Mailboxes within licensing of medicines

Updated 22 May 2018

For the purpose of correspondence about the licensing of medicines, you can write to us by email to the following email addresses. 

Below you can find a description of each email address.

 

Purpose

Examples

dkma@dkma.dk

The Danish Medicines Agency's main email address. Mails to this address are forwarded to the relevant division.

You can send your enquiry to this address if you do not know which division to contact.

licensing@dkma.dk

Main mailbox of the Medicines Licensing division. Mails to this address are forwarded to the relevant officer.

Dispatch lists
Working documents (e.g. national translations) without documentation (eCTD/NeeS/VNeeS).
Deregistration of medicinal products that cannot be made via DKMAnet.

god-validering@dkma.dk

Enquiries about an application for a new marketing authorisation – until an officer has been allocated to your case.

Validation of new applications in Workflow
Start-up of cases
Slot time requests

parallelimport@dkma.dk

Enquiries about applications for a parallel import authorisation.
Enquiries about variations, notifications and renewals of parallel imported products.
General enquiries about parallel import.

Questions about open cases.
Questions about package leaflets/labelling.

response@dkma.dk

Submission of supplementary information (eCTD, NeeS or VNeeS) for authorisation applications by email/Eudralink – instead of on CD/DVD.
Documentation is filed and technically validated according to the applicable format requirements. Working documents, if any, are filed in the case review system.
In general, we encourage applicants to use CESP instead.

eCTD sequence in response to LoQ.
Submission of adjusted sequence after the previous sequence was declared technically invalid.

esubmission@dkma.dk

Enquiries about format requirements and technical validation.

 

DKMAnet@dkma.dk

Enquiries about access to DKMAnet
Technical questions about functions at DKMAnet (including deregistration, upload of package leaflets, submission of parallel import cases).

Technical questions about deregistration of marketed medicinal products.
Enquiry about electronic submission of application for parallel import.
Enquiries about upload of package leaflets.

As regards enquiries about existing cases, please add the case reference in the Subject field: LMST case number (10 digits) or the EU procedure number with a variation serial number. Note that ”/MR” or ”/DC” at the end of a procedure number is a case reference to an application for a new marketing authorisation.

Please avoid

  • Submissions sent to many recipients at the Danish Medicines Agency.
  • Documentation already submitted via CESP or made available via Common Repository.
  • Enquiries sent to a specific employee, unless you have a current and relevant dialogue with this employee. Since areas of responsibility may change and employees may be absent, we recommend that you use the general mailboxes (especially licensing@dkma.dk) if you are unsure about who is the relevant officer.
  • Applicant's own validation reports.

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