Denmark phasing out NeeS

Mandatory eCTD format for national marketing authorization applications for medicinal products.

Mandatory eCTD format for national marketing authorization applications for medicinal products.
January 2, 2017
Please note that from 1 January 2017, NeeS will no longer be accepted in applications for new marketing authorisations (including switch from NP to MRP as well as Repeat Use Procedure (RUP)) by the Danish agency, Laegemiddelstyrelsen.
From 1 January 2018, eCTD will be the only acceptable electronic format in the human domain (all procedures and case types).
If you require any assistance for the switch to electronic working, please contact us: [email protected]
ASPHALION has extensive experience of eCTD publishing and implementation of publishing tools at companies.
If you require any support do not hesitate to contact us!

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