Format requirements for applications for authorisation of medicinal products

13 July 2015

We have issued the below guidelines on the technical set-up and submission of applications for marketing authorisation for medicinal products or applications related to marketing authorisations (variations etc.). To the extent possible, the guidelines are in line with the European guidelines:

Guidelines on submission of paper applications

Guidelines on submission of electronic applications

Technical details for electronic applications

eSubmission Roadmap

Submission of applications for marketing authorisation is being developed, which will imply changes to the requirements of the Danish Medicines Agency and the other European drug regulatory authorities in the coming years regarding the format and submission of applications. Read more:

eSubmission Roadmap

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