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Journal articles on the topic 'Pharmaceutical biotechnology – Law and legislation'

Author: Grafiati

Published: 10 March 2023

Last updated: 31 July 2025

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1

Omelchenko, Olha. "Some aspects of the intellectual property legislation development to expand access to biotechnology medicines." Theory and Practice of Intellectual Property, no. 1 (March 18, 2025): 97–104. https://doi.org/10.33731/12025.325004.

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The article examines the legal aspects of intellectual property and their impact on access to biotechnology medicines, considering prospects for legislative reform. The author analyzes legal mechanisms for ensuring access to medicines and their implementation in national legislation. Key priorities and reform prospects in intellectual property and pharmaceutical legislation are identified, addressing the challenges of martial law, European integration commitments, and the need to eliminate barriers to the timely market entry of generics and biosimilars. Intellectual property rights are a valua

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2

Del CASTILLO Rodríguez, Carlos. "PHARMACEUTICAL LEGISLATION OR PHARMACEUTICAL LAW? ANALYSIS." Vitae 18, no. 1 (2011): 83–87. http://dx.doi.org/10.17533/udea.vitae.8771.

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After legal enaltment in the pharmaceutical profession appear two intimately related concepts: the pharmaceutical law andt the pharmaceutical legislation that we should define and analyze. On the one hand, the pharmaceutical law is a heterogeneous group of dispositions regulating directly or indirectly the pharmaceutical activity. It cannot be considered an independent branch of the law, but it is possible for practical effects to order systematically the legal regulations. Such is the source of a new branch inside the sanitary law, the pharmaceutical legislation, that every pharmacies most kn

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3

Ivanenko, Dmytro, and Nataliia Hlushchenko. "LEGAL ASPECTS OF INTELLECTUAL PROPERTY IMPACT ON AVAILABILITY OF MEDICINES IN UKRAINE." Law Journal of Donbass 76, no. 3 (2021): 39–44. http://dx.doi.org/10.32366/2523-4269-2021-76-3-39-44.

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The right of a person to access medicines is derived from the right to health. At the time of the establishment of fundamental human rights, the issue of lack of access to medical supplies was not considered a violation of human rights. The spread of pandemics has led to the gradual recognition of the right of access to medicines. The TRIPS agreement fundamentally reformatted the discussion on access to medicines. Prior to the TRIPS Agreement, states had considerable independence in the formation and implementation of state policy in the field of intellectual property. TRIPS obliges countries

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4

Omelchenko, Olha. "Intellectual property rights in the context of biology, medicine and pharmacy: a look into the future." Theory and Practice of Intellectual Property, no. 3 (June 19, 2023): 109–17. http://dx.doi.org/10.33731/32023.282330.

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The article covers the study of some aspects of protecting the intellectual property rights in the areas of biology, medicine and pharmacy including biotechnological inventions. The rapid progress of science and technology, the generation and accumulation of knowledge, the possibilities to process large amounts of various data further stimulate the development of all social areas and unprecedentedly contribute to the emergence of innovations, in particular in the area of biotechnology. Intellectual property rights have a direct impact on the progress of medical and biological research, but inc

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5

Holman, Christopher M. "Congress Considering Legislation Aimed at Increasing Competition in Pharmaceuticals." Biotechnology Law Report 38, no. 3 (2019): 144–53. http://dx.doi.org/10.1089/blr.2019.29125.cmh.

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6

Albolino, Sara, Tommaso Bellandi, Simone Cappelletti, et al. "New Rules on Patient’s Safety and Professional Liability for the Italian Health Service." Current Pharmaceutical Biotechnology 20, no. 8 (2019): 615–24. http://dx.doi.org/10.2174/1389201020666190408094016.

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Background:The phenomenon of clinical negligence claims has rapidly spread to United States, Canada and Europe assuming the dimensions and the severity of a pandemia. Consequently, the issues related to medical malpractice need to be studied from a transnational perspective since they raise similar problems in different legal systems.Methods:Over the last two decades, medical liability has become a prominent issue in healthcare policy and a major concern for healthcare economics in Italy. The failures of the liability system and the high cost of healthcare have led to considerable legislative

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7

SEREBRENNIKOVA, ANNA. "PHARMACEUTICAL LAW: CRIMINAL ASPECTS." Gaps in Russian Legislation 14, no. 6 (2021): 203–9. http://dx.doi.org/10.33693/2072-3164-2021-14-6-203-209.

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The author, considering the possibility of the emergence of a new branch of law in the future - pharmaceutical law, focuses on the complexity of regulating the sphere of turnover of medicines, at the same time pointing to this as the main reason for the uncertainty of the legislator in matters of the correctness of the choice of the object and subject of legal regulation. The author, citing examples from practice, draws attention to the fact that pharmaceutical activity is gradually becoming the object of regulatory regulation of various legal institutions, where the turnover of medicines, as

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8

Frolova, O. "Implementation of EU legislation into the criminal legislation of Ukraine to ensure criminal legal protection of pharmaceutical activity." Scientific and informational bulletin of Ivano-Frankivsk University of Law named after King Danylo Halytskyi, no. 16(28) (December 13, 2023): 176–83. http://dx.doi.org/10.33098/2078-6670.2023.16.28.176-183.

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The purpose of the article is to determine the specifics of the implementation of EU legislation into the criminal law of Ukraine to ensure the criminal protection of pharmaceutical activity. The methodology includes the author's emphasis on basic international legal guidelines. Directive No. 2001/83/EC of the European Parliament and the Council of the EU on the Community Code on Medicinal Products for Human Use of November 6, 2001 serves as one of the main guidelines here. In the author's opinion, this is important based on the fact that the adopted Law of Ukraine "On Medicinal Products" of J

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9

Malinowski, Michael J. "Pharmaceutical Medicine, Biotechnology and European Law." Journal of Legal Medicine 23, no. 1 (2002): 159–66. http://dx.doi.org/10.1080/019476402317276722.

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10

Noguera Peña, Alfonso, and Carlos del Castillo Rodríguez. "Pharmaceutical Law and Pharmaceutical Legislation in Spain and in the European Union: Concept, Evolution and Sources." Anales de la Real Academia Nacional de Farmacia 87, no. 87(03) (2021): 275–322. http://dx.doi.org/10.53519/analesranf.2021.87.03.06.

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Medicines and the professional activity of the pharmacists are the subject of study of Pharmaceutical Law and Pharmaceutical Legislation. In this paper, on the one hand, the definition of these disciplines is examined, as well as their field of study, evolution and sources. On the other hand, the development of Pharmaceutical Legislation in the European Union is analysed in three clearly differentiated periods and related to different juridic enactments of generations of norms that affect medicines. Special attention has been paid to the so–called third generation standards, as the regulatory

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11

Frolova, O. G. "Criminal legal protection of pharmaceutical activity on the circulation of medicinal products in acts of foreign criminal legislation." Analytical and Comparative Jurisprudence, no. 5 (November 17, 2023): 495–501. http://dx.doi.org/10.24144/2788-6018.2023.05.89.

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The article examines the issue of the specifics of the criminal law protection of pharmaceutical activity in the circulation of medicinal products in acts of foreign criminal legislation. The author proposes to single out the most typical types of criminal offenses that encroach on pharmaceutical activity depending on the typical types of "impact” of pharmaceutical activity, namely when ensuring various stages of trade and other circulation (turnover) of medicinal products and other items of pharmaceutical activity. The author conducts a thorough review of the criminal legislation

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12

Yurkovska, Lidiia H., Volodymyr V. Krasnov, and Serhii H. Ubohov. "QUALITY ASSURANCE OF MEDICINES: THE STATE AND TRENDS OF THE EUROPEAN UNION AND UKRAINE LEGISLATION DEVELOPMENT." Wiadomości Lekarskie 74, no. 1 (2021): 150–54. http://dx.doi.org/10.36740/wlek202101129.

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The aim: Scientific substantiation of the state and tendencies of development at the present stage of the legislation of the European Union and Ukrainian legislation on quality assurance of medicines. Materials and methods: Using the biblio-semantic, systematic-review, analytical, formal-legal and comparative-law methods, the individual regulatory sources of pharmaceutical legislation of the EU and Ukraine were studied. Conclusions: The paper identifies that pharmaceutical legislation of the EU and Ukraine on quality assurance of medicines at the present stage of their development have common

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13

Aleksieiev, O. H. "Grounds for legal liability in the pharmaceutical sector of the healthcare sector." Zaporozhye Medical Journal 23, no. 2 (2021): 280–85. http://dx.doi.org/10.14739/2310-1210.2021.2.228794.

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The aim. To find out the content and essence of the legal liability grounds, to determine the main features of each element. Materials and methods. Synthesis, analysis and comparative law methods were used in the course of the study. Results. The grounds for legal liability in the pharmaceutical field are: 1) the fact of committing an act, defined as an offence by the relevant legislation, i.e. the factual basis; 2) the existence of a legal rule that prohibits such behavior and establishes appropriate sanctions, i.e. the regulatory basis; 3) lack of grounds for release from liability; 4) the e

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14

van Wyk, Christa. "Book Review: Pharmaceutical Medicine, Biotechnology, and European Law." Maastricht Journal of European and Comparative Law 8, no. 4 (2001): 397–405. http://dx.doi.org/10.1177/1023263x0100800404.

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15

Harris, Rebecca C. "State responses to biotechnology." Politics and the Life Sciences 34, no. 1 (2015): 1–27. http://dx.doi.org/10.1017/pls.2015.2.

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This article reviews biotechnology legislation in the 50 states for 11 policy areas spanning 1990–2010, an era of immense growth in biotechnology, genetic knowledge, and significant policy development. Policies regarding health insurance, life insurance, long-term care insurance, DNA data bank collection, biotech research protection, biotech promotion and support, employment discrimination, genetic counselor licensing, human cloning, and genetic privacy each represent major policy responses arising from biotechnology and coinciding with key areas of state regulation (insurance, criminal justic

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16

Brosch, Sabine, and Alessandro Spina. "International Conference on Harmonisation and Standardisation Initiatives in the Pharmaceutical Domain." European Journal of Risk Regulation 1, no. 3 (2010): 274–76. http://dx.doi.org/10.1017/s1867299x00000477.

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This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.

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17

Firman Erry Probo, Anis Widyawati, and Duhita Driyah Suprapti. "CRIMINAL LAW POLICY OF ILLEGAL PHARMACEUTICAL PREPARATIONS IN THE HEALTH OMNIBUS LAW." MORFAI JOURNAL 4, no. 4 (2025): 1566–71. https://doi.org/10.54443/morfai.v4i4.2428.

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The purpose of the omnibus law is to simplify the legislation amidst the overlapping legal conditions in Indonesia. The purpose of this article is to explain how the criminal law policy of the Omnibus Law applies to the circulation of illegal pharmaceutical preparations in Indonesia, seen from the position of the criminal article regarding the circulation of pharmaceutical preparations in Law Number 17 of 2023 concerning Health. Where Law Number 17 of 2023 concerning Health has revoked the old Health Law, namely Law Number 36 of 2009 concerning Health. This raises doubts for law enforcement of

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18

Drigo, A. E., L. I. Lavrenteva, O. V. Zheltkevich, and N. V. Korchkova. "Topical issues of pharmaceutical organization systematization." Remedium Journal about the Russian market of medicines and medical equipment, no. 11-12 (2020): 55–60. http://dx.doi.org/10.21518/1561-5936-2020-11-12-55-60.

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The article is devoted to the problems of legal regulation of pharmaceutical activities. The main contradictions of legislation in the approaches to the definition of the concepts of “pharmaceutical organization”, “subject of pharmaceutical activities”, “pharmacy organization”, “type of pharmacy organization” are considered. The problem of uncertainty in the status of a pharmacy organization, an individual entrepreneur with a pharmaceutical license has been identified. The need to develop an unified terminology for the types of pharmacy organizations, indicating their differences according to

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19

Varela, Justo Corti. "Biotechnology." European Journal of Risk Regulation 1, no. 1 (2010): 63–71. http://dx.doi.org/10.1017/s1867299x00000076.

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This section aims to update readers on decisions related to marketing products of modern biotechnology (e.g., GMOs, animal clones) at EU level and on national measures concerning their production. Special attention is devoted to problems of competence between Member States and the EU in regulating biotechnology issues; the institutional dynamics of decision making regarding products derived from modern biotechnology; the relationship between the EFSA and the EU institutions on green biotech-related issues; the evolution of EU regulatory framework and of national attitudes towards the risks and

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20

Lentz, Edward T. "Pharmaceutical and Biotechnology Research Revisited." Biotechnology Law Report 25, no. 1 (2006): 2–5. http://dx.doi.org/10.1089/blr.2006.25.2.

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21

Frolova, Olena. "CAUSING HARM TO PHARMACEUTICAL ACTIVITY AS AN OBJECT OF CRIMINAL LAW PROTECTION." Scientific Journal of Polonia University 62, no. 1 (2024): 151–57. http://dx.doi.org/10.23856/6220.

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The article is devoted to the issue of causing harm to pharmaceutical activity as an object of criminal law protection. As the author notes, the current legislation regulating the procedure for pharmaceutical activity contains certain guidelines for determining harm to the specified social values or its individual fragments. In the opinion of the author, characterizing the formation of harm "within" pharmaceutical activity as an object of criminal law protection and its consideration in the composition of criminal offenses, it is necessary to determine the types of actions that affect pharmace

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22

Morozova, Natalya Arkadyevna. "Issues of interaction and cooperation between prescribers and pharmaceutical companies." Ophthalmology journal 6, no. 3 (2013): 4–8. http://dx.doi.org/10.17816/ov201334-8.

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The prescription of a specific drug to treat a patient is influenced by the patient’s medical condition, the prescriber’s medical knowledge, and the pharmaceutical industry’s influence on the prescriber. This paper describes the different areas of interaction and cooperation between the prescriber and the pharmaceutical industry. This relationship is discussed in light of the requirements of the Federal law of the Russian Federation regarding the restrictions imposed on the prescribers. Problems of application of the standards of the law are discussed and ways of elimination of gaps of the leg

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23

Aleksieiev, O. H. "Conceptual and category apparatus of legislation, what determines legal responsibility in pharmaceutical activity." Current issues in pharmacy and medicine: science and practice 15, no. 2 (2022): 201–7. http://dx.doi.org/10.14739/2409-2932.2022.2.255817.

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The aim of the work – is to study the conceptual and categorical apparatus of the legislation of Ukraine, which determines the legal responsibility in pharmaceutical activities. Materials and methods. The study is based on a number of legislative terms and case law in cases of prosecuting violators of pharmaceutical legislation. During the work, we used methods of information retrieval, analysis, systematization, and generalization. Results. It is established that pharmaceutical activity is one of the branches in the field of health care, which is carried out by conducting licensed economic ac

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24

Olzhabayeva, X. B. "Analysis of Kazakhstan legislation regulating the labour of medical and pharmaceutical workers." BULLETIN of L.N. Gumilyov Eurasian National University. Law Series 137, no. 4 (2021): 132–41. http://dx.doi.org/10.32523/2616-6844-2021-137-4-132-141.

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The article analyzes the provisions of the Code of the Republic of Kazakhstan «On Health of people and healthcare system» dated July 7, 2020, as well as several departmental regulatory acts regulating the labor of medical and pharmaceutical workers, which were adopted in compliance with this Code. Chapter 30 «The status of medical and pharmaceutical workers» of this Code identifies gaps in the status, rights, duties, and social guarantees of this category of workers and offers specific measures to eliminate them. The Labor Code of the Republic of Kazakhstan dated November 23, 2015, is not incl

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25

Guţiu, Simona. "Some considerations of Romanian legal framework on online sale of OTC medicine. Coordination or contradiction to European legislation?" Proceedings of the International Conference on Business Excellence 15, no. 1 (2021): 930–35. http://dx.doi.org/10.2478/picbe-2021-0086.

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Abstract The present work is aimed to answer a very interesting and sensitive legal issue in the Romanian pharmaceutical field. This issues regard mainly the existence of coordination or contradiction between Romanian (i.e. Romanian Pharmacy Law no. 266/20081) and European legislation (art 34 TFEU2) in respect of the delivery of the online sale of OTC medicine only from pharmaceutical units.

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26

Pashkov, V. M. "LEGAL REGULATION OF MOST DANGEROUS MICROORGANISMS STRAINS HANDLING." Medicne pravo, no. 2(28) (October 7, 2021): 71–79. http://dx.doi.org/10.25040/medicallaw2021.02.071.

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Problem statement. The main issues that exist in the management of strains of particularly dangerous microorganisms are primarily related to the weakening of state supervision and control. Surprisingly, nowadays, there is no single official register of owners of pathogenic microorganisms and strains of dangerous and especially dangerous infectious diseases. Some biological objects are found, even in private collections. There are no permitting procedures for handling such facilities and sanctions for violating them. That is why it is not surprising that the Prosecutor General’s Office ha

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27

Spina, Alessandro. "Pharmaceuticals." European Journal of Risk Regulation 1, no. 1 (2010): 81–82. http://dx.doi.org/10.1017/s1867299x00000106.

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This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.

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28

Jablonski, Tomasz. "End of the Transitional Period for Traditional Herbal Medicinal Products Coming Soon." European Journal of Risk Regulation 1, no. 2 (2010): 156–59. http://dx.doi.org/10.1017/s1867299x0000026x.

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This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.

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29

Bombillar, Francisco. "The Case of Pandemic Flu Vaccines: Some Lessons Learned." European Journal of Risk Regulation 1, no. 4 (2010): 427–31. http://dx.doi.org/10.1017/s1867299x00000908.

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This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.

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30

Kiedrzynek, Michał. "Ewolucja administracji farmaceutycznej w Polsce." Studenckie Prace Prawnicze, Administratywistyczne i Ekonomiczne 20 (September 20, 2017): 65–76. http://dx.doi.org/10.19195/1733-5779.20.5.

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The evolution of pharmaceutical administration in PolandProduction and marketing of medicinal products are of interest to the legislature for many years. Already in 1919, they entered into force on the first rules governing the matter indicated. The basic health law was the first piece of legislation to regulate the issue of the pharmaceutical market. The legislator only in 1939 passed a new law in this area, which for several years was in force between 40 and 50. Only later came into force a new law on pharmaceuticals and drugs and sanitary articles, which was much more extensive than previou

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31

Pirtskhalava, Kh D. "Ethical Standards in Innovative Medicine." Courier of Kutafin Moscow State Law University (MSAL)), no. 9 (December 21, 2023): 182–87. http://dx.doi.org/10.17803/2311-5998.2023.109.9.182-187.

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States are trying to develop the sector of medicine and healthcare in general, as they are one of the factors contributing to the economic development of states. The trend towards the need to invent innovations, both in the field of technology and medicines, leads to changes in the legislation of regional integration associations, as well as in the domestic legislation of the member states of these integration associations. The development of medicine contributes to the development of medical tourism, which is a positive trend. At the same time, the need for innovative development of medicine

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32

Kondrat'ev, V. A. "Consumerism Qualification: Doctrine and Case Law." Rossijskoe pravosudie 5 (May 25, 2021): 22–28. http://dx.doi.org/10.37399/issn2072-909x.2021.5.22-28.

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А number of factors influence the qualification of relations as consumer relations, however, neither a scientific literature nor law enforcement practice has formed a common list of signs defining the relationship to the subject of regulation of consumer protection legislation. The main purpose of the article is to identify signs that qualify the relationship as consumer. Achieving the goal of the article is carried out by solving the following tasks: determining the influence of the subject composition of relations, the nature of their activities, as well as other signs on the qualification o

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33

Faltus, Timo. "The Medicinal Phage—Regulatory Roadmap for Phage Therapy under EU Pharmaceutical Legislation." Viruses 16, no. 3 (2024): 443. http://dx.doi.org/10.3390/v16030443.

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Bacteriophage therapy is a promising approach to treating bacterial infections. Research and development of bacteriophage therapy is intensifying due to the increase in antibiotic resistance and the faltering development of new antibiotics. Bacteriophage therapy uses bacteriophages (phages), i.e., prokaryotic viruses, to specifically target and kill pathogenic bacteria. The legal handling of this type of therapy raises several questions. These include whether phage therapeutics belong to a specially regulated class of medicinal products, and which legal framework should be followed with regard

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34

Zhang, Jing, Shuchen Tang, and Pengqing Sun. "From Command-Control to Lifecycle Regulation: Balancing Innovation and Safety in China’s Pharmaceutical Legislation." Healthcare 13, no. 6 (2025): 588. https://doi.org/10.3390/healthcare13060588.

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Background: China’s pharmaceutical regulatory framework is undergoing a pivotal shift from a traditional “command-control” model to a “lifecycle regulation” approach, aiming to balance drug safety, innovation, and accessibility. This study systematically examines the evolution, achievements, and challenges of China’s regulatory reforms, offering insights for global pharmaceutical governance. Methods: Using a mixed-methods approach integrating historical analysis, policy text mining, and case studies, we reviewed the pharmaceutical laws and regulations enacted since 1949, supplemented by case s

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35

Shapovalov, Valerii. "Судова фармація, організація фармацевтичної справи, технологія ліків, медичне, фармацевтичне та кримінальне право: державна система боротьби із незаконним обігом наркотичних засобів і психотропних речовин та зловживання ними в умовах пандемії". SSP Modern Law and Practice 2, № 3 (2022): 1–35. http://dx.doi.org/10.53933/sspmlp.v2i3.66.

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In the context of the COVID-19 pandemic, the burden on the sphere of health care, pharmacy, finance, economy, industry, and law enforcement are increasing. The level of the state system regarding the effectiveness of the criminal and legal struggle against the illegal circulation of narcotics (narcotic drugs and psychotropic substances) and their abuse by improving the legislation and normative legal acts of Ukraine in the conditions of the pandemic on the basis of forensic pharmacy, drug technology, the organization of the pharmaceutical case, medical and pharmaceutical law. Scientific inform

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36

Sdvizhkov, M. А. "Antitrust Compliance in the Pharmaceutical Industry: Problems and Prospects of Implementation." Russian competition law and economy, no. 4 (January 12, 2022): 52–59. http://dx.doi.org/10.47361/2542-0259-2021-4-28-52-59.

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The article examines the background of legislative consolidation and the main problems of the introduction by pharmaceutical companies of a new legal institution for the prevention of violations of antimonopoly legislation — antimonopoly compliance, introduced by Federal Law No. 33-FL of March 1, 2020.The definition of the concept and a brief description of the current state and trends in the development of the pharmaceutical industry in connection with the relations of competition are given.The necessity of introducing antimonopoly compliance by pharmaceutical companies as a relatively indepe

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37

Manak, Joseph M. "The Law of Written Description in Pharmaceutical and Biotechnology Patents." Biotechnology Law Report 23, no. 1 (2004): 30–47. http://dx.doi.org/10.1089/073003104322838231.

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38

Khassenov, M. K. "Some issues of labor regulation of medical and pharmaceutical workers in selected OECD countries." BULLETIN of L.N. Gumilyov Eurasian National University. Law Series 137, no. 4 (2021): 98–109. http://dx.doi.org/10.32523/2616-6844-2021-137-4-98-109.

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The article presents the results of a study of the legal basis for the labor activity of medical and pharmaceutical workers in some states that are members of the Organization for Economic Cooperation and Development (hereinafter - OECD). The author provides general features and specifics of labor regulation models in the healthcare sector. The article analyzes legislation and law enforcement. Thus, the European (continental) and Anglo-American models stand out, which differ in the direction of regulation. The first model is distinguished by the social orientation of labor regulation and publi

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39

Mokhov, A. A. "The Concept of Four "Bio" in Law and Legislation." Actual Problems of Russian Law 15, no. 8 (2020): 146–54. http://dx.doi.org/10.17803/1994-1471.2020.117.8.146-154.

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Developing biotechnologies have an impact not only on technical, technological and other economic processes, but also on industries and sectors of the economy, public relations, and change the prevailing stereotypes of behavior and habits. In this regard, new sprouts of an innovative economy, and the changing social sphere, the psychology of individual groups and communities determine the need for a unified balanced biopolitics. This policy manifests itself in the provisions of the rule of law and legislation, strategic planning documents, and in law enforcement. Due to the nontriviality of te

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40

Lisman, John A., and J. Frits F. Lekkerkerker. "Four decades of European medicines regulation: What have they brought us?" International Journal of Risk & Safety in Medicine 17, no. 1-2 (2005): 73–79. https://doi.org/10.3233/jrs-2005-337.

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This article gives an overview of the development of the European regulatory system. In 1965 the First Directive on medicinal products was adopted. In 2005 a total revision of the system will come into force. How effective the European Union legislation and regulatory system has been and why has the focus of regulation changed over the years? A famous philosopher said that to know the future, the past has to be explored. From the history of EU pharmaceutical legislation it becomes clear why the law has become as it is.

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Fernando, Andrian, and Tri Susilowati. "Legislative Functions of the House of Representatives in the Perspective of the 1945 Constitution of the Republic of Indonesia." Jurnal Indonesia Sosial Sains 4, no. 06 (2023): 523–30. http://dx.doi.org/10.59141/jiss.v4i06.828.

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All the objectives of the State are specified in the constitution or essential law of the State as expressed in the Prelude to the 1945 Constitution of the Republic of Indonesia (1945 Constitution), which is contained in the fourth passage which states: 1) safeguard the whole Indonesian country and Indonesia's slaughter; 2) advance public government assistance; 3) teach the existence of the country; and 4) take part in completing world request. In particular, in the 1945 Constitution, the scope and definition of the law are not very clear. Article 20 of the 1945 Constitution only mentions the

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Aleksieiev, O. H. "Conceptual and terminological apparatus for disciplinary responsibility in pharmaceutical activity." Current issues in pharmacy and medicine: science and practice 16, no. 2 (2023): 181–85. http://dx.doi.org/10.14739/2409-2932.2023.2.277085.

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The analysis of the content of the norm and its interpretation by the Constitutional Court of Ukraine leads to the conclusion that the labor legislation does not comply with the requirements of the Constitution of Ukraine, and the emphasis is placed on the need to harmonize the relevant norms with the Basic Law. The aim of the work is to analyze the modern problem of terminological aspects of disciplinary responsibility in pharmaceutical activity according to the current legislation. Materials and methods. The research was conducted using comparative legal, historical methods, methods of analy

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Vakhonieva, T. "LEGAL STATUS AND QUALIFICATION REQUIREMENTS FOR PHARMACEUTICAL WORKERS." Bulletin of Taras Shevchenko National University of Kyiv. Legal Studies, no. 116 (2021): 11–14. http://dx.doi.org/10.17721/1728-2195/2021/1.116-2.

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The article examines the features of the legal status of pharmaceutical workers and determines the place of pharmaceutical activity in the field of health care. Pharmaceutical workers are considered as a separate category of health workers, along with medical workers and workers working in the field of rehabilitation. The qualification requirements to pharmaceutical workers fixed by the legislation depending on the sphere and type of pharmaceutical activity are determined. Pharmaceutical workers include professionals and specialists who work on the basis of an employment contract in the field

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Хабриева, Талия, and Taliya Khabriyeva. "Main Vectors and Problems of Development of Social Legislation." Journal of Russian Law 2, no. 8 (2014): 5–15. http://dx.doi.org/10.12737/5271.

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The article on the guidelines for the development of social legislation of the Russian Federation predicts a rapid and accelerated development of this block of Russian law system.Among the largescale trends typical for social legislation the author includes: expanding of the scope of regulation (juridification) and the corresponding expansion of legal regulations, differentiation of social legislation on the new brunches (in particular, immigration legislation), the formation of new sub-brunches within the existing ones (for instance, labor relations in the public service) and institutio

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Prepyalov, Alexander V. "A medicine as an object of civil rights: A concept, attributes and comparison to the foreign approach." Vestnik of Saint Petersburg University. Law 13, no. 4 (2022): 1058–77. http://dx.doi.org/10.21638/spbu14.2022.414.

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The article addresses the issue of classifying a limited civil circulation thing as a medicine that is defined by a set of attributes including generic ones. After the adoption of the first specialized law — Federal law “On Medicines” N 86-FZ dated 22.06.1998 legal standards for different law branches where medicine is a law object have been formulated. This explains the relevance of this research and its practical applicability in further development of legislative initiatives and regulatory practices. The correctness of medicine definition in the Russian legislation can be determined by the

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Krasnianska, Tetiana, and Mykola Ponomarenko. "Organization of the Pharmaceutical Business, Drug Technology and Forensic Pharmacy: Modern Trends in The Development of the Science of Pharmaceutical Law During the Covid-19 Pandemic." SSP Modern Pharmacy and Medicine 2, no. 3 (2022): 1–15. http://dx.doi.org/10.53933/sspmpm.v2i3.59.

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The COVID-19 pandemic has affected modern trends in the training of doctors and pharmacists and their professional development. At the same time, the pandemic contributed to the development of the science of pharmaceutical law, as a basis for optimizing the legislation of Ukraine regarding the organization of pharmaceutical affairs in pharmacies and health care institutions, and thanks to modern research on the search for drug technology, it contributed to the creation of vital vaccines for the prevention of the SARS-CoV-2 coronavirus. At the same time, during the COVID-19 pandemic, the health

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Liikanen, Erkki. "Changes to the European Union pharmaceutical legislation: Implications of the ‘Pharma Review’ for biotechnology companies." Journal of Commercial Biotechnology 11, no. 1 (2004): 38–43. http://dx.doi.org/10.1057/palgrave.jcb.3040099.

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K. A., Krasnova. "Crime in Esports – Criminal Law Considerations." Rossijskoe pravosudie, no. 10 (September 27, 2021): 90–97. http://dx.doi.org/10.37399/issn2072-909x.2021.10.90-97.

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The phenomenon and development of modern digital technologies put imprint on almost all life spheres, including sports. Over the past years, there have been a rapid development of a new sport and a new direction of the sports business, i. e., esports, which, unlike traditional sports, is causally relating to information and telecommunication technologies and intellectual property. The Regulations on esports adopted in 2020 by the Ministry of Sports of the Russian Federation, expanded the concept of sport by officially recognizing esports as an independent sport. Today, esports is a fast-growin

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Beletsky, Leo. "21st Century Cures for the Opioid Crisis: Promise, Impact, and Missed Opportunities." American Journal of Law & Medicine 44, no. 2-3 (2018): 359–85. http://dx.doi.org/10.1177/0098858818789417.

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Signed into law in 2016, the landmark 21st Century Cures Act is as complex as it is divisive. For some stakeholders, including patient groups and representatives of regulated industries, the Act represented a major leap forward in pharmaceutical innovation, human subjects protections, and numerous other provisions. For other observers, this legislation was characterized as a major rollback in important regulations, which would leave patients worse off and the payers holding the bag. The one element of the Act that was relatively uncontroversial covered a number of provisions related to address

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Berzin, P., R. Volynets, and O. Frolova. "Atypical features of the Austrian model of criminal law protection of circulation of medical devices." Uzhhorod National University Herald. Series: Law 2, no. 80 (2024): 16–22. http://dx.doi.org/10.24144/2307-3322.2023.80.2.2.

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The article examines the atypicality of the Austrian model of criminal law protection of the circulation of medical products and medical devices. The authors note that the acts of foreign criminal legislation distinguish types of criminal offenses that encroach on pharmaceutical activity, which to a certain extent coincide with those provided for in the Criminal Code of Ukraine. At the same time, it is the Austrian model of protection of circulation of medical products and medical devices that most successfully, as the analysis of acts of foreign criminal legislation shows, demonstrates the le

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