| Avtor/Urednik | Ornik, Dragica | |
| Naslov | Primerjalna študija evropske in slovenske zakonodaje s področja nadzora prometa z zdravili za uporabo v veterinarski medicini | |
| Prevedeni naslov | Comparative study of European union and Slovenian legislation on the supervision of the trade of medicines for use in veterinary medicine | |
| Tip | članek | |
| Vir | Zb Vet Fak Univ Ljublj | |
| Vol. in št. | Letnik 34, št. 1 | |
| Leto izdaje | 1997 | |
| Obseg | str. 91-105 | |
| Jezik | slo | |
| Abstrakt | A comparative analysis of valid legislation in the field of trade in medicines for use in veterinary medicine in the Republic of Slovenia and the directives and regulations on trade in veterinary medicinal products in the European Union was carried out. The analysis of valid Slovene legislation covered regulations on laboratory, pharmacological-toxicological and clinical testing of medicines, the registration procedure, control and trade in medicines, the conditions to be fulfilled by the legal persons responsible for production, testing and control, and releasing for sale, as well as supervision of these activities. The analysis of the directives and regulations of the European Union in the field of trade in medicines covers analytical, pharmaco-toxicological and clinical standards and protocols in testing veterinary medicinal products, the maximum residue limits of medicines in individual foodstuffs of animal origin, the procedures for registration of medicines, description of the work of the European Agency for the Evaluation of Medicinal Products and the Committe for Veterinary Medicinal Products, distribution medicine in individual member states, the procedures for implementing pharmacovigilance concerning medicines on trade and supervision of these activities. Resolutions and proposals concern medicated feedingstuffs, premixes for medicated feedingstuffs, compound prescription medicines, antiparasitics, and fodder with added pharmacological properties. (Abstract truncated at 2000 characters) | |
| Deskriptorji | VETERINARY MEDICINE LEGISLATION, DRUG EUROPEAN ECONOMIC COMMUNITY SLOVENIA DRUG AND NARCOTIC CONTROL EUROPE |