Rosselkhoznadzor may restrict supplies of veterinary vaccines from a Spanish manufacturer.

According to the agency, laboratory animal tests of the drug have consistently revealed deviations in potency and safety. RUSSIA has requested information from the Spanish Agency for the Control of Medicines and Drugs on the results of its investigation into these incidents, as well as on the measures taken to prevent the supply of substandard products to Russia.

The report notes that the Spanish side did not provide responses to all requests sent by the Russian agency.

ROSSELKHOZNADZOR also clarifies that during the latest quality control conducted in Russia, non-compliance with quality requirements for the efficacy indicator was detected in the inactivated vaccine against atrophic rhinitis of pigs "Riniseng" (batch 502H-1, expiration date 06.01.2027) produced by the same manufacturer.

The test was conducted on laboratory animals. "According to laboratory test results, antibodies appeared in only 40% of the animals tested. According to the manufacturer's regulatory document, vaccination efficacy must be confirmed in at least 63% of the animals," the statement reads.

Withdrawal from circulation and supply restrictions

"The Service has decided to withdraw the specified batch of the Riniseng vaccine from civil circulation in accordance with paragraph 7 of Article 9 of Federal Law No. 61-FZ of April 12, 2010, 'On the Circulation of Medicines,'" the regulator added.

According to the agency, approximately 2 billion doses of various vaccines produced by Laboratorios Hipra S.A. have been imported into Russia.

"Considering the volume of supplies, the systematic nature of violations, the unequal approaches to monitoring the production of veterinary drugs, and the risks that may arise from the use of substandard vaccines in Russian agriculture, Rosselkhoznadzor sent a letter to the Spanish Agency for the Control of Medicines and Drugs warning of the possible introduction of restrictions on the import of these products following negotiations between the competent authorities," the statement reads.

The agency recalls that from 2017 to 2023, non-compliance with quality, safety, and efficacy criteria was repeatedly identified in veterinary drugs from six Spanish manufacturers: Laboratorios Hipra SA; Industrial Veterinaria SA INVESA; Laboratorios Maymo SA; Laboratorios SYVA sau; SP Veterinaria SA; Merck Sharp & Dohme AnimalHEALTH SL