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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.
Note regarding submission requirements: One copy of a CD/DVD, accompanied by the original signed cover letter and the "Confirmation of eCTD submission " (only required in case of the 1st eCTD submission of a certain product) is sufficient for the DKMA.
For electronic applications (eCTD/NeeS), the requirements regarding eSignatures have been detailed. Submissions on a CD or DVD must be accompanied by a dated cover letter bearing an original wet signature. DKMA does not require the electronic documents to be signed. The electronic version of the cover letter is not required to bear a signature.
For details regarding electronic submission see "Guidelines on submission of electronic applications" and "Technical details for electronic applications" on the DKMA" website
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Paper applications must include all required documents in paper. In addition, working documents must be provided electronically in MS Word format via Eudralink or via CD/DVD. In case of CD/DVD, these must be clearly labelled with "Working documents" in order to avoid beeing mixed-up with true electronic submissions (eCTD/NeeS). For details see "Guidelines on submission of paper applications" on the DKMA website.
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[Source: DKMA website]
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