DMA announces timelines to phase-in eCTD and VNeeS formats
The latest announcement from the Danish Medicine Agency (DMA) specifically points out elimination plan for NeeS format and emphasizes the consequent transition to eCTD for human domain / VNeeS for veterinary domain as directed in the eSubmission Roadmap. With the reports, it is to understand that the electronic format requirements will apply to both new applications for marketing authorizations of medicinal products as well as maintenance of variations or renewals.