LLC Elanco Rus to Cease AVPHARM Membership
Further work with the Russian representative office of Elanco Animal Health will change in view of the company's plans for further operations in Russia.
Russian subsidiary of Elanco Animal Health commented the recent decision: “LLC Elanco Rus made a decision to cease its membership in the Association of Veterinary Pharmaceutical Manufacturers (AVPHARM). Earlier the company informed other member companies of its intention to maintain its presence in the common market of the Eurasian Economic Union (EAEU) and to continue supporting consumers of Elanco products. The Corporation also takes the new Russian legislation requirements in regards to the veterinary medicinal products into account and continues internal discussions on the mode of further work and operations in the Russian Federation”.
Elanco Animal Health is one of the leading international developers of innovative solutions in farm animal and pet health solutions. The company’s portfolio includes more than 200 brands of veterinary drugs, and its products are marketed in more than 90 countries. Its Russian portfolio consists of about 50 marketing authorizations with more than 20 vaccines for farm animals.
Starting September 1, 2023, the majority of foreign VMP manufacturers won’t be able to continue their supplies to Russia due to the new market release procedure for veterinary drugs. The new requirement implies that all foreign-made VMPs in the Russian market are to be originated from production sites covered with valid EAEU GMP certificates issued by Russian authorities.
In total, foreign VMP manufacturers have made about 200 attempts to pass Russian GMP audits since their beginning in 2017 with most of them ending unsuccessfully. Among AVPHARM member companies, more than 70% of Russian audits for the described period ended in refusals to issue a GMP certificate.
AVPHARM has repeatedly emphasized that the planned entry into force of the new regulation would have a negative impact on the availability of imported veterinary drugs to consumers in Russia and other EAEU countries as well as on international businesses’ further operations in Russia. The new regulation has already influenced current supplies of a number of drugs with a long production cycle originating from production sites without the necessary Russian EAEU GMP certificates.
AVPHARM member companies and Elanco Animal Health prioritize the supply of quality and safe VMPs in accordance with the local legal requirements. Elanco Animal Health commented that the internal focus of the company and its Russian representative office, LLC Elanco Rus, will be on improving the production sites and bringing them into compliance with the requirements of the Russian authorities.
In the near future, the AVPHARM member companies will conduct internal discussion to elaborate a decision on further work with LLC Elanco Rus. The Association of Veterinary Pharmaceutical Manufacturers is to continue constructive dialogue with Elanco Animal Health in the interests of consumers in the EAEU common market.
