Report concerning the collaborative study for establish of reference standard efficacy of sodium colistimethate

Authors: Simona Sturzu, Daniela Turinoaga, Rodica Stancu, Georgeta Dan                                     Affiliation: Institutul pentru Controlul Produselor Biologice si Medicamentelor de Uz Veterinar, Bucuresti

Institute for the Control of Veterinary Biological Products and Medicines participated at the collaborative study for determine the potency of colistimethate sodium CRS, Lot 2, according to the protocol sent by the EDQM (European Directorate for the Quality of Medicines) – coordinator of the study. The purpose of the study was to determine the potency of the batch 2 colistimethate sodium in the characterization of the substance as reference standard. Potency was determined by microbiological method, based on comparing the inhibition zones of growth of micro-organisms sensitive to those of a reference standard, as specified in European Pharmacopoeia “Colistimethate sodium”, Chapter 2.7.2. – Microbiological testing of antibiotics. After analysis of received data from participants and their statistical processing by the EDQM, the potency of the batch 2, colistimethate sodium – reference materials, was established in 285000UI/vial.

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Short guide of cardio-vascular medication in animals

Author: Romeo T. Cristina                                                                                                           Affiliation: USAMVB Timisoara Facultatea de Medicină Veterinară

The medication of heart and blood in animals rise many problems in the current veterinary practice, on the one hand because of lack or very few of functional investigation means and of absence of specific training in this field and on the other hand because of lack of knowledge in what means fine medication in heart and blood disease in animal, many of the drugs being from the human medicine. In this respect we consider that this topic can be a new study direction in the curricula of veterinary universities. In the synthesis is concisely presented, on the vet’s comprehension the main aspects referring to: physiologic bases of heart therapy, the correlation between receptors, secondary messengers and drugs’ action, cardiac failure, cardiovascular medication, contractibility modifiers (cardiotonic medication), Rhythm modifiers, vasodilators etc.

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Centralized procedure for authorization of veterinary medicinal products

Author: Simona Sturzu                                                                                                                 Affiliation: Institutul pentru Controlul Produselor Biologice si Produs medicinalelor de Uz Veterinar, Bucuresti

The centralized authorization procedure is governed by Regulation (EC) no. 726/2004 of the European Parliament and the European Council laying down Community procedures for the authorization and supervision of medicinal products (pharmaceuticals and immunological). The centralized procedure allows applicants to obtain a marketing authorization that is valid throughout the EU. It is compulsory for medicinal products manufactured using biotechnological processes, for orphan medicinal products and for human products containing a new active substance which was not authorized in the Community before 20 May 2004 and which are intended for the treatment of AIDS, cancer, neuro-degenerative disorder or diabetes. The centralized procedure is also mandatory for veterinary medicinal products intended primarily for use as performance enhancers in order to promote growth of treated animals or to increase yields from treated animals. The centralized procedure is optional for any other products containing new active substances not authorized in the Community before 20 May 2004 or for products which constitute a significant therapeutic, scientific or technical innovation or for which a Community authorization is in the interests of patients or animal health at Community level.When a company wishes to place on the market a medicinal product that is eligible for the centralized procedure, it sends an application directly to the European Medicines Agency, to be assessed by the Committee for Medicinal Products for Human Use (CHMP) or the Committee for Medicinal Products for Veterinary Use (CVMP). The procedure results in a Commission decision, which is binding on all EU Member States, to authorize the product.

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New legislation on the marketing and use of feed: status of nutritional supplements

Authors: Simona Sturzu, Luminita Paraschiv                                                                                   Affiliation: Institutul pentru Controlul Produselor Biologice si Medicamentelor de Uz Veterinar, Bucuresti

The term “nutritional supplements” for animals is found first in the “Proposal for the European Parliament and of the Board amending Directive 93/74/EEC on feeding stuffs intended for particular nutritional purposes and amending Directives 74/63/EEC, 79/373/EEC and 82/471/EEC”, submitted by the European Commission to the European Parliament and Council Director for approval on July 28, 1997. The proposal was not approved, for the reasons it hat this category of “supplements for animal nutrition” is already regulated at EU level on legislation to feed, supplementary feed, feed premixes, food for particular nutritional purposes. In order to harmonize the conditions for the marketing and use of feed, to clarify of divergences and uncertainties due existing legislative vacuum, in order to ensure a high level of protection of public health and to provide adequate information to users and consumers, The Regulation (EC) No 767/2009 of the European Parliament and the Council on the marketing and use of feed, amending Regulation (EC) No 1831/2003 and repealing Council Directive 79 / 373/EEC, Council Directive 80/511/EEC, Directives 82 / 471/CEE, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217 / EC (1) approved. The new regulation simplifies and clarifies the existing procedures and renewal the legislation for the marketing and use of feed materials, compound feed and bio proteins, including dietary feed.

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Biocidal products: endorsement procedure for placing on the market

Authors: Mihaela Scripcariu, Simona Sturzu                                                                                 Affiliation: Institutul pentru Controlul Produselor Biologice si Medicamentelor de Uz Veterinar, Bucuresti

Biocidal products are active substances and preparations containing one or more active substances, put in a form that is supplied to the user, with aim to destroy, to prevent the action or to exercise control over a different effect any harmful organism by chemical or biological means. By definition, these products are susceptible to have harmful effects on humans, animals and the environment as the main objective of European legislative regulations in this area is to ensure the highest level protection by restricting the placing on the market and use only those biocidal products which have an acceptable risk of danger to humans or the environment. The favourable opinion for the placing on the market is made after the evaluation of technical documentation of biocidal products, completed by preparing a report of assessment with the formulation of the proposal to issue notice for placing on the market by the National Commission of Biocidal Products. ICBMV is designated as an authority competent to assess technical documentations on efficacy, chemistry and toxicity data of biocidal products, product type 3: Veterinary hygiene products.

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