Agency of veterinary medicinal products and feed additives

Mykola Verholyuk

Head of the Agency, Doctor of Philosophy in Veterinary Medicine

Tel: +38 (032) 252-82-84

The main functions of the Agency are:

1. Scientific expertise of the registration dossier for domestic and imported veterinary medicinal products (except biologicals), feed additives, premixes and prepared feed for the purpose of registration (re-registration) in Ukraine;

2. Giving the State Service of Food Safety and Consumer Protection of Ukraine suggestions on registration (re-registration, making changes (variations) in the registration materials, withdrawing the registration) grounded on data obtained in expertise and testing of investigated products;

3. Preparing Expert conclusions for the State Service of Food Safety and Consumer Protection of Ukraine and materials concerning the possibility of state registration of veterinary medicinal products, feed, feed additives, veterinary medicine means and remedies, products for veterinary purposes;

4. Monitoring of safety, quality and effectiveness of veterinary medicinal products (except biologicals), feed additives, premixes, prepared feed, veterinary medicine means and remedies, products for veterinary purposes, conducting targeted inspections and surveys;

5. Pharmacovigilance of veterinary medicinal products, registration, analysis and assessment of adverse effects revealed using authorized veterinary medicinal products and control compliance with its requirements;

6. Maintaining databases of authorized veterinary medicinal products, feed, feed additives, as well as adverse effects revealed using them;

7. Giving suggestions for prudent use of antibiotics in veterinary medicine for prevention the development of microbial resistance;

8. Carrying out the audit and inspections of companies for verification of compliance the requirements with good manufacturing practices, good distribution practices;

9. Ensuring technical and scientific support in State international cooperation on registration (re-registration) of veterinary medicinal products, feed and feed additives;

10. Within its competence, involved in adapting national legislation to EU as well as collaboration with with relevant institutions in EU.

The Agency is an information link, connecting Ukrainian veterinary medicine and the international community. Scientists of the Agency constantly carry out international harmonization of Ukraine regulatory documents and technical cooperation with leading organizations and scientific associations in the world, such as OIE, VICH FAO, FAH, EMA, Codex Allimentarius. Agency effectively collaborates with French Agency for Veterinary Medicinal Products (ANMV) Fougeres (France); Institute for State Control of Veterinary Biologicals and Medicines (ISCVBM), Brno (Czech Republic); National Veterinary Research Institute (NVRI) Pulawy (Poland). Annually the Agency receives about 1500 registration dossier for examination. Within the State registration Agency organize analytical testing. The Agency is collaborating with 160 firms in 39 countries. Agency co-workers conduct inspection of production of veterinary medicinal products and feed additives, both in Ukraine and abroad.

Main developments of laboratory:

1. Agency main developments.

2. Regulation on the procedure of examination, testing and registration of animal protection means, petfoods, feed additives and substances in Ukraine.

3. Requirements for the registration dossier for veterinary medicinal products, feed additives, premixes and prepared feed.

4. Requirements for documentation on expert evaluation of dossiers and protocols of clinical ttials of veterinary medicinal products, presented for registration in Ukraine.

5. The main provisions, procedures and rules of Good Manufacturing Practice (GMP).

6. Guidelines for the organization and functioning of the veterinary pharmacovigilance.

7. Regulation on the State pharmacological commission of veterinary medicine, approved by Cabinet of Ministers of Ukraine.

8. Draft of the Law of Ukraine “On feed additives”.

9. Published Reference books: 1) Veterinary Medicinal Products and 2) Feed Additives and Premixes.

10. National Programme for control residues of veterinary medicinal products in products of animal origin is developed.

11. The control over the turnover of antimicrobial veterinary products.