Alexander Panin, director The All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed (VGNKI) Collaborating Center of the World Organization for Animal Health (OIE) "Food Safety, Diagnosis and Control of Animal Diseases in Eastern Europe, Central Asia and Transcaucasia" State registration of Veterinary vaccines in Russian Federation.

 The system of State registration of Veterinary drugs in Russia has been elaborated on the basis Federal low " The use of drugs" and has been started from  The drugs may be used in Russia after registration by Federal service for veterinary and phytosanitary surveillance ( Rosselchoznadzor).  The procedure of drugs registration includes: state registration of drugs, confirmation of previous registration, corrections and changes in existing registration documents.  State registration is compulsory to : original drugs, generic preparations, drugs which have been already registered but produced in new form or new dosage.  State registration of Veterinary drugs includes its quality and risk assessment. This procedure as well as analysis of presented for registration documents are performed by specialists of the All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed (VGNKI) - Collaborating Center of the World Organization for Animal Health (OIE) Food Safety, Diagnosis and Control of Animal Diseases in Eastern Europe, Central Asia and Transcaucasia. The procedure takes 210 working days. Based on the procedures results, registration document is issued for 5 years (for drugs registered ).  Confirmation of State registration based on the results quality and risk assessment. The registration document after conformation of the state registration is issued timeless.

 Corrections and changes of existing certificate should be justified. In case of changing drug dosage and its withdraw period for productive animals ( permitting to use food of animal origin) the appropriate expertise would be conducted. The procedure takes 90 working days.  Besides the state registration of vaccines for animals have to be subject to obligatory certification by accredited organization. Since 1993 this function has been fulfilled by the VGNKI.  Main important problem during the state registration process is control of vaccines potency.  Very often different companies use not the same methods for this procedure. It makes problems for registration.  One of the important tasks of the VICH should be standardization vaccines control methods or exception of equivalency principle.

Veterinary vaccine registered in Russia Animal species Bacterial vaccines Viral vaccines Dermatomycoses vaccines Associated vaccines ImportHomeImportHomeImportHomeImportHome Cattle and small ruminants Pigs Poultry Horses Cats, dogs, fur animals Other species of animals All of them Total

Probiotic feed additives

Intended forNumber AllDomesticImported Pigs Poultry18117 All animal species Silage yeast23914 Total Probiotics registrated in Russia

Bacteria used for probiotic preparations

 Safety of probiotic feed additives is indispensable part of general system biosecurity of domestic market food of animal origin and has great importance for human and animal health. At present time assessment of safety probiotic feed additives is a key point to get permission for their marketing.

1. Assessment procedure of safety and efficacy probiotic feed additives, performed by VGNKI.  Assessment of safety probiotic strain  Taxonomic identification the strain (family and species) by standard phenotypic, microbiological and biochemical methods with usage API panels (Biomerieux). -confirmation of the above identification by PCR (gene fragments 16S pRNA). 2. Assessment of quality indexes and reproduction of methods. 3. Assessment of efficacy feed additive. 4. Safety guarantees for human and animals. 5. Observation microbiological standards of secure production. 6. Stability of quality. 7. Transperancy of productions from producer to consumer. 8.Secure marketing

1. Harmonization of methods identification of microorganisms and indexes of their security (antibiotic resistance, Qualified presumption of safety- (QPS). 2. Establish national collection GRAS microorganisms (Generally Recognized as Safe) for use in the feed chain. 3. Analysis indexes of quality and efficacy probiotics and harmonization with EC requirements. 4. Standardization of control methods and assessment of uncertainty measure to get acceptable quality standards. Objectives for harmonization registration system and monitoring of quality and efficacy probiotic feed additives.

 PCR usage for detection of microbiological purity biological preparations.  Assessment cases of detection, by PCR, in biologies only genetic microbial material in the absence of the causative agent (e.g.mycoplasma).  We believe that the main task for Russian veterinary authorities is urgent acceptance of VICH principles. Objectives, in the framework of VICH, which are needed to be solved in the nearest future.