AVPHARM Stresses Importance of Ongoing Dialogue
At the 10th Pan-Russian GMP Conference, AVPHARM’s Executive Director Simeon Zhavoronkov addressed the GMP audits of VMP manufacturers from third countries and outlined the factors hindering the transition to the EAEU common rules.
Currently, the majority of veterinary medicinal products in the Eurasian Economic Union are registered in Russia or by Russian legal entities. Now, with all five EAEU member states involved in the regulation of VMP circulation, new challenges are emerging alongside the existing ones.
“Businesses expect their national regulator — in our case, the Russian authority — to provide greater transparency about the process, including the frequency of document updates and the level of readiness of each EAEU member state to implement the Rules,” Zhavoronkov emphasized.
In response to a question from industry representatives, Anna Babushkina, Deputy Head of the Federal Service for Veterinary and Phytosanitary Supervision’s Department for State Veterinary Supervision, said that the Rosselkhoznadzor is preparing a dedicated section with information on the transition to the EAEU Rules, which will be published online shortly.
AVPHARM presented its analysis of GMP audits carried out at manufacturing sites outside the EAEU. The data shows a positive trend: for the second year in a row, the number of positive decisions has exceeded the number of negative ones. As of today, 63 manufacturing sites from 25 non-EAEU countries hold valid Russian GMP compliance decisions. According to the Association, the speed of obtaining such decisions has also increased in recent years, averaging 215 calendar days.
“We see a positive trend and expect it to continue both in Russia and in the transition towards new system of joint GMP audits under the EAEU Rules. <…> The workload for the inspection bodies in EAEU will be enormous: according to our estimates, more than 70 GMP certificates will need to be issued annually. This means there will be enough work for all the Union’s member states,” Zhavoronkov noted.
Following the session, AVPHARM will send additional technical questions requiring clarification to the relevant authorities. “It is crucial that the dialogue continues and that decisions are taken jointly. Only in this way will we be able to develop a competitive veterinary medicines market,” concluded AVPHARM’s Executive Director.
The panel session “EAEU Common Market for Veterinary Medicinal Products” was held as part of the 10th Pan-Russian GMP Conference on September 15. For the first time since 2022, the program included issues concerning veterinary pharmaceutical manufacturers. The session was organized by the FSFI “VGNKI”, the Association of Veterinary Pharmaceutical Manufacturers (AVPHARM), the National Veterinary Association, and the Vetbioprom Association.
Image by AVPHARM
