EMA's Committee for Veterinary Medicinal Products (CVMP) set up the Dosage Review and Adjustment of Established Veterinary Antibiotics (ADRA) project to refine the dosages for veterinary antibiotics that have been on the market for a long time.
The product information for these antibiotics may contain outdated dosage regimens that no longer reflect the current scientific knowledge.
ADRA's scientific assessments use already existing data to streamline the review process of the product information.
Overall, the ADRA project helps to further promote the responsible use of antibiotics in animals which contributes to lower the risk of antimicrobial resistance in both animals and humans in the European Union.
For more information, see:
The ADRA project intends to provide veterinarians and farmers with access to refined antibiotic dosages. This can help to:
ADRA's scientific assessments to update the dosage regimen in the product information rely on data from non-experimental methods.
There is no need for marketing authorisation holders to generate new data.
This approach is less costly for companies than the standard variation procedure, which requires new data and studies. As a result, it contributes to maintaining the availability of important and commonly used veterinary antibiotics.
This provides veterinarians and farmers with more treatment options, reduces reliance on other antibiotics, and ultimately protects animal health.
The ADRA project follows the principles laid out in the reflection paper below:
CVMP reviews each dosage regimen separately for specific combinations of:
In 2024, CVMP adopted a priority shortlist of antimicrobial candidate substances to guide the sequence of ADRA assessments. CVMP developed this shortlist in consultation with national competent authorities and the veterinary industry.
CVMP conducts its reviews under Article 141(1)(i) of Regulation (EU) No 2019/6, following the prioritisation set on the shortlist.
EMA identifies which veterinary medicines fall within the scope of each procedure so that all relevant marketing authorisation holders can be involved.
To check all Article 141(1)(i) procedures, see:
To bring together the relevant expertise to support ADRA's scientific assessments, CVMP established the Dosage Review and Adjustment of Established Veterinary Antibiotics temporary Working Party.
For more information, see:
The timeline below provides an overview of key activities supporting the implementation of the ADRA project.
All dates provided are estimates and may be subject to change.
Preparation phase
Included the definition and adoption of the priority shortlist of antimicrobial candidate substances and stakeholder engagement events
Ended in October 2025
CVMP scientific advice phase
Assessment of first scientific advice under Article 141(1)(i) procedure
From October 2025 to January 2027
Implementation phase
Submission of variations
From first quarter of 2027
EMA invites all relevant stakeholder groups to submit input that may support the CVMP’s work in developing scientific advice on the use of antimicrobials, including:
EMA organised stakeholder engagement events in the context of the ADRA project. These included an information session and a focus group meeting for marketing authorisation holders concerned in the first Article 141(1)(i) procedure.
For more information, see:
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The tracking of updates begins in March 2026.
12 March 2026
Page first published.