The Federal Institute for Drugs and Medical Devices will accept nearly paperless electronic-only submissions for new applications for authorisation or registration of medicinal products. This also applies to post-authorisation procedures (e.g. variations, renewals, PSURs, Educational Material, ASMF).

For new applications, BfArM prefers electronic submissions according to the eCTD format in accordance with published specifications of EU Module 1 and ICH Modules 2 to 5. Detailed information about structuring and formatting eCTD submissions is available at the EMA website. Agreements based on the eSubmission Roadmap as of 1 October 2014 agreed upon jointly by HMA and EMA need to be considered.

BfArM will also accept so-called "Non-eCTD electronic submissions" according to the requirements set out in the NeeS Guideline without the XML backbone of the eCTD format. Detailed information about structuring and formatting of Non-eCTD electronic submissions (NeeS) is available at the EMA website. Agreements based on the eSubmission Roadmap as of 1 October 2014 agreed upon jointly by HMA and EMA need to be considered specifically in regard to the time limitations for different procedure types.

For technical reasons, use of other electronic formats for electronic submissions is currently not possible, except for cases where Educational Material is submitted.

Although BfArM highly appreciates the submission of authorisation dossiers in electronic format and actively supports the implementation of the above-mentioned roadmap, it needs to be stated explicitly that the submission of dossiers in paper format is still an option.

In case of dossiers submitted in electronic format according to the above-mentioned rules, applicants have to request the so-called "Einreichungsnummer" (ENR) in advance.

The applicant automatically declares acceptance of the following processing rules:

CDs or DVDs being submitted as well as documentation uploaded via CESP will be checked with regard to their compliance with technical specifications (of eCTD or NeeS) prior to start of the content-related validation. Only in case of a positive outcome of the technical validation – if necessary, after the applicant has removed technical deficiencies – the receipt of the application can be confirmed. That is the moment the content-related validation starts. The applicant will then receive confirmation that the validation period has started.

Clarification: The term "technical validation" is used here and throughout the entire documentation on electronic submissions on our website in terms of testing the published technical specifications of the electronic media submitted (German legal term "Spezifikations-Überprüfung"). This is the basic difference between the technical validation and the content-related validation in accordance with Section 25a AMG (German Medicinal Products Act).