Danish: Closer attention to guidelines on submission of electronic applications for marketing authorisations

Our guidelines on submission of electronic applications to the Danish Health and Medicines Authority have been available on our website for some time, but we wish to draw attention to them once again.

As we have received a number of incorrect submissions, we kindly request applicants to read through the guidelines once more:

Guidelines on submission of electronic applications

Briefly stated, we remind applicants that we distinguish between "applications" and "submissions" in that one application consists of one or several submissions.

To find more information use the below mentioned weblink

http://laegemiddelstyrelsen.dk/en/topics/authorisation-and-supervision/licensing-of-medicines/news/closer-attention-to-guidelines-on-submis--orisations