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New categories of antibiotics have been established, with specific guidelines on their use in veterinary medicine to limit public health risks.
These guidelines are crucial for reducing antimicrobial resistance, a growing public health concern, and ultimately safeguard both human and animal health by regulating veterinary practices.
Veterinary practitioners must now adjust their prescribing practices in accordance with the AMEG guidelines and monitor compliance with the new restrictions as outlined in the EMA's directive.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Veterinary practitioners must now adjust their prescribing practices in accordance with the AMEG guidelines and monitor compliance with the new restrictions as outlined in the EMA's directive.
Veterinarians in the EU must now adhere to new guidance on the use of certain antimicrobials, categorizing them into groups with distinct usage rules to combat antimicrobial resistance effectively. The guidance includes lists of human-reserved antimicrobials that are prohibited in animal treatment and those recommended for limited use.
What changed: New categories of antibiotics have been established, with specific guidelines on their use in veterinary medicine to limit public health risks.
Why it matters: These guidelines are crucial for reducing antimicrobial resistance, a growing public health concern, and ultimately safeguard both human and animal health by regulating veterinary practices.
Practical implication: Veterinary practitioners must now adjust their prescribing practices in accordance with the AMEG guidelines and monitor compliance with the new restrictions as outlined in the EMA's directive.
Published from the regulator source ingestion pipeline after PV impact triage.
Comments on the draft guidance must be submitted by November 27, 2026. Facilities must comply with CGMP in accordance with specified enforcement policies to avoid potential enforcement actions.
Review and verify that any cosmetic products sourced or distributed comply with the manufacturers listed in the updated QUEST system.
Update internal systems and workflows to integrate monthly Excel reports from EMA starting March 2025, ensuring timely capture of information on medicines under evaluation and any extension applications.
Regulatory Intelligence leads should initiate monitoring of feedback and prepare for potential regulatory adjustments related to the specified substances.
