Format requirements for applications for authorisation of medicinal products
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:
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:
Correct use of life cycle attributes in the eCTD
It is important that applicants and/or marketing authorisation holders use the right attributes (new, replace, delete) when parts of the dossier are updated – e.g. in connection with a response or a variation application.
Whenever a sequence is submitted, it must be considered if the document in question is completely new (i.e. the attribute “new” must be used) or if it is to replace an existing document in the dossier (i.e. the attribute “replace” must be used). It is also possible to use the attribute “delete”, thereby deleting a document that no longer applies.
If, for example, the attribute ”new” is used when in fact it should have been ”replace”, a non-applicable document will become part of the dossier. For further information, please see section 2.9.6 Leaf Lifecycle Operation Attributes in the Harmonised Technical Guidance for eCTD Submissions in the EU.
In this connection, we kindly advise you that it is always possible to use a closing sequence.
Link to the eCTD guide: Harmonised Technical Guidance for eCTD Submissions in the EU.