Authors: Solcan Gh., Beschea Chiriac I. S. Affiliation: USAMV Iasi, Facultatea de Medicină Veterinară
Before the authorization for comercialization both medical and phyto-sanitary products must be tested for inocuity and toxicity, the risk assesment for persons working in drug industry, pharmacy, human beings and animals treated with the product and for the consummers of food products with drug residues being studied. The experimental studies of toxicity, after Milhaud et al., (1994), are classified in 7 groups: acute toxicity study; study of local irritant and allergic potential; study of mutagenic effect; subacute toxicity study; chronic toxicity and carcinogenic potential; study of embriotoxicity and adverse effect on reproduction; study of ecotoxicity.
Authors: Viorica Chiurciu1, Adina Faur (Baias)2, Eugenia Dumitrescu2, Romeo T. Cristina2
Affiliation: 1 Romvac Company Bucuresti, 2 USAMVB Timisoara, Facultatea de Medicina Veterinara
Laboratory animals (namely, mouse, rat, hamster, guinea pig, rabbit), chinchillas, birds and reptilian medicine is a relatively new specialty of veterinary medicine, being until recently in the “early” stages, therefore at least in the last decade, some studies on these types of animals appeared in the literature and consequently, therapy issues of various disease states in these animals. Besides the fact that laboratory animals and reptiles are used in biomedical research, we would say, already routinely not to neglect is the growing number of holders of such “pet animals”. In search of appropriate dosages to these species, scientists have tried to extrapolate doses from dog and cats, based on experimental studies and then published. Based on “accumulation” of therapists in the recent years, only few drugs have been approved yet (especially for rodents), most of them having still the status application beside instructions (off-label application). Already known increased susceptibility of mice and rabbits to the toxicity of antimicrobials is particularly important due to intestinal flora, dis microbism due to narrow spectrum antibiotics often leading to the increasing of gram-negative and gram positive anaerobic, organisms which will induce in these species toxicity and death. In conclusion, dosages presented are the result of some clinical studies that could be yet considered as “empirical” and “extrapolated from other species” and which are perfectible every day by the information accumulation following the administrations. In this respect an “up to date” self-improvement of vet specialists who have interests in this field is required.
Authors: Alina Karina Draghici, Lollita Taban Affiliation: Institutul pentru Controlul Produselor Biologice si Medicamentelor de Uz Veterinar, Bucuresti
The authorization process of veterinary medicinal products is an complex and laborious process, which is accomplished through multiple stages and by centralized procedures, communitary or nationals in the respect of 2001/82/EC Directive amended by the 2004/28/EC Directive; the 726/2004 Regulation; the Order no. 57/2009 and by the specific Guidelines. The Assessor is a person who has the right to recommend the granting or denial of veterinary medicine products marketing authorization. In the paper are presented the veterinary medicine products authorization process stages as well the possible authorizations application type versions.
Author: Romeo T. Cristina Affiliation: USAMVB Timișoara, Facultatea de Medicina Veterinara
Communitary concepts related to the drug residues assumption is essential to Romanias’ full integration amongst the countries where alimentary security and human consumers’ security have had become national policy. In this respect a concise enumeration of E.U. basic legislative notions, with the specific terminology and of technical premises presentation, it is proposed in the aim of Communitary veterinary medicinal products’ residues evaluation as well the MRL’s determination phases in the light of 2377/90 EU Regulation’s understanding.