DEPUTY DIRECTOR OF FSBI "VGNKI" VASILINA GRYTSYUK MADE A REPORT AT THE II INTERNATIONAL VETERINARY FORUM ON PIG BREEDING
From June 27 to June 28, 2023, the II International Veterinary Forum on Pig Breeding was held in Moscow. The event was attended by veterinary and zooengineering specialists of agro-industrial and pig-breeding complexes, representatives of federal and regional authorities of the agro-industrial complex, domestic and foreign companies - manufacturers of veterinary drugs and feed additives for animals, the scientific community and industry media.
The main issues for discussion at the forum were priority areas in the development of domestic pig breeding, the current situation in Russia regarding especially dangerous parasitic and infectious diseases of pigs, modern methods for diagnosing, preventing and controlling such diseases, as well as standards in the field of circulation of medical drugs for veterinary use.
The report presented by Vasilina Gritsyuk, Deputy Director of the “The Russian State Center for Animal Feed and Drug Standardization and Quality (FSBI "VGNKI"), was devoted to the introduction of veterinary medical drugs into civil circulation.
“From September 1, 2023, the procedure for introducing medicinal products for veterinary use into civil circulation is being established. This order is different for immunobiological and pharmacological drugs,” said Vasylina Gritsyuk.
Before putting into civil circulation each batch of a medicinal product for veterinary use produced in the Russian Federation, with the exception of an immunobiological one, the manufacturer shall notify the federal executive body of the following documents:
- a manufacturer's document confirming the compliance of the quality of the medicinal product for veterinary use, introduced into civil circulation, with the requirements established during its state registration;
- confirmation of the person authorized by the manufacturer of medicines that the medicinal product for veterinary use complies with the requirements established during its state registration;
In the event that each batch of a medicinal product for veterinary use imported into the Russian Federation, with the exception of immunobiological drugs, is put into civil circulation, the importing organization shall, in a notification procedure, submit to the federal executive body a partially different list of documents:
- a document from the manufacturer of medicinal products confirming the conformity of the quality of the medicinal product for veterinary use, introduced into civil circulation, with the requirements established during its state registration (same as when introducing into civil circulation each batch of a medicinal product manufactured in the Russian Federation);
- confirmation of the person authorized by the holder or owner of the registration certificate of the medicinal product for veterinary use, compliance with the requirements established during its state registration.
For the first two batches of a medicinal product for veterinary use, first produced in the Russian Federation or imported into the Russian Federation for the first time, test reports on their compliance with quality indicators are submitted. Tests are carried out by testing laboratories and centers accredited in the national accreditation system, among which is the Testing Center of the Federal State Budgetary Institution "VGNKI" on Zvenigorodskoye shosse.
“The introduction into civil circulation of an immunobiological medicinal product for veterinary use produced in the Russian Federation or imported into its territory is carried out on the basis of a permit issued by the federal executive body in the field of circulation of drugs for veterinary use,” explained Vasilina Gritsyuk.
In addition, the speaker drew attention to the fact that the provisions of Part 10 of Article 47 and Article 52.2 of the Federal Law of April 12, 2010 No. 61-FZ “On the Circulation of Medicines” do not apply to series of medicinal products for veterinary use put into civil circulation on the territory of the Russian Federation until the date of entry into force of this Federal Law.
At the end of her speech, Vasilina Gritsyuk reminded that for failure to submit or late submission of the necessary documents and information to the Rosselkhoznadzor, drug manufacturers and organizations that import them into the Russian Federation are liable in accordance with the legislation of the Russian Federation.