More medicines for children: impact of the EU paediatric regulation

2018 ◽  
Vol 103 (6) ◽  
pp. 557-564 ◽  
Author(s):  
Sofia Nordenmalm ◽  
Paolo Tomasi ◽  
Chrissi Pallidis
Keyword(s):  
Product Information ◽  
Positive Impact ◽  
The European Union ◽  
Medicinal Products ◽  
Paediatric Regulation ◽  
Line Extension ◽  
Pharmaceutical Form ◽  
Paediatric Drug Development ◽  
Medicines For Children ◽  
The Eu

IntroductionThis paper focuses on the authorisation of new medicines, new indications and new pharmaceutical forms or strengths for use in children and also on the availability of paediatric information in the product information of centrally authorised medicinal products following the enforcement of the Paediatric Regulation on 26 January 2007.ObjectivesTo investigate whether the Paediatric Regulation has led to more medicines available for children in the European Union (EU) and if more information on paediatric use is now available in the product information of medicines authorised via the centralised procedure.Materials and methodsWe retrospectively analysed the centrally authorised medicinal products in the EU that had an approval for an initial marketing authorisation, a type II variation, or a line extension during the years 2004–2006 and 2012–2014. Medicinal products not subjected to the obligations of the Paediatric Regulation were excluded.ResultsIn 2004–2006, 20 new medicines and 10 new indications were centrally authorised for paediatric use compared with 26 new medicines and 37 new indications in 2012–2014. The number of medicines with a new pharmaceutical form or strength for use in children was eight in 2004–2006 and seven in 2012–2014. There was a huge increase in the number of products with changes of paediatric relevance in the summary of product characteristics in 2012–2014 compared with 2004–2006.ConclusionsThe entry into force of the Paediatric Regulation has had a positive impact on paediatric drug development with more medicines available for children in the EU and substantially more information available for clinicians on paediatric use in the product information.

scholarly journals Reforming of legislation on the residues of veterinary medicinal products in foodstuffs of animal origin as a component of Ukraine food security

2020 ◽  
Vol 22 (100) ◽  
pp. 108-115
Author(s):  
I. Berezovska
Keyword(s):  
Food Security ◽  
Legal Regulation ◽  
Economic Security ◽  
Animal Origin ◽  
The European Union ◽  
Medicinal Products ◽  
Association Agreement ◽  
National Legislation ◽  
The Eu ◽  
Veterinary Medicinal Products

It is known that the food security of the state, aimed at providing the population with quality and healthy food, is an important component of economic security. Recent developments in the world and national security challenges posed by the Covid-19 virus pandemic necessitate a reassessment of approaches to the legal regulation of issues that significantly affect human health. Today, the reform of the relevant national legislation on FAR residues in food requires a systematic and holistic approach and the definition of its priorities in such a way as to promote food safety and the development of domestic business. The article is devoted to the analysis of the current Ukraine legislation concerning regulation of residues of veterinary medicinal products in foodstuffs of animal origin. It was shown that the formation of such legislation was due to the development of international trade, including the fulfilment of the European Union requirements for the safety of foodstuffs imported into its market. At the same time, the conclusion of the Association Agreement and the introduction of a Free trade zone with the EU was a significant impetus to the reforming of national legislation on residues. The analysis of EU regulations, which serves as a legal basis for the residues control at the EU level, was carried out. It is noted that today in the Ukrainian legislation, despite the introduction of annual national plans for state monitoring of residues of veterinary medicinal products and contaminants in live animals and unprocessed foodstuffs of animal origin, there are a number of gaps that require urgent legislative regulation. It was proved that the completion of the reform of the national legislation on residues will contribute to improving safety of domestic foodstuffs, and therefore, will have important positive consequences not only for the development of trade with the EU, but primarily for the food security of Ukraine and the protection of the health of Ukrainian citizens.

scholarly journals Macroeconomic stability and the level of competitiveness in EU member states: a comparative dynamic approach

2020 ◽  
Vol 11 (4) ◽  
pp. 657-688
Author(s):  
Elżbieta Roszko-Wójtowicz ◽  
Maria M. Grzelak
Keyword(s):  
Positive Impact ◽  
Value Added ◽  
Linear Ordering ◽  
The European Union ◽  
Member States ◽  
Eu Member States ◽  
Competitiveness Index ◽  
Polish Economy ◽  
The Eu ◽  
Diagnostic Variables

Research background: The choice of the issue of international competitive-ness of economies as the research problem addressed in this paper has been mainly dictated by the changes observed in the nature of the development of EU economies and the need to assess the competitiveness of the Polish economy. It is time to evaluate and learn from the largest enlargement in the history of the EU which took place in May 2004. An assessment of changes in the state of EU economies, including the Polish economy, is in the centre of research interest of many scientists. National competitiveness is the subject of a great deal of research and economic studies. Integration and globalisation processes in the world economy are the main reasons for the popularity of this topic. The efficient use of sources and factors determining the competitiveness of economies, sectors and enterprises is associated with prosperity over the long term. One of the methods based on the observation of selected basic indicators of economic competitiveness is the method of analysis called the macroeconomic stabilisation pentagon. The method illustrates the extent to which the government achieves five macroeconomic objectives. It is very difficult, if not impossible, to meet all these objectives at the same time. The difficulty of meeting all these goals concurrently is due to the fact that they are more or less competitive rather than complementary. The proposed assessment of competitiveness based on the developed model of macroeconomic stabilisation pentagon is a unique approach in terms of discussion of country?s competitiveness. This approach significantly distinguishes the current study in comparison with standard international reports on competitiveness such as the Global Competitiveness Index or the EU Regional Competitiveness Index. Purpose of the article: The main aim of the paper is to assess the competitiveness of EU economies in the years 2005?2018, based on a selected set of diagnostic variables referring to the concept of macroeconomic stabilisation pentagon. The paper also formulates a detailed list of four research hypotheses. Methods: In order to characterise the competitiveness of the European Union economies, including the EU?15 and EU?13 groups, as well as the Visegrad group, six diagnostic variables affecting the economic situation of individual EU countries were analysed. The variables for analysis were chosen so as to reliably describe the competitive position of a given country, at the same time referring in a substantive sense to the concept of macroeconomic stabilisation pentagon. The linear ordering of objects was made using the reference Hellwig method. The selected method enabled the development of competitiveness rankings of EU Member States in the years 2005, 2009, and 2018. Findings & Value added: The comparative analysis of the main macroeconomic indicators conducted in the paper forms the basis for assessing the cur-rent state of the EU economy in relation to other countries. In the paper, the authors depart from the standard elaboration of ?magic pentagon.? Instead, they apply the variables used in the macroeconomic stabilisation pentagon analysis to develop competitiveness rankings of EU Member States. The con-ducted empirical study has confirmed that the 15th anniversary of EU member-ship had a decidedly positive impact on the level of economic development of the EU?13 countries.

scholarly journals DAMP AI( HAMBATAN NON-TARIF TERHADAP PERMINT AAN EKSPOR UDANG INDONESIA KE UNI EROPA

Agro Ekonomi ◽  
2016 ◽  
Vol 14 (1) ◽  
pp. 17
Author(s):  
Toni Kuswoyo ◽  
Dwidjono Hadi Darwanto ◽  
Slamet Hartono
Keyword(s):  
Food Security ◽  
Negative Impact ◽  
Positive Impact ◽  
Export Price ◽  
Least Square ◽  
The Other ◽  
The European Union ◽  
Analysis Model ◽  
Dummy Variables ◽  
The Eu

This research was aimed to determine theforms of the non-tarifbarrier and its impact to the Indonesian shrimp export demand to the European Union (EU), beside the other factors as constructor of demand function. This research used secondary data (lime series) during 23 years (1984-2006): shrimp export volume (Qd), shrimp export price (Px), domestic shrimp price (Pd), crab export price (Pk), exchange rate from the importing countries, and commerce regulations which is peiformed by EU as dummy variables. The data collected from DKP, BPS, Depdag, internet, and other relevant institutions. Peculiarly, the dummy variable grouped into 6 groups: RASFF (DI), contaminant (D2), certain substances & residues (D3), health conditions & food hVf!iene rules (D4), HCCP (D5), and marketinf! standards (D6).This research used the multiple regression analysis model, with the tolerant time (!gg) I year from tfor several dummy variables. Analysis were conducted at 6 markets: UE as a whole, Dutch, United Kingdom (UK), French, Germany, and Belgia and Luxemburg. Testing of the classical assumptions conducted by the econometric criterions is covering the economic and statistic criterions. The estimation of the regression parameters conducted by the smallest square method (ordinarv least SQuare. OLS) and model repaired as the effect of existence of the first order autocorrelation by a comand "auto". The equation model related to the Coob-Douglas model, was transformed into the natural logarithm model in order to easiZv analyzed in package program of statistics.Result of the analysis indicated that the commerce regulations applied by the EU, which its vary to each state, entirely has the negative impact to the Indonesian shrimp export to the UE, except D4 for the UK that shown the positive impact. Several regulations known newly indicated the effect which itsformed into Jgg or its impact is newly felt I year after the regulations enter into force. Thefact strengthen the assumption that applying of commerce regulations by the UE can be the disguised restriction to trade, in this case included to the non tarifbarrier. The sixth groups of the regulationswere very related to the food security and traceability aspect, or in its bearing with the WTO agreements were very related to the SPS and TBT aspect. This invention also strengthen the assumption that non-tarif barrier which newly developed by the advanced countries to control the importation from the other countries were deal with the food security and traceability aspect, or the SPS and TBT aspect. The quantitative non- tarif barrier, example import quota or embargo, were rarer in used. Ap-parently, the EU doesn't wishtoooutspokenin theeffort to control its commerce with the other countries.Realizedor not, in thepresentnon-tarif barrier haveimportantposition to determinewhetheror not thefluent of theinternational trade

scholarly journals RESEARCH ON UKRAINE’S SUSTAINABLE DEVELOPMENT GOALS AND COMPARISON WITH THE EU’S ENERGY VISION

2020 ◽  
pp. 83-88
Author(s):  
О.І. Савченко ◽  
Туран Угур
Keyword(s):  
Sustainable Development ◽  
Sustainable Development Goals ◽  
Positive Impact ◽  
The European Union ◽  
The Sustainable Development ◽  
Energy Economy ◽  
Common Goals ◽  
Development Goals ◽  
Strategic Perspective ◽  
The Eu

The main goal of this study is to show the performance of the indicators under 4 integrated main groups by using the multifactorial analysis methodology in the light of the selected indicators, by drawing attention to the integration of the energy network, which Ukraine has developed in line with the sustainable development goals, in the field of the energy economy, which has been planned with the European Union. Observing these performances is among the aims of the author’s research to draw attention to the importance of reform steps Ukraine has taken in line with its sustainable development goals and these reforms will be expected a positive impact on the country’s accession to the EU. 17 sustainable development goals developed by UNDP, where efficiency and innovation are imperative, focus on the improvement of countries and play a role in the formation of the indicators and groups of this study. According to the results of the study, it is observed that the indicators selected for Ukraine are linked to the data used in line with the country’s common goals with the EU and 2035 energy targets, as observed in the analysis results in integrated groups. The ambition of this study, which focuses on the development of Ukraine, is aimed by the author to offer an alternative and strategic perspective to small and medium-sized entrepreneurs (SMEs) in the energy sector.

Implementation of pharmacogenomics in product information

2020 ◽  
Vol 21 (7) ◽  
pp. 443-448
Author(s):  
Nikica Mirošević Skvrce ◽  
Sonja Krivokapić ◽  
Nada Božina
Keyword(s):  
Nervous System ◽  
Product Information ◽  
Anatomical Therapeutic Chemical ◽  
Medicinal Products ◽  
Anatomical Therapeutic Chemical Classification ◽  
Chemical Classification ◽  
The Eu

Aim: The aim of our study was to analyse the level of implementation of pharmacogenomics (PGx) in product information (PI) of medicinal products approved through national procedures in the EU. Materials & methods: In the analysis, we included nationally approved medicinal products in Croatia if guidelines for relevant substances were published. Results: Overall, 265 marketing authorizations were analyzed. The majority of data included in PI was only informative, while the most frequent PGx biomarkers were genes which code CYP P450. Analysis according to the Anatomical Therapeutic Chemical classification revealed that most substances belonged to the nervous system. Conclusion: Although hindrances in implementation are anticipated, PI should be more specific in terms of when the testing is indicated and should include actionable recommendations according to the results of PGx testing.

Ukraine’s compliance with the Copenhagen criteria for accession to the European Union

2021 ◽  
pp. 34-41
Author(s):  
Olesya Trahniuk ◽  
Maksym Vytvytsky ◽  
Konstantin Shpak
Keyword(s):  
European Union ◽  
Member State ◽  
European Integration ◽  
Positive Impact ◽  
Main Body ◽  
The European Union ◽  
Political Movement ◽  
Association Agreement ◽  
Daily Work ◽  
The Eu

Problem setting. Since gaining independence, Ukraine has been steadily moving towards integration into European and Euro-Atlantic structures. However, the process of acquiring membership of our state in the European Union is quite long and involves a number of criteria, in particular, in addition to the general ones specified in Art. 49 of the Treaty on European Union of 1993, and additional Copenhagen criteria to be met by the applicant state. European integration processes have a positive impact on the development of Ukraine as a democratic, social, legal state, strengthen its position in the international arena, contribute to economic reforms. Which, in turn, should be demonstrated in practice by bringing Ukraine closer to the requirements set by the EU for states that have expressed a desire to join the union. Recent research on the topic. Various aspects of the issue of European integration were developed primarily by European lawyers and political scientists, among whom the works of K. Baimi, A. Bogdandi, J. Buchanan, M. Burgess, W. Della Sala, A. Dashwood, G. De Burke are of special interest. J. Zimmerman, L. Cartou, N. Catalano, P. King, P. Craig, D. Lassok, S. Leikoff, W. Ostrom, D. Sidzhansky, R. Watts and many other authors. The list of scientific researches is not limited to the works of Western authors, as the integration process is quite dynamic, and therefore scientists are no less interested in the scientific developments of their colleagues from countries seeking to gain EU membership, including Ukrainian lawyers, including I. Bratsuk, O. Golovko-Gavrisheva, V. Kopiyka, T. Komarova, K. Smirnova, L. Luts, M. Mikievich, Z. Makarukha, V. Muravyov, V. Poselsky, R. Petrov, O. Tragnyuk, I. Yakovyuk and others. The purpose of this research is to analyze the current state of the legislative, legal and economic base of Ukraine for compliance with the Copenhagen criteria for accession to the European Union. Article’s main body. The article is devoted to the issue of Ukraine's compliance with each of the Copenhagen criteria. First of all, the authors note that the main purpose of the Copenhagen criteria is to select the most "worthy" applicants for membership in the Union. And compliance with these criteria must indicate the ability of the state to perform the duties of a member state of the Union. In addition, specific examples are given of the requirements that Ukraine has met as of 2021 and that it must meet in the near future. It indicates in which direction Ukraine should move in order to acquire the full status of a member state of the European Union. In conclusion, the opinions of scientists on the prospects of Ukraine's further accession to the European Union are presented. Conclusions and prospects for development. The research shows that Ukraine does not yet fully meet the Copenhagen criteria for accession to the EU, as for a number of objective and subjective reasons there is a lack of stable economic development and a well-established understanding of the direction of the political movement. Despite significant advances, national legislation also needs to be improved. After the entry into force of the Association Agreement between Ukraine and the EU, the development of integration processes has significantly intensified. The implementation of the planned reforms is undoubtedly able to bring our country's accession to the EU closer, which should add optimism and encourage daily work in this direction.

scholarly journals A regulatory take on cannabis and cannabinoids for medicinal use in the European Union

2020 ◽  
Vol 71 (1) ◽  
pp. 12-18
Author(s):  
Metoda Lipnik-Štangelj ◽  
Barbara Razinger
Keyword(s):  
European Union ◽  
Public Interest ◽  
Marketing Authorisation ◽  
Synthetic Cannabinoids ◽  
Endocannabinoid System ◽  
Legal Framework ◽  
The European Union ◽  
Medicinal Products ◽  
Medicinal Use ◽  
The Eu

AbstractThe discovery of the endocannabinoid system has raised public interest in the medicinal use of cannabis, phytocannabinoids, and synthetic cannabinoids, which has always been closely regulated due to their psychotropic effects and potential abuse. The review takes a quick look at the current legal framework in the European Union, which regulates cannabis use and cultivation for medicinal purposes in line with the United Nations Conventions on the production, trade, and use of cannabis, phytocannabinoids, and synthetic cannabinoids. And while the EU legislation precisely defines requirements and marketing authorisation procedures for medicinal products for all EU member states, there is no common regulatory framework for magistral and officinal preparations containing cannabinoids, as they are exempt from marketing authorisation. Instead, their regulation is left to each member state, and it is quite uneven at this point, mainly due to cultural and historical differences between the countries, leading to different access to non-authorised medicinal products. Therefore, to meet great public interest, harmonised approaches on cannabinoid-containing products without marketing authorisation would be welcome to level the playing field in the EU.

scholarly journals European Union Foreign Direct Investment Outflows to ASEAN Countries

2013 ◽  
Vol 16 (1) ◽  
pp. 5-19
Author(s):  
Agnieszka Drzymała
Keyword(s):  
European Union ◽  
Economic Development ◽  
Foreign Direct Investment ◽  
Southeast Asia ◽  
Direct Investment ◽  
Positive Impact ◽  
The European Union ◽  
Asean Countries ◽  
Economic Ties ◽  
The Eu

The paper analyses foreign direct investment outflows from the European Union to the ASEAN countries. The region of Southeast Asia is very important for the EU in terms of economic cooperation. Previous relations between the European Union and ASEAN countries laid the foundations and became the basis for subsequent business initiatives, first encompassing trade and later investment initiatives. Today the liberalisation of foreign direct investment (FDI) flows is taking place, which has a positive impact on the increase in exports of ASEAN countries and in turn affects the economic development of these countries. The European Union deepens its economic ties with the region through FDI, which results in increased economic interdependence.

scholarly journals Economic impact of the EU Eastern enlargement on New Member States revisited: The role of economic institutions

2021 ◽  
Vol 8 (55) ◽  
pp. 126-143
Author(s):  
Jan Hagemejer ◽  
Jan J. Michałek ◽  
Pavel Svatko
Keyword(s):  
Control Method ◽  
Positive Impact ◽  
Comparative Case Study ◽  
Economic Institutions ◽  
Synthetic Control ◽  
The European Union ◽  
Member States ◽  
Economic Implications ◽  
New Member States ◽  
The Eu

Abstract The paper analyses the economic implications of the accession of New Member States (NMS) to the European Union (EU) in 2004 and 2007. The estimation effects of integration with the EU were carried out as a comparative case study using the synthetic control method (SCM) proposed by Abadie and Gardeazabal. Compared to previous studies analysing the effects of accession to the EU (Campos, Coricelli and Moretti), we check for the importance of the quality of economic institutions for the matching process of the analysed economies with their comparators. The results of the econometric analysis show a positive impact on the country performance 6 years and 12 years after accession to the EU. The gains from accession are large but not universal. For 5 of the 10 analysed countries the difference in levels of per capita gross domestic product (GDP) against the counterfactual is at least 30%.

scholarly journals The Emergence of an European Union Cultural Diplomacy

2020 ◽  
Vol 65 (3) ◽  
pp. 77-91
Author(s):  
Cristina Mărășescu
Keyword(s):  
Economic Growth ◽  
European Union ◽  
Developing Countries ◽  
International Development ◽  
Public Diplomacy ◽  
Positive Impact ◽  
Cultural Diplomacy ◽  
The European Union ◽  
Member States ◽  
The Eu

"On 16 April 2020, the Organisation for Economic Co-operation and Development (OECD) released preliminary figures according to which the collective Official Development Assistance (ODA) from the European Union (EU) and its Member States to developing countries amounted to 75.2 billion in 2019, representing 55.2% of global assistance. The EU and its Member States therefore maintain their position as the largest international aid donor. In spite of the vast amount of resources spent annually by the EU, there is widespread perception that the EU punches below its weight. Notwithstanding the undeniable positive impact that the EU external policies have on the ground, the EU’s role in international development remains mostly invisible. This paper presents the perception of the EU and EU’s policies abroad and makes the case for the necessity of an integrated and fully coordinated EU Public Diplomacy (PD) capable of communicating effectively and strengthening EU’s role as a global actor. It argues that culture has a substantial potential in Europe’s international relations, making the case for the necessity of an integrated and tailor-made EU Cultural Diplomacy. This paper shows that culture is a worthwhile investment in driving economic growth. Failure to capitalise on this would be a huge missed opportunity for Europe. Keywords: European Union, Economic Support to Developing Countries, Economic Growth, Public Diplomacy, Cultural Diplomacy, European External Action Service JEL classification: O10, Z10 "

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