Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation

This meeting will allow a direct exchange of views between the Agency's working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental approaches for dose optimisation and evaluating the consequences on withdrawal periods, target animal safety, and environmental risk assessment, with the objective of improving the SPC of veterinary antibiotics authorised in the European Union.

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