LABORATORY ОF EXPERTISE OF NEW PRODUCTS
tel.: (380322)52-82-84
fax: (380322)52-11-93,
fax: (380322)52-11-93,
Laboratory chief
Candidate of Biological Sciences
Kosenko Yuri M.
Functions of laboratory:
- Expert evaluation of materials (files, scientific developments, normative documentation) on veterinary medical products and fodder additives of the Ukrainian and foreign production.
- Organization and conducting of testing of veterinary products and fodder additives aiming at their registration in Ukraine, preparation of expert’s conclusions due to their usage.
- Development of normative documentation that regulates the order of development, testing and registration of veterinary medical products, establishes requirements to their presentation on the market.
- International harmonization and technical cooperation with OIE, FAO, FAH, control institutes and national agencies of Europe and CIS.
- Scientifically methodological and consultative activity.
- Development of conception and coordination Governmental program of MRL control of veterinary medical products in products of animal origin.
- Secretariat of Governmental pharmacological commission on veterinary medicine.
- Statements about order of testing and registration of animal protection means, fodders, fodder additives in Ukraine.
- Requirements to documentation for expert evaluation of files and protocols of clinical testing of animal protection means presented for registration in Ukraine.
- Requirements to veterinary medical products testing aiming at their registration in Ukraine.
- Main statements of good manufacturing practice (GMP), good laboratory practice (GLP), good clinical practice (GCP).
- Statement about Governmental pharmacological commission on veterinary medicine is developed and justified by Minister Cabinet of Ukraine.
- Reference book of veterinary medical products and fodder additives of foreign production is published.
- Governmental program of MRL control of veterinary medical products in products of animal origin is developed.
Scientists of the laboratory provide expert evaluation of such materials as dossiers, developments, and normative documentation for veterinary preparations, feed additives and petfoods with the purpose of their further registration in Ukraine. They also prepare the expert conclusions about appropriateness of application of veterinary medicinal products. Development of normative documentation, which regulates the procedure for trials and registration and determines the conditions of placing on the market for veterinary medicinal products, is performed by laboratory. Another line of activities is guidance and consultations, which include organization of seminars, conferences, exhibitions, creation of geoinformation systems, formation of database of veterinary medicinal products, preparation of publications. The laboratory is responsible for international harmonization and technical cooperation with such organizations as OIE, FAO, FAH, EMEA, Codex Allimentarius, control institutes and national agencies of Europe and CIS; it maintains professional contacts with 156 companies from 39 countries. The laboratory also acts as concept creator and coordinator of the National System of Pharmacovigilance of veterimary medicin, and as secretariat of The State Pharmacological Committee for Veterinary Medicine of Ukraine.
Зразки необхідних для реєстрації документів
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