Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation

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Download document Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation
Reference number EMA/CVMP/849775/2017
Status draft: consultation open
First published 2018-07-27
Last updated 2018-07-27
Consultation start date 2018-07-27
Consultation end date 2019-01-31
Email address for submissions vet-guidelines@ema.europa.eu

Summary

Established veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance. Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the consumer of animal produce, or the environment. This may reduce product availability, which could have a negative impact on antimicrobial resistance development. At the same time, the principles for ethical use of animals in medicine testing encourage alternatives to the use of animals in the testing of medicines. Therefore, the CVMP has launched a pilot project to develop and test desk-based methodologies to optimise the dose of established veterinary antibiotics. The resulting reflection paper is available for public consultation until 31 January 2019.