All applications must be in eCTD format as of October first 2019

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.

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 autorisation of medicinal products”.

If you need help preparing you eCTD application, please contact us.