The working party provides relevant expertise and input to EMA's CVMP on all matters related to the dosage review and adjustment of selected veterinary antibiotics (ADRA) project.
This project aims to minimise antimicrobial resistance while safeguarding the availability of first-line treatment veterinary antibiotics in the European Union (EU). This helps ensure antibiotics are efficacious and safe when used in accordance with the product information.
For more information on CVMP working parties and other groups, see:
The working party provides ad-hoc support to the CVMP rapporteurs on matters on preparation of the respective scientific advice.
The support involves reviewing and refining dosage regimen in the product information of selected antimicrobial substances.
This is in line with the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6).
In this way, the working party ensures the continued efficacy and safety of antibiotics, and supports minimising the occurrence of antimicrobial resistance in the EU.
The working party also provides expert advice on specific matters in relation to dosage review and adjustment, when CVMP requests it. This refers to:
The working party's scientific advice has implications for:
The initial CVMP scientific advice procedures in ADRA are a pilot, providing temporary additional support for designing methodologies. That is why this working group is called temporary.
Full information on the working party's activities, responsibilities, composition and procedures is available in the documents below:
CVMP nominates and appoints the European experts that make up the composition of the working party.
Additional observers may also attend the meetings of the working party, if required.
Below (in alphabetical order of surname) are the current members of the working group. The members' declarations of interests are available in the European expert list.