scholarly journals Good Manufacturing Practice: The Role of Local Manufacturers and Competent Authorities

2010 ◽  
Vol 61 (4) ◽  
pp. 425-436 ◽  
Author(s):  
Siniša Tomić ◽  
Anita Sučić ◽  
Adrijana Martinac
Keyword(s):  
Regulatory Network ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Product ◽  
Vital Role ◽  
Medicinal Products ◽  
Eu Member States ◽  
Eu Membership ◽  
European Regulatory ◽  
The Eu

Good Manufacturing Practice: The Role of Local Manufacturers and Competent AuthoritiesIn every country, a manufacturer of medicinal products for either human or veterinary use is required to operate in compliance with local legislation. In all EU Member States, legislation is approximated to the effect that they are committed to abide by the same standards. The candidate countries transpose the acquis into their national legislation, including the good manufacturing practice (GMP). Consequently, the local manufacturer is required to strictly comply with GMP and the manufacturing licence, including for medicinal products exclusively intended for export. A vital role is also played by national regulatory authorities, in Croatia by the Agency for Medicinal Products and Medical Devices which issues the manufacturing licence, GMP certificate, and the Certificate of a Pharmaceutical Product (CPP) and conducts laboratory control of products. GMP inspection is carried out by the Pharmaceutical Inspectorate with the Ministry of Health and Social Welfare. Both authorities are responsible only for human medicines. There are legislative issues not yet harmonised with the acquis, but as a country aspiring for the EU membership, Croatia is expected to demonstrate that its industry and competent authorities are able to conform to current requirements and thus fully adhere to the integrated European regulatory network. Hence the importance of strengthening the institutional capacity of the competent authorities, as insufficient resources may have a direct bearing on patients by limiting their access to affordable treatment.

scholarly journals Inequalities in the European Union—A Partial Order Analysis of the Main Indicators

2021 ◽  
Vol 13 (11) ◽  
pp. 6278
Author(s):  
Lars Carlsen ◽  
Rainer Bruggemann
Keyword(s):  
Indicator System ◽  
Partial Ordering ◽  
Disposable Income ◽  
The European Union ◽  
Member States ◽  
Eu Member States ◽  
Per Capita ◽  
Educational Aspect ◽  
The Eu

The inequality within the 27 European member states has been studied. Six indicators proclaimed by Eurostat to be the main indicators charactere the countries: (i) the relative median at-risk-of-poverty gap, (ii) the income distribution, (iii) the income share of the bottom 40% of the population, (iv) the purchasing power adjusted GDP per capita, (v) the adjusted gross disposable income of households per capita and (vi) the asylum applications by state of procedure. The resulting multi-indicator system was analyzed applying partial ordering methodology, i.e., including all indicators simultaneously without any pretreatment. The degree of inequality was studied for the years 2010, 2015 and 2019. The EU member states were partially ordered and ranked. For all three years Luxembourg, The Netherlands, Austria, and Finland are found to be highly ranked, i.e., having rather low inequality. Bulgaria and Romania are, on the other hand, for all three years ranked low, with the highest degree of inequality. Excluding the asylum indicator, the risk-poverty-gap and the adjusted gross disposable income were found as the most important indicators. If, however, the asylum application is included, this indicator turns out as the most important for the mutual ranking of the countries. A set of additional indicators was studied disclosing the educational aspect as of major importance to achieve equality. Special partial ordering tools were applied to study the role of the single indicators, e.g., in relation to elucidate the incomparability of some countries to all other countries within the union.

International Aspects of Investment Liberalization in the PRC: A Case of EU-China Cooperation

2021 ◽  
Vol 13 (3) ◽  
pp. 190-224
Author(s):  
D. A. Potapov
Keyword(s):  
Foreign Investment ◽  
World Order ◽  
Special Focus ◽  
The European Union ◽  
Human Right ◽  
Foreign Investments ◽  
Eu Member States ◽  
International Aspects ◽  
The Eu

The paper examines the role of investment cooperation and national foreign investment regime as a means to promote China’s economic and political interests and to respond to new global challenges that the country faces nowadays. To this end, the author examines the main stages of China’s liberalization of the legal regime for foreign investment from the end of the 1970s with a special focus on a new foreign investment law. In doing so the author attempts to link the evolution of investment regulation in the PRC with the dynamics of international relations development and the changing role of China as a regional and global actor. The author emphasizes that a trend towards the emergence of a polycentric world order not only provokes the rise of international tensions but also provides new incentives to promote dialogue and enhance cooperation between states and non-governmental actors, particularly by encouraging foreign investments. At the same time, there is a growing need to improve regulatory mechanisms for direct foreign investments. All these contradictory trends have directly affected China’s foreign investment regime reform. In this context the investment cooperation between the PRC and the European Union is of particular importance. The EU possesses a set of innovative technological solutions and competencies that are of particular interest to the Chinese leaders in the context of their efforts to modernize the country’s economy. The paper examines the volume, dynamics and key directions of investment flows between China and the EU member-states. The fact that after seven years of difficult negotiations, the EU and China managed to develop a special bilateral regulatory mechanism — EU-China Comprehensive Agreement on Investment — underscores again the importance of this cooperation for both parties. Even though the EU has suspended the ratification of this deal on the pretext of human right violations in the Xinjiang Uygur Autonomous Region, the author concludes, that in the future this agreement will come into force, since the very logic of the emerging polycentric world order urges for deeper cooperation between the EU and China. In this context, the investment regulation appears not only as a means to protect the Chinese economic interests, but also as an instrument to strengthen China’s international positions in the changing global context.

Turkey and Europe: The Role of Migration

2013 ◽  
Vol 21 (3) ◽  
pp. 394-399
Author(s):  
Pieter Emmer
Keyword(s):  
European Union ◽  
Political Parties ◽  
The Netherlands ◽  
The European Union ◽  
Full Member ◽  
Turkish Immigrants ◽  
Eu Member States ◽  
The Difference ◽  
The Eu

In spite of the fact that negotiations have been going on for years, the chances that Turkey will eventually become a full member of the European Union are slim. At present, a political majority among the EU-member states headed by Germany seems to oppose Turkey entering the EU. In the Netherlands, however, most political parties are still in favour of Turkey's membership. That difference coincides with the difference in the position of Turkish immigrants in German and Dutch societies.

scholarly journals FDI determinants in Europe and Chinese influence

2021 ◽  
Vol 16 (1) ◽  
pp. 21-37
Author(s):  
Alena Dorakh
Keyword(s):  
Trade Costs ◽  
The European Union ◽  
Western Balkans ◽  
Eu Member States ◽  
Eu Membership ◽  
Vertical Fdi ◽  
Belt And Road ◽  
The Cost ◽  
The Impact ◽  
The Eu

Despite recent concerns about the increasing influence of outside investors on the European Union (EU) and Western Balkans, the developed European countries are still a dominant source of foreign direct investment (FDI) in the region, confirming the benefits of EU membership. At the same time, fast-growing connectivity and lower trade costs in accession and neighboring countries determine the FDI growth from China, particularly via the Belt and Road Initiative (BRI). By applying panel data over 2000-2019 for 34 countries, which form 89% of all European FDI, we first examine FDI patterns around Europe, compare the EU, NMS, and Western Balkans; verify the importance of EU membership for FDI, caused reducing trade costs and improving connectivity. Thus, the new EU member states (NMS) and Western Balkans appear both as a home country and as a pre- entry destination to the EU. Then, we calculate trade costs indices for each selected country and partners over time and find that Europe and China are closely interconnected through trade and FDI. It means that stronger ties with China can be realized for the sample countries at the cost of easing relations with the EU. Finally, incorporating trade costs indices into the FDI model; we evaluate the impact of connectivity on FDI and estimate how BRI affected FDI in Europe. Additionally, we validate that the old framework of horizontal and vertical FDI not representative well and even new complex vertical or export-oriented FDI strategies are shifting today.

European Union Rights and Values in Human Health

2019 ◽  
pp. 16-51
Author(s):  
Anniek de Ruijter
Keyword(s):  
Public Health ◽  
European Union ◽  
National Policy ◽  
Fundamental Rights ◽  
The European Union ◽  
Member States ◽  
Eu Member States ◽  
Eu Fundamental Rights ◽  
The Eu

This book looks at the impact of the expanding power of the EU in terms of fundamental rights and values. The current chapter lays down the framework for this analysis. Law did not always have a central role to play in the context of medicine and health. The role of law grew after the Second Word War and the Nuremberg Doctors Trials (1947), in which preventing the repetition of atrocities that were committed in the name of medicine became a guidepost for future law regarding patients’ rights and bioethics. In the period after the War, across the EU Member States, health law developed as a legal discipline in which a balance was struck in medicine and public health between law, bioethics, and fundamental rights. The role of EU fundamental rights protections in the context of public health and health care developed in relation with the growth of multilevel governance and litigation (national, international, Council of Europe, and European Union). For the analysis here, this chapter develops an EU rights and values framework that goes beyond the strictly legal and allows for a ‘normative language’ that takes into consideration fundamental rights as an expression of important shared values in the context of the European Union. The perspective of EU fundamental rights and values can demonstrate possible tensions caused by EU health policy: implications in terms of fundamental rights can show how highly sensitive national policy issues may be affected by the Member States’ participation in EU policymaking activities.

Labour Immigration Policy in the European Union: How to Overcome the Tension between Further Europeanisation and the Protection of National Interests?

2020 ◽  
Vol 22 (2) ◽  
pp. 198-223
Author(s):  
Jean-Baptiste Farcy
Keyword(s):  
Immigration Policy ◽  
Added Value ◽  
The European Union ◽  
National Interests ◽  
Member States ◽  
Eu Member States ◽  
Labour Immigration ◽  
Eu Directives ◽  
The Eu

Abstract This article critically assesses EU harmonisation in the field of labour immigration. It argues that EU directives are limited both in scope and intensity which explains their relatively low effectiveness and added value. Given the current political and institutional context, the article claims that a truly common labour immigration policy is unrealistic. Labour immigration remains a predominantly national prerogative and EU rules have done little to overcome normative competition between EU Member States. Looking forward, the EU should adopt complementary measures to Member States’ policies. The role of the EU in this sensitive policy area should be better defined and justified, in particular in relation to the principle of subsidiarity.

scholarly journals Integration of Transcriptomes, Small RNAs, and Degradome Sequencing to Identify Putative miRNAs and their Targets Related to Eu-Rubber Biosynthesis in Eucommia ulmoides

Genes ◽  
2019 ◽  
Vol 10 (8) ◽  
pp. 623
Author(s):  
Jing Ye ◽  
Wenjing Han ◽  
Ruisheng Fan ◽  
Minhao Liu ◽  
Long Li ◽  
...  
Keyword(s):  
Regulatory Network ◽  
Small Rnas ◽  
High Throughput Sequencing ◽  
Expression Profiles ◽  
Vital Role ◽  
Eucommia Ulmoides ◽  
Messenger Rnas ◽  
Rubber Biosynthesis ◽  
Degradome Sequencing ◽  
The Eu

Eucommia ulmoides has attracted much attention as a valuable natural rubber (Eu-rubber) production tree. As a strategic material, Eu-rubber plays a vital role in general and defence industries. However, the study of Eu-rubber biosynthesis at a molecular level is scarce, and the regulatory network between microRNAs (miRNAs) and messenger RNAs (mRNAs) in Eu-rubber biosynthesis has not been assessed. In this study, we comprehensively analyzed the transcriptomes, small RNAs (sRNAs) and degradome to reveal the regulatory network of Eu-rubber biosynthesis in E. ulmoides. A total of 82,065 unigenes and 221 miRNAs were identified using high-throughput sequencing; 20,815 targets were predicted using psRNATarget software. Of these targets, 779 miRNA-target pairs were identified via degradome sequencing. Thirty-one miRNAs were differentially expressed; 22 targets of 34 miRNAs were annotated in the terpenoid backbone biosynthesis pathway (ko00900) based on the Kyoto Encyclopedia of Genes and Genomes (KEGG). These miRNAs were putatively related to Eu-rubber biosynthesis. A regulatory network was constructed according to the expression profiles of miRNAs and their targets. These results provide a comprehensive analysis of transcriptomics, sRNAs and degradome to reveal the Eu-rubber accumulation, and provide new insights into genetic engineering techniques which may improve the content of Eu-rubber in E. ulmoides.

scholarly journals Analysing the Power of the European Union’s Diplomatic Service: Do the eu Member States Control the European External Action Service?

2016 ◽  
Vol 11 (1) ◽  
pp. 26-48 ◽  
Author(s):  
Hrant Kostanyan
Keyword(s):  
External Action ◽  
Principal Agent ◽  
The European Union ◽  
Member States ◽  
Agent Model ◽  
Eu Member States ◽  
Principal Agent Model ◽  
European Union Member States ◽  
The Eu

By applying the rational choice principal–agent model, this article examines the European Union member states’ principal control of the European External Action Service (eeas) agent. More specifically, the article applies mechanisms of agency monitoring, control and sanctions that are inherent in the principal–agent model to analyse the establishment and functioning of the eeas. These mechanisms aim to ensure the eeas’s compliance with its mandate, thereby curtailing its ability to pursue own objectives that are independent from the principal. The findings reveal that the eeas is tightly controlled by the eu member states. Moreover the European Commission has tools to exercise horizontal checks vis-à-vis the eeas. The application of the principal–agent model to control the eeas is not without its limits. The model falls short of conceptualizing the role of the European Parliament, which remains an outlier to this model.

scholarly journals The role of national intellectual capital in the digital transformation of EU countries. Another digital divide?

2020 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Jadranka Švarc ◽  
Jasminka Lažnjak ◽  
Marina Dabić
Keyword(s):  
Human Capital ◽  
Digital Divide ◽  
Conceptual Model ◽  
Intellectual Capital ◽  
Digital Transformation ◽  
Member States ◽  
Content Type ◽  
Eu Member States ◽  
The Eu

PurposeThis study, an exploratory one, aims to empirically investigate the association of national intellectual capital (NIC) with the national digital transformation readiness of the European Union's (EU’s) member states. Apart from building the conceptual model of NIC, this study explores the role of NIC dimensions in the digital divide between European countries.Design/methodology/approachBased on the literature review and the available EU statistical data and indexes, the theoretical framework and conceptual model for NIC were developed. The model explores the relation of NIC and its dimensions (human, social, structural, relational and renewable/development capital) on the readiness of European countries for digital transformation and the digital divide. Significant differences between EU countries in NIC and digital readiness were tested. Multiple linear regression was used to explore the association of each NIC dimension with digital transformation and digital divide within the EU.FindingsDespite a positive association between all dimensions of NIC and digital transformation readiness, the proposed model of NIC was not confirmed in full. Regression analysis proved social capital and working skills, a dimension of human capital, to be the predictors of digital transformation at a national level, able to detect certain elements of digital divide between EU member states. Structural capital, knowledge and education, as dimensions of human capital, were predictors of the digital divide in terms of the integration of digital media in companies.Research limitations/implicationsThis research has a limited propensity for generalisation due to the lack of common measurement models in the field of NIC exploration.Practical implicationsThis research offers policy makers an indication of the relationships between NIC and digital transformation, pointing out which dimensions of NIC should be strengthened to allow the EU to meet the challenges of digital economy and to overcome the digital divide between EU member states.Social implicationsThe use of digital technologies is key in creating active and informed citizens in the public sphere and productive companies and economic growth in the business sphere.Originality/valueThis study provides an original theoretical framework and conceptual model through which to analyse the relationship between NIC and digital transformation, which has thus far not been explored at the level of the EU. This research makes an original contribution to the empirical exploration of NIC and produces new insights in the fields of digital transformation and intellectual capital.

scholarly journals The geopolitics of future tourism development in an expanding EU

2016 ◽  
Vol 2 (2) ◽  
pp. 155-164
Author(s):  
Peter Antony Singleton
Keyword(s):  
Tourism Development ◽  
Political Stability ◽  
Large Degree ◽  
Content Type ◽  
Eu Member States ◽  
Beneficial Effects ◽  
Eu Membership ◽  
Eastern European Countries ◽  
Tourism Flows ◽  
The Eu

Purpose The purpose of this paper is to assert the link between the process of EU accession, the consolidation of democratic processes and the improvement of economic and tourism infrastructure to incoming tourism flows. Design/methodology/approach The methodology of this paper involves explanation of an analysis exploring links between governmental systems and the order necessary for economic development and tourism. The argument is supported by the recent history of tourism development in three countries, two within the EU and one outside. Findings Accession to the EU (especially in the case of Eastern European countries) constitutes a way to emulate the democratic freedoms and greater economic prosperity of existing EU member states. Tourism is one of the areas of economy that benefits from the stability and growth EU membership can bring. Accession to the EU has had beneficial effects for acceding in terms of political stability and tourism growth. Originality/value The opportunities that EU membership can bring to tourism development for example (also strategies to exploit these opportunities) depend to a large degree on the international relations between the EU and its rivals. The extent to which tourism demands ebb and flow is governed by a range of factors, but the issues of conflict and security are game breakers. Understanding the factors and trends involved in the peaceful resolution of conflict (democratic model) or use of force to resolve conflict (military model) is key in the analysis of future tourism opportunities.

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