantor of legality and protection of citizens' rights, and therefore issues related to the development and improvement of the procedural mechanism are among the top priorities. The procedural mechanism is the most important structural element of the legal regulation system, which includes entire procedural branches. The article substantiates the need to develop and legislate procedures within which actions can be carried out to reconcile and make amends for harm, compensation for damage or otherwise make amends for harm (since gaps and shortcomings in the legislation associated with the lack of procedural mechanisms do not allow to fully realize the human rights potential of Articles 25, 25.1, 28 Part 1, 28.1 of the Criminal Procedure Code of the Russian Federation), as well as the need to classify these procedures (which has not been previously carried out). The author proposes to divide such procedures into conciliatory and restorative ones. The author's definitions of conciliation and restorative procedures in pre-trial proceedings are given.


2019 ◽  
Vol 23 (4) ◽  
pp. 546-564
Author(s):  
Emil V. Alimov

This article is devoted to the analysis of the genomic research legal regulation in the Russian Federation and the USA. In the United States, in addition to the legislation great importance is attached to medical and scientific institutions self-regulation, and such information is usually open. It is concluded that in Russia, despite the presence of both state and non-state scientific institutions engaged in genomic research, the mechanism of self-regulation as a whole is fragmented. It is also noted that Russia and the United States have specific legal regulation of these relations, which is reflected in the text of the article. For example, in the United States, unlike Russia, most organizations conducting genomic research, including genomic testing, are non-governmental. Currently, the general trend in the legal regulation of genomic research in Russia and the USA is the active development of normative legal regulation. Moreover, a significant difference in the approaches of these countries is the active role of the US states in the development of regional legal regulation on these issues. Despite the fact that Russia is a federal state, the subjects of the Russian Federation are significantly limited in the genomic research legal regulation possibilities. This is largely due to both legal and political reasons that were given in this article. In the United States, a number of statutes have been adopted at the state level that regulate genomic research in such aspects as health insurance, confidential of personal information, the prohibition of discrimination, screening of newborns, and certain types of clinical and scientific research. It should be noted that the genomic research regulation in the United States is not integrated into a single national consolidated act, which is a feature of this legal system. A comparative legal study of the fundamentals of legal regulation and self-regulation of genomic research in Russia and the USA made it possible to understand the specifics of regulation of these issues in different legal systems. The positive regulatory experience in conducting genomic research in the United States can be used to improve the regulatory framework of the Russian Federation in this area.


2016 ◽  
Vol 4 (2) ◽  
pp. 0-0
Author(s):  
Владимир Селезнев ◽  
Vladimir Seleznev

Increasing of efficacy of judicial acts proceedings is an actual problem of the governmental management. There are many changes that have been inserted in Code of the Russian Federation on Administrative Violations, nevertheless there are questions about legal norms certainty, legal regulation system conformity including the part of administrative punishment execution. Several questions concerning execution of these kinds of administrative punishments such as administrative financial penalty, administrative suspension of activities, administrative exile of foreign citizen or stateless person outside the Russian Federation, compulsory work are considered in the article. The attention is paid to problems of legislation imperfection that regulates the order of judicial acts proceedings in cases on administrative violations, which can tend to violations of warranties in governmental protection of rights, liberties and legitimate interests of people. The author has formulated the suggestions about making amendments to Code of the Russian Federation on Administrative Violations in order to increase the efficacy of law-enforcement activity in judicial acts proceedings.


2021 ◽  
Vol 11 (1) ◽  
pp. 237-242
Author(s):  
I.I. GILAZOV

This article is devoted to the modern codification of civil procedural legislation of the Russian Federation. The author substantiated the necessity to intensify work on the determination of unified procedural mechanisms in various types of legal proceedings and the necessity to conceptual unification of legislation. The ultimate goal of unification is the adoption of a single codified normative legal act regulating civil procedural relations. In particular, the study points out the objective necessity, at this stage, of scientifically and practically grounded, deliberate, gradual and progressive actions for the conceptual unification of legislation, the ultimate goal of which is the adoption of a single codified normative legal act regulating civil procedural relations. At the same time, the unity of the legal regulation system will depend primarily on the extent to which all the features of various types of legal proceedings are identified and taken into account. Particular attention should be paid to judicial practice: both courts of general jurisdiction and arbitration courts.


Author(s):  
G. V. Dmitriev ◽  
R. N. Lemeshkin ◽  
I. F. Savchenko ◽  
A. V. Stepanov

Relevance. Currently, the solution to the problem of medical support for troops (forces) and the population during the liquidation of the health consequences of emergencies by forces and means of the medical service of the Armed Forces of the Russian Federation does not lose its relevance.Intention. The system-morphological method to create a multidimensional morphological matrix with the corresponding morphological features and develop solutions to the problem of medical support in responding to the health consequences of emergencies.Methodology. The methodology of system-morphological analysis is presented, which allows creating alternative solutions. Variants of medical support for troops (forces) and the population were developed during the liquidation of the health consequences of emergency situations of a natural, technogenic and social nature: “Departmental”, “Interdepartmental”, “International”. In relation to each option, 9 indicators (criteria) are proposed: normative legal regulation; system controllability; complexity of organizing the system; resource (material) cost; staffing; the adequacy of medical care; efficiency; experience and innovation; autonomy of action. To achieve the goal of the study, the original MPRIORITY 1.0 dialog system (MY PRIORITY) was used which implements a method for analyzing hierarchies through repetitions (iterations).Results and Discussion. The results characterize each of the considered alternative options with an appropriate weight priority, and their preference is determined. During the first iteration, priorities were identified for a system of indicators and criteria that are characteristic for achieving a result with an emphasis on normative legal regulation of activities with its organizational structure and management system. In the second one, the priorities for the system of indicators and criteria were changed with a focus on the organization of medical care with the existing system of material and technical support, medical supply, as well as the proper level of training of medical personnel.Conclusion Proposals have been developed for the medical service of the Armed Forces of the Russian Federation, in particular for the Service for Disaster Medicine of the Ministry of Defense of Russia, on the organization of a medical support system for troops (forces) and the population during mitigation of the health consequences of emergencies.


Author(s):  
Yanis Arturovich Sekste ◽  
Anna Sergeevna Markevich

The subject of this research is the problems emerging in the process of establishment and development of the Institution of personal data protection in the Russian Federation. Special attention is turned to the comparison of Soviet and Western models of protection of private life and personal data. The authors used interdisciplinary approach, as comprehensive and coherent understanding of socio-legal institution of personal data protection in the Russian Federation is only possible in inseparable connection with examination of peculiarities of the key historical stages in legal regulation of private life of the citizen. After dissolution of the Soviet political and legal system, the primary task of Russian law consisted in development and legal formalization of the institution of protection of human and civil rights and freedoms, first and foremost by means of restricting invasion of privacy by the state and enjoyment of personal freedom. It is concluded that the peculiarities of development of the new Russian political and legal model significantly impacted the formation of the institution of personal data protection in the Russian Federation. The authors believe that the Russian legislator and competent government branches are not always capable to manage the entire information flow of personal data; therefore, one of the priority tasks in modern Russian society is the permanent analysis and constant monitoring of the development of information technologies.


2018 ◽  
Author(s):  
Михаил Геннадьевич Чепрасов ◽  
Юлия Станиславовна Лисачева ◽  
Евгения Дмитриевна Стрельникова

This article discusses the problematic aspects of the financial and legal regulation of innovation activity in the Russian Federation, as well as ways to solve them. A comparative analysis with foreign countries is presented. В данной статье рассмотрены проблемные аспекты финансово-правового регулирования инновационной деятельности в РФ, а также пути их решения. Представлен сравнительный анализ с зарубежными странами.


Author(s):  
Yuliya Chernenilova

This article describes the periods of development of the legal institution of employment contract in Russia. The characteristic features for each of them are defined. The first period was the longest and was marked by develogment of the contract of personal employment as the origin of the modern institution of employment contract. In the second period, the contract of personal employment represented the institution of civil law, and later became the subject of study of the civil law science. At that time the industrial law of the country was forming. A distinctive feature of the third period was the adoption of codified acts, as well as differentiation in the legal regulation of labor relations of temporary and seasonal workers. The fourth period is characterized by changes in state-legal methods of economic management. With the adoption of the Constitution of the Russian Federation labor legislation was assigned to the joint jurisdiction of the Russian Federation and its subjects. It is concluded that the adoption of the Labor Code of the Russian Federation necessitates a more accurate study of the problems arising in the application of specific rules of law governing the peculiarities of labor of certain categories of workers (for example, labor relations with persons with disabilities are not yet perfect because of the youth of the labor law), conflict of laws issues arising in practice, contradictions that occur in a huge array of legal documents not only in labor law, but also in other branches of law.


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