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Guidelines on submission of electronic applications

29 July 2011, Updated 12 April 2018

These guidelines describe the requirements that applicants must meet when submitting electronic applications for authorisation of medicinal products to the Danish Medicines Agency.

Introduction
Terminology applied
Mixed submissions
Format switch
Format requirements
Media
Parallel submissions
Number of copies
Signatures
Contact persons at the applicant
Special notes on email and Eudralink
Special notes on Common European Submission Platform (CESP)
Special notes on NeeS and VNeeS
Special notes on eCTD
Special notes on ASMF
Special notes on working documents
Special notes on preliminary submissions

Introduction

In connection with the application for a marketing authorisation, variation, update prior to MRP, renewal, follow-up and referral to CMD, companies can submit the application and supplemental information on paper or electronically. Please find below the Danish Medicines Agency's guidelines on submission of electronic applications and supplemental information.

The guidelines also apply to Active Substance Master Files (ASMFs) submitted by the applicant and ASMF holder (please see the section "Special notes on ASMF").

The Danish Medicines Agency's guidelines complement guidelines issued by the EMA and CMD and apply to applications submitted under the national procedure (NP), mutual recognition procedure (MRP) and the decentralised procedure (DCP). With regard to applications under the centralised procedure, we refer to the guidelines on the EMA website. When using the national procedure for a medicinal product authorised under MRP, it must appear clearly from the cover letter so that the application is not rejected on arrival.

A physical submission is considered an electronic submission if it contains an electronic media (CD or DVD). An application is considered an electronic application if the first submission is electronic.

The Danish Medicines Agency prefers to receive electronic applications. For human applications, we prefer to receive eCTD rather than NeeS.

The Danish Medicines Agency's internal workflow processes are fully electronic. After we have verified the signature, we scan and OCR process any parts of the application that must be submitted on paper (cover letter and if applicable the form "Confirmation for eCTD submissions"), after which all our internal processes are electronic.

File names must indicate the contents of the files (e.g. ”applicationform.pdf” and ”coverletter.pdf” instead of ”doc1.pdf” and ”appendix.pdf”).

Terminology applied

In this context, we distinguish between "applications" and "submissions" in that an application is a regulatory activity consisting of one or more 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 Medicines Agency.

Please note: A preliminary submission is not considered a formal submission. A preliminary submission refers to a submission in which the content is complete, but still awaits being set up in a valid format. Preliminary submissions are typically made when time constraints are felt by applicants, and they are common in the late phases of a procedure. Preliminary submissions are addressed in the section Special notes on preliminary submissions, but are otherwise not covered by these guidelines.

Mixed submissions

We only accept submissions that are either fully electronic or fully on paper (see "Guidelines on submission of paper applications").

Paper documentation that is not required to be submitted in paper is assumed to be included in the electronic version and will be disposed of without further processing. A signed cover letter and, in case of the first eCTD submission, the "Confirmation for eCTD submissions" must be provided on paper when submission is made on CD/DVD.

Format switch

We do not accept paper applications or applications in the NeeS format from applicants having switched to eCTD for the medicinal product in question, and we advise applicants not to submit paper applications after they have switched to NeeS/VNeeS.

Any supplemental information for a paper application may be submitted on paper or in NeeS/VNeeS format. Any supplemental information for an NeeS/VNeeS application must be submitted in NeeS/VNeeS format. Any supplemental information of an eCTD application must be submitted in eCTD format.

Moreover, for paper applications and NeeS applications it is allowed to switch to eCTD format.. Please see the section "First eCTD-based submission and transition to eCTD" in "Technical details for electronic applications". For reasons of clarity, the Danish Medicines Agency recommends that switching to eCTD takes place at the start-up of a new regulatory activity.

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. A link to these standards is found in the right-hand box. Please see the section "First eCTD-based submission and transition to eCTD" in "Technical details for electronic applications".

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. For veterinary medicinal products, the working documents are placed in the folder "add-info" (additional information). It must clearly appear from the cover letter and imprint on the CD or from the email, Eudralink or CESP message field that the submission concerns working documents only.

Media

The applicant must send the first submission of an electronic application by ordinary post or courier to the Danish Medicines Agency's postal address or via CESP. If the submission is made by ordinary post or courier, it 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. If the submission is made via CESP, the procedure and case type must be identifiable from the "delivery file" (the XML file).

Supplemental information is to be submitted on CD/DVD with a signed cover letter or submitted by email via Eudralink to response@dkma.dk or submitted via CESP. Please note that the Danish Medicines Agency imposes the same format requirements on submissions via email, Eudralink or CESP as apply to submissions on CD/DVD.

Working documents should generally be submitted by email or via Eudralink to response@dkma.dk, but could also be submitted via CESP or on a CD or DVD (e.g. together with an electronic submission). Submissions which do not contain an eCTD or NeeS/VNeeS submission must be clearly indicated with the words "working documents" labelled/imprinted on the CD/DVD or written into a text field of the email/Eudralink/CESP, just as it must clearly appear from the cover letter that the submission concerns working documents only.

The Danish Medicines Agency, does not accept USB memory sticks as submission media.

The completed and signed form "Confirmation for eCTD submissions" (see the section "First eCTD-based submission and transition to eCTD") must be submitted in paper or via CESP.

Please see the respective sections "CD and DVD", "Email and Eudralink" and "CESP" in the "Technical details for electronic applications".

The applicant is responsible for checking that the medium does not contain any malware.

We do not accept supplemental information on paper for electronic applications.

Parallel submissions

It is crucial that applicants do not submit the same documentation in parallel via different routes (e.g. via both Eudralink and on CD or via both CESP and by email) as this would require unnecessary resources to handle and compare documentation with already received versions.

Number of copies

For electronic applications, the submission of one CD/DVD is fully sufficient, regardless of the type of application or the procedure type (NP/MRP/DCP).

The Danish Medicines Agency reserves the right to request additional copies of a CD/DVD during the review phase, if, by exception, this should prove necessary.

Signatures

Submissions on a CD or DVD must be accompanied by a dated cover letter bearing an original wet signature. The Danish Medicines Agency does not require the electronic documents to be signed. The electronic version of the cover letter thus distinguishes itself from the physical version in that the electronic cover letter is not required to bear a signature.

For submissions made via CESP, we consider the CESP security configuration sufficient to verify user authentication. Therefore, we do not require CESP submissions to be signed.

Because supplemental information and working documents do not initiate a regulatory activity, a physical signature is not required for these documents. As regards submissions by email and via Eudralink, a credible email address, various information in the email header as well as Eudralink's security settings is sufficient confirmation that the submission is authentic.

Contact persons at the applicant

The cover letter must include an email address and telephone number of the applicant's contact person.

Special notes on email and Eudralink

Supplemental information and working documents, submitted by email or via Eudralink, must be sent to response@dkma.dk. We do not accept the first submission of an application to be made by email or via Eudralink.

Any material sent to response@dkma.dk is handled and technically validated as if it had been submitted on a CD/DVD.

The subject heading of the email/Eudralink message must clearly refer to the Danish Medicines Agency's case number and/or corresponding unambiguous reference, which the documents relate to.

The attached documentation must be capable of being read independently of the subject heading and message body of the email/Eudralink message. Information contained in the message or subject field is generally not included in the review.

Please also see the section "Email and Eudralink" in "Technical details for electronic applications".

Special notes on Common European Submission Platform (CESP)

Submission via CESP is accepted for the first submission of an application as well as for any supplemental information and working documents. Submissions via CESP are accepted for DCP, MRP as well as national procedure.

Any material sent via CESP is handled and technically validated as if it had been submitted on a CD/DVD.

It is sufficient to make a submission via CESP, and any material sent via CESP must not be submitted via other channels unless you are explicitly asked to do so.

The "delivery file" (the XML file) must contain sufficient information so as to enable precise identification of procedure and case type. Submissions that are not the first submission of an application must furthermore refer to the case number of the Danish Medicines Agency and /or corresponding unique reference to the application to which the documentation relates.

Please note that the Danish Medicines Agency does not require CESP submissions to be accompanied by a signed cover letter. If a submission is made via CESP, the procedure and case type must be identifiable from the "delivery file". The information contained in the "delivery file" is used to identify the material and is generally not subject to review.

For guidance on how to use CESP, please see cesp.hma.eu.

Please also see the section "CESP" in "Technical details for electronic applications".

Special notes on NeeS and VNeeS

The preferred electronic format is eCTD. The NeeS format is considered as a set of minimum requirements for electronic documentation to the extent that it is not possible to use eCTD.

In order to ensure an unambiguous reference to the documentation, the Danish Medicines Agency strongly recommends that NeeS and VNeeS submissions, like eCTD sequences, be placed in a folder named 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 Medicines Agency's electronic archives, we request applicants to describe to the Danish Medicines Agency the structure applied on their dossiers and to follow this structure consistently, so that documentation which affect several dossiers is submitted in separate submissions and so that documentation is not repeated within the same dossier.

Special notes on eCTD

The preferred electronic format is eCTD. See "Technical details for electronic applications" regarding "baseline" as well as first eCTD-based submission.

Special notes on ASMF

To facilitate the identification and handling of submissions related to the Active Substance Master File (ASMF), we request that the ASMF holder clearly refers to the Danish Medicines Agency's case number (typically 2215-xxxx) in the cover letter and to indicate that the submission is an "ASMF-related submission made on behalf of the ASMF holder.

Please also see EMA's ASMF eCTD Guidance (under "eCTD and ASMF") for guidance on ASMF in eCTD format.

Special notes on working documents

Working documents presented together with other documentation (first submission or supplemental information) should be submitted together with such documentation on the same CD/DVD, in the same archive file or in the same CESP submission.

Working documents submitted separately, should be sent by email or via Eudralink to licensing@dkma.dk. It must clearly appear from the email or Eudralink that the submission concerns working documents only.

Please also see the section "Special notes on email and Eudralink".

Special notes on preliminary submissions

We regularly see that applicants fail to set up supplemental information in the required electronic format (eCTD/NeeS/VNeeS) due to time constraints, but they send in the material as a preliminary submission anyway. Such submissions are technically invalid according to the common-European guidelines.

Applicants who still want to make a preliminary submission during a procedure must ensure the following:

  • The submission made concerns supplemental material only.
  • The material must be submitted by email or via Eudralink to response@dkma.dk or via CESP according the applicable guidelines.
  • The cover letter as well as the subject heading of the email/Eudralink or the CESP comment field must refer to the Danish Medicines Agency's case number and/or corresponding unique reference to the application to which the material is related.
  • In the email/Eudralink message or CESP comment field, the following phrase must be included: "This is a preliminary submission. The content will be submitted later without amendments in [eCTD/NeeS/VNeeS] format."
  • As soon as possible and no later than 5 days after the procedure has ended, the applicant must submit the material in correct electronic format to the Danish Medicines Agency with the following phrase in the cover letter: "The content of this submission is identical with the content of the previously submitted preliminary submission." This also applies to applications where RMS handled the circulation of supplemental information.

The reviewing officer may decide, on a case-by-case basis, to include a preliminary submission in the assessment of an application. The Danish Medicines Agency cannot finish its review before it has received the material in the correct electronic format together with a confirmation stating that the material is identical with the previously submitted material. An application cannot be assumed to be authorised until the Danish Medicines Agency receives the material in the correct electronic format.

In any event, the Danish Medicines Agency has the right to reject material that does not comply with the format requirements for supplemental information.

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