Our guidelines on submission of electronic applications to the Danish Health and Medicines Authority have been available on our website for some time, but we wish to draw attention to them once again.
As we have received a number of incorrect submissions, we kindly request applicants to read through the guidelines once more:
Guidelines on submission of electronic applications
Briefly stated, we remind applicants that we distinguish between "applications" and "submissions" in that one application consists of one or several submissions:
- First submission on a regulatory activity means the approach commencing a marketing authorisation application, variation, commitment, follow-up measure, referral to CMD or similar regulatory activity. The format of the first submission determines the format of the application.
- Supplemental information means a submission supplementing or correcting previously submitted documents under the same regulatory activity. This also applies to response to LoQ, etc.
- Working documents means draft versions of summary of product characteristics, package leaflet, and labelling editable by the Danish Health and Medicines Authority.
Format requirements
Submissions for human electronic applications must conform to either the eCTD (preferred format) or the NeeS standard. Submissions for veterinary electronic applications must conform to the VNeeS standard.
For requirements regarding PDF documents, please also see Technical details for electronic applications".
Working documents must be submitted in an electronic and editable format. The documents must be in MS Word format and must have a meaningful file name. For human medicinal products, please place the working documents outside eCTD/NeeS in a folder next to the eCTD/NeeS folder.
Name the working documents folder "XXXX-workingdocuments" where "XXXX" is the four-digit sequential number of the sequence which the working documents concern.
It must clearly appear from the cover letter and imprint on the CD or from the email that the submission concerns working documents only. For veterinary medicinal products, the working documents are placed in the folder "add-info" (additional information).
Media
The applicant must send the first submission of an electronic application by ordinary post or courier to the Danish Health and Medicines Authority's postal address. The submission must be made on a CD or DVD and accompanied by a signed and dated cover letter.
An identical copy of the cover letter (preferably generated from text source without signature) must be part of the electronic documentation. We do not accept the first submission of an application to be made by email or via Eudralink.
Supplemental information as well as working documents are to be submitted on CD/DVD with a signed cover letter or submitted by email via Eudralink to response@dkma.dk.
Please note that the Danish Health and Medicines Authority imposes the same format requirements on submissions via email or Eudralink as apply to submissions on CD/DVD – including naming requirements.
The subject heading must clearly refer to the Danish Health and Medicines Authority's case number and/or corresponding unambiguous reference, which the documents relate to.
In the case of working documents, these should generally be submitted by email or via Eudralink to response@dkma.dk, but could also be submitted on a CD or DVD (e.g. together with an electronic submission).
If the applicant submits more than one file by email or via Eudralink, the applicant must compress the attached files in a single archive file.
Documentation in NeeS/VNeeS or eCTD format must be compressed in an archive file, which maintains the original folder structure with an unambiguous four-digit sequential number, so that sequential numbers within the same dossier are only repeated for a new collective submission of a submission, which has been declared technically invalid.
Because of the Danish Health and Medicines Authority's electronic archives, we request applicants to describe to the Danish Health and Medicines Authority the structure applied on their dossiers and to follow this structure consistently, so that documentation which affect several dossiers are submitted in separate submissions and so that documentation is not repeated within the same dossier.
It is crucial that applicants do not submit the same documentation in parallel via different routes (e.g. via Eudralink and on CD at the same time) as this would require unnecessary resources to handle and compare documentation with already received versions.
Applicants must never send documents directly to the scientific officer, but must follow the submissions channels described above.
