News about Licensing and supervision

  • Zinc oxide for young pigs to be phased out

    | 19 December 2016 |

    The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

  • Phasing-out of the NeeS format for applications for marketing authorisations of medicinal products

    | 12 December 2016 |

    Due to an increasing number of requests, we would like to point out the phasing-out plan for NeeS and the transition to eCTD/VNeeS as outlined in the eSubmission Roadmap. The format requirements apply to applications for marketing authorisations for medicinal products as well as maintenance of these (variations, renewals etc.). The changes do not apply to parallel import and parallel distribution.