New EMA regulations 2019/5 and 2019/6

European Union On January 7th, 2019 regulation 2019/5 was published in the Official Journal of the European Union “amending Regulation 726/2004, known as the Regulation on the Centralized Procedure. The new Regulation will apply from 28 January 2019. Regulation 2019/5...

Revision of guidelines of veterinary medicines for MUMS

EMA The Committee for Medicinal Products for Veterinary Use (CVMP) has updated the current guidelines on veterinary medicines for minor uses and minor species (MUMS). These revised guidelines provide more clarity on data requirements and include three guidelines...