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Guidelines on updating of documentation before start-up of MRP/RUP

Updated 31 July 2017

In the following, you can find our general guidelines on how to update the assessment report before start-up of the mutual recognition procedure (MRP) and repeat use procedures (RUP).

Contents:

  1. Request for start-up of MRP or RUP
  2. After a purely national authorisation
  3. RUP immediately after completed DCP/MRP
  4. If a simplified MRP is possible
  5. When several variations/renewals have been made and/or the original authorisation is several years old
  6. If the documentation is handled in eCTD
  7. Concerning Active Substance Master Files (ASMF)

Request for start-up of MRP or RUP

If you want Denmark to act as Reference Member State (RMS) in an MRP or RUP, you should submit the following documents to the Danish Medicines Agency:

  • A filled in request form, see the box to the right.
  • An overview of any variations since the initial authorisation (appendix 1).
  • Updated documentation or an indication of the latest eCTD sequence.

The documentation should be emailed to god-validering@dkma.dk or sent via CESP/post if the request contains updated documentation.

We will confirm receipt of the documentation and, if required, start the updating of the assessment report.

Before an agreement is made with the Danish Medicines Agency, you should not submit the application for the marketing authorisation to the new concerned member states (CMS).

After a purely national authorisation

In the national procedure, the assessment report is not updated regularly after each phase. It will be updated when the marketing authorisation is intended for use in a subsequent mutual recognition procedure (MRP).

The update will take place after the marketing authorisation has been issued and when an updated dossier has been submitted to the Danish Medicines Agency.

The updated dossier must include all relevant changes that have given rise to questions from the Danish Medicines Agency during the primary assessment and subsequent rounds of questions and answers. The same principle applies where variations have been approved before initiation of an MRP.

Unless otherwise agreed, the Danish Medicines Agency will observe the 90-day deadline laid down by article 28 of Directive 2001/83/EC (human)/Article 32 of Directive 2001/82/EC (veterinary) for updating of assessment reports before initiation of an MRP.

The dossier must be updated correctly with an accurate summary of all changes.

The updated dossier should only include changes arising as a result of questions raised by the Danish Medicines Agency, approved variations or changes which are otherwise preapproved by the Danish Medicines Agency.

Updated documentation should be submitted after approval of potential variations, which are submitted after the marketing authorisation is issued.

The Danish Medicines Agency does not intend to reassess the submitted dossier in connection with the updating of the assessment report (AR), nor will new issues be raised.

Benefits of this practice

The Danish Medicines Agency has experienced many cases where an MRP has been initiated although the applicant has failed to update the dossier in accordance with the issues raised during the national approval procedure. Consequently, there has been a discrepancy between the assessment report and the dossier.

This practice is intended to ensure better alignment between the applicant and the Danish Medicines Agency during the MRP. This will also ensure better agreement with the intentions of the procedure as described in the EU legislation.

RUP immediately after completed DCP/MRP

In connection with the assessment of the applicant’s request form for an MRP/RUP, we will consider whether there is a need for updating the AR or whether the assessment reports from the original procedure can be reused.

Other matters that may play a role include new legislation and/or EU decisions that should be taken into account before start-up of an RUP.

If a simplified MRP is possible

The Danish Medicines Agency will meet the requirements of the CMSs for the assessment report, because the application is new for the relevant member state(s).

When several variations/renewals have been made and/or the original authorisation is several years old

If an authorisation is several years old and/or several variations/renewals have been made, it is often necessary to make an updated assessment report. It is important that the request is filled in correctly so that we have an accurate overview of the status of the dossier and so that any shortcomings in relation to applicable law and EU guidelines can be assessed and discussed before updating of the AR is initiated.

The same requirements as those mentioned under ”After a purely national authorisation” apply to the submission of updated documentation.

If the documentation is handled in eCTD

If the documentation is handled in eCTD and the Danish Medicines Agency has received an updated dossier, the documentation should not be resubmitted. In such case, only the request for an MRP/RUP including any other new documentation should be placed in an eCTD sequence (marking the sequence number clearly).

The eCTD dossier is considered updated if all refused and withdrawn changes have been reversed to initial status and all parts of any previous paper dossier have been converted to eCTD and the Danish Medicines Agency has all the relevant eCTD sequences.

Concerning Active Substance Master Files (ASMF)

Active Substance Master Files (ASMF) must be updated according to the same principles as the rest of the dossier.

The documentation must include the latest updated and approved ASMF version. Note that the updated ASMF version must not include other changes than those approved in connection with the procedure. In that case, such changes must be approved via a variation procedure before the assessment report can be completed.

If an updated ASMF version is not available, we accept that the documentation is updated as an addendum to the originally submitted ASMF, including a summary of questions and answers and other documents belonging to the open part of the ASMF. In the latter case, a variation concerning the updating of the ASMF to a new version must be submitted after completion of the procedure.

The summary of changes for the restricted part of the ASMF may be submitted directly to the Danish Medicines Agency by the active substance manufacturer.

The above principles also apply to repeat use MRPs and where variations have been approved between repeat MRPs.

The intention is that the summary should form part of the company's request submitted with the updated dossier, and thus it should not be an integral part of the dossier.

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