Antimicrobial-resistance surveillance as post-marketing authorisation commitment - Scientific guideline

This document has been developed to address requirements for post-authorisation studies for antimicrobial veterinary medicinal products in order to ensure the benefit-risk balance remains positive in case of development of antimicrobial resistance, as laid out in Article 36(2) of the Regulation.

Keywords: Antimicrobials, antibiotics, antiprotozoals, antivirals, antifungals, antimicrobial resistance, monitoring, surveillance, post-authorisation, benefit-risk, MIC, susceptibility testing, resistance mechanisms

Current version

Concept paper on a guideline on data requirements for post-authorisation studies for antimicrobial veterinary medicinal products under Article 36(2) of Regulation (EU) 2019/6

Draft: consultation closedConsultation dates: 16/09/2022 to 31/01/2023Reference Number: EMA/CVMP/AWP/201064/2022

Reflection paper on antimicrobial resistance surveillance as post-marketing authorisation commitment

Reference Number: EMEA/CVMP/SAGAM/428938/2007

Document history

Overview of comments received on reflection paper on antimicrobial resistance surveillance as postmarketing authorisation commitment (EMEA/CVMP/SAGAM/428938/2007)

Reference Number: MEA/CVMP/SAGAM/341254/2008