The Danish Medicines Agency has formulated new guidelines on submittable formats for applications for marketing authorisation, variations, update prior to MRP, renewal, follow-up and referral to CMD. In addition, the guidelines on submission of paper applications have been revised. The new guidelines are intended to make it easier for companies to submit applications electronically and to ease our electronic processing of applications.
Guidelines are to facilitate electronic submission and processing
Since 1 January 2009, the Danish Medicines Agency has accepted the submission of electronic applications for marketing authorisations, variations, renewals, etc. under the centralised procedure, and the other procedures followed on 1 January 2010. In December 2010, the Danish Medicines Agency switched to full electronic processing. This has outdated the original guidelines on both paper and electronic applications and our with electronic-only applications and feedback from applicants have highlighted inconveniences, which have prompted a revision of the guidelines.
The Danish Medicines Agency has therefore developed a new set of guidelines for electronic applications. A number of technical details regarding these guidelines have been described in a separate document. We have also used the opportunity to compile, revise and structure the guidelines on submission of paper applications (the guidelines and technical details can be found in the box to the right). This revision has made it necessary to update the form "Confirmation for electronic-only submissions". The new guidelines enter into force today by the publication on the Danish Medicines Agency's website. We still accept submissions prepared under the previous guidelines, but advise applicants that the paper copy submitted as part of a mixed submission will not be considered (see below).
Applications under the centralised procedure are not covered by the new guidelines. We refer to the EMA's website instead.
Most important changes
We draw attention to the following changes in particular:
Preferred format
The Danish Medicines Agency's preferred format is eCTD for human medicines and VNeeS for veterinary medicines.
Paper applications
The Danish Medicines Agency still accepts paper applications, but we urge applicants to submit full electronic applications to the greatest extent possible.
Mixed submissions
For submissions made both on paper and electronically, we will assume the paper version to be included in the electronic version. Therefore, we dispose of the paper version without further processing and review the application according to the guidelines for submission of electronic applications.
Format switch
Until today, applicants who were unable to submit all application types electronically have been forced to submit all applications on paper. In order to give these applicants the possibility to submit electronic-only applications, the Danish Medicines Agency now accepts paper applications after submission of applications in NeeS or VNeeS format. This way, applicants do not preclude themselves from submitting paper-based applications by using the NeeS/VNeeS format.
This also means that the form "Confirmation for electronic-only submissions" need not be completed for submissions in the NeeS/VNeeS-format.
As before, we do not accept switches from applications in eCTD format to other formats.
Supplemental information submitted electronically
Even though an application has been submitted on paper, it still helps us considerably when any supplemental information is submitted only electronically. Consequently, we now accept supplemental information in NeeS or VNeeS format even though the first submission was on paper. We accept supplemental information in eCTD format, provided that the applicant commits to using the eCTD format for all subsequent submissions for the medicinal product in question.
As a result, the format requirements for supplemental information of a human application are:
And the format requirements for supplemental information of a veterinary application are:
Email and Eudralink
It is new that we now accept supplemental information and working documents (draft summary of product characteristics, package leaflet and labelling) to be submitted by email or via Eudralink. For working documents, email or Eudralink is the preferred submission route.
The documentation that the applicant submits by email or via Eudralink must:
- be supplemental information or working documents related to an application that was submitted previously by ordinary post,
- contain a clear and unambiguous reference to the case in the form of the Danish Medicines Agency's 10-digit case number or EU procedure number,
- comply with the same format requirements as apply to other electronic submissions,
- be compressed (zipped) in one single file,
- be sent to the email address response@dkma.dk
- be sent by email/via Eudralink as the only submission route (submissions both by email/via Eudralink and on CD are not accepted),
- for Eudralink: have a maximum expiry time (90 days).
If any of the above criteria are not met, the documents will be rejected without further processing.
The first submission (the actual application) of a case cannot be submitted by email or via Eudralink, but must still be submitted on CD or DVD together with a signed cover letter.
Number of copies
For both paper applications and electronic applications, one copy is fully sufficient. We advise applicants not to submit identical copies as we would have to allocate unnecessary resources to check if the documentation contains new information.
Identification of dossier
The Danish Medicines Agency archives electronic applications according to the structure of the dossier as chosen by the applicant. Each individual (technically valid) submission within each dossier must be named uniquely, and submissions affecting more dossiers must be archived in each affected dossier.
One dossier usually covers the entire product family (all forms and strengths), but it is up to the individual applicant to define the individual dossier. Therefore, we encourage applicants to describe to the Danish Medicines Agency the structure applied on the individual dossiers as well as to follow this structure consistently throughout the life cycle of the medicinal product.
