Within a very short deadline paper submissions will no longer be accepted by the Danish Medicines Agency.

All applications must be in eCTD format as of 1 October 2019.

By Susanne Felumb

Paper-based submissions will be phased out for nationally approved human medicinal products in Denmark, and all submissions must be in eCTD format as of 1 October 2019, according to the Danish Medicines Agency website page: “Format requirements for applications for authorisation of medicinal products”.

Let us help you prepare your eCTD

If your regulatory submissions are still paper-based, we can help you prepare eCTD submissions or advise you on how to proceed.

Please contact
For an initial talk, please feel free to contact Susanne Felumb directly at: +45 4450 3206.

Susanne FelumbCEO and QA Manager, MSc. Pharm.
Susanne is the owner and CEO of PharmAdvice, and has more than 20 years of experience in the international pharmaceutical industry with QA and regulatory affairs.

Contact information

Feel free to contact Susanne directly at: +45 4450 3206  or via