Elina S. Petkova-Gueorguieva, Ilko N. Getov, Kalin V. Ivanov, Stanislava D. Ivanova, Stanislav R. Gueorguiev, Violeta I. Getova, Anna A. Mihaylova, Vasil G. Madzharov and Radiana A. Staynova
/07/2002), p. 0051-0057.
4. Duleva V. [Aspects of regulation of food supplements in the EuropeanUnion. 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 Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.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
Rada M. Grubovic, Emilija Velkova, Primoz Rozman and Henk W. Reesink
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 EuropeanUnion, L33 of 08/02/2003]
3. Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European
Michał Skrzypek, Lucyna Pachocka, Karolina Goral and Adamina Partycka-Skrzypek
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 EuropeanUnion; L 255/22 30.9.2005.
29. http://www.sejm.gov.pl/ [Internet] Sejm Rzeczypospolitej Polskiej
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.
Mikołaj Bielański, Susanna Saari, Anna Wilkońska, Telle Tuominen, Inma Mora, Daniel Binder, Deborah Kendale, Harprit Thacker, Agata Pluszyńska and Paweł Adamski
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.
1. Charter of Fundamental Rights of the EuropeanUnion, 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.
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 EuropeanUnion. 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
ABBREVIATIONS USED IN THIS ARTICLE
HBV hepatitis B virus
HCV hepatitis C virus
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
1. National Center of Infectious and Parasitic Diseases (NCIPD), Sofia, Bulgaria. [Annual reports of the infectious diseases in Bulgaria (2000
Bartłomiej Drop, Marian Jędrych, Agnieszka Barańska, Ewelina Firlej and Mariola Janiszewska
-SPC Joint Report on Pensions, Brussels. [ http://europa.eu/epc/pdf/interim_epc-spc_joint_report_on_pensions_final_en.pdf .]
9. Lewis J. The Council of the EuropeanUnion and the European Council. In: M. Cini, N. Pѐrez-Solόrzano Borragan. EuropeanUnion Politics. Oxford United Kingdom 2013.p. 142-5.
10. Komisja Europejska. [ http://ec.europa.eu/about/index_pl.htm ]
11. Komisja Europejska. Zielona Księga. Wobec zmian demograficznych: nowa solidarność między pokoleniami. Bruksela, COM (2005) 94 końcowy. [ http
Edyta Czepielewska, Magdalena Szpakiewicz and Małgorzata Kozłowska-Wojciechowska
7. Fan TP, Deal G, Koo HL, et al. Future development of global regulations of Chinese herbal products. J Ethnopharmacol. 2012;140:568-86.
8. Sammons HM, Gubarev MI, Krepkova LV, et al. Herbal medicines: challenges in the modern world. Part 2. EuropeanUnion and Russia. Expert Rev Clin Pharmacol. 2016;9:1117-27.
9. Wiesener S, Falkenberg T, Hegyi G, et al. Legal status and regulation of CAM in Europe. Part I – CAM regulations in the European countries. CAMbrella Final Report Work Package 2. (cited 2018 Feb 2). [ http