Veterinary Medicinal Products
Veterinary medicines, also known as medicinal products for veterinary use, veterinary drugs or veterinary medicinal products (VMPs), are substances or combinations of substances to treat, prevent or diagnose disease in animals (EC).
Manufacturers of drugs, feed and feed additives for the veterinary industry must guarantee the safety of their products in four different areas: effect on target species, on people and those who handle them (work environment), on consumers of the derived food products and on the environment.
The current requirements and procedures (incl. safety toxicology for granting a marketing authorisation for veterinary medicinal products are laid down primarily in Directive 2001/82/EC and in Regulation (EC) No 726/2004. The new Regulation (EU) 2019/6 on veterinary medicinal products, published on 7 January 2019, repeals Directive 2001/82/EC and brings some new achievements.
Toxicity for the target species is evaluated preferably by means of in vivo testing performed on the species, in some justified cases it can be replaced by in vitro testing, which it is also acceptable by the authorities. InterBioTox offers a broad range of in vivo and in vitro toxicity studies in compliance with GLP to assess the safety of the veterinary drug according to requirements of VICH and CVMP (EMEA).
InterBioTox supports you as well in conduct of the environmental risk assessment (ERA) for the registration of your veterinary medicinal product in accordance with the requirements of the European Medicines Agency (EMEA)/ CVMP/ERA/418282/2005-Ref.1. The assessment consists of two phases. All ERA should follow the phased, step-wise approach detailed in the guidelines as issued by VICH and adopted by CVPM.
InterBioTox offers a complete GLP analytical services for determination of your veterinary medicinal product during in vivo toxicology studies, in order to achieve the product safety and regulatory compliance, and maintain the highest levels of laboratory quality control. The laboratories perform a method development and analytical validation of the veterinary products / active substances in many matrices. Choose the study...
InterBioTox can assist you in performance of the aquatic and terrestrial ecotoxicology to support ERA (Environmental Risk assessment, Phase II, acc. to CVMP/ERA/418282/2005) on veterinary medicinal product substances for your environmental safety assessment, fully in compliance with principles of GLP. Choose the study...
The specific soil biodegradation studies are recommended for Environmental Risk Phase II, acc. to CVMP/ERA/418282/2005. Laboratories of InterBioTox can help you to suggest the right strategy in GLP to evaluate a potential biodegradation and persistency of your veterinary medicinal product. Choose the study...
InterBioTox provides a wide spectrum of physico – chemical studies (e.g. OECD 105 Water solubility, OECD 107 or 117 Partition coefficient log Kow, OECD 104 Vapour pressure etc.) for compliance with Environmental Risk assessment, Phase II acc. to CVMP/ERA/418282/2005. Choose the study...
In the same way like biodegradation studies, the GLP laboratories of InterBioTox offer selected environmental fate studies (e.g. OECD 106 Adsorption/Desorption, OECD 308 Aerobic and Anaerobic Transformation in Aquatic Sediment Systems etc.) to be complied with Environmental Risk assessment, Phase II acc. to CVMP/ERA/418282/2005. Choose the study...
Where it is allowed, InterBioTox provides a replacement of in vivo testing with in vitro toxicology studies in GLP quality as an suitable alternative for in vivo safety assessment of the veterinary medicinal products.
Typical in vitro studies are in vitro genotox studies within the assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products (EMA/CVMP/SWP/377245/2016) and respective VICH guidelines. Choose the study...
InterBioTox performs a comprehensive mammalian / in vivo toxicology for your veterinary medicinal products to be performed as acute, sub-chronic, chronic and reproductive & developmental toxicology studies, genotox studies, local tolerance studies in GLP regime for purposes of the safety evaluation (specific VICH guidelines). Choose the study...
Histopathology, as a requisite part of the in vivo toxicology studies is performed by the laboratory of InterBioTox to support an evaluation of the veterinary medicinal products with respect to impacts to livestock health and safety evaluation. Choose the study...
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