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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. The changes, however, will not apply to parallel import and distribution.
eCTD for Human and VNees for Veterinary Domains
Ever since the DMA has started accepting electronic-only applications, eCTD prevailed as the only acceptable electronic format in case of Human Domain, and VNeeS as the only acceptable electronic format for the Veterinary Domain.
On a European level, however, no common plan has been made for eliminating the NeeS format in the National Procedure (NP). Hence, the DMA has also decided to apply the existing format requirements for both NP as well as the Mutual Recognition Procedure (MRP) to avoid national maintenance of the NeeS format. In case a common European plan is made for the format requirements for NP, the DMA expected to follow suit to simplify the regulatory authorities’ requirements for industry which is expected to be announced on its official website.
DMA deadlines for eCTD and VNeeS
As published on the DMA website, implementation of eCTD and VNeeS as the only acceptable electronic formats will take place as follows:
- NeeS applications will no longer be accepted, from 1 January 2017, for new marketing authorisations (including switch from NP to MRP as well as Repeat Use Procedure (RUP))
- VNeeS applications will be the only acceptable electronic format, from 1 January 2017, in the veterinary domain (all procedures and case types)
- eCTD will be the only acceptable electronic format, from 1 January 2018, in the human domain (all procedures and case types)
However, as per the guidelines, manufacturers are still eligible to send paper-based applications to the DMA until the further notice, but receipt and assessment of such applications are exhaustive and time-consuming is what to be considered. So, to reduce the agency’s overall review time, you are encouraged to switch to the eCTD/ VNeeS formats at the earliest. To streamline your NeeS to eCTD conversions, avail a flexible publishing and submissions tool to effectively manage and overcome the procedural and operational complexities.
