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Regulatory Requirements for Food Supplements in the European Union and Bulgaria

/07/2002), p. 0051-0057. 4. Duleva V. [Aspects of regulation of food supplements in the European Union. National Center of Public Health and Analyses], Sofia, 2013 (Article in Bulgarian). 5. FDA. Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. Retrieved January 15, 2013, from http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/dietarysupplements/ucm257563.htm .; 2011. 6. European Food Safety Authority. E. Compendium of botanicals reported to contain naturally occurring

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Strengthening of the Blood Safety System in the National Blood Transfusion Service - Implementation of the European Union IPA Project - at the Institute for Transfusion Medicine of the Republic of Macedonia

References 1. WHO: Blood Transfusion Safety. http://www.who.int/bloodsafety/en/ 2. Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. [Official Journal of European Union, L33 of 08/02/2003] 3. Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European

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Selected determinants of the professional identity of dietitian in the context of legal regulations on the practice of dietitian in Poland and the European Union

położnej podstawowej opieki zdrowotnej (Dz. U. z 2016 r., poz. 1567). 27. bda.uk.com [Internet] British Dietetic Association, Birmingham; [cited 2018 Jul 20] Available from: https://www.bda.uk.com/improvinghealth/healthprofessionals/cost_benefit_of_dietitians . 28. Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications, article 3, point 1(a). Official Journal of the European Union; L 255/22 30.9.2005. 29. http://www.sejm.gov.pl/ [Internet] Sejm Rzeczypospolitej Polskiej

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European Union’s strategy on endocrine disrupting chemicals and the current position of Slovenia

Abstract

In view of the European Union regulations 1107/2009 and 528/2012, which say that basic substances in plant protection and biocidal products marketed in the European Union (EU) should not have an inherent capacity to cause endocrine disruption, an initiative was started to define scientific criteria for the identification of endocrine disruptors (EDs). The objectives of the EU strategy on EDs are to protect human health and the environment, to assure the functioning of the market, and to provide clear and coherent criteria for the identification of EDs that could have broad application in the EU legislation. Policy issues were to be addressed by the Ad-hoc group of Commission Services, EU Agencies and Member States established in 2010, whereas the scientific issues were to be addressed by the Endocrine Disruptors Expert Advisory Group (ED EAG), established in 2011. The ED EAG adopted the 2002 World Health Organization (WHO) definition of endocrine disruptor and agreed that for its identification it is necessary to produce convincing evidence of a biologically plausible causal link between an adverse effect and endocrine disrupting mode of action. In 2014, the European Commission proposed four ED identification criteria options and three regulatory options, which are now being assessed for socio-economic, environmental, and health impact. Slovenia supports the establishing of identification criteria and favours option 4, according to which ED identification should be based on the WHO definition with the addition of potency as an element of hazard characterisation. As for regulatory options, Slovenia favours the risk-based rather than hazard-based regulation.

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Research on Approaches for Regulation of the “Off-label” use of Medicinal Products in the European Union

Abstract

Despite the increasingly strict legislation on medicinal products, the „off-label use“ or „use of medicinal product outside the approved summary of product characteristics (SmPC)“ is a weak point of today’s drug regulation and raises many questions about the risk, ethics, and legality of this type of practice. In recent years, through guidance and legal changes in some countries were defined the conditions and responsibilities, but in the most European countries still lack rules for off-label prescribing. The purpose of this study was to identify and analyse different approaches to regulation, adopted by some member states as well as to summarize the efforts in demand of common harmonized approach to solve this problem within the European Union. In the study, we used the available regulatory information in different electronic resources associated with the off-label drug use in selected European countries without limited time range. The results show that decisions taken to regulate the issue have significant differences and specific approach, while none of them is enough satisfactory and comprehensive. In conclusion, it can be claimed that the existing regulatory rules in various countries require significant improvement and update.

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Composition, labelling, and safety of food supplements based on bee products in the legislative framework of the European Union – Croatian experiences / Sastav, označavanje i zdravstvena ispravnost dodataka prehrani koji se temelje na pčelinjim proizvodima u pravnom okviru Europske unije – hrvatska iskustva

The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union “nutrivigilance” system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family.

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Challenges for the European SPA Management. Results of the ILIS Project

Challenges for the European SPA Management. Results of the ILIS Project

Introduction. The spa industry has been rapidly growing throughout Europe in recent years, which has led to an associated increase in educational demand in spa management. The aim of the study was to identify the most important needs for training and the most significant skills among the spa managers and their personnel throughout Europe. Moreover, it was to research the background of spas were the study had taken place. Material and methods. 30 managers took part in semi structured interviews that used a pre-prepared questionnaire. The answers were analysed with Wilcoxon signed rank test and also the mean values were compared. Results. The needs for training and importance of skills vary from country to country but common areas of interest are: sales, marketing, quality and innovation management, legal regulations, operational and social skills. The complex character of answers to questionnaire was a result of different spa business models and differing domestic spa markets as well as variety of legal environments. Conclusions. Spa tourism creates a significant income among the other tourism disciplines since that further research is needed. Demands for the spa education differed accordingly to a stage of each country spa business development. Spa managers tend to express higher training needs for their employees than for themselves.

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Access to Ethics Committees in Bulgaria – Possibility or Probability

REFERENCES 1. Charter of Fundamental Rights of the European Union, 2012 / C 326/02. 2. Constitution of the Republic of Bulgaria, State Gazette No. 56/13. 07.1991. 3. Law on Medical Establishments, Prom. SG. No. 62 of 9 July 1999. 4. Law on Medicinal Products in Human Medicine, Prom. SG. no. 31 of 13 April 2007. 5. Code of professional ethics of physicians in Bulgaria – issued by the Ministry of Health – Prom. SG. No. 79 of 29 September, 2000, amend. SG 85 of 28 September 2013.

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Current regulatory and market environment for biosimilars in Serbia

References 1. Giezen TJ, Mantel-Teeuwisse AK, Straus SM, Schellekens H, Leufkens HG, Egberts AC. Safety-related regulatory actions for biologicals approved in the United States and the European Union. J Am Med Assoc 2008; 300: 1887-96. 2. EvaluatePharma® World Preview to 2012, 6 June 2008. 3. Kresse GB. Biosimilars - science, status and strategic perspective. Eur J Pharm Biopharm 2009; 72: 479-86. 4. Grabowski HG, Ridley DB, Schulman KA. Entry and competition in generic biologics

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Trends in the Acute Hepatitis B and Acute Hepatitis C in Bulgaria

ABBREVIATIONS USED IN THIS ARTICLE HBV hepatitis B virus HCV hepatitis C virus EU European Union NCIPD National Center of Infectious and Parasitic Diseases NCPHA National Center of Public Health and Analyses EEA European Economic Area ECDC European Centre for Disease Prevention and Control SPSS Statistical Package for the Social Sciences IBM International Business Machines REFERENCES 1. National Center of Infectious and Parasitic Diseases (NCIPD), Sofia, Bulgaria. [Annual reports of the infectious diseases in Bulgaria (2000

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