Chromatographic study of Euphorbia cyparissias

Authors: Romeo T. Cristina, Faltinski Flavius                                                                             Affiliation: USAMVB Timisoara, Facultatea de Medicină Veterinară

The ectoparasitic population control is very difficult and includes numerous chemical substances and therapeutic techniques. Although efficient at first, the repeated use of acaricidal substances leads to the appearance of resistance. The more and more reduced efficacy of the therapeutic arsenal puts serious problems for the practitioners and increases the need of newer substances on the market. Besides this appears the problem of residues in eggs and meat, which is a serious impediment. Because of this the use of plant extracts is an attractive and promising research path. The investigations tied to the parasitic biocontrol have diversified with the study of the numerous control sources (fungi, plant extracts, volatile oils etc.). In this context, the plant extracts can become an alternative source for the acaricidal control knowing that they constitute a rich source of efficient bioactive compounds. Unfortunately although at hand until today, not very much data is known about what determines the acaricidal activity of some plant extracts against the argaside ticks. The present work describes an in vitro CG-MS study for identification of Euphorbia cyparissias’ chemical composition.

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Authorisation procedures for veterinary medicinal produscts and application types

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.

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Evaluation of the risk for the medium of the veterinary medicinal products and thew actual legislative requirements in the domain

Authors: Ioana Diaconu, Lollita Taban                                                                                             Affiliation: Institutul pentru Controlul Produselor Biologice si Medicamentelor de Uz Veterinar, Bucuresti

The Veterinary Medicine Products are authorized for marketing by the Regulating authorities, if they fulfill the scientific quality, efficiency and the safety criteria. The Veterinary Medicine Products Safety refers to the treated animal safety, the consumers safety, the safety for the persons that are handling the products during the treatment and the environment’s safety, which will be presented next. The Evaluation of the Veterinary Medicine Products Risk on the Environment represents an objective appreciation of the risk of appearance of some unwanted side effects on the environment during or after the use of veterinary medicine products.

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Drug’s analithycal investigation

Authors: Romeo T. Cristina1, Tiță D2, Eugenia Dumitrescu1, Tiță B2

Affiliation: 1 Facultatea de Medicină Veterinară Timișoara                                                                                               2 Universitatea de Medicină și Farmacie Victor Babeș Timișoara, Facultatea de Farmacie

Chemical analysis is the main method of drugs investigation. It is currently used in all scientific fields that have a greater or lesser connection with the chemistry. In a simple way we can say that the chemical analysis consists into the characterization of the analyzed system. Characterization means the obtaining and processing of all linked information that allowing the substances or components identifying of the system analysis – so called analytical information. Analytical information is obtained through the complex investigation (analysis) of the studied substance or of the analyzed system (the analytical system). This investigation is done through the monitoring and measurement of certain properties (P) depending on the concentration (C) or volume (V). Instrumental methods can be used to determine other substances characteristics as: determination of some analytical constants, structure determination, the reaction mechanisms’ elucidation, etc. Practice has shown that the best results are obtained for an analytical method by coupling the chemical techniques with the instrumental ones. In this report are presented the main features, and analytical methods used in the drugs testing.

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Obtaining of the UE’s Fabrication Autorisation and of Good Manufacturing Fabrication Practice

Author: Rodica Morcov                                                                                                                   Affiliation: A.N.S.V.S.A. Bucuresti

The harmonization of Romanian legislation with the European Union’s one has as purpose the authentic equivalence archiving of the elaborated and applied measures on the Romanian theritory with the ones legislated and applied in the other European Union state members. This is mandatory for the administrative procedure for the drow up of fabrication / import authorizations for the veterinary medicine products, in conformity with the European Commission published models and is assured in our country by the ANSVSA Presidents’ Order no. 57/2009, to the modification of the earlier ANSVSA Presidents Order no. 187/2007 about the approval of the Veterinary Medicine Products Code, Sanitary Veterinary Norm, order which transponds the Commission Directive 2009/9/CE from 10th February 2009 and modifying the Directive 2001/82/CE of the European Parliament and of the Council for the institution of the Communitary code regarding the veterinary medicine products, published in the Official Journal of the European Union (JOUE) no. L 44 from 14th February 2009, which implements in the national legislations the authorizations for fabrication/ import communitary format for the veterinary medicine products, published by the European Commission in the Reglementation of the Veterinary Medicine Products Norms, volume 4, published in the Official Monitor Part 1, no. 611 / 08.09.2009.

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UE organisms for the reglementation and market’s maintenance of veterinary use products

Authors: Lolita Taban, Iuliana Moloiu                                                                                             Affiliation: Institutul pentru Controlul Produselor Biologice si Medicamentelor de uz Veterinar

Following the Romania’s EU accession in 2007, national legislation licensing, distribution and circulation of veterinary medicinal products has been harmonized with relevant Community legislation, namely Directive 2001/82 amended by Directive 2004/28 and translated by Order of ANSVSA no.187/2007 (which amended the Order ANSVSA no. 69/2005). Institute for the Control of Biological Products and Veterinary Medicines (ICBMV) is the competent authority in the licensing of veterinary medicinal products, working with European institutions, notably the European Medicines Agency (EMEA), in matters related to the licensing and post-marketing surveillance, together with ANSVSA. In the up mentioned context, ICBMV representatives attending to meetings of Working Groups of the CVMP (Committee for Medicinal Products for Veterinary Use) and the Coordination Group for Mutual Recognition production and decentralized procedure (CMDv), on different fields. Working groups are meeting in sessions, quarterly, and the CVMP and CMDv Committees meetings are held monthly, according to a timetable. By participating to the work meetings, the ICBMV representatives have the opportunity to improve their knowledge in them specific areas and to receive up to date information in the field of the veterinary medicinal products. Also, the information received is transmitted to the Romanian pharmaceutical industry for implementing the new UE requirements, to ensure an adequate level of quality, safety and efficacy in the field of veterinary medicinal products.

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Elements for identification of the prohibited practices in ecquines

Authors: Romeo T Cristina., Alina Netotea, Diana Iacob – Obistioiu, Flavia Hanganu                                         Affiliation: USAMVB Timisoara, Facultatea de Medicină Veterinară

In the Romanian veterinary medicine, animal doping, in the one hand, has not yet been so expanded like in the developed countries, where equestrian sports practice are known for long time, the lack of sustained national activities in this area and the other hand due to lack of material means. However the development of dog breeding and of the equestrian sports will undoubtedly make place for fraud. Medicines or medications have been tested in horse racing since 1903. Today racehorses testing for the identification of the prohibited substances are by far the oldest, largest and most sensitive way for determination of drug testing. Tests on doped horses are conducted under strict regulatory context and extremely precise. Although is known the fact that drugs can affect in a decisive way the performances of the race horses, though scientific evidence found in the literature to support this are still relatively poor. This report introduces in Romania the elements of identification and prevention of illegal practices in sport horses.

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Elements of veterinary pharmacovigilance

Authors: Romeo T. Cristina1, Valer Teusdea2, Sorin Paidac1

Affiliations: 1 Facultatea de Medicină Veterinară Timișoara                                                                                                      2 ANFPUV Bucuresti

In general sense, the main mission of a pharmacovigilance system is the drug safety monitoring after it’s market approval and is mostly considered to be an important part of the activities under the guidance of EMEA and competent veterinary authorities. The Agency regularly receives reports from the Union but also from outside in terms regarding the products authorized centrally and coordinates the activities related to safety and quality of the medicinal products. The veterinary pharmacovigilance is monitoring the safety of veterinary use products, including vaccines, diagnosis or treatment of animal diseases after they reached the market, running all licensing procedures. To ensure ongoing safety of veterinary medicines is required the swift implementation of a National System of Pharmacovigilance where permanent improvements will have to consider the available data, based on lack of efficacy. The domain legislation recommends that where there yet are no data, the use of approved electronic means of communication of information relating to medicinal products marketed in the community. Centralized data for veterinary medicinal products in Romania can be achieved by The National Authority for Sanitary Veterinary and Food Safety of the Ministry of Agriculture and Food by Institute for the Control of Biological Products and Veterinary Medicines (ICPBMV).

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