Electronic Common Technical Documents (eCTD)
- For all procedures BfArM prefers electronic submissions according to the eCTD format. Detailed information about structuring and formatting of eCTD Submissions is available at the EMA website.
- Before uploading a sequence via the Common European Submission Platform (CESP) or sending CDs / DVDs you have to be sure that the data can be read correctly. (E.g. CRC errors which may occur during the copying process must be ruled out.)
- For the technical validation, make sure that the sequence for testing is entirely identical to what you will upload via CESP or burn on CD.
- BfArM does not require a report on technical validation; however, you should have the report available in case questions are raised.
- The root directory must be named by procedure number (e.g. the national ENR or main part of the DCP number and the national ENR) or name of the medicinal product following the rules for naming leaves within eCTD. The product structure should be mirrored accordingly.
- Beneath the root directory, the sequence folders and the folders for working documents should be created. Working documents are understood as those which are required to be submitted in office format (doc or docx) by the submission ordinance AMG-EV, namely Module 1.3.1 and Module 2. The folder is named “<sequence>-workingdocuments”.
If a submission concerns multiple applications or authorised products (e.g. several ENRs), the respective folders have to be created named by <procedure number.> or <ENR> (e.g. de-h-09999-001, de-h-09999-002 etc.).
- Multiple strengths and/or pharmaceutical forms of one product name can be combined in one eCTD structure. Details are given in Annex 3 of the Harmonised Technical Guidance on eCTD. In such cases, only the main part of the procedure number is to be used to name the root directory.
- If several sequences are to be submitted in one container for CESP upload or one CD / DVD, the respective sequence folders need to be created according to the following example:
