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AMG-Submission Ordinance

AMG-EV regulates the electronic submission of documents including the procedures that should be used. The Submission Ordinance as well as 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. Unless otherwise stipulated by the AMG-EV, 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.

Product information text for publication

Electronic submission according to Section 11 sub-section 1a, and Section 11a sub-section 3 AMG

The BfArM has introduced the new document types

spcdeff.pdf
spcenff.pdf
paldeff.pdf
palenff.pdf

In this connection please name the attribut.txt file e.g as follows

pnr = 0000000
enr = 1999023
verf = freigabe
dat = 18.09.2013

The "short instructions" contain further information.

The basis for such electronic submissions is provided by the AMG-EV.

Files should be created in PDF format using the text version sent by BfArM after closure of the procedure or along with the authorisation letter. You have to eliminate all contents from headers and footers (except for page numbers), all marked changes or comments and all personal details of the person editing the file and similar items not relevant to the public. These text versions will be used in accordance with Section 34 AMG.

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

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

zulassung@amg-zulassung.de

The procedure is described using the test ENR 1999023 as an example.

Our table "Specifications of the metadata in the file "attribut.txt" provides information on how to use relevant metadata contained in the file attribut.txt.


You will find the elements of file names at the following link:

An example of how to create a complete container for upload:


The BfArM has published the new BfArM key for the period from 1 January 2015 to 1 October 2018.
The validity of this key begins on 1 January 2015 and expires on 10 January 2018.

Note:
The public key is valid for real submissions and test submissions

  • to the BfArM:
    < zulassung@amg-zulassung.de >
    < testeinreichung@amg-zulassung.de >
  • to the BVL:
    < tam-zulassung@amg-zulassung.de >
    < tam-testeinreichung@amg-zulassung.de >

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

Key fingerprint = 52F9 A18B 4665 4A8F 9230 DF7C 097E D27E 2E17 3876

Note: Encode only and do not sign!

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

Which is my ‘PNR’ and how to find the ‘ENR’

On 10 September 2010, the BfArM published the "Information on AMIS-Search for external users":

It is possible, prior to submission of the documents, to check the processing number (ENR) assigned to your medicinal product at the PharmNet.Bund-Portal.

Date 2016.02.09