Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor)
FGBI ARRIAH Experts Participated in Negotiations on FGBI ARRIAH Vaccine Registration in Unified EU Register and on GMP Audits


07.07.2017 09:24

On April 5-8, 2017, the delegation of the Rosselkhoznadzor subordinate FGBI “Federal Centre for Animal Health” represented by D. Lozovoy (Director) and S. Starov (Deputy Director for Quality) participated in the negotiations on registration of the FGBI ARRIAH-manufactured vaccines in the Unified EU Register, on GMP audits and distribution of the FGBI ARRIAH products in Bulgaria. The negotiations were held in the Bulgarian Food Safety Agency (BFSA), Sophia, Bulgaria.

The Bulgarian party was represented by the officers of Mintech Co EOOD and GMP experts. Paskal Zhelyazkov, BFSA Director, Doctor of Biology, told about the agency’s activities and basic trends of its development. The Bulgarian Food Safety Agency (BFSA) is the only authority charged with official control of compliance with phytosanitary requirements, means of plant protection and fertilizers, veterinary activities, animal health and welfare.

Dmitry Lozovoy in his turn made a presentation on the ARRIAH’s activities, told about research results in the area of biosafety and veterinary welfare. Sergey Starov continued the presentation giving data on surveillance and control of veterinary products manufactured in the FGBI ARRIAH.

Over the years FGBI ARRIAH has been acting in strict compliance with the Good Manufacturing Practice for medical products approved by the Order of the Ministry of Trade of Russia on 14.06.2013 No. 916 that is an effective tool for maintenance exports of competitive products. The national GMP is based on scientifically grounded and EU approved GMP model.

In December 2016, certification audit was performed in the FGBI ARRIAH with the participation of Mintech Co EOOD. During the audit compliance with the EU GMP requirements was checked. Analysis of audit results by the BFSA demonstrated full compliance with the EU GMP requirements.

In February 2017, FGBI ARRIAH was awarded with GMP Certificate No. 61/2017/GMP stating compliance with the EU Good Manufacturing Practice. The certificate confirms the fact that the products for veterinary use manufactured by the FGBI ARRIAH are compliant with the EudraLex, V.4 EU Guidelines for Good Manufacturing Practice for Drugs for Humans and Animals published following Directive 2003/94/EC.

Being the biggest national manufacturer of immonobiological products the FGBI ARRIAH complies with GMP requirements thus gaining competitive position on the market of biopreparations and working on good recognition in the manufacturing area as well as on public image perfection and ability for development of new projects and business technologies.

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