Guidelines on updating of assessment report before start-up of MRP or RUP/SRP

This page has been updated with the new request form adopted by the CMDh in September 2022. With the adoption of the new request form, it is no longer a requirement to submit the draft application form together with the request for updating the assessment report. In addition, the page has been updated to reflect current practice and external links have been added.

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), repeat use procedure (RUP) or subsequent recognition procedure (SRP).

Contents:

1. Request for updated assessment report before start-up of
     MRP or RUP/SRP

2. MRP after a purely national authorisation

3. RUP/SRP immediately after completed DCP/MRP

4. Concerning eCTD

5. Concerning Active Substance Master Files (ASMF)

1. Request for updated assessment report before start-up of MRP or RUP/SRP

Send an email if you want Denmark to act as Reference Member State (RMS) in an MRP or RUP/SRP. You should submit the following documents to the Danish Medicines Agency:

• A filled in request form. The request form can be found in the box to the right.
• A filled in Appendix I with an overview of any variations since the initial authorisation.Appendix I can be found in the box to the right.
• Updated documentation or an indication of the latest eCTD sequence.

If the request contains updated documentation it must be sent via CESP.

The Danish Medicines Agency will then 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).

2. MRP 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 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 deadline laid down by article 28 of Directive 2001/83/EC (human)/Article 52 og 53 of Directive 20019/6 (veterinary) for updating of assessment reports before initiation of an MRP/RUP/SRP.

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

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, nor will new issues be raised.

3. RUP/SRP immediately after completed DCP/MRP

In connection with the assessment of the applicant’s request form for an MRP/RUP/SRP, we will consider whether there is a need for updating the assessment report or whether the assessment reports from the DCP/MRP can be reused together with assessment reports from any subsequent variations.

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/SRP.

If a DCP/MRP authorisation is several years old and/or several variations/renewals have been made, it is often necessary to prepare an updated assessment report.

It is important that the request form 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 assessment report is initiated.

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

4. Concerning eCTD

If the dossier or parts of the dossier have not previously been submitted in eCTD format, the applicant must update the dossier to eCTD before the update of the assessment report can be started.

If all the documentation is handled in eCTD and the Danish Medicines Agency therefore already has 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.

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.

5. 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 RUPs and SRPs and where variations have been approved between RUPs or between SRPs.

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.