Within the sequence, subfolders for the modules must be present, and also a table of contents 'ctd-toc.pdf'.Įlectronic submission in vNeeS format This avoids problems with the timing in the evaluation process. In this context, the sequential numbering of the sequences of a dossier is also recommended. for a worksharing procedure), the appropriate directories must be set up in accordance with the above-mentioned naming scheme. If the submission concerns several applications for authorisations or granted authorisations (e.g. These correspond to the minimum electronic submission documents specified in the AMG-EV (in accordance with module 1.3.1 and module 2) and must be submitted as rtf documents. Preferred Nameīelow the root directory, the sequence folders of the submission () are created as well as separate folders for so-called working documents ( working documents). The name should provide informational value that takes into account the product structure. The authorisation number should be indicated in the name of the root directory, the name of the drug or the procedure number or both or, as a further alternative to the authorisation number. Structure and naming of the NeeS directory structure It comprises at least modules 1 and 3 and is a great help for the evaluation process.

on the occasion of amarketing authorisation, a renewal or a change notification (variation)), you are requested to submit a so-called baseline (Sequence 0000) for this product. When changing the submission format from paper to NeeS (e.g. Please note that the NeeS format cannot be used in the centralised procedure. without the XML backbone of the eCTD format. In addition, however, electronic submissions will continue to be accepted using the NeeS Guideline, i.e. The Paul-Ehrlich-Institut ( PEI) prefers submissions in the eCTD format, because only in this format can the lifecycle of the dossier can be mapped accordingly. Source: PEI EU Module 1 - Content of EU Envelopeįor all eCTD submissions, the following elements and attributes must be filled in the XML structure for module 1 within the eu envelope:Įlectronic Submission in NeeS Format Subfolders for the modules, a util directory with the schemes used, a valid XML backbone and the associated md5 checksum must be present within the sequence. If several sequences are submitted in one submission step, the appropriate directories for each sequence have to be created using the following pattern: If the submission concerns several applications for authorisations or granted authorisations ( e.g.

Preferred Nameīelow the root directory, the sequence folders of the submission () as well as separate folders for so-called working documents ( -working documents) are created. The authorisation number should be indicated in the name of the root directory, the name of the drug or the procedure number or both or, as a further alternative.

Structure and naming of the eCTD Directory on the occasion of a marketing authorisation, a renewal or a change notification (variation)), you are requested to submit a Baseline (Sequence 0000) for this product.

If a change ofsubmission format is made from paper or NeeS to eCTD ( e.g. A mixed submission eCTD / NeeS is not possible, this would render a lifecycle management of the documentation impossible ('once eCTD always eCTD'). If a product is submitted in the eCTD format, all subsequent submissions are expected in this format. The Paul Ehrlich Institute ( PEI) prefers electronic submissions for all procedures in the eCTD format, because only in this format can the lifecycle of the dossier be mapped accordingly.

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