Guidelines for submission and technical validation of applications
These guidelines concern applications for marketing authorisations, including variations, updates before MRP, extensions and follow-up cases. The guidelines also apply to Active Substance Master Files (ASMFs) submitted by the applicant and ASMF holder (see the section "Special notes on ASMF" below).
These guidelines complement the guidelines etc. issued by the EMA, CMDv, CMDh and apply to applications submitted under the national procedure, mutual recognition procedure (MRP) and the decentralised procedure (DCP).
For information about applications under the centralised procedure, please see the guidelines on the EMA website. Read information about applications for parallel import here.
Correct use of life cycle attributes in the eCTD
It is important that applicants and/or marketing authorisation holders use the right attributes (new, replace, delete) when parts of the dossier are updated – e.g. in connection with a response or a variation application.
Whenever a sequence is submitted, it must be considered if the document in question is completely new (i.e. the attribute “new” must be used) or if it is to replace an existing document in the dossier (i.e. the attribute “replace” must be used). It is also possible to use the attribute “delete”, thereby deleting a document that no longer applies.
If, for example, the attribute ”new” is used when in fact it should have been ”replace”, a non-applicable document will become part of the dossier. For further information, please see section 2.9.6 Leaf Lifecycle Operation Attributes in the Harmonised Technical Guidance for eCTD Submissions in the EU.
In this connection, we kindly advise you that it is always possible to use a closing sequence.
Link to the eCTD guide: Harmonised Technical Guidance for eCTD Submissions in the EU.
Submission via CESP
Submission of the initial application as well as supplemental information and working documents must be done via CESP. Submission via CESP is possible for DCP, MRP and the national procedure. For guidelines on CESP submissions, please see cespportal.hma.eu.
Physical submissions
The Danish Medicines Agency doesn´t accept physical submissions, e.g. in paper form or on CD/DVD. These submissions must instead be made electronically and according to the guidelines for electronic submissions.
Electronic format requirements
Submissions for human electronic applications must be made in eCTD format. Submissions for veterinary electronic applications must be made in VNees format. Please find links to these standards in the box to the right.
In special circumstances, where it is not possible to submit in eCTD format, e.g. in connection with the change of MAH or representative, the application can be submitted via CESP in a non-eCTD/VNeeS in PDF format. If a non-eCTD/VNeeS submission is made, the applicant should make an explicit note about this, for example in the CESP comment field.
Technical validation
The documentation submitted must comply with the technical specifications laid down by ICH, EMA and CMDh/CMDv.
The Danish Medicines Agency will perform a technical validation of the applications pursuant to the criteria of the common European specifications.
The Danish Medicines Agency may choose to accept an application that does not fully comply with all criteria.
Supplemental information and working documents
Supplemental information and working documents can be submitted via CESP, Eudralink or email. Please note that the Danish Medicines Agency imposes the same format requirements on submissions via email, Eudralink and CESP. See the list of mailboxes in the medicines licensing area.
If more than one file is submitted by email or via Eudralink, the applicant must compress the attached files in a single archive file. Documentation submitted in eCTD or VNeeS format must also be compressed in an archive file, maintaining the original folder structure. The archive file must be an MS Windows zip file.
Parallel submissions
It is important that applicants do not submit the same documentation in parallel via different routes (e.g. via Eudralink, CESP and email at the same time) as it would draw on unnecessary resources to handle and compare documentation to already received versions.
Special notes on ASMF
In order to facilitate the identification and handling of submissions related to the Active Substance Master File (ASMF), we ask the ASMF holder to clearly reference the case number of the Danish Medicines Agency (the format number is usually 2215-xxxx) in the cover letter and indicate that it concerns an "ASMF-related submission submitted on behalf of an ASMF holder".
Please also see the EMA's ASMF eCTD Guidance (under "eCTD and ASMF") for guidance on ASMF in eCTD-format.
Special notes on preliminary submissions
We regularly experience that applicants come under time pressure and cannot arrange the supplemental information in the correct electronic format (eCTD/VNeeS), and that they nonetheless choose to submit it as supplemental information. Any such submissions are technically invalid according to the common European guidelines.
Nevertheless, if an applicant wishes to make a preliminary submission during a procedure, the following should be met:
- The material should be sent by email or via Eudralink or CESP. Send an email.
- Reference must be made to the Danish Medicines Agency’s case number in the cover letter as well as in the email/Eudralink subject field or CESP comment field, and/or to a corresponding, unique reference to the application which the material concerns.
- The email/Eudralink message or CESP comment field must clearly indicate: “This is a preliminary submission. The content will be submitted later in unchanged form in [eCTD/VNeeS] format."
- The applicant will, as soon as possible and no later than five days after completion of the procedure, submit the material in the correct electronic format to the Danish Medicines Agency, noting the following in the cover letter: “The content of this submission is identical to the content of the previous preliminary submission.” This applies also to applications where the RMS has been responsible for the circulation of the supplemental information.
The individual administrative officer can decide to include a preliminary submission in the assessment of an application. The Danish Medicines Agency cannot complete the review of a case until the material has been received in the correct electronic format and with a confirmation that the material is identical to the previous submission. An application cannot be considered approved until the Danish Medicines Agency has received the material in the correct electronic format.
The Danish Medicines Agency reserves the right in any event to refuse material that does not meet the format requirements for supplemental information.