Methodology for environmental risk assessment associated with the use of veterinary medicinal products

Author: Ioana Valentina Tihulca                                                                                                               Affiliation: Institute for Control of Veterinary Biological Products and Medicines

Environmental risk assessment (ERA) is mandatory for all new applications for centralized marketing authorization or national regardless of their legal basis. ERA aims to protect the environment. Risk assessment has two phases of veterinary product evaluation possible role of exposure and its effects. Phase I of the ERA is based on filling a decision tree with 19 questions. If the answers to these questions do not stop the assessment at this stage then is advancing to Phase II. It uses a two stage approach stage A and stage B. The first stage, stage A, studies using simple, less expensive studies. I f the assessment is not complete, then is appealed to Step B to drill ERA. If there is still a risk indicator after filling and assessment in stage B, then, to mitigate risk, is recommended the file discussing and of the proposals for additional data.

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Veterinary medicinal products for the bees – the current situation and future strategies – an important topic discussed at European level

Authors: Alina Karina Draghici, Anca Bitoiu, Lollita Taban                                                               Affiliation: Institutul pentru Controlul Produselor Biologice si Medicamentelor de Uz Veterinar, Bucuresti

To analyze the current situation and future issues relating to health and treatment options bees, bee breeders in Europe, agencies and drug manufacturers in Europe have held several meetings. One of these took place last year in December at the EMEA (European Medicines Agency) in London, United Kingdom. The purpose of this meeting was to consider the current situation of pathology in bees to identify the most common diseases found in this species, identification and lack of treatment options for some diseases, and identifying solutions to improve the situation.

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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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