The Danish Medicines Agency (DKMA) has restructured the information regarding submission format for paper applications and electronic drug applications in eCTD / NeeS format. In parallel the instructions provided have been more detailed.
Formats still accepted are paper, eCTD and NeeS/VNeeS. The DKMA strongly prefers electronic formats. For human drugs,the eCTD is the preferred format. "Mixed" formats are no longer accepted: With the exception of the cover letter and (for the 1st eCTD submission of a product) the "Confirmation for eCTD submissions", all paper documents provided as supportive information to an electronic application in eCTD / NeeS format will no longer be processed, but destroyed. With regard to electronic applications, the DKMA does now consider applications that include acceptable electronic media (CD/DVD) as electronic submissions, unless the CD/DVD contains supportive working documents to a paper submissions.
For More information click here: Exalon: Danish Medicines Agency updated information on the format and submission requirements for eCTD / NeeS and paper
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