eSubmission
Details to 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 - eCTD format mandatory in purely national procedures for all submission types as of 1 January 2019
The BfArM wishes to emphasise that for implementation of the HMA eSubmission Roadmap, all submission types in purely national procedures as of 1 January 2019 must be in eCTD format in accordance with corresponding European harmonised decisions. Parallel imports and standardised marketing authorisations ("Standardzulassung") are exempt from this requirement.
Further information can be found in the Question & Answer Document of the Human Harmonisation Group.
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.
| Time point | Milestone |
|---|---|
| 1 July 2015 | New marketing authorisation applications in DCP in eCTD format |
| 1 January 2016 | Electronic Application Forms (eAF) for all procedures. Word files previously provided will no longer be available.* |
| June 2016 | Electronic submission of PSURs and any documentation in PSUSAs in eCTD format recommended |
| 1 January 2017 | New marketing authorisation applications in MRP in eCTD format (incl. Duplicates, Repeat-Use Procedures and Extensions) |
| 1 January 2018 | Electronic submission s for all regulatory activities in eCTD format; recommended to apply to the restricted part of ASMFs as well |
| 1 January 2019 | Electronic submission for all regulatory activities on a purely national basis in eCTD format (according to current understanding, parallel import, Standardzulassung (standard marketing authorisation) are not included) |
* 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.
AMG-Submission Ordinance
AMG-EV regulates the electronic submission of documents including the procedures that should be used. The Submission Ordinance as well as the Explanatory Notes, within the scope of their application, take priority over previous submission rules. Where previous announcements provide partly differing requirements, the latter are replaced by the current Explanatory Notes. Unless otherwise stipulated by the AMG-EV, the previous submission rules remain valid. This means, if, e.g., documents can or must be submitted in paper version according to sections 3 and 4 AMG-EV, the respective previous requirements are still valid and need to be complied with.