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**Re: EMA request reference ASK-116484** Dear Dr. << Antragsteller:in >>, Thank you for contacting the European Medicines Agency. Your request will be dealt in accordance with the principles and limits established in Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents (the Regulation), as applicable to the European Medicines Agency (EMA) pursuant to Article 73 of Regulation (EC) No 726/2004. Please note that the EMA is currently operating within a business continuity plan to ensure operational continuity during the continuing COVID-19 pandemic. Whilst every effort is being made to process all requests as soon as possible, you should be aware that due to these exceptional circumstances requests cannot be processed immediately and will be dealt in a chronological order from the time they were received. You can find out more information about this in our guidance document under Question 16 linked below: https://www.ema.europa.eu/en/document... ( https://www.ema.europa.eu/en/document... ) This decision is also in line with the principle set out in our policy 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 workload related to activities within the Regulation. You will be informed by an ATD coordinator when your procedure starts. Thank you for considering the above. Yours sincerely, Access to Documents Service Documents Access and Publication Department **European Medicines Agency** Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands Telephone: +31 (0)88 781 6000 Got a question? Ask EMA at www.ema.europa.eu/contact ( http://www.ema.europa.eu/contact ) This message 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. ============================================= Original Subject: (VY) Myo/Perikarditis im Zusammenhang mit Comirnaty [#253096] Original Description: Antrag nach EU-Verordnungen 1049/2001 sowie 1367/2006 Sehr geehrte Damen und Herren, sehr << Antragsteller:in >> auf Basis der Verordnungen 1049/2001 sowie 1367/2006 bitte ich Sie um Übersendung von Dokumenten, die folgende Informationen enthalten: Basierend auf meiner Anfrage #246682 vom 21 April 2022 bitte ich um die Beantwortung/ Bereitstellung der folgenden Fragen/ Informationen: # Nach Auskunft von Herrn Juan Garcia Burgos wurde die EMA erstmals am 28 Februar 2021 vom israelischen Gesundheitsministerium per e-Mail über das Auftreten von etwa 40 Fällen von Myo-/Perikarditis informiert, die in zeitlichem Zusammenhang mit einer Impfung bei Personen gemeldet wurden, die Comirnaty erhalten hatten. Bitte stellen Sie das Originaldokument zur Verfügung. # Bitte schildern Sie detailliert, und unter Angabe der jeweiligen Zeitpunkte, die von der EMA in Folge eingeleiteten Schritte und Maßnahmen. Ich möchte diesbezüglich freundlich um die Beantwortung der nachfolgenden Fragen bitten: # a) Wann und in welcher Form reagierte die EMA auf das unter Punkt 1. genannte Dokument aus Israel? Welche Schritte wurden von der EMA eingeleitet? Welche Konsultationen (intern sowie auch extern: bspw. mit anderen Behörden) haben stattgefunden? Bitte stellen Sie die Originaldokumente (Kommunikation, Fragen, Antworten o.ä.) zur Verfügung. # b) Welche Informationen wurden - insbesondere mit den israelischen, amerikanischen und britischen Behörden - bis zum 19 Juli 2021 ausgetauscht (auch im Sinne von: welche Informationen hat die EMA von den vorbenannten Behörden erhalten) ? Bitte stellen Sie die Originaldokumente (Kommunikation, Fragen, Antworten o.ä.) zur Verfügung. # c) Wann und in welcher Form wurde mit dem MAH von Comirnaty über den Bericht aus Israel diskutiert? Welche Informationen wurden von der EMA daraufhin beim MAH angefragt? Wann und wie antwortete der MAH auf die Anfrage der EMA? Bitte stellen Sie die Originaldokumente (Kommunikation, Fragen, Antworten o.ä.) zur Verfügung. # d) Welche Fragen/ Auskunftsersuche blieben vom MAH unbeantwortet und was waren die Gründe hierfür? Welche Schritte leitete die EMA ein um die Beantwortung (Bereitstellung) der Frage (von Informationen) sicherzustellen, da gem. EMA/PRAC/325882/2021 auch zu einem deutlich späteren Zeitpunkt eine Reihe von Fragen nicht beantwortet wurden. Bitte stellen Sie die Originaldokumente (Kommunikation, Fragen, Antworten o.ä.) zur Verfügung. 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

Sehr << Antragsteller:in >> Vielen Dank, dass Sie sich an die Europäische Arzneimittel-Agentur gewandt haben. Wie Ihnen am 01 August mitgeteilt wurde, arbeitet die EMA derzeit im Rahmen eines Notfallplans, um die Betriebskontinuität während der anhaltenden COVID-19-Pandemie zu gewährleisten. Diese Entscheidung steht auch im Einklang mit dem Grundsatz unserer Politik, wonach die Agentur den Grundsatz der Verhältnismäßigkeit anwenden wird, um zu vermeiden, dass die Kernaufgaben der Agentur und ihre Leistung durch die Arbeitsbelastung im Zusammenhang mit den Tätigkeiten im Rahmen der Verordnung gefährdet werden. Weitere Informationen zu dieser Entscheidung und Erläuterungen zur chronologischen Warteschlange finden Sie in unserem kürzlich aktualisierten Dokument „Leitfaden zum Zugang zu unveröffentlichten Dokumenten" (https://www.ema.europa.eu/en/document... ( https://www.ema.europa.eu/en/document... )), diese finden Sie unter Frage 16. Sie werden von einem Koordinator für den Zugang zu Dokumenten über den Beginn Ihres Verfahrens informiert. Zu diesem Zeitpunkt können wir nicht abschätzen, wann wir mit der Bearbeitung Ihres Antrags beginnen können, aber ich versichere Ihnen, dass die Warteschlange von dem zuständigen Team sehr genau überwacht wird und Sie informiert werden, sobald wir in der Lage sind, die Bearbeitung des Antrags zu beginnen. Wenn Ihr Antrag jedoch dringend ist, wenden Sie sich bitte erneut an uns, indem Sie den Grund oder die Gründe für die Dringlichkeit erläutern. Bitte senden Sie Ihre Weiterverfolgung auf unserem Webformular ein (https://www.ema.europa.eu/en/about-us... ( https://www.ema.europa.eu/en/about-us... )), unter Angabe der oben genannten ASK-Referenznummer oder über <<E-Mail-Adresse>> . Vielen Dank für die Berücksichtigung der oben genannten Punkte. Mit freundlichen Grüßen

Dear Sir/Madam **ASK-122290 - AW: AskEMA - Response to ASK-117764 - AW: [EMA Service Desk] (ASK-116484) (VY) Myo/Perikarditis im Zusammenhang mit Comirnaty [#253096] received on 28/09/2022** Thank you for your message and your interest in the European Medicines Agency. Your request has been given the reference number ASK-122290. We will reply to you as soon as we can. For complex queries, it may take longer to answer. In any case we will write back to you within 2 months from the date of receipt. **Please do not reply to this email**, this is an automated response to confirm that we have received your request. If you need to contact us again about the same matter, please use the form on our website and mention the reference number. Kind regards **European Medicines Agency** Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands Send us a question. Go towww.ema.europa.eu/contact ( http:://www.ema.europa.eu/contact ) Telephone: +31 (0)88 781 6000 ____________________________________________________________ We received your question(s) on: **28/09/2022** Subject of your enquiry: **AW: AskEMA - Response to ASK-117764 - AW: [EMA Service Desk] (ASK-116484) (VY) Myo/Perikarditis im Zusammenhang mit Comirnaty [#253096]** Your question(s): **Sehr geehrte Damen und Herren, meine Informationsfreiheitsanfrage „Myo/Perikarditis im Zusammenhang mit Comirnaty" vom 12.07.2022 (#253096) wurde von Ihnen nicht in der gesetzlich vorgeschriebenen Zeit beantwortet. Sie haben die Frist mittlerweile um 57 Tage überschritten.Bitte informieren Sie mich umgehend über den Stand meiner Anfrage. Mit freundlichen Grüßen

Sehr << Antragsteller:in >> Vielen Dank, dass Sie sich an die Europäische Arzneimittel-Agentur gewandt haben. Wie Ihnen am 01 August und 26 August 2022 mitgeteilt wurde, arbeitet die EMA derzeit im Rahmen eines Notfallplans, um die Betriebskontinuität während der anhaltenden COVID-19-Pandemie zu gewährleisten. Diese Entscheidung steht auch im Einklang mit dem Grundsatz unserer Politik, wonach die Agentur den Grundsatz der Verhältnismäßigkeit anwenden wird, um zu vermeiden, dass die Kernaufgaben der Agentur und ihre Leistung durch die Arbeitsbelastung im Zusammenhang mit den Tätigkeiten im Rahmen der Verordnung gefährdet werden. Weitere Informationen zu dieser Entscheidung und Erläuterungen zur chronologischen Warteschlange finden Sie in unserem kürzlich aktualisierten Dokument „Leitfaden zum Zugang zu unveröffentlichten Dokumenten" (https://www.ema.europa.eu/en/document... ( https://www.ema.europa.eu/en/document... )), diese finden Sie unter Frage 16. Sie werden von einem Koordinator für den Zugang zu Dokumenten über den Beginn Ihres Verfahrens informiert. Zu diesem Zeitpunkt können wir nicht abschätzen, wann wir mit der Bearbeitung Ihres Antrags beginnen können, aber ich versichere Ihnen, dass die Warteschlange von dem zuständigen Team sehr genau überwacht wird und Sie informiert werden, sobald wir in der Lage sind, die Bearbeitung des Antrags zu beginnen. Wenn Ihr Antrag jedoch dringend ist, wenden Sie sich bitte erneut an uns, indem Sie den Grund oder die Gründe für die Dringlichkeit erläutern. Bitte senden Sie Ihre Weiterverfolgung auf unserem Webformular ein (https://www.ema.europa.eu/en/about-us... ( https://www.ema.europa.eu/en/about-us... )), unter Angabe der oben genannten ASK-Referenznummer oder über <<E-Mail-Adresse>> . Vielen Dank für die Berücksichtigung der oben genannten Punkte. Mit freundlichen Grüßen

Dear Mr << Antragsteller:in >>, We hereby acknowledge receipt of your application for access to documents, which was registered under reference number ASK-116484. Further to our email of 1 August 2022, and the further replies sent on 26 August and 17 October 2022, I write to inform you that we have now opened your request for access to documents for Comirnaty. The Agency endeavours to provide you with sets of documents at regular intervals. You will receive the decision regarding the first batch of documents no later than by 29 November 2022. With reference to your last follow up email sent to us on 31 October 2022 where you asked to receive the documentation by 9 November, please note that we have further reviewed your request and as it concerns a large number of documents, each of which the Agency has to examine individually to ensure that no private or public interests are being compromised, we are not in a position to fulfil your request immediately. 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. Please note that the European Medicines Agency is currently operating within a business continuity plan to ensure operational continuity 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

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 of the batch of the above request 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/other/policy/0043-european-medicines-agency-policy-access-documents_en.pdf ) 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 20 December 2022. However, we fully expect to be in a position to inform you of the EMA’s decision well before that date. Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=0e72255cad76ac5bfe7b0162a615d554 The package will expire on Wed, 01 Mar 2023 16:05:11 +0100 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Requester, The decision letter and the document regarding the batch of the above request has just been sent 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-XXXXX-YYYY It is the ASK reference number for this request (ASK-XXXXX, written exactly as it appears in the subject line ) + the year (-YYYY) in which you submitted your request to the Agency Kind regards,

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 of the batch 2 of the above request 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/other/policy/0043-european-medicines-agency-policy-access-documents_en.pdf ) 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 23 January 2023. However, we fully expect to be in a position to inform you of the EMA’s decision well before that date. Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=3351506859972eec66cef6af90901528 The package will expire on Wed, 19 Apr 2023 11:15:46 +0200 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Requester, The decision letter and the document regarding the batch of the above request has just been sent 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-XXXXX-YYYY It is the ASK reference number for this request (ASK-XXXXX, written exactly as it appears in the subject line ) + the year (-YYYY) in which you submitted your request to the Agency Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=42b5f93b4e915c15008fcf41c4bf6c0e The package will expire on Thu, 04 May 2023 12:07:34 +0200 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Requester, The decision letter and the document regarding the batch of the above request has just been sent 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-XXXXX-YYYY It is the ASK reference number for this request (ASK-XXXXX, written exactly as it appears in the subject line ) + the year (-YYYY) in which you submitted your request to the Agency Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=37a853b0d95b66e17efcf3fdd7d8357f The package will expire on Sun, 28 May 2023 09:36:35 +0200 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Requester, The decision letter and the document regarding the batch of the above request has just been sent 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-XXXXX-YYYY It is the ASK reference number for this request (ASK-XXXXX, written exactly as it appears in the subject line ) + the year (-YYYY) in which you submitted your request to the Agency Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=33ae0913f117fc24f7fc0ba83669b393 The package will expire on Tue, 13 Jun 2023 10:18:32 +0200 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Requester, The decision letter and the document regarding the batch of the above request has just been sent 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-XXXXX-YYYY It is the ASK reference number for this request (ASK-XXXXX, written exactly as it appears in the subject line ) + the year (-YYYY) in which you submitted your request to the Agency Kind regards,

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 of the batch 6 of the above request 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/other/policy/0043-european-medicines-agency-policy-access-documents_en.pdf ) 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 3 May 2023. However, we fully expect to be in a position to inform you of the EMA’s decision well before that date. Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=b4e630a5e482edd8d5cd716cbaf6bf63 The package will expire on Thu, 27 Jul 2023 12:42:27 +0200 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Requester, The decision letter and the document regarding the batch of the above request has just been sent 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-XXXXX-YYYY It is the ASK reference number for this request (ASK-XXXXX, written exactly as it appears in the subject line ) + the year (-YYYY) in which you submitted your request to the Agency Kind regards,

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 of the batch 6 of the above request 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/other/policy/0043-european-medicines-agency-policy-access-documents_en.pdf ) 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 16 June 2023. However, we fully expect to be in a position to inform you of the EMA’s decision well before that date. Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=ca59d5e7b5d26353227e67b81d536223 The package will expire on Tue, 29 Aug 2023 16:29:29 +0200 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Requester, The decision letter and the document regarding the batch of the above request has just been sent 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-XXXXX-YYYY It is the ASK reference number for this request (ASK-XXXXX, written exactly as it appears in the subject line ) + the year (-YYYY) in which you submitted your request to the Agency Kind regards,

Dear requester, We are facing with some issue with Eudralink, the tool that we use to send you the decision letter and the document related to your request. At the moment we are not able to send package with password, but we have a solution that can help us to move forward with the process of your request for access to documents. Saying that, I kindly invite you to request the Eudralink account. You can do so by submitting a request directly to the Agency’s IT service desk (which is responsible for EMA Information Technology (IT) systems) using the link below: https://servicedesk.ema.europa.eu/ To do this, you will need to use the Single Sign On (SSO) credentials to access the EMA Customer Service Portal (https://support.ema.europa.eu/esc<https://support.ema.europa.eu/esc?id=sc_cat_item&sys_id=3d0d0aebc3d015508719596ce0013188> ) and you can then report an issue, ask a question or make a request (eg access to Eudralink or to other applications): If you do not yet have SSO credentials, please apply for a login ID and Password to access the EMA Customer Service Portal: https://accounts.ema.europa.eu/registration Please note that these SSO credentials are used to access the EMA Customer Portal, Eudralink, MMD, EudraCT, EVDAS, BI, PedRa and MMS-e (but NOT EudraVigilance). Please access the EMA portal from Firefox or Google chrome. If in future you require a password reset/login ID reminder, please email <<E-Mail-Adresse>><mailto:<<E-Mail-Adresse>>> and if you continue to experience any difficulty in accessing the EMA portal, please telephone the IT service desk on +31887818520. Thank you for your understanding, Kind regards

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 of the batch 8 of the above request 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/other/policy/0043-european-medicines-agency-policy-access-documents_en.pdf ) 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 12 July 2023. However, we fully expect to be in a position to inform you of the EMA’s decision well before that date. Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=a8fc23ac1cda1716cdd4592342c7d1e5 The package will expire on Tue, 10 Oct 2023 11:44:37 +0200 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Mr << Antragsteller:in >>, The decision letter and the document regarding the batch of the above request has just been sent to you via a secure Eudralink. Please ensure that you download and save the document before the package expires. Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=2aedcec26b985fbe6d75087486622236 The package will expire on Tue, 31 Oct 2023 11:21:43 +0100 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Mr << Antragsteller:in >>, The decision letter and the document regarding the batch of the above request has just been sent to you via a secure Eudralink. Please ensure that you download and save the document before the package expires. Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=bffd3f1a3f29388fbb7262620a8ba010 The package will expire on Thu, 16 Nov 2023 07:13:00 +0100 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Mr << Antragsteller:in >>, The decision letter and the document regarding the batch of the above request has just been sent to you via a secure Eudralink. Please ensure that you download and save the document before the package expires. Kind regards,

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 of the batch 11 of the above request 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/other/policy/0043-european-medicines-agency-policy-access-documents_en.pdf ) 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 29 September 2023. However, we fully expect to be in a position to inform you of the EMA’s decision well before that date. Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=05146a7f048ee72701b41fe4ee070c4d The package will expire on Thu, 28 Dec 2023 13:56:27 +0100 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Mr << Antragsteller:in >>, The decision letter and the document regarding the batch of the above request has just been sent to you via a secure Eudralink. Please ensure that you download and save the document before the package expires. Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=6489b3800173f854683d200cf1ea5965 The package will expire on Mon, 15 Jan 2024 15:51:43 +0100 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Mr << Antragsteller:in >>, The decision letter and the documents regarding the batch of the above request has just been sent to you via a secure Eudralink. Please ensure that you download and save the document before the package expires. Kind regards,

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 of the batch 13 of the above request 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/other/policy/0043-european-medicines-agency-policy-access-documents_en.pdf ) 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 30 November 2023. However, we fully expect to be in a position to inform you of the EMA’s decision well before that date. Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=ed980db68a730e254528c47f776c7692 The package will expire on Mon, 26 Feb 2024 16:05:09 +0100 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Mr << Antragsteller:in >>, The decision letter and documents of the above request have just been released to you via a secure Eudralink. Please ensure that you download and save the documents 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. Kind regards,

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 of the batch 14 of the above request 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/other/policy/0043-european-medicines-agency-policy-access-documents_en.pdf ) 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 18 January 2024. However, we fully expect to be in a position to inform you of the EMA’s decision well before that date. Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=2cda3ee54bcde291c3e7e30a19815edf The package will expire on Wed, 17 Apr 2024 17:42:45 +0200 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Mr << Antragsteller:in >>, The decision letter and documents of the above request have just been released to you via a secure Eudralink. Please ensure that you download and save the documents 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. Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=ec479cbcf40bc7dfe3ed6974c48136dd The package will expire on Wed, 08 May 2024 16:42:42 +0200 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Mr << Antragsteller:in >>, The decision letter and documents of the above request have just been released to you via a secure Eudralink. Please ensure that you download and save the documents 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. Kind regards,

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 of the batch 16 of the above request 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/other/policy/0043-european-medicines-agency-policy-access-documents_en.pdf ) 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 21 March 2024. However, we fully expect to be in a position to inform you of the EMA’s decision well before that date. Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=17cb6894611c8697c95098ab66b6937b The package will expire on Wed, 19 Jun 2024 18:20:08 +0200 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Mr << Antragsteller:in >>, The decision letter and documents of the above request have just been released to you via a secure Eudralink. Please ensure that you download and save the documents 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. Kind regards,

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=b65ccff978b01bf1647deae36c1178c5 The package will expire on Thu, 20 Jun 2024 16:21:00 +0200 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

+++++++++++++++++++++++++++++++++++++++++++++ You have been sent a package by "European Medicines Agency" <<Name und E-Mail-Adresse>> To retrieve your package use the hyperlink below (click or paste it into browser address bar): https://eudralink.ema.europa.eu/dl.php?d=d1f111f78041b72f64483b6f018ce765 The package will expire on Mon, 15 Jul 2024 15:56:47 +0200 If you forward this email notification, only registered Eudralink users within your organisation (with the same domain) will be able to access it*. You should create a new package to send to third parties. +++++++++++++++++++++++++++++++++++++++++++++ *Other restrictions apply. See https://eudralink.ema.europa.eu/EudraLink-User-Guide.pdf (search forwarding)

Dear Mr << Antragsteller:in >>, The decision letter and documents of the above request have just been released to you via a secure Eudralink. Please ensure that you download and save the documents 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. Kind regards,