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The process of reviewing the European pharmaceutical legislation resulted in a codex, which contains two new instruments related to marketing authorisation of biological medicines: Plasma Master File (PMF) and Vaccine Antigen Master File (VAMF). In the manufacture of plasma derivatives (e. g. coagulation factors, albumin, immunoglobulins), usually the same starting material, i. e. a plasma pool, is used for several products. In the case of vaccines, the same active substance, i.e. vaccine antigen, may be included in several combination vaccine products. The intention behind the introduction of PMF and VAMF was to avoid unnecessary and redundant documentation, and to improve and harmonise assessment by means of procedures for certification of master files on the community level.

The article discusses a European Commission position paper published in February 2007 on scientific information in the digital age. The paper calls for better access to online scientific information in digital form and preservation of research results for future generations. The European Union supports the Open Access initiative and has budgeted € 25 million for research into the maintenance of digital contents.

The article discusses the provisions of a strategy paper commissioned by the European State Secretaries on April 14, 1989 and its focus on the problem of "mittelbare Disckriminierung" (indirect discrimination) and the principle of territoriality in social policy. In particular the topic of the influence European policy on German social policy is investigated for its political and financial implications.

Copyright of KritV, CritQ, RCrit. Kritische Vierteljahresschrift für Gesetzgebung und Rechtswissenschaft / Critical Quarterly for Legislation & Law / Revue critique trimestrielle de jurisprudence et de législation is the property of Nomos Verlagsgesellschaft mbH & Co. KG and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of ORDO: Jahrbuch für die Ordnung von Wirtschaft und Gesellschaft is the property of De Gruyter and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Zeitschrift fur Wirtschaftspolitik is the property of De Gruyter and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The PlaCE project aims at investigating technologies and solutions for the ecosustainable reuse of offshore platforms at the end of their production phase. In this context, robotic mobile solutions that allow in a versatile way to monitor the activities by acquiring environmental data and parameters in the entire area of interest have been explored. This paper presents a solution achieved through the development of the proof-of-concept of a robotic technology concerning a hybrid Autonomous / Remotely Piloted Aircraft System (A/RPAS), hereinafter referred to as Amphibious Drone, operating in complete autonomy and having the platform as an operational base. The Amphibious Drone is developed to cover the entire area of interest surrounding the platform being converted, with the ability to carry the measuring instruments and probes in aerial overflight for monitoring the sea surface and the surface structures as well as ditching to deploy a sensors-equipped probe for measuring underwater parameters along the water column. A wide range of probes and instruments have been integrated into the system such as multispectral camera, Photosynthetically Active Radiation (PAR) probes, Conductivity-Temperature-Depth (CTD) probes, etc. for the analysis of oceanographic and biological parameters of the marine ecosystem. The management of the Amphibious Drone, as regards the shelter between missions, battery recharging, data exchange, required reconfigurations and missions scheduling is carried out from a specially designed Docking Station. The PlaCE project is co-funded by the European Union within the projects "PON Ricerca e Innovazione 2014-2020". [ABSTRACT FROM AUTHOR]

Copyright of KritV, CritQ, RCrit. Kritische Vierteljahresschrift für Gesetzgebung und Rechtswissenschaft / Critical Quarterly for Legislation & Law / Revue critique trimestrielle de jurisprudence et de législation is the property of Nomos Verlagsgesellschaft mbH & Co. KG and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Special economic zones have long been argued to promote social and economic “development” and, more recently, to “activate” and integrate refugees. In this paper, we critically examine a supposedly prime example of the nexus between “development” and “refugee integration”: the Jordan Compact, a bilateral agreement between Jordan and the European Union adopted in 2016. In the article, we draw on world-systems approaches, on the one hand, while emphasising the necessity of their spatial-theoretical updating, on the other hand. By presenting the empirical example of the garment industry’s global production networks and the working and living conditions in the Jordanian special economic zones, we highlight that uneven development glocally constituted the multi-scalar socio-spatial fragmentation of labour and the reproduction of conditions, constitutive of neoliberal globalisation. [ABSTRACT FROM AUTHOR]

This paper asks whether the traditional European nation-state has eroded or transformed as a consequence of European integration. In order to answer this research question, several aspects are being analyzed. Since more and more decisions that are taken on the supranational political level have a direct impact on the daily lives of the so-called European citizens, the author argues that Europeanization represents a tremendous challenge for traditional nation-states. The European Union evolved to a unique supranational entity that takes on many state-like functions, although it is not (yet) a state. Nevertheless, European nation-states still remain at the heart of the political decision-making processes, because the European Union is a) mainly founded by nation-states, b) there is no European army and c) the European Union is unlike nation-states unable to tax its citizens. The paper concludes that there has rather been a transformation and not an erosion of the traditional European states. Statehood is now being shared between nation-states and the supranational European level. [ABSTRACT FROM AUTHOR]

The topic of digital transformation in our country has had a major impact on both society and the economy, with all its sectors being a paradigm for them. At the same time, the digital transformation of our country is one of the most important components of the National Recovery and Resilience Plans. This fact is also due to the position on which Romania is ranked within the hierarchy based on the Digital Economy and Society Index (European Commission, 2021. Referring to it, we observe a less favorable position of our country, ranking 27th out of the 27 member states of the European Union (European Commision, 2022) with an annual growth lower than the other countries and less convergent. Thus, in order for the European Union to fulfill its objective of the digital decade, Romania must create the ideal context for a significant change in the pace of training and acquisition of basic digital skills. We therefore observe how the introduction of digital technology has corroborated the way tourism companies assert themselves. Digital technology has become an invaluable business tool widely used in the travel and tourism sector Lee & Wicks (2010). We are talking about an economic-social phenomenon reflected in one of the basic sectors of many nations, whose expansion was particularly pronounced in 2019, 2020, as a result of the collapse left in this industry by the COVID19 pandemic. Digital transformation represents a substantial challenge for both organizations and national economies, being a topic that has sparked interest for academic studies and researchers. Starting from this necessity and carrying out a review of the existing works on the market, it was found that there are no studies related to the digitalization level of tourism businesses in Romania. Thus, the present work evaluates, measures and quantifies the level of digitization of small and medium-sized enterprises in the field of tourism, with Băile Felix resort in Bihor county as a working sample. [ABSTRACT FROM AUTHOR]

Copyright of Zeitschrift für Soziologie is the property of De Gruyter and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

On 1 January 1994 - almost 30 years ago - the Agreement on the European Economic Area (EEA) entered into force. Its purpose is to create a homogeneous and dynamic economic area between the Member States of the European Union (EU) and the members of the European Free Trade Association (EFTA) Iceland, Liechtenstein, and Norway. Today, the EEA Agreement is still the most far-reaching and institutionalised agreement between the EU and non-member states and can therefore be seen as a benchmark for a privileged partnership with the EU. This paper describes how the institutional rules of the EEA and the level of integration of the EEA/EFTA states have changed over time. It shows that developments towards both more integration and more differentiation can be observed in the EEA. It thus addresses various institutional challenges in the relationship between the EU and associated states. [ABSTRACT FROM AUTHOR]

Recent political science research has shown the increasing differentiation of the European Union (EU) and it has worked out the associated opportunities and risks for effective and legitimate politics in the EU. This raises the question to what extent politicians in the member states pay attention to differentiated integration. Based on an analysis of official government documents and parliamentary minutes from 25 member states, this article shows that this form of integration was rarely politicized in national politics between 2004 and 2020. In national parliaments, it was mainly discussed around EU-treaty changes (around 2008), the euro crisis (around 2012) or during the debate on the future of Europe (around 2017). The final part of the paper shows that differentiated integration is discussed more frequently and more positively in French politics than in German politics. [ABSTRACT FROM AUTHOR]

Trade is at the centre of Europe’s model of economic prosperity and competitiveness. As stated in the new Trade Policy Strategy set out by the European Commission (2021), the trade policy has a key role to play in the recovery from the COVID-19 pandemic. Meanwhile, this role was emphasised even better by the effects derived from the war in Ukraine. As the pandemic hit in 2020, the growth drivers of the EU’s economy relented, among which the external trade, putting million jobs at risk and leading to rise in unemployment and to depression of economic activity, while many companies had to close down. Competitiveness is a term which increased in significance in the last few decades. Trade competitiveness and, especially, export competitiveness is one of the most valuable variables a country must improve in order to increase its overall competitive position among nations and also the welfare of its citizens. The export statistics of many EU’s economies changed since the COVID-19 crisis and later, the war stroke. The research questions this paper addresses are: what is the extent of these changes in which sectors? Have they come to an end or the process of recovery has already started within the EU? What effects has the war in Ukraine onto the EU exports competitiveness? Are there any chances for the EU to maintain its exports competitiveness after these crises? What is to be one and what measures to be taken to recover? After introductory theoretical remarks and a brief literature review followed by a survey of various techniques to measure export competitiveness, the paper shifts its focus on statistical data and analyse how much damage has the pandemic and nowadays, the war caused to the EU’s export competitiveness, and which EU Member States were the most affected, based on statistical data analysis and other various indicators.

After the Second World War, Europe faced the question of what kind of political future to choose. Exactly five years after the end of the war, Robert Schuman proposed a declaration that opened the way for European integration: the European Community, later renamed the European Union, was created. This paper presents the circumstances of the creation of the Schuman Declaration and the vision that led him and other founding fathers to the realization of a completely new way of connecting European states. Three of the founding fathers of the European Community, Robert Schuman, Konrad Adenauer and Alcide de Gasperi, were devout Christians. In the paper, we show their understanding of the relationship between democracy, European integration and Christianity. According to Schuman, European institutions need a spirit, Europe needs a soul. What does this mean and how is it that only a few of the later European political leaders paid attention to this aspect? The last part of the article regards the efforts of Pope Francis to make Europe a place of peace and economic development, and furthermore, to strengthen the essence of its identity, encourage creativity and recognize its responsibility to its own nations and citizens, as well as responsibility to others in a globally connected world. The series of speeches by Pope Francis on Europe, including in the European Parliament, shows his closeness to the vision of Schuman and the founding fathers of the European Union on the one hand, and on the other hand, he directs attention to the present and the future.

Copyright of Zeitschrift für Pädagogik is the property of Julius Beltz GmbH & Co. KG Beltz Juventa and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Der Moderne Staat is the property of Verlag Barbara Budrich GmbH and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of GAIA: Ecological Perspectives for Science & Society is the property of Oekom Verlag GmbH and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The European Union macro-regional strategies represent a policy framework that aims to enable EU Member States and third countries sharing common interests to better coordinate their potentials in order to make the best possible use of available opportunities. This paper looks into the specificities of four EU macro-regional strategies covering 19 European Union Member States and nine non-EU countries. Given the challenging situation caused by the COVID-19 pandemic, it also considers the future perspectives of EU macro-regional strategies as well as their adaptability to new circumstances. More specifically, it focuses on intergovernmental initiatives and their implementation, underlying the importance of the application of the principle of subsidiarity. In addition, the aim of the paper is to provide a critical overview of the subject by highlighting two pivotal elements. First, it assesses whether the EU macro-regional strategies could be genuinely successful, given the fact that they do not have their separate allocation but use the existing funding instead. Second, it explores the ability of the EU macro-regional strategies to bridge wider EU-level policies on the one hand and local policies on the other. Finally, the idea of the paper is to offer an overview of the state of affairs when macro-regions are concerned.

This paper deals with civil aviation, which is highly international. Therefore, harmonization of regulation in this area on a global scale is inevitable, which means that aviation law requires an integrated approach. However, only slightly over half of the countries fully comply with the standards issued by the International Civil Aviation Organization for basic international aviation regulation, which poses a serious threat to aviation safety and security. In this respect, the integrative nature of the European Union offers us to look at the Union’s activities in the context of aviation regulation. The aim of this paper is to investigate the impact that the harmonization of civil aviation safety and security regulations in the EU has on the development of global aviation regulations. The paper provides a more detailed analysis of the beginning and further integration of the EU’s internal aviation market and the formation of the Union’s external policy in this area, which has played a key role in harmonizing the legal framework for aviation safety and security. The study revealed the preconditions for the harmonization of aviation safety and security rules in the European Union highlighted the essential features of this process and its impact on the convergence of aviation regulation on a wider scale (beyond the EU).

This article discusses the question of how the EU member states deal with the prosecution of Foreign Terrorist Fighters (FTF). Since the rise of the so-called Islamic State, thousands of EU nationals have travelled or attempted to travel in conflict zones in Iraq and Syria to join Daesh or other terrorist groups. Many have already returned to their home countries and several have been prosecuted. However, most member states are reluctant to actively repatriate the thousands of FTF who are still in the conflict region. Some European countries would suggest the establishment of an international tribunal or a mixed national/international tribunal in Syria or Iraq. This paper deals with pros and cons of the different options available to prosecute FTF outside their home countries. [ABSTRACT FROM AUTHOR]

Copyright of Tematy & Konteksty is the property of University of Rzeszow and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

In this paper, I will discuss Bulgarian and Romanian balkanisms in legal terminology in the context of the European Union. To begin, I will give a short overview of the importance of balkanisms and I will discuss Bulgarian and Romanian in the context of Balkan languages in the European Union. Following Schaller (2012, 2018), I will comment on different features of Balkan languages. As Lyutakova (2017, 2018) puts it, the recent development is characterized by significant political, social and economic changes, which are taking place in both Bulgaria and Romania. This development is important in shaping both Bulgarian and Romanian languages, and is therefore important in shaping legal language in both countries. Thus, I will characterize legal language as a technical language, and present its particularities. I will highlight (un)intelligibility, (in)comparability, and (un)translatability as main features of legal documents. Then, I will analyze examples from the Consolidated Version of the Treaty on the Functioning of the European Union. The main scope is to discuss balkanisms in this Treaty, and to regard balkanisms in the European legal language as EUbalkanisms. [ABSTRACT FROM AUTHOR]

Copyright of Zeitschrift für Vergleichende Politikwissenschaft is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The European Medicines Agency (EMA) is developing a web-based EU portal with a database "at Union level as a single entry point for the submission of data and information relating to clinical trials in accordance with" the new EU regulation No. 536/2014. The specifications are mostly published, but some documents are still missing. Because the project is integrated and has dependencies on other projects, this could result in other specification upgrades. The IT solution is under ongoing development until project completion in quarter III of 2019. The EU Portal and the database will be audited. If the audit is successful, the new regulation will come into force in October 2018. The use of the EU Portal will then be mandatory with some transition rules. The software development of the portal is restricted to the regulation and the derived requirements. It is not possible to implement any national requirements. We describe in this paper the current key functionalities of the portal and try to derive requirements for a national IT system.On 16.06.2017 the EMA Management Board announced that the development of the new portal has been delayed and it is foreseen that the new regulation can come into effect in 2019 at the earliest. The press release can be found here: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/06/news_detail_002764.jsp%26mid=WC0b01ac058004d5c1 (accessed: 12.07.2017).

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The application of modern technologies, with the multimedia distribution of media content through the online platform, in the context of the Bosnia and Herzegovina path of accession to the European Union and NATO, inevitably explores the role of modern media in the political education of citizens as active participants in politics. Bearing in mind the increasing number of Internet users in Bosnia and Herzegovina, as well as the audience’s primary orientation towards online media distribution platforms, this paper deals with the perception of Euro-Atlantic integrations in online media in Bosnia and Herzegovina. It is an analysis of the sources and forms used for informing citizens on the political processes that represent the future political path of Bosnia and Herzegovina. The focus of this paper is primarily the total number of published content about Euro-Atlantic integrations in online media, intending to discuss the period of the internal crisis of the political system at the time of the survey (April/May 2019), and that in the same period there was not formed government after the last general elections, which significantly redefines or aggravates the position of Bosnia and Herzegovina to implement the reforms necessary for joining the European Union and NATO. Conclusion of the research, bearing in mind the results and international treatment of Bosnia and Herzegovina as a country in transition is a limited communication framework of online media, which on the one hand, sees a citizen as a user of information, but does not intervene in the process of political education or orientation of citizens in the field of political action or creating active public opinion.

European Governance is an important approach to the study of European Integration and the European Union. However, it falls short of offering a sound metaphor that gives the new polity a name for its political order. The approach is well suited for analyzing the European Union's political system, but it cannot describe the political community in the way that the term 'nation states' describes the member states. An ongoing debate discusses terms like 'empire' to offer an alternative description. The paper enters this debate by criticizing these metaphors and offering the figure of pilgrimage instead. The contribution is embedded in the debate of social science and cultural science approaches in European studies and the question of legitimacy and identity. Methodologically the paper draws heavily from Aleida Assmann's concept of memory and Habermas' concept of a postsecular society which is used to recall historical and religious terms to bring about new ways of offering meaning to the developing political community of Europeans. [ABSTRACT FROM AUTHOR]

The paper looks at the European Union's involvement in the Western Balkans and points out some of the imminent problems when dealing with a region with disputed territorial issues and trying to support reform processes in countries with divided societies. Although the Western Balkans and the South Caucasus can hardly be compared with each other, at least when it comes to the engagement of the EU, it can be assumed that similar strategies will be pursued and policy instruments deployed. Therefore, it is useful to identify some lessons taken from the Western Balkans that are applicable for the South Caucasus. The paper deals 1) with the controversies on Kosovo's independence and the problems of the EU to deal with its consequences, and 2) with the EU's efforts to support the constitutional and police reform processes in Bosnia and Herzegovina in order to illustrate the challenges the EU faces when it has to deal with a "divided" country. In the second part, the paper looks at the EU's engagement in the South Caucasus, where the EU might play a similar role in the future as it does in the Balkans. The investigations demonstrate that European foreign policy has often lacked consistent strategies towards the Western Balkans, which prevented the EU from achieving "satisfactory" outcomes in its neighbourhood. [ABSTRACT FROM AUTHOR]

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How can European integration be made compatible with maintaining decentrality and variety within Europe? This paper argues that both aims can only be achieved simultaneously by applying the concept of competitive federalism to the EU. After showing that interjurisdictional competition is a logical consequence of the removal of mobility barriers within the EU, basic tenets of the theory of a multi–level system of competing jurisdictions are presented. As a consequence, the EU has to provide an institutional framework for the proper working of interjurisdictional competition. In the second half of the paper, consequences of the application of competitive federalism to the EU are examined, e.g. the possibility that also many public goods and regulations might be provided competitively by lower–level jurisdictions. Finally, the problem of regulatory competition vs. harmonization is discussed, leading on to exploring advantages and problems of decentralised legal systems (legal federalism). [ABSTRACT FROM AUTHOR]

This paper analyses the importance of stakeholders’ actions on the effectiveness of the European competition policy. The national governments, European decision-makers, advisory institutions and civil society take the form of interest groups that have expectations, invest resources and advocate on competition policy. The paper follows the process of adopting a specific strategy (insider/outsider), depending on the type of the interest group and it divides the organizations in those with ”strong ties” and ”weak ties”. The goal of each interest group is to arrive at the main European competition law authority, the European Commission. As it has the full power to investigate cases and manage the process, as well as implementing decisions based on proposals, influencing this institution represents a real challenge for the stakeholders. In this process, some relevant aspects are the perfect timing for lobby, the dimension of the lobbying coalitions and also the capacity of attracting supporters of the cause. Interest groups do not have equal amount of influence power nor the resources but they do change the policy, according to their particular interests, by choosing the right strategies, partnerships and means to influence the decision-makers.

Investment in research and development (R&D) creates preconditions for the implementation of more advanced and better technologies. It enables the introduction of new products or production processes which can result in higher earnings and potential economic growth. Even though research and development is a catalyst for the genesis of aggregate economic activity, its importance is not widely researched at regional levels. The European Union has defined strategies which view innovation as an essential element in stimulating growth and job creation. The aim of this paper is to establish and measure the impact of investment in R&D on economic growth of port regions. The data used in this research were panel data of the European Union’s port regions for NUTS 2 classification for the period from 2005 to 2015. The results of the two-step Generalized Method of Moments (GMM) indicate that investment in R&D has a significant impact on the economic growth of the port regions in European Union. However, in order for innovations to be accepted and implemented, it is also necessary for regions to have specific economic structure which was further analyzed in this paper. Regions with high innovation capacity create greater economic benefits and are considered to grow faster than other regions.

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