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Impfstoffe

zu den beiden neuartigen Impfstoffen Comirnaty (Biontech/Pfizer) und Covid-19 Vaccine (ModeRNA) jeweils Modul 3 des Dossier Common Technical Document (CTD), den Herstellungsprozess benötige ich nicht, mir geht es in erster Linie um die Qualität der Ausgangsstoffe.

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  • Datum
    28. Januar 2021
  • Frist
    18. Februar 2021
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<< Anfragesteller/in >>
Antrag nach EU-Verordnungen 1049/2001 sowie 1367/2006 Sehr geehrte Antragsteller/in auf Basis der Verordnungen 10…
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<< Anfragesteller/in >>
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Impfstoffe [#210033]
Datum
28. Januar 2021 18:28
An
Europäische Arzneimittel-Agentur
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Warte auf Antwort — E-Mail wurde erfolgreich versendet.
Antrag nach EU-Verordnungen 1049/2001 sowie 1367/2006 Sehr geehrte Antragsteller/in auf Basis der Verordnungen 1049/2001 sowie 1367/2006 bitte ich Sie um Übersendung von Dokumenten, die folgende Informationen enthalten:
zu den beiden neuartigen Impfstoffen Comirnaty (Biontech/Pfizer) und Covid-19 Vaccine (ModeRNA) jeweils Modul 3 des Dossier Common Technical Document (CTD), den Herstellungsprozess benötige ich nicht, mir geht es in erster Linie um die Qualität der Ausgangsstoffe.
Ich weise ausdrücklich darauf hin, dass ich eine Antwort per E-Mail an diese Adresse und nicht über ein Webportal wünsche. Ich möchte Sie um eine Empfangsbestätigung bitten und danke Ihnen für Ihre Mühe! Mit freundlichen Grüßen Antragsteller/in Antragsteller/in Anfragenr: 210033 Antwort an: <<E-Mail-Adresse>> Laden Sie große Dateien zu dieser Anfrage hier hoch: https://fragdenstaat.de/a/210033/ Postanschrift Antragsteller/in Antragsteller/in << Adresse entfernt >> << Adresse entfernt >>
Mit freundlichen Grüßen << Anfragesteller/in >>
Europäische Arzneimittel-Agentur
Dear Sir/Madam **ASK-78118 ( https://servicedesk.ema.europa.eu/jira/… ) - (VY) Impfstoffe [#210033] received on 2…
Von
Europäische Arzneimittel-Agentur
Betreff
[EMA Service Desk] AskEMA ASK-78118 - (VY) Impfstoffe [#210033]
Datum
29. Januar 2021 17:10
Status
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Dear Sir/Madam **ASK-78118 ( https://servicedesk.ema.europa.eu/jira/… ) - (VY) Impfstoffe [#210033] received on 29/Jan/21** Thank you for submitting your request. This is an automated response to confirm that we have received your request; please do not respond directly to this message as this email address is not monitored. A member of Agency staff will now review your request. We will send an acknowledgement of receipt to the email address you have provided, quoting your unique reference number. We endeavour to review all requests as soon as possible, but no later than within 48 hours of receipt, during our normal business hours (see Business hours and holidays ( https://www.ema.europa.eu/en/about-us/c… )). Should you need to contact us in relation to this request please submit your updated query through the webform ( https://www.ema.europa.eu/en/about-us/c… ), quoting the ASK reference number given above. Kind regards,
Europäische Arzneimittel-Agentur
Comirnaty (Biontech/Pfizer) and Covid-19 Vaccine Moderna - ASK-78118Acknowledgement of receipt Dear Mr. Antragstel…
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Europäische Arzneimittel-Agentur
Betreff
Comirnaty (Biontech/Pfizer) and Covid-19 Vaccine Moderna - ASK-78118Acknowledgement of receipt
Datum
5. Februar 2021 14:45
Status
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Dear Mr. Antragsteller/in, Thank you for contacting us on 28th January 2021. We hereby acknowledge receipt of your application for access to documents, which was registered on 3rd February 2021 under reference number ASK-78118, in which you ask for the documents regarding the quality of the raw materials contained in the Module 3 of the Common Technical Document (CTD) for Comirnaty (Biontech / Pfizer) and Covid-19 Vaccine Moderna. We will deal with your request as soon as possible and in accordance with the principles and limits established in Regulation (EC) 1049/2001 regarding public access to European Parliament, Council and Commission documents (the Regulation), as applicable to the EMA pursuant to Article 73 of Regulation (EC) 726/2004. In accordance with the Regulation, you will receive a reply via a secure Eudralink within 15 working days. The Agency may extend this period by a further 15 working days in exceptional circumstances in accordance with the Regulation. Please note that the European Medicines Agency is currently operating within a business continuity plan to ensure operational continuity following its relocation to Amsterdam and during the continuing COVID-19 pandemic. Whilst every effort is being made to process your request as soon as possible, you should be aware that due to these exceptional circumstances, we may have to extend the deadline as outlined above. Should such an extension be applied by the Agency, you will be informed at the time. In case this email becomes publicly available, please redact personal data such as the first name and surname of the sender, e-mail address as well as any other personal data. The Agency considers this information to be protected personal data in the meaning of Article 3(1) of Regulation (EU) No 2018/1725 and Article 4(1) of the General Data Protection Regulation EU 2016/679. Personal data is information that permits to identify a natural person Kind regards,
Europäische Arzneimittel-Agentur
Comirnaty (Biontech/Pfizer) and Covid-19 Vaccine Moderna - ASK-78118Notification of deadline extension Dear Mr. An…
Von
Europäische Arzneimittel-Agentur
Betreff
Comirnaty (Biontech/Pfizer) and Covid-19 Vaccine Moderna - ASK-78118Notification of deadline extension
Datum
23. Februar 2021 14:54
Status
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Dear Mr. Antragsteller/in, I write with an update on the above request. Unfortunately, due to the current high volume of requests resulting in an excessive workload, we are not in a position to issue a decision concerning the release the documents requested within the initial timeline of 15 working days provided for in Article 7(1) of Regulation (EC) No 1049/2001 ("Regulation"). The Agency is required, in these exceptional circumstances, to extend this deadline by another 15 working days in accordance with Article 7(3) of the Regulation. This decision to extend is in line with the principle set out in our Policy on access to documents (available at https://www.ema.europa.eu/en/documents/… ) which states that the Agency will apply the principle of proportionality in order to avoid the core business tasks of the Agency and its performance being jeopardised by the administrative workload related to activities within Regulation 1049/2001. Under the above stated Regulation, you will receive a reply within 30 working days (initial period of 15 working days + 15 working days extension). The deadline has therefore been extended to 15th March 2021. However, we fully expect to be in a position to inform you of the EMA's decision well before that date. Please accept our apologies for any inconvenience that this may cause. If you have any queries or require further information, please do not hesitate to contact me. Kind regards,
<< Anfragesteller/in >>
AW: Comirnaty (Biontech/Pfizer) and Covid-19 Vaccine Moderna - ASK-78118Notification of deadline extension [#21003…
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<< Anfragesteller/in >>
Betreff
AW: Comirnaty (Biontech/Pfizer) and Covid-19 Vaccine Moderna - ASK-78118Notification of deadline extension [#210033]
Datum
24. Februar 2021 19:48
An
Europäische Arzneimittel-Agentur
Status
E-Mail wurde erfolgreich versendet.
Dear Ms. Hassan, thank you very much for the information, I will wait and see and look forward to hearing from you soon. Best regards Antragsteller/in Antragsteller/in Anfragenr: 210033 Antwort an: <<E-Mail-Adresse>> Laden Sie große Dateien zu dieser Anfrage hier hoch: https://fragdenstaat.de/a/210033/ Postanschrift Antragsteller/in Antragsteller/in << Adresse entfernt >> << Adresse entfernt >>
Europäische Arzneimittel-Agentur
Comirnaty (COVID-19 mRNA vaccine (nucleoside-modified)) and COVID-19 Vaccine Moderna (COVID-19 mRNA Vaccine (nucle…
Von
Europäische Arzneimittel-Agentur
Betreff
Comirnaty (COVID-19 mRNA vaccine (nucleoside-modified)) and COVID-19 Vaccine Moderna (COVID-19 mRNA Vaccine (nucleoside-modified)) ASK-78118 - Rejection letter to the requester
Datum
15. März 2021 18:21
Status
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Dear Requester, The decision regarding the document of the above request has just been released to you via a secure Eudralink. Please ensure that you download and save the document before the package expires. Please note that you will need to enter a password to access this Eudralink package. Your unique password takes the following format: ASK-XXXX-YYYY It is the ASK reference number for this request (ASK-XXXX, written exactly as it appears in the subject line ) + the year (-YYYY) in which you submitted your request to the Agency. In case this email becomes publicly available, please redact personal data such as the first name and surname of the sender, e-mail address as well as any other personal data. The Agency considers this information to be protected personal data in the meaning of Article 3(1) of Regulation (EU) No 2018/1725 and Article 4(1) of the General Data Protection Regulation EU 2016/679. Personal data is information that permits to identify a natural person. Kind regards,
Europäische Arzneimittel-Agentur
EudraLink - Comirnaty (COVID-19 mRNA vaccine (nucleoside-modified)) and COVID-19 Vaccine Moderna (COVID-19 mRNA Va…
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Europäische Arzneimittel-Agentur
Betreff
EudraLink - Comirnaty (COVID-19 mRNA vaccine (nucleoside-modified)) and COVID-19 Vaccine Moderna (COVID-19 mRNA Vaccine (nucleoside-modified)) ASK-78118 - Rejection letter to the requester
Datum
15. März 2021 18:22
Status
Warte auf Antwort
+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below https://eudralink.ema.europa.eu/dl.php?… The package will expire on Sun, 13 Jun 2021 19:22:02 +0200 HOW TO PICK UP YOUR PACKAGE: If the Web address above is highlighted, click on it to open a browser window. You will automatically be taken to the package. If the Web address above is not highlighted, follow these steps: - Open a Web browser window. - Copy and paste the entire Web address into the "location" or "address" bar of the browser. - Press enter. Once you arrive at the Web page, you can access the package. +++++++++++++++++++++++++++++++++++++++++++++
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Datum
16. März 2021 18:27
Status
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<< Anfragesteller/in >>
AW: EudraLink - Comirnaty (COVID-19 mRNA vaccine (nucleoside-modified)) and COVID-19 Vaccine Moderna (COVID-19 mRN…
An Europäische Arzneimittel-Agentur Details
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<< Anfragesteller/in >>
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AW: EudraLink - Comirnaty (COVID-19 mRNA vaccine (nucleoside-modified)) and COVID-19 Vaccine Moderna (COVID-19 mRNA Vaccine (nucleoside-modified)) ASK-78118 - Rejection letter to the requester [#210033]
Datum
18. März 2021 22:39
An
Europäische Arzneimittel-Agentur
Status
E-Mail wurde erfolgreich versendet.
Sehr << Anrede >> schade, dass Sie die gefragten Informationen nicht herausgeben. Bitte nehmen Sie meinen schriftlichen Zweitantrag - Widerspruch zur Kenntnis. Bitte überdenken Sie Ihre Entscheidung der Öffentlichkeit die nötigen Informationen vorzuenthalten, um Sicherheit und Qualität der von Ihrer Behörde zugelassenen Arzneimittel zu überprüfen. 1. Es liegt sehr wohl ein öffentliches Interesse vor, ob die Ausgangsstoffe, speziell die Hilfsstoffe die nötige Qualität nach Ph.Eur. besitzen. Sie selbst haben am 30.11.2020 im "EMA/CHMP/641856/2020EMA/CHMP/641856/2020 Committee for Medicinal Products for Human Use Quality rolling review CHMP overview and list of questions" zu bedenken gegeben, dass die Qualität mancher Hilfsstoffe nicht dem Ph.Eur. entspricht, z.B.: "It should be confirmed that cholesterol will be controlled in line with Ph. Eur. monograph Cholesterol for parenteral use (2397) for future batches and not Ph. Eur. monograph Cholesterol (0993)." (Page 67/81). 2. Ich frage mich, wie z.B. im o.g. Fall, aufgrund der Änderung mindestens eines Hilfsstoffes in der Formulierung des Arzneimittels, der Hersteller es geschafft hat, Ihnen die nötigen und neu durchzuführenden Tests und Untersuchungen sowie deren Validierung innerhalb dieser kurzen Zeit von 21 Tagen ( 30.11.2020 bis 21.12.2020 ) zur Überprüfung vorlegen konnte, was das öffentliche Interesse noch weiter verstärkt. 3. Durch die von Ihnen und den EU-Richtlinien geforderte Umstellung mindestens eines Hilfsstoffs auf einen Hilfsstoff von tierischem Ursprung frage ich nach TSE Bescheinigungen, welche mit keinem Wort im Comirnaty EPAR in Bezug auf die Hilfsstoffe erwähnt werden? 4. Die Qualität der Ausgangs- und Hilfsstoffe beeinflusst den „CRM“, wurde dieser neu bestimmt? 5. Ich frage mich auch, ob die Qualität der Ausgangs- und Hilfsstoffe gewährleistet ist, welche von einem Arzneimittelhersteller eingesetzt werden, der zum Zeitpunkt des Beginns seiner ersten Studie BNT162-01 am 23.04.2020 keine Erlaubnis zum Herstellen oder zur Einfuhr von sterilen Produkten ( Impfstoffen ) besaß, vgl. DE_RP_01_MIA_2020_0020, DE_RP_01_MIA_2020_0013, DE_RP_01_MIA_2019_0034, DE_RP_01_MIA_2020_0050, DE_RP_01_MIA_2020_0045, DE_RP_01_MIA_2020_0010. 6. Ich wundere mich über die Unkenntnis des Arzneimittelherstellers darüber, dass bei der Arzneimittelherstellung nur solche (Hilfs-)Stoffe zu verwenden sind, die dem Ph.Eur. entsprechen, sofern eine Monografie besteht. Was mich aber besonders wundert und sicherlich auch von großem öffentlichem Interesse ist, was von der Qualität der Hilfsmittel und Ausgangsstoffe zu halten ist, wenn von einem Arzneimittelhersteller zumindest Prüfarzneimittel mit Hilfsstoffen ohne zwingend nötige pharmazeutische Qualität hergestellt und am Menschen angewendet werden (, denn warum sollte der Hersteller in den Prüfarzneimitteln andere Hilfsstoffe eingesetzt haben als in den Ihrer Behörde vorgelegten Arzneimittelchargen?). Mit freundlichen Grüßen Antragsteller/in Antragsteller/in Anfragenr: 210033 Antwort an: <<E-Mail-Adresse>> Laden Sie große Dateien zu dieser Anfrage hier hoch: https://fragdenstaat.de/a/210033/ Postanschrift Antragsteller/in Antragsteller/in << Adresse entfernt >> << Adresse entfernt >>
<< Anfragesteller/in >>
AW: EudraLink - Comirnaty (COVID-19 mRNA vaccine (nucleoside-modified)) and COVID-19 Vaccine Moderna (COVID-19 mRN…
An Europäische Arzneimittel-Agentur Details
Von
<< Anfragesteller/in >>
Betreff
AW: EudraLink - Comirnaty (COVID-19 mRNA vaccine (nucleoside-modified)) and COVID-19 Vaccine Moderna (COVID-19 mRNA Vaccine (nucleoside-modified)) ASK-78118 - Rejection letter to the requester [#210033]
Datum
20. April 2021 21:35
An
Europäische Arzneimittel-Agentur
Status
E-Mail wurde erfolgreich versendet.
Sehr << Anrede >> mein Widerspruch (EMA/82015/2021 // ASK-78118 // Confirmatory Application, #210033) wurde von Ihnen nicht in der gesetzlich vorgeschriebenen Zeit beantwortet. Sie haben die Frist mittlerweile um 2 Tage überschritten. Bitte informieren Sie mich umgehend über den Stand meiner Anfrage. Mit freundlichen Grüßen Antragsteller/in Antragsteller/in Anfragenr: 210033 Antwort an: <<E-Mail-Adresse>> Laden Sie große Dateien zu dieser Anfrage hier hoch: https://fragdenstaat.de/a/210033/ Postanschrift Antragsteller/in Antragsteller/in << Adresse entfernt >> << Adresse entfernt >>
Europäische Arzneimittel-Agentur
Acknowledgement of receipt - Confirmatory Application ASK- 82701
Dear Mr. Antragsteller/in, Thank you for contact…
Von
Europäische Arzneimittel-Agentur
Betreff
Acknowledgement of receipt - Confirmatory Application ASK- 82701
Datum
23. April 2021 16:02
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Dear Mr. Antragsteller/in, Thank you for contacting the European Medicines Agency regarding a confirmatory application to your access to documents request ASK-78118 (Comirnaty and Moderna module 3). In the Agency's decision letter (EMA/82015/2021) of ASK-78118, sent to you on the 15th March 2021, you were informed that you may submit a confirmatory application (appeal) via the below web-form. More specifically, the Agency's decision letter indicated (second page): "The appeal should be submitted using the on-line request for, available on the European Medicines Agency website, under the following location: https://www.ema.europa.eu/en/about-us/c… The same decision letter was sent to you via the access to documents coordinator's e-mail address which email you were invited to use to communicate on ASK-78118. However, your confirmatory application was received on the 18th March 2021, via the inbox <<E-Mail-Adresse>>, inbox that is not managed by the ATD team. Therefore, for your future consideration, please note that submitting your request via the webform ensures that it will reach the access to documents team and will be handled in a timely and effective manner. Alternatively, you may consider sending your request at <<E-Mail-Adresse>>. This inbox is regularly monitored by the ATD team. Please note that your confirmatory request, received on the 21st April by the ATD team, has now been entered in our system with the reference number ASK-82701 and is being processed. You will be contacted shortly by an access to documents coordinator. If you have any further queries on the above, do not hesitate to contact us via <<E-Mail-Adresse>> Please use the ASK- 82701 procedure number in any correspondence related to your request. Thank you for considering the above. Yours Sincerely, Documents Access and Publication Service Stakeholders and Communication Division European Medicines Agency Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands www.ema.europa.eu<https://www.ema.eu… Follow us: [Twitter-icon] <https://twitter.com/EMA_News> [RSS-icon] <https://www.ema.europa.eu/en/news-event/rss-feeds> [Youtube-icon] <https://www.youtube.com/user/emainfo> [EMA_logo]<https://www.ema.europa.eu/en> This message and any attachment contain information which may be confidential or otherwise protected from disclosure. It is intended for the addressee(s) only and should not be relied upon as legal advice unless it is otherwise stated. If you are not the intended recipient(s) (or authorised by an addressee who received this message), access to this e-mail, or any disclosure or copying of its contents, or any action taken (or not taken) in reliance on it is unauthorised and may be unlawful. If you have received this e-mail in error, please inform the sender immediately.
Europäische Arzneimittel-Agentur
Acknowledgement of receipt of appeal ASK-82701 regarding ASK-78118 Dear Mr Antragsteller/in, We hereby acknowledg…
Von
Europäische Arzneimittel-Agentur
Betreff
Acknowledgement of receipt of appeal ASK-82701 regarding ASK-78118
Datum
26. April 2021 18:05
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Dear Mr Antragsteller/in, We hereby acknowledge receipt of your confirmatory application (appeal) to your access to documents request ASK-78118. Your appeal was registered on 21st April 2021 under reference number ASK-82701. We will deal with your request as soon as possible and in accordance with the principles and limits established in Regulation (EC) 1049/2001 regarding public access to European Parliament, Council and Commission documents (the Regulation), as applicable to the EMA pursuant to Article 73 of Regulation (EC) 726/2004. In accordance with the Regulation, you will receive a reply via a secure Eudralink within 15 working days. The Agency may extend this period by a further 15 working days in exceptional circumstances in accordance with the Regulation. Please note that the European Medicines Agency is currently operating within a business continuity plan to ensure operational continuity following its relocation to Amsterdam and during the continuing COVID-19 pandemic. Whilst every effort is being made to process your request as soon as possible, you should be aware that due to these exceptional circumstances, we may have to extend the deadline as outlined above. Should such an extension be applied by the Agency, you will be informed at the time. Kind regards,
<< Anfragesteller/in >>
AW: Acknowledgement of receipt of appeal ASK-82701 regarding ASK-78118 [#210033]
Sehr << Anrede >> ja…
An Europäische Arzneimittel-Agentur Details
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<< Anfragesteller/in >>
Betreff
AW: Acknowledgement of receipt of appeal ASK-82701 regarding ASK-78118 [#210033]
Datum
26. April 2021 21:54
An
Europäische Arzneimittel-Agentur
Status
E-Mail wurde erfolgreich versendet.
Sehr << Anrede >> ja, is klar...ich bin gespannt. Mit freundlichen Grüßen Antragsteller/in Antragsteller/in Anfragenr: 210033 Antwort an: <<E-Mail-Adresse>> Laden Sie große Dateien zu dieser Anfrage hier hoch: https://fragdenstaat.de/a/210033/
Europäische Arzneimittel-Agentur
COVID-19 Vaccine Moderna - ASK-82701 - Batch 1 - Notification of deadline extension Dear Mr. Antragsteller/in, I …
Von
Europäische Arzneimittel-Agentur
Betreff
COVID-19 Vaccine Moderna - ASK-82701 - Batch 1 - Notification of deadline extension
Datum
17. Mai 2021 14:27
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Dear Mr. Antragsteller/in, I write with an update on the above request. Unfortunately, due to the complexity of consultation with third parties we are not in a position to issue a decision concerning the requested document in the timeline provided for in Regulation (EC) No 1049/2001 ("Regulation"). The deadline has therefore been extended. This decision is in line with the principle set out in our policy which states the Agency will apply the principle of proportionality in order to avoid the core business tasks of the Agency and its performance being jeopardised by the administrative workload related to activities within Regulation 1049/2001. Under the above stated Regulation, you will receive a reply within 30 working days (initial period of 15 working days + 15 working days extension). In case this email becomes publicly available, please redact personal data such as the first name and surname of the sender, e-mail address as well as any other personal data. The Agency considers this information to be protected personal data in the meaning of Article 3(1) of Regulation (EU) No 2018/1725 and Article 4(1) of the General Data Protection Regulation EU 2016/679. Personal data is information that permits to identify a natural person. Kind regards,

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<< Anfragesteller/in >>
AW: COVID-19 Vaccine Moderna - ASK-82701 - Batch 1 - Notification of deadline extension [#210033]
Sehr << An…
An Europäische Arzneimittel-Agentur Details
Von
<< Anfragesteller/in >>
Betreff
AW: COVID-19 Vaccine Moderna - ASK-82701 - Batch 1 - Notification of deadline extension [#210033]
Datum
17. Mai 2021 15:08
An
Europäische Arzneimittel-Agentur
Status
E-Mail wurde erfolgreich versendet.
Sehr << Anrede >> es bleibt spannend, dann erwarte ich bis 03.06.2021 eine Antwort! ... Mit freundlichen Grüßen Antragsteller/in Antragsteller/in Anfragenr: 210033 Antwort an: <<E-Mail-Adresse>> Laden Sie große Dateien zu dieser Anfrage hier hoch: https://fragdenstaat.de/a/210033/ Postanschrift Antragsteller/in Antragsteller/in << Adresse entfernt >> << Adresse entfernt >>