Mailboxes within licensing of medicines

For enquiries concerning the licensing of medicines please send a mail to one of the following mailboxes depending on the purpose:

• Enquiries where the relevant professional unit is not known must be sent to the main mailbox of the Danish Medicines Agency.
• Enquiries regarding parallel imports, such as applications for permission to import parallel imports of medicinal products, variations, notifications and re-registrations, must be sent to the mailbox for parallel imports.
• Enquiries regarding applications for new marketing authorisations up to the assignment of case managers, such as initiation of cases and slot time requests, must be sent to the mailbox for validation.
• Submission of supplementary material for applications via EudraLink must be sent to the Response mailbox.
• Dispatch lists, working documents (e.g. national translations) without documentation (eCTD/NeeS/VNeeS) and deregistering of medicinal products that cannot be carried out via DKMAnet must be sent to the mailbox for approval of medicinal products.
• Questions about format requirements and technical validation should be sent to the eSubmission mailbox.
• Enquiries regarding access to DKMAnet, such as technical questions about the deregistration of medicinal products, upload of package leaflets and submission of parallel import cases, or enquiries about electronic submission of the application for parallel import must be sent to the DKMAnet mailbox.

• Enquiries about the status of submitted applications for medicinal products approved via DCP, MRP or national procedure should be sent to the mailbox for status.

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.