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Antrag nach EU-Verordnungen 1049/2001 sowie 1367/2006 Sehr geehrteAntragsteller/in auf Basis der Verordnungen 1049/2001 sowie 1367/2006 bitte ich Sie um Übersendung von Dokumenten, die folgende Informationen enthalten:

Dear Sir/Madam **ASK-77120 ( https://servicedesk.ema.europa.eu/jira/browse/ASK-77120 ) - Zulassungsantrag und Beurteilungsbericht für den Impfstoff mRNA-1273 von Moderna [#208044] received on 7/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/contact/business-hours-holidays )). 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/contact/send-question-european-medicines-agency ), quoting the ASK reference number given above. Kind regards,

Dear Mr Antragsteller/in, I am writing in regard to your recent correspondence concerning Moderna and Comirnaty vaccines. You have contacted the European Medicines Agency's Press office in order to request access to documents. Colleagues have passed your requests to the Documents Access and Publication Service were we have logged them in the AskEMA system. Request concerning Moderna has a reference number ASK-77120 and the request concerning Comirnaty has a reference number ASK-77118. You should have received 2 automated acknowledgements. As they are now your requests are not clear and in order to start an access to documents procedure we would like to ask for further clarification. Towards requests for information received via the EMA web form, EMA has an obligation to reply in the language the request has been submitted, as long as it is one of the EU official languages. However, your requests are requests for access to documents. Most documents EMA holds are in the official EMA working language, which is English. Documents related to the marketing authorisation applications for Moderna and Comirnaty vaccines are in English. Also the decision letters concerning the ATD procedure are drafted in the official working language, therefore, we are hoping that, in order to speed up the process, the clarification can be carried out in English too. As for the request ASK-77118 concerning Comirnaty, you have asked to receive the marketing authorization application and the assessment report for the vaccine. The assessment report is available on the EMA web site. Please find a link for your convenience: https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf Please note that a marketing authorisation application dossier consists of hundreds of documents. Prior release, EMA has to examine each document individually to ensure that no private or public interests are being compromised. The release of a full dossier over an access to documents procedure might take years. Therefore, we would like to ask you to consider which of the documents from the dossier you would like to receive, it might be possible that you are interested only in few of the documents depending on their scope. I am attaching a structure of a MAA for your reference. Could you please confirm which documents of the dossier you would like to request. As for the request ASK-77120, you have asked to receive the marketing authorization application and the assessment report. The latter will be made available on the EMA web site shortly. Likely towards the end of the next week. As for the MAA for Moderna vaccine the same applies as above. Please kindly provide a list of the documents from the dossier that you would like to receive. Do not hesitate to contact me if you need more information. I will be awaiting your feedback in order to start the access to documents procedure. Thank you, Kind regards,