14 results
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Withdrawn application: Oxapex
date of withdrawal: 13/03/2012, Initial authorisation, Last updated: 25/06/2012 -
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Veterinary limited markets (updated)
Last updated: 08/11/2023 -
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Former EMA policy on minor use / minor species (MUMS) / veterinary limited markets (updated)
Last updated: 08/11/2023 -
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Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Scientific guideline
Last updated: 25/03/2022 -
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Classifications as minor-use-minor-species and limited-market according to former EMA policy
Last updated: 06/12/2021 -
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Data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 - Scientific guideline
Last updated: 01/10/2021 -
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Efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6
Last updated: 01/10/2021 -
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Safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 - Scientific guideline
Last updated: 01/10/2021 -
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Classification of a product as intended for a limited market and eligibility for authorisation under Article 23 of Regulation (EU) 2019/6 (Applications for limited markets)
Last updated: 23/07/2021 -
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News: Revised guidelines to encourage development of veterinary medicines for minor uses and minor species
CVMP, Last updated: 21/04/2017 -
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News: European Medicines Agency revises MUMS / limited-market policy
CVMP, Last updated: 18/06/2013 -
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News: Ten years of MUMS: 22 new veterinary medicines authorised for minor uses and minor species
Last updated: 25/03/2020 -
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Safety and residue data requirements for the establishment of maximum residue limits in minor species - Scientific guideline
Last updated: 25/02/2021 -
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Quality data requirements for applications for veterinary medicinal products other than biologicals intended for limited markets - Scientific guideline
Last updated: 21/07/2023