New rules for preparing registration dossiers came into effect on September 1

Since autumn 2025, companies producing veterinary medicines have adopted a new approach to working with registration dossiers.

This change is linked to the creation of a veterinary medicines unified register within the Eurasian Economic Union.

If an existing dossier does not meet the new requirements or lacks preclinical research data, manufacturers must conduct additional studies. This applies to products that were previously registered under national procedures.

Special attention should be given to:

• product safety evidence;
• pharmacokinetic reports;
• methods for determining residual levels of active substances in pet origin products;
• documents confirming these analytical methods validation.

Source: fsvps.gov.ru