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According to the European Directive 2001/83/EC, medicinal products, contrary to foodstuffs, require a pre-marketing authorisation by competent authorities. Quality has to be proven in accordance with the European directives and guidelines, while safety and efficacy through pharmacological- toxicological and clinical studies and/or bibliographic application (Art. 10.1 (a) (ii)). Apart from these options, some European countries have established a simplified proof of efficacy, e.g. for traditional herbal medicinal products. The study of AESGP (European Medicines Manufacturers’ Association), “Herbal Medicinal Products in the European Union”, which was performed in 1998 on behalf of the European Commission, elucidates the regulatory situation in member states of the European Union, in particular the implementation of the option of bibliographic application. ESCOP, the European Scientific Cooperative on Phytotherapy, has published 80 monographs on the medicinal use of herbal drugs in order to provide harmonised criteria of assessment on a European level. A similar project has been initiated by the World Health Organisation (WHO). The Herbal Medicinal Products Working Party (HMPWP) at the European Agency for the Evaluation of Medicines (EMEA) has published various guidelines on the quality, safety and efficacy of herbal medicinal products, e.g. the so-called core-data on herbal drugs based on monographs.Apart from the area of the ‘well-established medicinal use’ products suitable for bibliographic applications, a further category of traditionally used herbal medicinal products is being established on a European level. The European directive on traditional herbal medicinal products amending Directive 2001/83/EC provides the option of a simplified registration procedure under certainconditions, e.g. established safety, plausible efficacy on the basis of long-term use and experience as well as proven quality. A new Committee for Herbal Medicinal Products is being founded which is to be responsible for the preparation of Community herbal monographs on products with well- established medicinal use and on traditional herbal medicinal products. The parties involved hope that further discussion in ESCOP/ WHO monographs and the preparation of new core-data takes place as a basis for well-established medicinal use in order to facilitate mutual recognition and to achieve a European-wide rational assessment for all kinds of herbal medicinal products.
The results were based on mustards produced in the Vinegar and Mustard Factory in Parczew during the years 1995-1998; major components were Nakielska (Sinapis alba) and Małopolska (Brassica júncea). Four items were the experimental factors (stołowa - dainty mustard, sarepska - popular mustard, kremska - popular mustard, pa- pric - popular mustard). There 1-5 g of mustard from 3 repetitions of every combination were taken for laboratory analyses. The following were determined: dry matter content - by gravimetric method, total acidity - by means of titration, chloride content - by means of Mohr, organoleptic valuation (taste, flavour, consistency, colour and appearance) by 9°scale. They were statistically elaborated using variance analysis. Significance of variability sources was calculated using Fischer-Snedecor’s “F” test. Tukey’s test was helpful to estimate the difference significance. They were features of four mustards quality appeared to be with PN-A-86964 [2002]. Contents of NaCl turned out in years of research changeable in mustards, that show in the recipe of the product a high liability of the component. In the following way it is possible to range the analysed kinds in respect of the stability: stołowa dainity > popular papric > popular sarepska > popular kremska. The biggest changes in dry mass contents, and smallest stability of acidity characterized mustards papric and sarepska. The contents of dry mass turned out among comparable features stable - chemical in mustards, least - concentrate NaCl. Taste turned out to be stable from the organoleptical features of mustards, however, least colour and appearance. Most stable, in respect of the researched features - chemical and organoleptical - turned out dainty and the least sarepska mustard.
The paper presents the results of a study on Biała Podlaska county residents' perceived sense of safety in their place of residence. The survey, carried out in 2008, covered 1097 respondents, both men and women, residents of rural and urban areas in Biała Podlaska county. The results of the survey suggest that the majority of dwellers of Biała Podlaska county feel safe in their place of residence.
Background: The aim of this study was to develop a research tool used to assess the efficiency a goalkeeper’s actions in a game of futsal. Material/Methods: Author’s own proposal of an observation sheet was created and subject to a validation procedure. To assess intra-rater reliability and inter-rater reliability, the ICC test was used. Results: There was a strong compatibility of ratings of the intra-rater reliability – 1.00 (95% Cl 1.00-1.00) and the inter-rater reliability – 0.99 (95% CI 0.99-1.00), which proves the reliability of the proposed research tool. Conclusions: The developed sheet allows the registration and evaluation of individual performance and cooperation in terms of goalkeeper’s game objectives pursued both in offence and defence.
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В статье рассмотрены основные типы измельчителей фуражного зерна, обоснован выбор рациональной конструкции измельчителя.
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