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AMG-Submission Ordinance

created: 2007.07.12
updated: 2013.04.24

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

1. Ordinance on the Submission of Documents

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.

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2. Explanatory Notes on the enforcement of the AMG-EV

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 21st of December 2000The following e-mail address should be used for electronic transmission of documents required by the a.m. Submission Ordinance:

zulassung@amg-zulassung.de

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3. Short instructions for electronic submissions according to the AMG-EV
(submission ordinance according to the German Medicinal Products Act/AMG)

The procedure is described by the EXAMPLE of the test ENR 1999023.

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4. 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.

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5. Elements of file names for electronic submission to BfArM

The elements of file names you will find:

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6. Zip-File; example for your electronic submission

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7. BfArM Key

The BfArM has published the new BfArM key for the 1st half-year in 2013
(Validity: From the 01st of January, 2013 up to the end of the 10th of July, 2013).

Note:
The validity of the key used for the 2ndst half-year in 2012 goes out with expiry of the 10th of January, 2013.

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


Not barrier-free file. BfArM-OpenPGP-AS-Key.asc (file size: 5 KB) file.

Key fingerprint = 3640 E4DD 4CB0 3AE5 C6E0 B7BD 0265 1FB9 11AA 2D34

Note: Encode only and do not sign!


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

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8. eCTD or NeeS as alternatives to AMG-EV

Do I still have to comply with the AMG-Submission Ordinance (AMG-EV)?

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.

Please, follow moreover our FAQ on the subject eCTD or NeeS

Contact:

• Dr. Klaus Menges, Tel. +49 (0) 228 99-307-3458 or +49 (0) 228/207-3458

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9. Information on AMIS-Search for external users

On the 10th of 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 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.

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