European regulation model for herbal medicine: The assessment of the EU monograph and the safety and efficacy evaluation in marketing authorization or registration in Member States

Phytomedicine ◽  
2018 ◽  
Vol 42 ◽  
pp. 219-225 ◽  
Author(s):  
Liping Qu ◽  
Wenjun Zou ◽  
YiTao Wang ◽  
Mei Wang
Keyword(s):  
Herbal Medicine ◽  
Marketing Authorization ◽  
Efficacy Evaluation ◽  
Member States ◽  
European Regulation ◽  
Safety And Efficacy ◽  
Regulation Model ◽  
The Eu

Propiedades tecnológicas y regulación de los edulcorantes de alta intensidad en la Unión Europea Technological properties and regulatory status of high intensity sweeteners in the European Union

1998 ◽  
Vol 4 (1) ◽  
pp. 5-16 ◽  
Author(s):  
H. Montijano ◽  
F.A. Tomás-Barberán ◽  
F. Borrego
Keyword(s):  
European Union ◽  
High Intensity ◽  
Sensory Properties ◽  
The European Union ◽  
Technological Properties ◽  
Member States ◽  
European Regulation ◽  
Regulatory Status ◽  
The Eu

The European regulation of sweeteners has recently been changed with the publication and implementation by Member States of Directive 94/35/EC, which authorizes the use of six bulk sweeteners and six intense sweeteners for the formulation of reduced energy and/or non-sugar-added foods. An update of the technological properties of the high intensity sweeteners presently authorized in the EU is presented. We also report on the use of sweetener combinations as a means to optimize the sensory properties of the finished product and reduce sweetening costs.

scholarly journals THE HARMONIZATION OF THE AVOIDANCE RULES IN EUROPEAN UNION INSOLVENCIES

2016 ◽  
Vol 66 (1) ◽  
pp. 79-105 ◽  
Author(s):  
Andrew Keay
Keyword(s):  
European Union ◽  
Insolvency Law ◽  
Member States ◽  
European Regulation ◽  
Legal Proceedings ◽  
Eu Member States ◽  
Cross Border ◽  
Insolvency Proceedings ◽  
The Eu

AbstractCross-border transactions and resultant legal proceedings often cause problems. One major problem is knowing which law should govern the transaction and any legal proceedings. Cross-border insolvencies in the EU are subject to the European Regulation on Insolvency Proceedings (EIR) but this legislation does not determine which substantive insolvency law rules apply in a given insolvency. There are many differences in the insolvency rules applicable in the various EU Member States and this has caused concern in relation to the avoidance of transactions entered into by an insolvent prior to the opening of insolvency proceedings. In light of this, the paper examines options to address divergence between national avoidance rules. One option, harmonization, is analysed as well as its possible benefits and drawbacks.

scholarly journals Dossier for marketing authorization in the European union

2003 ◽  
Vol 3 (1) ◽  
pp. 56-60 ◽  
Author(s):  
Maida Todić
Keyword(s):  
European Union ◽  
Medicinal Product ◽  
Transition Period ◽  
Complete Information ◽  
Marketing Authorization ◽  
Technical Document ◽  
The European Union ◽  
Safety And Efficacy ◽  
The Common ◽  
The Eu

Extensive and complete documentation must be presented for marketing authorization of a medicinal product in the EU. Presented documentation should prove quality, safety and efficacy of the medicinal product. It is ensured that the applicant supplies the authorities with complete information. The legislation in Federation of Bosnia and Herzegovina has also taken more steps towards those European directions.The presentation and content of the dossier in the European Union has been redefined. The “old” EU format will be replaced with the Common Technical Document (EU CTD format) agreed in 2000, within the International Conference on Harmonization framework. These two formats are intended to coexist during the transition period until July 2003. The CTD is an internationally agreed upon format for the preparation of a well structured presentation for applications to be submitted to regulatory authorities in the three ICH regions of Europe, US and Japan.

scholarly journals The Implementation of ‘Access and Benefit-sharing’ in Five eu Member States: The Achievements and Deficiencies of the Nagoya Protocol and the eu Regulation 511/2014

2017 ◽  
Vol 14 (1) ◽  
pp. 7-40 ◽  
Author(s):  
Bernard Vanheusden ◽  
Griet Van den Berghe
Keyword(s):  
National Level ◽  
Benefit Sharing ◽  
Access And Benefit Sharing ◽  
Member States ◽  
European Regulation ◽  
Nagoya Protocol ◽  
Eu Member States ◽  
Clear Delineation ◽  
Enforcement Mechanisms ◽  
The Eu

The Nagoya Protocol of 2010 on Access and Benefit-sharing and the related European Regulation 511/2014 provide an answer to the question how access to genetic resources may be ensured. However, the eu itself as well as several eu member states struggle with the implementation of the protocol (and the regulation). This article analyses the difficulties encountered at the European and the national level (in five member states) with the implementation of the Nagoya Protocol obligations. It concludes that, although the Nagoya Protocol is an important step forward for the protection of biodiversity and the fight against biopiracy, it clearly is a compromise text, with all the issues arising therefrom. Also Regulation 511/2014 drops a few stiches in the clear delineation of obligations. However, on the national level this does not lead to extremely discrepant national enforcement mechanisms, at least within the five reviewed member states.

Bir güvensizlik ülkesi olarak Türkiye’nin mültecileri, Suriyeliler ve Türk mülteciler

2017 ◽  
Vol 4 (1) ◽  
pp. 21-40 ◽  
Author(s):  
Ibrahim Sirkeci
Keyword(s):  
European Union ◽  
Asylum Seekers ◽  
Military Coup ◽  
Syrian Refugees ◽  
Member States ◽  
Refugee Population ◽  
Syrian Crisis ◽  
Syrian Refugee ◽  
Generous Support ◽  
The Eu

Doğu ve güney komşuları üzerinde gelen göç akınlarının ve üye ülkeler arasındaki göçlerin artışıyla Avrupa Birliği (AB) en büyük krizlerinden birini yaşamaktadır. Avrupa’daki en ana tartışma konuları arasında Avrupa’ya göçü ve AB içindeki göçü sınırlamak ve üye ülkeler arasında mülteci kotası ve külfet paylaşımına yapılan itirazlar yer aldı. Bu krizde Türkiye anahtar ülke olarak ortaya çıktı ve ülkedeki büyük Suriyeli mülteci nüfusu ve bu nüfusun Avrupa’ya gitmesini engellemesi karşılığında vaat edilen milyarlarca Avro nedeniyle tartışmaların odağında yer aldı. Suriye krizi 4,8 milyon mülteci yarattı ve 2016 yılı sonu itibariyle bunların 2,8 milyonu Türkiye’de ikamet etmekteydi. Suriyeli mültecilere karşı cömert tavrıyla Türkiye güvenli bir ülke olarak tescil edilmiş oldu. Bu, hikayenin daha karanlık bir başka yüzünü gölgelemektedir. Çünkü aynı ülkenin vatandaşları 1980 askeri darbesinden bu yana milyonu aşkın sığınma başvurusu yaptılar. Ülkenin bugünkü şartları ve yeni veriler, Türkiye’den AB’ye yönelen daha çok mülteci akını olacağını gösteriyor. ABSTRACT IN ENGLISHTurkey’s refugees, Syrians and refugees from Turkey: a country of insecurityThe European Union (EU) has faced one of its biggest crises with the rise of population inflows through its Eastern and Southern neighbours as well as movements within the Union. In 2016, the main debate that dominated Europe was on restricting migration within and into the EU along with concerns and objections to the refugee quota systems and the sharing of the burden among member states. Turkey emerged as a ‘gate keeper’ in this crisis and has since been at the centre of debates because of the large Syrian refugee population in the country and billions of Euros it was promised to prevent refugees travelling to Europe. The Syrian crisis produced over 4.8 million refugees with over 2.8 million were based in Turkey by the end of 2016. Turkey with its generous support for Syrian refugees has been confirmed as a ‘country of security’. This shadows the darker side of affairs as the very same country has also produced millions of asylum seekers since the 1980 military coup. Current circumstances and fresh evidence indicate that there will be more EU bound refugees coming through and from Turkey. 

BIOECONOMY DEVELOPMENT POTENTIAL BASED ON MORE EFFICIENT LAND USE IN THE EU

2015 ◽  
Author(s):  
Irina PILVERE ◽  
Aleksejs NIPERS ◽  
Bartosz MICKIEWICZ
Keyword(s):  
Green Growth ◽  
Member States ◽  
Eu Member States ◽  
Growing Stock ◽  
Europe 2020 ◽  
Europe 2020 Strategy ◽  
Analysis And Synthesis ◽  
Key Industries ◽  
The Eu ◽  
Production Resource

Europe 2020 Strategy highlights bioeconomy as a key element for smart and green growth in Europe. Bioeconomy in this case includes agriculture, forestry, fisheries, food and pulp and paper production, parts of chemical, biotechnological and energy industries and plays an important role in the EU’s economy. The growth of key industries of bioeconomy – agriculture and forestry – highly depends on an efficient and productive use of land as a production resource. The overall aim of this paper is to evaluate opportunities for development of the main sectors of bioeconomy (agriculture and forestry) in the EU based on the available resources of land. To achieve this aim, several methods were used – monographic, analysis and synthesis, induction and deduction, statistical analysis methods. The findings show that it is possible to improve the use of land in the EU Member States. If all the Member States reached the average EU level, agricultural products worth EUR 77 bln would be annually additionally produced, which is 19 % more than in 2014, and an extra 5 billion m3 volume of forest growing stock would be gained, which is 20 % more than in 2010.

On the Future of the Financial Redistribution across Member States in the EU

2006 ◽  
Vol 56 (1) ◽  
pp. 1-43
Author(s):  
Sándor Richter
Keyword(s):  
Value Added ◽  
The Other ◽  
Current Debate ◽  
Member States ◽  
New Member States ◽  
Financial Position ◽  
Cross Member ◽  
Expenditure Structure ◽  
The Eu ◽  
Made In

The order and modalities of cross-member state redistribution as well as the net financial position of the member states are one of the most widely discussed aspects of European integration. The paper addresses selected issues in the current debate on the EU budget for the period 2007 to 2013 and introduces four scenarios. The first is identical to the European Commission's proposal; the second is based on reducing the budget to 1% of the EU's GNI, as proposed by the six net-payer countries, while maintaining the expenditure structure of the Commission's proposal. The next two scenarios represent radical reforms: one of them also features a '1% EU GNI'; however, the expenditures for providing 'EU-wide value-added' are left unchanged and it is envisaged that the requisite cuts will be made in the expenditures earmarked for cohesion. The other reform scenario is different from the former one in that the cohesion-related expenditures are left unchanged and the expenditures for providing 'EU-wide value-added' are reduced. After the comparison of the various scenarios, the allocation of transfers to the new member states in terms of the conditions prevailing in the different scenarios is analysed.

THE STANDARD OF LIVING OF HOUSEHOLDS IN POLAND COMPARED TO OTHER EU MEMBER STATES

2015 ◽  
Vol 5 (2) ◽  
pp. 634-638
Author(s):  
Joanna Szwacka Mokrzycka
Keyword(s):  
Economic Development ◽  
Economic Condition ◽  
Standard Of Living ◽  
Consumption Expenditure ◽  
Member States ◽  
Eu Member States ◽  
Financial Condition ◽  
Starting Point ◽  
Structure Of Consumption ◽  
The Eu

The objective of this article is to present the standard of living of households in Poland in comparison with other EU member states. The starting point for analysis was the economic condition of Poland against the background of other EU member states. The next step consisted of assessment of the standard of living of inhabitants of individual EU member states on the basis of financial condition of households and the structure of consumption expenditure. It was found that the differences within the EU in terms of economic development and the standard of living of households still remain substantial.

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