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2009, vol. 59, iss. 2-3, pp. 128-152
Classification and safe administration of products containing vitamins and minerals
Agencija za lekove i medicinska sredstva Srbije, Beograd

emaildragan.djurovic@alims.gov.rs
Abstract
Pursuant to Law on medicines and medical devices (RS Official Gazette No. 84/04 and 85/05, other law) Medicines and Medical Devices Agency of Serbia issues Marketing Authorizations for medicines (vitamins and minerals) and expert opinions on product classification. Aim of this paper is to point out the significance of classification, which contributes to placing clearly defined products on the market. This paper explains in detail: What is medicine? It presents list of products containing vitamins and minerals with Marketing Authorization in Republic of Serbia. Status of these products is often on the borderline between medicines and dietary supplements, and, therefore, this paper discusses this problem in detail. Documentation necessary for product classification and classification process is presented. Contemporary criteria and legislation based on scientific and expert principles are used in classification process. Agency issues expert opinions on product classification, and this paper comments on results for year 2008. This paper also presents risk assessment and characterization - models for establishing upper vitamin and mineral levels which can be added safely into dietary supplements. Establishing the system for classification, assessment and verification, based on legislation and determined jurisdiction of authorities, would enable marketing of products which enable safe self-medication.
References
*** (2001) Directive 2001/83 EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. OJ L, 311, 28. 11
*** (2008) Commission Directive 2008/100/EC of 28 October 2008 amending Council Directive 90/496/EEC on nutrition labeling for foodstuffs as regards recommended daily allowances, energy conversion factors and definitions. Official Journal of the European Union, L 285, 29.10
*** (1990) Directive 90/496/EEC of the Council European Communities of 24 September 1990 on nutrition labeling rules of foodstuffs. Official Journal of the European Communities, L 276, 06.10
*** (2006) Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods. Official Journal of the European Union, L404, 30. 12
*** (1989) Directive 89/398 EEC of the Council European Communities of 14 June 1993. of 3. May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses. Official Journal of the European Communities, L186, 30.06
*** (1999) Directive 1999/21/EC of the Commission of the European Communities of 25 March on dietary foods for special medical purposes. Official Journal of the European Communities, L 91, 7. 4. 1999
*** (2006) Scientific Committee on Food: Scientific Panel on Dietetic Products, Nutrition and Allergies: Tolerable upper intake levels for vitamins and minerals. European Food Safety Authority, http://www.efsa.eu.int
*** (2004) Amended by Commission Directive 2004/27 EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83 EC on the Community code relating to medicinal products for human use. OJ L, 136, 30. 4
*** (2002) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. Official Journal of the European Communities, L 183, 12.07
*** (2006) Commission Directive 2006/37/EC of 30 March 2006 amending Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards the inclusion of certain substances. Official Journal of the European Union, L 94, 1.4
Agencija za lekove i medicinska sredstva Srbije (2009) Nacionalni registar lekova. Beograd
Đurović, D. (2007) Farmaceutska regulativa - značajna osnova za klasifikaciju proizvoda. Arhiv za farmaciju, vol. 57, br. 3, str. 178-191
European Commission, Health, and C.protection directorate-general (2006) Discussion Paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs. European Communities
FDA Consumer Health Information, U.S. Food Drug Administration (2009) Fortify Your Knowledge About Vitamins. www.fda.gov
FDA Office of Women's Health (2007) Dietary supplements. www.fda.gov/womens
Hathcock, J.N., Azzi, A., Blumberg, J., Bray, T., Dickinson, A., Frei, B., Jialal, I., Johnston, C.S., Kelly, F.J., Kraemer, K., Packer, L., Parthasarathy, S., Sies, H., Traber, M.G. (2005) Vitamins E and C are safe across a broad range of intakes. Am J Clin Nutr, 81(4): 736-45
Institute of Medicine - Food and Nutrition Board (2001) Dietary reference intakes: Guiding principles for nutrition labeling and fortification. Washington, DC: National Academy Press, www.napedu/catalog10872.html
Mason, P. (2007) Dietary supplements. London, Chicago: Pharmaceutical Press
Medicines Healthcare Products Regulatory Agency (2007) A guide to what is a medicinal product: MHRA guidance product. Guidance Note br. 8
Ross, E.M., Rosenberg, I.H. (2000) Chapter 5: Nutrition. in: Carruthers S.G., Hoffman B.B., Melmon K.L., Nierenberg D.W. [ed.] Melmon and Morrellis Clinical Pharmacology, McGraw-Hill, str. 341-358
Thorp, C.M. (2008) Pharmacology for the health care professions. Chichester: Wiley-Blackwell, 1st ed
 

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article language: Serbian
document type: Professional Paper
published in SCIndeks: 16/06/2009

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