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eSubmission

With regard to submissions in electronic format details and additional conditions for paperless submissions will be explained concerning the following topics:

Implementation of the HMA eSubmission Roadmap in Germany - new marketing authorisation applications in DCP required to be in eCTD format as of 1 July 2015

BfArM and PEI declare expressly, that related to the implementation of the HMA eSubmission Roadmap new marketing authorisation applications in DCP are required to be in eCTD format as of 1 July 2015 in accordance with corresponding European harmonised decisions. Both federal competent authorities will ensure that not only technical and organisational requirements are in place but also that any legislative prerequisites are fullfiled as soon as possible in order to allow requesting electronic submissions. BfArM and PEI intend to implement all further milestones of the eSubmission Roadmap appropriately.
An overview on the most important milestones for human medicinal products is displayed in the table below:

Time pointMilestone
1 July 2015New marketing authorisation applications in DCP in eCTD format
1 January 2016Electronic Application Forms (eAF) for all procedures. Word files previously provided will no longer be available.*
June 2016Electronic submission of PSURs and any documentation in PSUSAs in eCTD format recommended
1 January 2017New marketing authorisation applications in MRP in eCTD format (incl. Duplicates, Repeat-Use Procedures and Extensions)
1 January 2018Electronic submission s for all regulatory activities in eCTD format; recommended to apply to the restricted part of ASMFs as well

* In regard to eAF use, two exemptions apply: For centralised procedures eAF are already required as of 1 July 2015. For homeopathic products the previously used word documents remain usable as no eAF can be offered.

Details of the HMA eSubmission Roadmap in general or specifically regarding Implementation of the eCTD format, the Usage of the eAF and the Submission of PSURs are accessible at the eSubmission website of the EMA respectively at the CMDh website.

Date 2016.02.09