Yes. Typically, an eCTD / NeeS application will cover all dosage forms and strengths of a product with any one invented name. In MRP / DCP, a single eCTD / NeeS application should preferably be used for each procedure (e.g. DE/H/1005/001-002/DC). If the applicant decides to have one NeeS per strength or dosage form this would also be acceptable, however, consequences with regard to transformation into eCTD at a later stage should be borne in mind.

Applicants should carefully consider what an eCTD application should cover before submitting the first sequence, as this choice could have implications for maintenance work throughout the lifespan of the product. For example, if the applicant decides to have one eCTD per strength or dosage form, it is expected that each of these eCTD applications will be maintained individually, such that submission of a single sequence that covers more than one strength or dosage form will no longer be possible unless very good reasons for a change are presented. In these rare cases, please contact BfArM at an early planning stage if you are an RMS. However, documents required in paper need to be submitted individually per strength and dosage form applied for.

The cover letter lists all medicinal products for which marketing authorisation is sought and to which the eCTD / NeeS submission applies, together with the corresponding procedure and processing numbers (ENR, "Eingangsnummern"). The electronic format needs to be specified as well as the number of discs / hard media. Statement of a return e-mail address to which the confirmation of receipt can be sent is highly recommended. Please also consider the recommendations of the CMDh regarding the Cover Letter.

Prior to filing an application, an informal letter should be sent, either by telefax to Bundesinstitut für Arzneimittel und Medizinprodukte, Fachregistratur Z14.1, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn - telefax number: +49 228 207 3681 or by e-mail to the attention of antragseingang@bfarm.de stating the name and pharmaceutical form of the medicinal product and requesting a processing number.

If an electronic submission is made in accordance with the "electronic-only" rules, this should be stated explicitly on the package and in the cover letter. A proposal on how to mark the address label and the cover letter is available here.

Any time an electronic submission in eCTD or NeeS format is submitted, an updated “history of sequences“ named “tracking.pdf“ must be placed in the same folder as the cover letter and submitted in paper as well. This will support transparency and ease tracking of sequences regardless of the format. An example can be reviewed here.

In this folder, the product information and the Non-clinical and Clinical Overview / Summary or the Overall Summary should be made available as MS Word compatible, editable files in docx format. This also applies to the product information in English for decentralized or in the mutual recognition procedures.

If you have provided information about your e-mail contact, BfArM will send the confirmation of receipt via e-mail, otherwise we will use conventional mail.

For new applications, BfArM recommends uploading the documentation via CESP. For all national and European variations, BfArM recommends using the portal www.pharmnet-bund.de for additional process-relevant information in addition to the upload of sequences via CESP. If using the PharmNet.Bund-Portal or alternatively the folder <sequence>-workingdocuments, additional transfer of documents in accordance with the e-Submission Ordinance (AMG-EV) is no longer required.

Detailed information regarding electronic variations is provided here.

No, as long as you comply with the eCTD or NeeS requirements for electronic submissions and if you place all documents required by the eSubmission Ordinance (which were otherwise sent by e-mail) in the folder <sequence>workingdocuments.

The rules for variations submitted via PharmNet-bund-Portal remain unaffected.

Along with implementing the eGovernment-law and after careful re-evaluation of previous requirements, the decision was taken to omit the request for wet-signed documents or digitally qualified signed files for new applications for marketing authorisations, variations and renewals. The BfArM considers the registration and log-in procedure for the national portal at www.pharmnet.bund.de and the Common European Submission Platform (CESP) as sufficient in the light of the rules of the new eGovernment law. In case of doubts, wet-signed documents in paper format maybe required.

Yes, but only if a full paper dossier is provided at the same time (all modules need to be printed). In case of electronic submissions not in accordance with the eCTD specifications or the NeeS guideline a paper dossier is required and the eSubmission Ordinance (AMG-EV) also needs to be observed. Further advice can be found at AMG-EV and Explanatory Notes on the Enforcement of the AMG-Submission Ordinance.

Basically, yes. However, it should be considered that the standard procedure cannot be followed in such cases and that delays cannot be excluded. In this case the eSubmission Ordinance (AMG-EV) also needs to be observed. Further advice can be found at AMG-EV and Explanatory Notes on the Enforcement of the AMG-Submission Ordinance.

Yes, the same requirements apply as for full dossiers for marketing authorisations. BfArM is willing to accept electronic submissions for ASMF according to the rules published on the EMA website. For details follow the link.

A dedicated application at PharmNet-bund-Portal can be used for electronic reports regarding the Sunset Clause. An additional paper version of the report is not required. For details follow the link.

General Rules

The advantage of avoiding paper submissions can be used only when

• switching to or maintaining the eCTD or NeeS format in accordance with the published specifications for EU Module 1 and ICH Modules 2 to 5 respectively the NeeS submission guidance,
• the sequence is technically validated according to the most recently published validation criteria and
• the sequence will be submitted via the Common European Submission Platform (CESP) or in case of variations via PharmNet.Bund.de in addition.

For technical details please consult the eCTD specifications of EU module 1 and ICH modules 2 to 5 and the NeeS submission guidance. You will find more details regarding implementation aspects on the eSubmission webpage of the Telematic Implementation Group on eSubmission (TIGes). For procedural guidance please also refer to the information from CMDh.

Change to eCTD Format

If the dossier is already provided in eCTD format, you can submit any further new data as a new sequence in accordance with current eCTD specifications. In this case you should document the technical validation performed prior to submission in the cover letter and provide signed paper copies of the application form including annexes, the cover letter including tracking table and – if appropriate – statements of the experts (Module 1.4). For reasons of clarity, you should explicitly state in the cover letter that you want to switch to eOnly submission in the eCTD format and wish to take advantage of the BfArM's offer to forego submission of further paper copies.

Change of NeeS Format

If the dossier is already provided in NeeS format, you should submit any further new data as usual and state explicitly in the cover letter that you want to switch to eOnly submission and wish to take advantage of the offer to forego submission of further paper copies.
If you want to switch to the eCTD format at the same time, you can submit any new data as a new sequence in eCTD format in accordance with current eCTD specifications, documenting the technical validation performed prior to submission in the cover letter and providing signed paper copies of any application form including annexes, the cover letter including tracking table and – if appropriate – statements of the experts (Module 1.4). For reasons of clarity, you should explicitly state in the cover letter that you want to switch to eOnly submission in eCTD format and wish to forego submission of further paper copies.
It is possible to switch to eCTD format without preparing a baseline. The first sequence number will be 0000.
In case you want to submit all previously submitted parts of the dossier as a consolidated baseline in eCTD format, you should use the submission type “reformat” in the eCTD envelope. In addition, you should state in the cover letter, that no content changes have been made except for those changes technically required due to the eCTD format.

Change from Paper Format

If the dossier has been provided in paper format in the past, you can submit any further new data as a new sequence in accordance with current eCTD specifications or NeeS submission guidance. In this case you should document the technical validation performed prior to submission in the cover letter and provide signed paper copies of any application form including annexes, the cover letter including tracking table and – if appropriate – statements of the experts (Module 1.4). For reasons of clarity, you should explicitly state in the cover letter that you want to switch to eOnly submission in eCTD or NeeS format and wish to take advantage of the BfArM's offer to forego submission of further paper copies.
It is possible to switch to eCTD or NeeS format without preparing a baseline. The first sequence number will be 0000.
Depending on the availability of data in an appropriate electronic format, it may be suitable to reformat Module 3 as most of the variations can be expected for this part of the dossier. The same principles apply as do to the format switch to CTD.

The possibility of submission via the PharmNet.Bund-Portal remains unaffected by this.