The Agency is hosting an information session on the dosage review and adjustment of established nationally authorised veterinary antibiotics (ADRA) project.

 This meeting will facilitate a direct dialogue between the European Medicines Agency (EMA) and veterinary industry stakeholders.

The ADRA project aims to minimise the occurrence of resistance in the Union whilst safeguarding the availability of first-line treatment veterinary antibiotics in the EU, ensuring they are efficacious and safe when used in accordance with the product information.

The ADRA project aligns with the 2017 CVMP reflection paper, which highlights the development of non-experimental approaches to refine the dosage regimens of established veterinary antibiotics.

Additionally, the project seeks to evaluate the implications of any dose review on withdrawal periods, target animal safety and environmental risk assessment without necessitating the generation of new data.

Refined dosages in the product information will further ensure the responsible use of antibiotics in veterinary medicine.

A video recording of the event, along with the relevant presentations, will be made available on this page after the event.

Veterinary industry representatives are encouraged to submit questions in advance via Slido.