Implementation of The Russian Pharmacovigilance regulation Alexander Panin State Veterinary and Phytosanitary Surveillance Agency of the Russian Federation

The system of the pharmacovigilance implementation based on the Federal Law “ Circulation of the Medical products”(cover the veterinary products)

State Registration of the veterinary products The registration of the veterinary products including antimicrobials and substances for it preparation is carried out by Russia State Veterinary and Phytosanitary Surveillance Agency (Rosselkhoznadzor) The most important part of the registration procedure is the expertize of register dossier The expertise is carried out with a special focus on the term of antibiotics withdraw from animal organisms to define the withdrawal period Accepted levels of antibiotics is harmonised with regulation of the “Codex Alimentarius”

Antimicrobials registration procedure consists of the two steps : -- the registration document is issued and valid for 5 years. During this period Rosselkhoznadzor controls the pharmaceutical products circulation, including control for animal food products safety and antimicrobial resistance. - in case of absence of negative consequences after antibiotics application, the termless registration documente is issued. (For example: nowadays, due to the “strict” (zero) requirements determination to the level of nitrofurans, metronidazol and chloramphenicol residues in animal food products during the process of registration confirmation, the pharmocological products with content of above mentioned active substances do not receive approval for the further circulation in Russian Federation).

Certification of Registered antibiotics The registration of antibiotics means the right to its application on the territory of Russian Federation, while certification is the right of antibiotics’ trading. The certification process is focused on quality of antibiotics that confirm its application safety during the certificate validation period.

Monitoring for pharmacological products circulation The Rosselkhoznadzor on the basis of the annual plan carry out the selection of pharmacological products that contain antibiotics from producers, vendors and consumers of pharmacological products in all regions of Russian Federation for the quality control.

Antibiotics content medecines production Producers systematically (first two years after registration – every three month, next three years – annually and later – every three years) provide to Rosselkhoznadzor the information about quantity of produces pharmacological products and side effect after antibiotic application.

Antibiotics residues in animal products state monitoring According to the annual plan, by order of Rosselkhoznadzor the sampling the products of the animal origin are executed in every region in Russian Federation. The cases of detection of antibiotics residues in meat, milk, eggs, honey are determined as the improper use of products and investigated by Rosselkhoznadzor for exclusion of such cases in the future.

The list of documents that regulate the circulation of the antimicrobials Federal Law of Russian Federation from ‘’ Circulation of the medical products’’, 2010 Ministry of Agriculture of Russian Federation. The order ‘’Concerning the approval of administrative regulations for execution of functions of federal state surveillance in the field of veterinary pharmaceutical products by Rosselkhoznadzor”, 2013 Russian State resolution “ Concerning the approval of Regulation for pharmaceutical products production licensing”, 2012 Russian State resolution “ Concerning the licensing of pharmaceutical practice”, 2011

Expertise of register antimicrobials dossiers Quantity of register dossiers (2013)

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