New format requirements for marketing authorisation applications

The Danish Medicines Agency is postponing the phasing-out of NeeS and tightens the format requirements for updating the assessment report prior to MRP/RUP.

The phasing-out of NeeS is relevant to submissions for human medicinal products. The tightened format requirement is relevant to submissions for both human and veterinary medicinal products. Parallel import and parallel distribution are not covered.

Updated eSubmission Roadmap – phasing-out of NeeS in NP

In the absence of a common European plan for the phasing-out of the NeeS submission format in the national procedure (NP), the Danish Medicines Agency decided to apply the same format requirements for the national procedure as the format requirements applying to the mutual recognition procedure (MRP). At its meeting at the end of February, the Heads of Medicines Agencies (HMA) adopted a new version of the eSubmission Roadmap and thereby gave their backing to a common European plan for the phasing-out of NeeS – also in the national procedure.

The Danish Medicines Agency supports a common European approach to format requirements and will follow the recommendations in the new version of the eSubmission Roadmap. As a result, the phasing-out of NeeS in favour of the eCTD electronic submission format for human medicines will be implemented as follows:

• Done: Centralised procedure (CP), all types of applications
• Done: Decentralised procedure (DCP)
• Done: Mutual recognition procedure (MRP), new marketing authorisation
• 01/07/2017 (NEW): Updating of assessment report prior to MRP/RUP (see below)
• 01/01/2018: MRP, other cases
• 01/07/2018 (NEW): National procedure (NP), new marketing authorisation
• 01/01/2019 (NEW): National procedure (NP), other cases

Even though this allows for a longer transition to eCTD, the Danish Medicines Agency encourages applicants to switch to eCTD as soon as possible to help us reduce the overall assessment time.

See the link to the eSubmission Roadmap in the External links box. We have updated our page about the eSubmission Roadmap.

Format requirements for updating of the assessment report prior to RUP/MRP

Since the transition to the mandatory eCTD electronic submissions for applications for new marketing authorisations under MRP (including Repeat Use Procedure), the documentation for our updating of the assessment report is not necessarily submitted to us in eCTD. As of 1 July, we ask you to submit documentation for our update of the assessment report in the same format as the format used for the subsequent MRP/RUP.

This same applies to veterinary medicines, although we have not seen a similar change in format in this field.