AVPHARM member companies continue to supply veterinary medicinal products

Members of AVPHARM are to continue supplying veterinary medicinal products as long as the national legislation allows. According to the Federal Service for Veterinary and Phytosanitary Supervision, the import of veterinary drugs to the Russian market continues alongside the increase in local production. To date, around 3,000 market authorizations for foreign veterinary drugs manufactured by more than 150 foreign production sites have been issued in Russia and other Eurasian Economic Union countries. Officially, imports from outside the EAEU exceed half of the local demand. Typically, the authorized bodies rely on import statistics and gross output figures of individual local manufacturers – this gives a limited picture of the actual state of the market. Such estimations may not recognize qualitative characteristics of drugs when one combination vaccine can replace several individual vaccines; market demand for treatments for less common animal diseases, which are critical for some pet owners, may be ignored; the status and dynamics of stocks are not taken into account.

AVPHARM notes that the difficulties in prompt supply to Russia of certain industry-specific materials and reagents for quality control of veterinary medicinal products will persist in 2023 and focuses efforts on overcoming this situation and preventing its impact on consumers. However, the main challenge for the international supply of veterinary medicinal products remains the Russian regulation and a new requirement to have a Russian certificate of compliance with the EAEU GMP for all foreign manufacturers entering into force on September 1, 2023. This new regulation is already affecting the supply of some popular drugs with long manufacturing cycles from production sites that do not have the necessary Russian certificates.

GMP is a list of quality and safety principles the human and animal health industries use in more than 100 countries. AVPHARM members take a responsible approach to quality and safety and confirm that their production sites involved in the production of veterinary drugs entering Russian and dozens of other markets worldwide meet the international requirements of GMP rules, as well as comply with the licensing requirements established in the countries of production.

AVPHARM member companies continue to undergo Russian EAEU GMP inspections to prepare for the new market release procedure of veterinary medicinal products that starts in September. Although the production sites of AVPHARM members have passed about 85 Russian EAEU GMP compliance audits, more than 70% of them ended unsatisfactorily, despite the international and Russian GMP certificates obtained before. Foreign companies continue to apply for new GMP compliance audits and pass them. Due to the legal impossibility to change the Russian inspection date, sometimes the applications are withdrawn to submit new ones. For example, the authorities indicate the withdrawal by Zoetis of the application for the audit of a production site located in Italy. The application was simultaneously replaced by a new one, requesting to advance the audit and to conduct it before the new requirement came into force, i.e., in summer instead of autumn, as planned. Currently, a new audit date has been set.

Unfortunately, the current dynamics and results of Russian EAEU GMP audits raise serious concerns. Despite the issuance of several new GMP certificates, including to the sites of AVPHARM members in late 2022 and spring 2023, there has been no radical change in the situation. Currently, less than 4% of veterinary drugs marketed by AVPHARM participants are “covered” with Russian GMP certificates.

To preserve access to imported drugs for local consumers, AVPHARM suggests that the authorities should consider establishing a transitional period in terms of the entry into force of the requirement to have a Russian EAEU GMP certificate for the new market release procedure. This would give all responsible companies, intending to continue the supply of their medicines, an opportunity to complete audits and, if necessary, to make the required changes, submit new applications, and successfully pass the audits.