On 15^th July 2007 BfArM published the “Erläuterungen zum elektronischen Einreichungsverfahren gemäß AMG-EV“/Explanatory notes to the electronic submission procedure according to the AMG-EV, Version 5.0, as of 1 July 2007.

Four new document types were introduced:

• phvsys (Pharmacovigilance system and qualified person - EU Module 1; 1.8.1
• riskmp (Risk Management Plan - EU Module 1; 1.8.2)
• palde (Packungsbeilage - CTD 1.3.1)
• palen (Package Leaflet - CTD 1.3.1)

The document types palde and palen replace the previous document type pal; you should no longer use pal, otherwise you will receive a negative system feedback (BAD mails).

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Short instructions for electronic submissions according to the AMG-EV
(submission ordinance according to the German Medicines Act/AMG)

The procedure is described by the EXAMPLE of the test ENR 1999023.
Note: Please use your own real ENR instead of the test ENR.

PNR means ‘number of applicant’, ENR means ‘processing number’.
ENR and PNR can be looked up in AMIS Public Section
(chargeable part of the DIMDI database offer which can be reached via www.dimdi.de)

1. generate a file called attribut.txt
   (including metadata for our database system;
   see table ”Specifications of metadata in attribut.txt”).
   
   pnr = 0000000
   enr = 1999023
   verf = zulassung
   edat = 24.12.2006
   
   
2. Generate a zip file (zip container), in our example: 1999023.zip)
   
   
3. Save your zip container in thesubdirectory containing your documents (rtf file) for the electronic submission. This way you avoid loading paths into the zip container.
   
   Please comply with the requirements for file names of rtf documents (see table "Elements of file names for electronic submissions to BfArM”, 1^st column on the left). File names may be individually expanded by hyphens and lower case letters.
   
   Within file names, please avoid the use of
   
   Ø      upper case letters
   Ø      spaces
   Ø      punctuation symbols
   Ø      underscores
   Ø      umlaut (ä or ö or ü)
   
   Example:
   spcde-etc-etc-2006-12-24.rtf              (if you additionally submit a pdf format
   spcde-etc-etc-2006-12-24.pdf           please use the same name as in the rtf file)
   qos-001-etc-etc-2006-12-24.pdf
   
   Notation examples of file names are found in the zip container 1999023.zip.
   
   Note:
   On 15^th July 2007 BfArM published the “Erläuterungen zum elektronischen Einreichungsverfahren gemäß AMG-EV“/Explanatory notes to the electronic submission procedure according to the AMG-EV, Version 5.0, as of 1 July 2007.
   
   Four new document types were introduced:
   phvsys (Pharmacovigilance system and qualified person - EU Module 1; 1.8.1
   riskmp (Risk Management Plan - EU Module 1; 1.8.2)
   palde (Packungsbeilage - CTD 1.3.1)
   palen (Package Leaflet - CTD 1.3.1)
   
   The document types palde and palen replace the previous document type pal; you should no longer use pal, otherwise you will receive a negative system feedback (BAD mails).
   
   
4. Load attribut.txt and rtf documents into your zip container.
   
   
5. E-Mail: In the e-mail subject line, please insert the 7-digit ENR, no more no less. Otherwise you will receive no system feedback.
   
   
6. Attach the zip container to your submission mail; please attach only one zip container per mail.
   
   
7. Switch off logos, automatic signatures, gif-files, etc; if not they would automatically be added as further attachments, which are not accepted and produce a negative system feedback. Turn to your system administrator if you need help.
   
   
8. For a test submission, please use the following e-mail address:
   testeinreichung@amg-zulassung.de
   
   Note: Any system feedback to your test submission is only a test feedback, no real feedback and does not replace a real submission.
   
   
9. This is the e-mail address for your real electronic submission:
   zulassung@amg-zulassung.de
   
   You will receive a system feedback within one hour, always directed to the e-mail address from which the electronic submission came. If not, please contact us via our e-mail hotline:
   amg-ev.hotline@bfarm.de

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Specifications of the metadata in the attribut.txt

In our table "Specifications of the metadata in the attribut.txt" you get short informations about metadata contains in attribut.txt.

Specifications of the metadata in the attribut.txt (Größe: 14.86 KB) (Size: 14.86 KB)

Elements of file names for electronic submission to BfArM

The elements of file names you will find:

Table: Elements of file names for electronic submission to BfArM (Größe: 72.68 KB) (Size: 70.39 KB)

Zip-File; example for your electronic submission

Zip-Container with data (Example) (Größe: 100.55 KB) (Size: 100.55 KB)

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On legal basis all applicants have to submitt special parts of the documentation electronically to the BfArM.

Ordinance on the Submission of Documents within Licensing and Renewal Procedures For Medicinal Products (AMG-Submission-Ordinance, AMG- Einreichungsverordnung, AMG-EV) from 21st of December 2000 (Größe: 50.21 KB)

AMG-EV regulates the electronic submission of documents including the proceedings that should be used. The Submission Ordinance and 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. Otherwise, where AMG-EV does not differ, 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.

Explanatory Notes on the enforcement of the Ordinance on the Submission of Documents within Licensing and Renewal Procedures for Medicinal Products (Größe: 508.27 KB) (AMG-Submission-Ordinance AMG-EV) from 21^st December 2000
- Version 5.0 of 1 July 2007 -

E-mail address and public key to implement the Ordinance on the Submission of Documents within Licensing and Renewal Procedures for Medicinal Products (AMG-Submission-Ordinance AMG-EV) from 21^st of December 2000

The following e-mail address should be used for electronic transmission of documents required by the a.m. Submission Ordinance:

BfArM Key

On 1 January 2010, the BfArM published the new BfArM key. The validity of which expires on 12 July 2010.

Note: The validity period of the key published on 1 July 2009 will expire on 10 January 2010.



Provided data to be transmitted shall be encoded using the public AS-key contained in the

Key fingerprint = EDFF 0481 716E 1B15 F449 109F ADEA 29A5 4E5E DC3C

Note: Encode only and do not sign!

(For further details see a.m. Explanatory Notes)

It is possible, prior to submission of the documents, to check the processing number (ENR) assigned to your medicinal product in AMIS - Public Part (fee-based part of the DIMDI database, access via DIMDI-Homepage (DIMDI Databases).


You find all other texts concerning AMG-Submission Ordinance on the German Website.