Agencies Without the Rooseveltian State: Legal Regime of Regulatory Agencies in Brazil

2017 ◽  
Author(s):  
Juliana Bonacorsi Palma ◽  
Bruno M. Salama
Keyword(s):  
Regulatory Agencies ◽  
Legal Regime

scholarly journals Considerações Iniciais sobre a Lei Geral das Agências Reguladoras

2020 ◽  
Vol 1 (1) ◽  
Author(s):  
Alexandre Santos de Aragão
Keyword(s):  
Decision Making ◽  
Social Control ◽  
Impact Analysis ◽  
Practical Experience ◽  
Regulatory Agencies ◽  
Decision Making Process ◽  
Legal Regime ◽  
Regulatory Impact Analysis ◽  
General Law ◽  
Regulatory Impact

<p><strong>Initial Considerations on the General Law of Regulatory Agencies</strong></p><p><strong>RESUMO: </strong>O presente trabalho busca apresentar opiniões preambulares acerca de temas interessantes, polêmicos ou que demandarão uma hermenêutica mais complexa da Lei nº 13.848/2019. A chamada (nova) Lei Geral das Agências dispõe sobre a gestão, a organização, o processo decisório e o controle social das agências reguladoras, tendo como escopo central a criação de um regime jurídico uniforme para todas essas autarquias especiais, procurando resolver alguns problemas que foram sendo verificados ao longo das suas primeiras décadas de experiência prática.</p><p><strong>PALAVRAS-CHAVES: </strong>Regulação; Agências; Prerrogativas; Sujeições; Análise de Impacto Regulatório.</p><p><strong>ABSTRACT:</strong> The present work seeks to present preambular opinions about interesting, controversial or topics that will demand a more complex hermeneutics of Law No. 13,848 / 2019. The so-called (new) General Law of Agencies provides for the management, organization, decision-making process and social control of regulatory agencies, with the central aim of creating a uniform legal regime for all these special autarchies, seeking to solve some problems that were verified throughout their first decades of practical experience.</p><p><strong>KEYWORDS:</strong> Regulation; Agencies; Prerogatives; Subjections; Regulatory Impact Analysis.</p><p><strong>Data da submissão: 05/05/2020</strong><br /><strong>Data da aceitação: 05/06/2020</strong></p>

Boilerplate

2012 ◽  
Author(s):  
Margaret Jane Radin
Keyword(s):  
Economic Efficiency ◽  
Analytical Framework ◽  
Daily Basis ◽  
Regulatory Agencies ◽  
Jury Trial ◽  
Comprehensive Treatment ◽  
New Methods ◽  
And Control ◽  
Fine Print

Boilerplate—the fine-print terms and conditions that we become subject to when we click “I agree” online, rent an apartment, or enter an employment contract, for example—pervades all aspects of our modern lives. On a daily basis, most of us accept boilerplate provisions without realizing that should a dispute arise about a purchased good or service, the nonnegotiable boilerplate terms can deprive us of our right to jury trial and relieve providers of responsibility for harm. Boilerplate is the first comprehensive treatment of the problems posed by the increasing use of these terms, demonstrating how their use has degraded traditional notions of consent, agreement, and contract, and sacrificed core rights whose loss threatens the democratic order. This book examines attempts to justify the use of boilerplate provisions by claiming either that recipients freely consent to them or that economic efficiency demands them, and it finds these justifications wanting. It argues that our courts, legislatures, and regulatory agencies have fallen short in their evaluation and oversight of the use of boilerplate clauses. To improve legal evaluation of boilerplate, the book offers a new analytical framework, one that takes into account the nature of the rights affected, the quality of the recipient's consent, and the extent of the use of these terms. It goes on to offer possibilities for new methods of boilerplate evaluation and control, and concludes by discussing positive steps that NGOs, legislators, regulators, courts, and scholars could take to bring about better practices.

ADMINISTRATIVE AND LEGAL STATUS OF THE CAPITAL OF UKRAINE - THE HERO CITY OF KYIV AS A GUARANTEE OF THE RIGHTS OF CITIZENS OF UKRAINE AND THE TERRITORIAL COMMUNITY OF THE CITY

2017 ◽  
Author(s):  
Oleksii Chepov ◽  
Keyword(s):  
Legal Status ◽  
Modern World ◽  
Legal Regime ◽  
Legal Doctrine ◽  
City Councils ◽  
The Social ◽  
District Management ◽  
Definition Of ◽  
The Relationship ◽  
The City

The qualitative and clear definition of the legal regime of the capital of Ukraine, the hero city of Kyiv, is influenced by its legislative enshrinement, however, it should be noted that discussions are ongoing and one of the reasons for the unclear legal status of the capital is the ambiguity of current legislation in this area. Separation of the functions of the city of Kyiv, which are carried out to ensure the rights of citizens of Ukraine and the functions that guarantee the rights of the territorial community of the city of Kyiv. In the modern world, in legal doctrine and practice, the capital is understood as the capital of the country, which at the legislative level received this status and, accordingly, is the administrative and political center of the state, which houses the main state bodies and diplomatic missions of other states. It is the identification of the boundaries of the relationship between the competencies of state administrations and local self-government, in practice, often raises questions about their delimitation and ways of regulatory solution. Peculiarities of local self-government in Kyiv city districts are defined in the provisions of the Law on the Capital, which reveal the norms of the Constitution in these legal relations, according to which the issue of organizing district management in cities belongs to city councils. Likewise, it is unregulated by law to lose the particularity of the legal status of the territory of the city. It should be emphasized that the subject of administrative-legal relations is not a certain administrative-territorial entity, but the social group is designated - the territorial community of the city of Kiev, kiyani. Thus, the provisions on the city of Kyiv partially ignore the potential of the territorial community.

Positions of the non-Arctic States on the legal regime of the Arctic Ocean

2018 ◽  
pp. 124-135 ◽  
Author(s):  
A. Vylegzhanin ◽  
◽  
V. Salygin ◽  
I. Dudykina ◽  
E. Kienko ◽  
...  
Keyword(s):  
Arctic Ocean ◽  
The Arctic ◽  
Legal Regime ◽  
The Arctic Ocean

Alternativas farmacéuticas: ¿pueden ser intercambiables?

2020 ◽  
Vol 2 (2) ◽  
pp. 38-42
Author(s):  
Miriam del Carmen Carrasco-Portugal ◽  
Francisco Javier Flores-Murrieta
Keyword(s):  
Generic Substitution ◽  
In Vivo Studies ◽  
Regulatory Agencies ◽  
European Medicines Agency ◽  
Reference Formulation ◽  
Active Moiety ◽  
Significant Difference ◽  
Pharmaceutical Form ◽  
Extent Of Absorption

Pharmaceutical alternatives are products with the same active moiety, but different salt, ester or pharmaceutical form. Regulatory agencies have different criteria for this kind of drug. The European Medicines Agency (EMA) accepts the generic substitution using these alternatives, whereas the Food and Drug Administration (FDA) only authorizes generic substitution of pharmaceutical equivalents. The objective of this paper is to describe some relevant aspects that should be considered before deciding on making a generic substitution with pharmaceutical alternatives. It is important to note that a pharmaceutical alternative must show no significant difference in the rate and extent of absorption (bioequivalence) in a well-conducted in vivo study when compared with the reference formulation. Current Mexican regulations state that generic substitution is possible using pharmaceutical alternatives when bioequivalence is demonstrated in in vivo studies conducted under the NOM-177-SSA1-2013 criteria. In conclusion, generic substitution with pharmaceutical alternatives is possible if these products demonstrate in vivo bioequivalence when compared with the reference product.

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