Benutzerdokumentation

Transcrição

AZ: 5300-05-214191
Benutzerdokumentation
Date:
01.02.2008
AMG-EV
Explanatory Notes on the Enforcement of the Ordinance on the
Submission of Documents within Licensing and Renewal Procedures for
Medicinal Products (AMG-Einreichungsverordnung - AMG-EV)
of 21st December 2000
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NOTES ON THE ENFORCEMENT OF THE AMG-EV
BVL
__________________________________________________________________________________
Explanatory Notes on the Enforcement of the Ordinance on the Submission
of Documents within Licensing and Renewal Procedures
for Medicinal Products (AMG-Submission Ordinance, AMGEinreichungsverordnung, AMG-EV) of
21 December 2000
- Version 1 of 17th September 2004 Contents
1
General remarks............................................................................................................................................................. 3
2
E-mail addresses............................................................................................................................................................. 3
3
Procedures for electronic submission ........................................................................................................................... 3
4
3.1
General .................................................................................................................................................................... 3
3.2
Documents to be submitted ...................................................................................................................................... 4
3.3
Supplemental and additional documents to be submitted ........................................................................................ 4
3.4
New applications for marketing authorisation in accordance with Section 21 ff. AMG .......................................... 5
Technical specifications concerning e-mails................................................................................................................. 5
4.1 E-mail subject .............................................................................................................................................................. 5
4.2 E-mail content.............................................................................................................................................................. 5
4.3 E-mail attachments and file formats ............................................................................................................................ 6
4.3.1 Zip containers...................................................................................................................................................... 6
4.3.2 Files with documents to be submitted ................................................................................................................. 6
4.3.3 Files with metadata ............................................................................................................................................. 6
4.3.4 Encryption of the containers ............................................................................................................................... 7
4.3.5 Encryption software ............................................................................................................................................ 7
4.3.6 Encryption with the BfArM key.......................................................................................................................... 8
4.3.7 Downloading of the BfArM key ......................................................................................................................... 8
4.4
File name convention ............................................................................................................................................. 15
4.4.1 Elements of file names for electronic submission to BVL ................................................................................ 15
4.4.2 File name convention ........................................................................................................................................ 17
4.4.3 Check-list to monitor whether all conditions have been fulfilled...................................................................... 17
5
Verification and confirmation of e-mails.................................................................................................................... 18
5.1
6
Possible error messages regarding electronic verification of coherence of formal/technical characteristics ..... 19
Information................................................................................................................................................................... 23
7
Important notes concerning permission of exclusive submission of paper documents in accordance with
Section 3 AMG-EV................................................................................................................................................................ 23
Version 2.1 of February 2008
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1
General remarks
The AMG-Submission Ordinance (AMG-Einreichungsverordnung, called AMG-EV in the following)
regulates the electronic submission of documents. Within this purview, the AMG-EV as well as
these explanatory notes override earlier regulations on the submission of documents. Divergent
requirements in previous notifications are replaced by these explanatory notes. Aside from this,
unless otherwise specified by the AMG-EV, the currently existing regulations on the submission of
documents apply. This means e.g. that if documents can or must be submitted on paper
according to Sections 3 and 4 of the AMG-EV, the existing requirements for such submissions
must still be observed.
These explanatory notes override the previous explanatory notes (available only in German).
BVL joined the procedure of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für
Arzneimittel und Medizinprodukte - BfArM). All confirmations or error messages will be sent from a
BfArM e-mail address (cf. Point 5., for encoding via BfArM-key see point 4.3.6)
2
E-mail addresses
[email protected]
For test purposes, documents can be sent to the following address:
[email protected]
Attention: Electronic submissions to the test address exclusively serve for testing for
possibly existing formal errors and are not further processed by BVL.
3
Procedures for electronic submission
3.1
General
Electronic submission of documents is to be made to the a.m. e-mail addresses. At the same time
the written version is to be sent to the regular mailing addresses – depending on which procedure
is used.
For electronic submission of documents in accordance with Section 1 sub-section 2 of the AMGEV only the web-technology e-mail is to be used. Thus, transfer of data via disk or CD is
impossible. For more information please refer to the reasoning of the Federal Council of Germany
(Bundesrat) on the AMG-EV of 10 November 2000 (BR-Drs./resolution 745/00).
The same applies to supplements, insofar as these are included in Section 2 sub-section 1 of the
AMG-EV.
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3.2
Documents to be submitted
All documents listed in Section 2 sub-section 1 AMG-EV, i.e. drafts for labelling in accordance
with Section 10 AMG, for package leaflets in accordance with Section 11 AMG and for expert
information ("Fachinformation") in accordance with Section 11a AMG are to be submitted
electronically.
For a transitional period the BVL waives the obligatory requirement of the submission of Expert
Reports in accordance with Section 24 sub-section 1 numbers 1-4 AMG.
The complete list of document types to be submitted (cf. Point 4.4.1) applies to all applications for
marketing authorisation, renewals of marketing authorisation in accordance with Section 31
and/or 105 AMG, and variations in accordance with Section 29 AMG. In order to accelerate all
Mutual Recognition Procedures (RMS and CMS procedures) it is recommended to submit all
informative texts during the ongoing procedure in accordance with the regulations of the AMG-EV
and these explanatory notes.
Registration procedures in accordance with Section 38 AMG and centralised European
Procedures are not subject to the purview of Section 1 AMG-EV.
Electronic submissions for registration and/or re-registration procedures are not prescribed by
law, however, in the interest of accelerating the procedure it is urgently recommended.
The documentation according to Sections 10, 11, 11a as well as the Expert Reports according to
Section 24 AMG each must be submitted electronically as separate files (i.e. no summary of
drafts of labelling and wording in accordance with Sections 10, 11 and 11a in one file).
Furthermore, all links to other files in the respective file must be removed prior to saving.
Depending on the type of application (= processing number of the medicinal product) a separate
e-mail is to be sent to the e-mail address mentioned under Point 2.
Attention: If, for one ENR, one and the same type of document occurs repeatedly within an email, this e-mail is rejected, exception: cf. Point 4.4.
3.3
Supplemental and additional documents to be submitted
After 1 January 2001, supplements or additional documents concerning drafts for labelling in
accordance with Section 10, for the package leaflet in accordance with Section 11, for the expert
information ("Fachinformation") in accordance with Section 11a and for the Expert Reports in
accordance with Section 24 AMG sub-section 1, numbers 1-4, i.e. concerning the documentation
in accordance with Section 2 sub-section 1 AMG-EV are also to be submitted electronically.
This also applies to applications filed prior to 1 January 2001.
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3.4
New applications for marketing authorisation in accordance with
Section 21 ff. AMG
If a new licensing procedure is intended, the BVL is first to be informed of this in writing
- mailing address –
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit
Fachregistratur Tierarzneimittel
Mauerstr. 39 - 42
D-10117 Berlin,
preferably via telefax no.: +49-30-18444-30138 stating the name of the medicinal product and the
pharmaceutical form. As a response to this informal letter the applicant will receive a
corresponding processing number (Eingangsnummer, ENR) reserved for this procedure.
This processing number should always be stated throughout the documents for application as
well as in the dossier (e.g. in the corresponding field of the application forms).
Note:
4
Please do not reserve processing numbers as so-called "variables". The application
should be submitted within four weeks after reservation of a processing number. As
before, only actual submission of the application is relevant for the date of receipt of the
application and not the advance assignment of the processing number.
Technical specifications concerning e-mails
The files to be sent with the submitted documents shall be compressed with the help of a compression
program (e.g. .zip or .tar format) (cf. Point 4.3.1).
Note: The following examples use zip containers, however, these also apply to tar containers.
4.1
E-mail subject
Only the 7-digit processing number (ENR) which is intended for the submission is to be stated in
the subject line of the e-mail. The validation program checks whether the subject line exclusively
states the processing number (ENR), if not, the e-mail is rejected. The e-mail is likewise rejected if
the subject line is empty. The sender is not informed of this fact as the e-mail is considered spam
mail.
4.2
E-mail content
The content of the e-mail is optional and is not evaluated by BVL but is returned as an attachment
to the confirmation of receipt. Therefore, the text can be used for in-house purposes.
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4.3
E-mail attachments and file formats
Every e-mail contains a zip container with the files of the documents to be submitted including the
file of metadata (attribut.txt) as an attachment. If necessary, the zip container can be encrypted,
cf. Point 4.3.4.
4.3.1
Zip containers
Exactly one zip container shall be provided with every e-mail. The name of the zip container
shall be as follows:
<7-digit ENR>. zip
Example: 1234567.zip
4.3.2
Files with documents to be submitted
Currently, the only file format readable by the BVL with a justifiable effort in accordance with Section 1
sub-section 2 AMG-EV with regard to the texts as per AMG is the Rich Text Format (*.rtf) (cf. BRDrs./resolution 745/00, p. 5). Use of the .pdf format (*.pdf) is permissible for complete documents if
the text contained therein is additionally submitted separately as an .rtf file with identical name (cf.
Point 4.4). However, the .pdf files must not contain any restricted or scanned documents.
Due to the possibility of transmitting macro viruses, files in MS Word format are excluded from
processing.
Furthermore, the use of text fields in the actual text is not permitted for safety reasons (with the
exception of headers and footers).
Attention: The files must be saved with MS Word as .rtf files. It is not sufficient to change the file
extension to ".rtf".
4.3.3
Files with metadata
Each e-mail must be accompanied by exactly one file with metadata. The file format is text, the
standard file name is:
attribut.txt
This file must contain the attributes described in the following.
•
pnr =
Pharmazeutische Unternehmer-Nummer [number for pharmaceutical entrepreneur]
(7-digit, if necessary, leading zeros)
•
enr =
Eingangsnummer [processing number] (7-digit, if necessary, leading zeros)
•
verf =
Verfahren [procedure]; one of the following is to be selected:
aenderung [variation]
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nachzulassung [post-approval]
registrierung [registration]
nachregistrierung [post-registration]
verlaengerung [renewal]
zulassung [marketing authorisation]
either
• edat
=
Date of submission (in all procedures except for variation procedures):
dd.mm.yyyy
(This date must be that of the cover letter (paper version))
or
• aend
=
Date of notification of variation (only in the case of variations):
dd.mm.yyyy
(This date must be that of the cover letter (paper version))
Note:
<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).
Example for the content of the file "attribut.txt":
pnr = 8040743
enr = 0000313
verf = nachzulassung
edat = 12.12.2002
The following notation is preferred: lower case letters for the field names, blanks before and after the
equals sign, lower case letters for the value list, date format (dd.mm.yyyy).
4.3.4
Encryption of the containers
Optionally, the zip container can be encrypted.
The name of the encrypted container is automatically assigned by the encryption software and –
depending on the software used – is
<7-digit ENR>. zip.pgp
or
<7-digit ENR>. zip.gpg
Only entire zip or tar containers should be encrypted.
Individual files of a zip container shall not be encrypted.
4.3.5
Encryption software
Exclusively the PGP (Pretty Good Privacy) program or a product compatible with OpenPGP are to be
used for encryption. Other encryption methods cannot be processed or used without an unjustifiable
effort. The free program GnuPG and information on its use can be found on the internet under
www.winpt.org or www.gnupg.de. The product is called e.g. Windows Privacy Tray (WinPT Tray 07.96
released).
Attention: Depending on the version of the program, German is not used continuously. Example:
Windows Privacy Tray, Version 07.96rc1 (2003-04-26)
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The following is a description of the necessary steps for downloading the encryption software:
1. Download of "gnupp-1.1-de-installer.exe" to a specified directory (e.g. C:\Programs\GnuPP) and
installation of the program.
2. The program Windows Privacy Tray is started from the start menu (Start → Programs → GnuPP
→ Windows Privacy Tray) and is then constantly available in the taskbar.
4.3.6
Encryption with the BfArM key (Federal Institute for Drugs and Medical Devices)
You will find the respective valid public key of the BfArM in the file: BfArM-OpenPGP-AS-Key.asc for
encryption in the course of submissions in accordance with AMG-EV on the page:
http://www.bfarm.de/de/Arzneimittel/amg_ev/index.php
The public key is replaced by a new one every six months on
2 January and on
1 July.
This serves to increase the safety of both parties.
Use of an expired key generates an error message.
4.3.7
Downloading of the BfArM key
The following is a description of the necessary steps for downloading the public BfArM key:
1. Download and save the public BfArM key.
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The file with the key is stored e.g. in the download directory.
2. The BfArM key is integrated via the menu option "Key Manager" of the Windows Privacy Tray. In
order to do this, the item "Import" is chosen from the menu "Key".
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3. The downloaded BfArM key file is selected and then imported.
4. After having clicked on the "Open" dialog, the "File Import" box appears.
5. After having clicked "Import" you will receive the message:
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6. After confirmation by clicking "OK" the imported key is listed in the key manager. Possibly the key is
not displayed immediately in which case the key manager must be closed and then reopened.
7. For the BfArM key the fingerprint can be checked and the degree of Ownertrust can be set in the
menu "Key" under the item "Properties".
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8. The fingerprint of the imported key can be checked here.
9. After having opened the file to be encrypted, encryption of the .zip file takes place in the file
manager. The item "Encrypt" is chosen from the menu "File".
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10. The BfArM key is chosen in the dialog box "File Encrypt".
Attention: The key imported in step 6 is shown here with its two subkeys. It makes no difference
which subkey is chosen for encryption. The program will automatically use the correct key.
11. The status in the file manager states that the file has been encrypted. This is also apparent from
the additional automatically appended extension ".gpg". The file with the double extension
"~.zip.gpg" is the encrypted zip file to be transmitted to the BfArM.
12. The e-mail can now be compiled with the attachment:
- 1234567.zip.gpg (= encrypted zip container)
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4.4
File name convention
In accordance with the AMG-EV, the applicant must name the files in a zip container of an electronic
submission pursuant to a harmonised file name convention:
•
The minimum designation for the BVL (type of document as per the list below) shall precede any
company term. Type of document (possibly with a respective sequential number which is added
after a hyphen) and company term are separated by a hyphen. The hyphen after the type of
document is only necessary if a company term is added. Further hyphens can be included within
this designation.
•
Only one file of one type of document may be sent per mail.
•
For several types of document, submission of multiple files per type is permitted. In this case the
files are to be named with the corresponding type of document and the sequential 3-digit number.
The numbering is an inherent part of the file name and must also be assigned if only a single file
is submitted. Thus, the following file name would result e.g. for "labelling (inner pack)":
labip-001.rtf
labip-002.rtf
etc.
•
It is permitted and even encouraged that the files be submitted, possibly with the text corrections
automatically made by MS Word highlighted. However, the identification of such files in the name
of the file is not required. Further versions of this file (e.g. without the markings (clean version))
shall not be submitted.
•
If a document contains diagrams or pictures, handling can be simplified as follows:
a) in the .rtf format, diagrams and pictures are omitted
b) in addition to the .rtf file, a .pdf file shall be submitted with the same file name which contains
the complete text including diagrams and pictures.
Attention: The .pdf file must not contain any restrictions. The submission is also rejected if
only the .pdf file is submitted without the corresponding .rtf file.
•
Hyperlinks are not permissible.
4.4.1
Elements of file names for electronic submission to BVL
Only those types of documents stated in the list below shall be submitted electronically.
For texts:
<Type of document according to the list below>[-<optional>].extension
Example: pal-blabla.rtf
For files with diagrams and pictures:
<Type of document according to the list below>[-<optional>].extension
Example: pal-blabla.pdf
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Attention:
Example:
The brackets are not part of the file name. They specify the part that can be
inserted optionally. Of course, the limitations stated in Point 4.4.2 with regard to
use of upper and lower case and characters are also to be observed for this part.
labbl-text-according-to-paragraph-10-amg.rtf
Type of
German Term
Document
(to be used
in file
name)
spcde
Fachinformation gemäß § 11a AMG
spcen
spcpal
labbl
labip-001*
labop-001*
labpal-001*
pal
qo
Summary of Product Characteristics (die
zu harmonisierende englische Version)
Fach- / Gebrauchsinformation
gemäß § 11a Abs. 4 AMG
Kennzeichnung gemäß § 10 AMG
Kennzeichnung gemäß § 10 AMG mit
Gebrauchsinformation (von Labelling –
package leaflet)
Gebrauchsinformation gemäß § 11 AMG
Analytisches Sachverständigengutachten
qts
nco
Pharmakologisch-toxikologisches
Sachverständigengutachten gemäß
§ 24 Abs. 1 Nr. 1 AMG
ncts
ro
Sachverständigengutachten über die
Rückstandsprüfung gemaß
§ 24 Abs. 1 Nr. 4 AMG
rots
co
*
Klinisches Sachverständigengutachten
gemäß § 24 Abs. 1 Nr. 3 AMG
English Term
(NTA , Vol. 6B)
Summary of Product Characteristics
national language (Part I B3)
Summary of Product Characteristics
in English (Part I B1)
Labelling (Blister) (I B2)
Labelling (inner pack) (I B2)
Labelling (outer pack) (I B2)
Package Leaflet
Chemical/pharmaceutical/biological
Expert Report (I C)
Tabular Formats for the
pharmaceutical expert report (I C)
Safety Expert Report (I C)
Tabular formats for the safety expert
report (I C)
Residues Expert Report (I C)
Tabular formats for the residues expert
report (I C)
Clinical Expert Report (I C )
Sequential 3-digit numbering beginning at 001, this numbering is inherent part of the type of document and
must also be assigned if only one sinlge file is submitted:
for submission of different drafts for labelling in accordance with Section 10 AMG regarding various package
sizes, beginning with the smallest.
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4.4.2
File name convention
File extension:
All files must have only one file extension (i.e. only 1 dot!), e.g.
nnnnn.pdf
nnnnn.rtf
Name:
The file name must have no more than 64 characters. Only lower case letters are allowed – this also
applies to the extension. The following characters are admissible:
• letters from "a" to "z" [U+0061 to U+007A]
• numbers "0“ to "9" [U+0030 to U+0039]
• special characters "-" [HYPHEN, U+002D]
The notation "U" refers to Unicode.
Note: incorrect file names without extension are e.g.:
part a
(' '; blank is not permissible)
myfile.xml
('.'; dot is not permissible)
hello:pdf
(':'; colon is not permissible)
part_a
('_': underscore is not permissible)
änd
('ä' or 'ö' or 'ü' umlauts are not permissible)
4.4.3
Check-list to monitor whether all conditions have been fulfilled
Item
Entry
Example
Create .txt file with metadata
with the standard name
"attribut.txt"
(cf. Point 4.3.3)
pnr = number for pharmaceutical
entrepreneur
enr = processing number
verf= value list:
aenderung
nachzulassung
registrierung
nachregistrierung
verlaengerung
zulassung
either
edat = date of submission
dd.mm.yyyy
or
aend = date of variation
(only in case of notifications
of variation)
dd.mm.yyyy
- no more than 64 characters
- no special characters
- only lower case letters
- give term for type of document first
and separate from the company file
name by way of a hyphen
pnr = 7654321
enr = 1234567
verf = zulassung
edat = 12.12.2002
File name convention for text files
(cf. Points 4.4.1, 4.4.2)
spcde-xxxyyybbb-20030303-dkl.rtf
- .rtf is the only file format
permissible
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Item
Entry
Example
Treatment of documents that
contain diagrams and pictures:
create .rtf file with text and enter
wildcards [<Type of Document-ENRpdf>] for the pictures. Additionally
submit complete document as .pdf
file (must not contain any
restrictions). Except for the
extension, both files must be given
an identical file name
(cf. Points 4.4.1, 4.4.2)
Expert Report
•
File name (cf. Point 4.4.1)
- term for type of document
- hyphen
- company file name
- .rtf (for the text file)
spcde-blabla.rtf
spcde-blabla.pdf
Compress files: make containers
(cf. Point 4.3.1)
Encryption of containers
(cf. Point 4.3.4)
Sending of e-mail attachments
(cf. Point 4.3)
E-mail subject
(cf. Point 4.1)
E-mail content
(cf. Point 4.2)
5
- term for type of document
- hyphen
- company file name
- .pdf (for the complete document
(text with diagrams and pictures)
- Expert Reports must likewise be
renamed in accordance with the file
name convention.
By way of a compression program
(.zip format or .tar format) the file
"attribut.txt" and the files with the
documentation to be submitted are
put into a container. The container
receives the ENR as file name.
Optionally the container can be
encrypted
The container is attached to the email
qo-xxxyy.rtf
Processing number (ENR)
1234567
Optional
blabla
1234567.zip
1234567.zip.pgp
1234567.zip
or
1234567.zip.pgp
Verification and confirmation of e-mails
The submitter receives several confirmations by e-mail, depending on the status of the
verification. All response mails are furnished with a unique number. This number is to be quoted
in case of queries.
•
Confirmation of receipt and confirmation as to the coherence of the formal/technical
properties
After receipt of the e-mail at the DIMDI's server designated for submissions in accordance with
the AMG-EV it is verified according to the following purely formal criteria:
-
-
Does the e-mail contain the required attachments (zip container) with the required
extensions?
Are file names in accordance with the file name convention?
Is the name of the zip container in accordance with the name convention?
Are the characteristics of the file "attribut.txt" as required?
Does the e-mail's subject line exclusively contain the 7-digit processing number (ENR)?
Has the zip container been encrypted exclusively with the mandatory encryption?
Are the files in the zip container unencrypted?
Was the BfArM key used to encrypt the file container?
Was the required compression program (.zip or .tar) used?
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If no mistakes are found, the submitter receives a confirmation of receipt with the subject line
"Positivmeldung <sequential number>"; however, this merely refers to the formal accuracy of
the e-mail. There are no further positive notices.
Incorrect e-mails are rejected promptly with a confirmation of receipt with the subject line:
"Negativmeldung <sequential number>".
E-mails with no or faulty subject lines are discarded as spam without notification of the sender.
•
Confirmation as to the intellectual verification of content
Further formal mistakes can only be determined intellectually, e.g.
Processing number and content do not correspond.
The file cannot be opened.
The file cannot be read.
The file is not in the correct format.
The submitter is likewise informed of these mistakes via e-mail.
The intellectual verification of the submission's content can result in different confirmations
(notice of marketing authorisation etc.). Should further mistakes be observed during the
course of this, they will be communicated via individual correspondence.
Should one of the formal/technical errors be recognised in the course of processing, further
validation is discontinued and a mail with the corresponding error message (cf. Point 5.1) is
returned to the sender's address. We kindly ask that such error messages initially be analysed by
the sender before contacting BfArM/BVL with possible queries.
If a submission is correct as to formal/technical aspects, receipt is confirmed in an e-mail (subject
line: "Positivmeldung").
5.1
Possible error messages regarding electronic verification of coherence
of formal/technical characteristics
Note: This list of errors is dynamic and will be updated on an ongoing basis as new errors
emerge.
Error Message
Possible Cause
Die Maildatei ist fehlerhaft. The structure of the mail is incorrect and
it can therefore not be processed.
Der Mailanhang konnte
The structure of the encrypted file is
nicht entschlüsselt
presumably defective.
werden.
Only one encrypted container per mail is
Die Mail enthält mehr als
permitted.
eine GPG/PGP-Datei.
Es darf nur eine
verschlüsselte Datei im
Mailanhang vorhanden
sein.
Proposed Solution
Check type, version, or
settings of own mail client.
Check type, version, or
settings of own encryption
software.
Send a separate mail per
container.
Fehler beim Entpacken
der Zip-Datei. Die Zip-
Check the archiving
program employed and
The archiving format employed (*.zip) is
faulty (the check sum is incorrect, data
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Error Message
Datei ist wahrscheinlich
beschädigt.
Die Anzahl oder der Typ
der Mailanhänge
entspricht nicht den
formalen Vorgaben.
Fehler beim Extrahieren
der Tar-Datei. Die TarDatei ist wahrscheinlich
beschädigt.
Der Mailanhang enhält
nicht zulässige Dateitypen.
Die Datei <DATEI>
formalen Vorgaben.
Der Name der Datei
<DATEI> enthält nicht
zulässige Zeichen.
Die Mail enthält keine
Attributdatei im Anhang.
Die Mail enthält mehr als
eine Attributdatei im
Anhang.
Die Angaben in der
Attributdatei sind nicht
vollständig.
Das Format der ENR
<ENR> in der Attributdatei
ist nicht korrekt. Die ENR
muss immer siebenstellig
angegeben werden.
Das Format der PNR
<PNR> in der Attributdatei
ist nicht korrekt.
Das Format des Feldes
EDAT in der Attributdatei
ist nicht korrekt.
Der Name einer Datei
(<DATEI>) im Mailanhang
formalen Vorgaben.
Der Mailanhang enthält
nicht zulässige
Dokumenttypen. Die Datei
ERRVAO> enspricht nicht
den formalen Vorgaben
Die ENR (<ENR>) in der
Attributdatei ist unbekannt.
Es sind mehrere
Possible Cause
is incomplete, etc.)
Only the container and its separate
signature may be attached.
The archiving format employed (*.tar) is
faulty (the check sum is incorrect, data
is incomplete, etc.)
Only files with the extensions .rtf, .pdf,
and the "attribut.txt" file are permissible.
Permissible characters are: lower case
letters [a-z], numbers [0-9], and
hyphens.
The "attribut" file is necessary for
validation and processing of the
submission
Only one "attribut.txt" is permitted.
Proposed Solution
settings. Create a new mail
with archive file and send.
Create a new mail with
archive and signature file
and send.
Check the archiving
program employed and
settings. Create a new mail
Correct types of file and
create new container.
The container shall be
named "<ENR>.zip" or
"<ENR.tar".
Details in Point 4.3.3.
Delete redundant files and
create new container.
Syntax error in the file "attribut.txt".
Details in Point 4.3.3.
Syntax error in the file "attribut.txt". The
ENR must always consist of 7 digits.
Details in Point 4.3.3
The correct ENR can be
found in "AMIS Public
Section".
PNR must always consist of 7 digits.
Your correct PNR can be
Section".
Check spelling, observe
date format, cf. Point 4.3.3.
format is "dd.mm.yyyy".
Permissible characters are: lower case
letters [a-z], numbers [0-9], and
hyphens.
Details in Points 4.4.1 and
4.4.2.
The file name convention was
disregarded.
Compare with the list of
types of document 4.4.1
and change accordingly.
The ENR is possibly incorrect.
Section".
Exactly one archive file must be
Page 20 of 23
BVL
__________________________________________________________________________________
Error Message
Dateiarchive (zip oder tar)
im Mailanhang vorhanden.
Es ist kein Dateiarchiv (zip
oder tar) im Mailanhang
vorhanden.
Die ENR (<ENR>) aus
Mail-Betreff,
Containernamen und
Attributdatei stimmen nicht
überein.
Die ENR im Betreff-Feld
der Mail ist unbekannt.
Possible Cause
attached
Proposed Solution
archive file and send.
Exactly one archive file must be
attached
archive file and send.
Only the 7-digit ENR is to be stated in
the subject line.
Details in Point 4.1
Section".
Give archive file correct
name, create a new mail
Section".
Check spelling, observe
date format, cf. also Point
4.3.3.
Der Name der Archivdatei The name must read <ENR>.zip or
in der Mail ist nicht korrekt. <ENR>.tar. Details in Point 4.3.1.
Die ENR (<ENR>) im
Namen der Archivdatei der
Mail ist unbekannt.
Die Bezeichnung des
Verfahrens (<VERF>) in
der Datei "attribut.txt" ist
nicht korrekt.
Der Datencontainer im
Mailanhang enhält
verschlüsselte Dateien.
Das Format des Feldes
"AEND" (<ERRVARO>) in
der Attributdatei ist nicht
korrekt
Die Datei <ERRVARO>
enthält nicht das
angegebene Dateiformat
Der Datencontainer im
Mailanhang enthält
Unterverzeichnisse
Das Einreichungsdatum ist
ungültig
Das Änderungsdatum ist
ungültig
Die PNR (<ERRVARO>)
in der Attributdatei ist
unbekannt
Eine PDF-Datei ist kein
zulässiges Format für ein
Textdokument oder der
Name einer Bilddatei
formalen Vorgaben.
Mehrere Dokumente eines
The file name contains characters
indicative of a picture file, but the format
is not suitable.
Syntax error in the file "attribut.txt".
Files in a container must not be
encrypted.
Typing error
Make new container with
unencrypted files. Send
mail again.
Date = dd.mm.yyyy
cf. 4.3.3.
The extension of a doc-file was changed .doc files must be saved as
to .rtf
.rtf files.
Result of copying.
Remove subdirectories.
Typing error, invalid date such as
30.2.2004.
Typing error, invalid date such as
30.2.2004.
Typing error.
Date = dd.mm.yyyy
cf. 4.3.3.
Date = dd.mm.yyyy
cf. 4.3.3.
7-digit number
Section".
Correct file name.
Several files were created for one type
Exception cf. Point 4.4.
Page 21 of 23
BVL
__________________________________________________________________________________
Error Message
Dokumenttyps
(<DOCTYPE<) sind nicht
zulässig
Zu der Bilddatei
(<DATEI>) existiert kein
Textdokument
Das Änderungsdatum ist
in der Attributdatei nicht
vorhanden
Die Angabe eines
Einreichungsdatums in der
Attributdatei im Verfahren
"aenderung" ist nicht
zulässig
Das Einreichungsdatum ist
in der Attributdatei nicht
vorhanden
Possible Cause
of document type.
Proposed Solution
Otherwise merge all files to
a type of document.
Text document was forgotten.
New e-mail with picture file
and respective text
document.
Date = dd.mm.yyyy
cf. Point 4.3.3.
Die Angabe eines
Änderungsdatums in der
Attributdatei im Verfahren
"<ERRVARO>" ist nicht
zulässig
Im Dokumentnamen
"<ERRVARO>" fehlt ein
Bindestrich nach dem
Dokumenttyp.
Das Format der ENR im
Betreff-Feld der Mail ist
nicht korrekt. Die ENR
muss immer siebenstellig
angegeben werden
The following is not stated under
"procedure":
verf = aenderung.
The declaration
verf = aenderung
lacks the respective date.
Typing error.
State the date of the
variation in the "attribut" file
cf. Point 4.3.3.
State the date of
submission in the "attribut"
file
cf. Point 4.3.3.
Check which procedure is
meant cf. Point 4.3.3.
File name convention cf.
Point 4.4.1.
Send the mail again with
the corrected subject line.
Page 22 of 23
BVL
__________________________________________________________________________________
6
Information
As the BVL joins the BfArM procedure please contact BfArM e-mail and telephone hotlines for
additional questions, which are regularly evaluated. Frequently asked questions are answered on
the BfArM's homepage under FAQ.
AMG-EV hotline:
E-mail address:
01888 307 3700 or 0228 207 3700
[email protected]
As a rule, BfArM cannot answer questions as to use and functionality of compression
programs.
In case of questions related to submitted documents, reference must be made to the number of
the BfArM's response mail. E-mails concerning veterinary medicinal products will be forwarded to
the BVL.
7
Important notes concerning permission of exclusive submission of paper
documents in accordance with Section 3 AMG-EV
We advise you that applications for exceptional permissions in accordance with Section 3 number
1 AMG-EV can only be made related to the procedure, i.e. with reference to the individual
veterinary medicinal product.
As a rule, an exception can only be granted without further inquiry, if the reasoning of the
application shows comprehensibly and conclusively, that the applicant fulfils all prerequisites of an
"undue hardship". Global statements without further explanation necessarily lead to procedural
delays and/or to rejection of the application. In this context please also observe the following:
If an undue financial burden is claimed, more details are necessary especially as to the
expected costs of compilation and submission of the required documents electronically as well as
a comparison of these costs with the presumed turnover from the medicinal product concerned.
If technical reasons are present these are to be explained in detail and are to be justified. If
applicable, it should be stated why electronic submission of the documents is not possible even if
the help of others is enlisted.
Exceptional permissions in accordance with Section 3 number 1 AMG-EV are generally only
granted temporarily. This means that the documents must be supplemented electronically during
the course of the subsequent procedure after termination of the exemption granted. In order to
ensure an adequate assessment of the time limit, applicants are requested to declare when the
obstacles asserted will presumably be removed upon submitting the application.
Page 23 of 23

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