National Agency of Veterinary Immunobiological Drugs
Head of department
Protchenko Nataliya Ivaniivna
DEGREE: candidate of veterinary sciences
ACADEMIC STATUS: senior research fellow
Publications: he is a co-author of 10 scientific and review articles, 5 printed editions of DSTU, GSTU.
AWARDS:
- Labor award of the Ministry of Agrarian Policy of Ukraine “Badge of Honor”
- certificates of SSCIBSM
PARTICIPATION IN SCIENTIFIC COUNCILS, COMMISSIONS:
- Deputy Chairman of the Expert Council of the SSCIBSM
Information about the unit
The National Agency of Veterinary Immunobiological Preparations is a structural division of the State Scientific Control Institute of Biotechnology and Strains of Microorganisms.
The national agency was created to implement state policy in the field of state registration/re-registration and control of veterinary immunobiological drugs, veterinary medicine and veterinary products with the aim of:
- examination of registration dossiers and registration tests during registration/re-registration of veterinary immunobiological drugs of domestic and foreign production in Ukraine;
- monitoring the quality, harmlessness and effectiveness of veterinary immunobiological drugs, veterinary medicine and products for veterinary use, carrying out targeted inspections and surveys;
- organization of pharmacological supervision of veterinary medicinal products;
- implementation of monitoring and coordination of the market of veterinary medicines, veterinary medicine and products for veterinary use;
- coordination and effective use of scientific resources in the field of veterinary pharmacology to ensure the quality and effectiveness of veterinary immunobiological drugs;
- conducting audits and inspections of enterprises to confirm good manufacturing practice (GMP), good distribution practice (GDP), good clinical practice (GLP).
Within the limits of its powers, the National Agency organizes the implementation of legislative acts and exercises control over their implementation, summarizes the practice of applying legislation on issues within its competence, develops proposals for improving the legislation and, in the established order, submits them for consideration by authorized state bodies.
Structure
- Sector of technical examination and storage of registration dossiers – Nataliya Ivanivna Protchenko.
- Sector for the organization of work on the registration of veterinary immunobiological means – Serhii Oleksandrovych Boyanovskyi.
The main directions of the unit's work
The National Agency carries out a coordinated comprehensive scientific and technical examination of veterinary immunobiological preparations, veterinary medicine and veterinary products submitted for registration/re-registration. Provides expert opinions with recommendations to the State Service of Ukraine on Food Safety and Consumer Protection and the State Pharmacological Commission of Veterinary Medicine of Ukraine.
The National Agency organizes and coordinates registration trials of veterinary immunobiological drugs, veterinary medicine and veterinary products submitted for registration/re-registration. On the basis of the received data, submits proposals to the State Production and Consumer Service for registration, re-registration, making changes to the registration dossier, refusal to register researched drugs.
Prepares conclusions and materials for the State Production and Consumer Service regarding the possibility of state registration of veterinary immunobiological drugs.
Develops and approves normative legal acts on issues within his authority.
Maintains databases of registered veterinary immunobiological drugs.
Provides consultations on issues within his competence.
Provides technical and scientific support in the field of international cooperation of the state on registration/re-registration and control of veterinary immunobiological drugs.
The National Agency is an arbitral body in the field of veterinary pharmacy and in case of conflicting conclusions of various organizations regarding the quality of veterinary immunobiological preparations, it provides the final conclusions. During their preparation, the National Agency contacts all interested parties to take into account all possible information and identify any contradictions.
Within the scope of its powers, the National Agency participates in the adaptation of national legislation to the legislation of the European Union, and also cooperates with relevant EU institutions.
