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

Dear Sir/Madam **ASK-105383 ( https://servicedesk.ema.europa.eu/jira/browse/ASK-105383 ) - (VY) Bewertung der bedingten Zulassungsverlängerung Comirnaty und Spikevax , Nutzen-Risk-Bewertung [#238365 received on 21/Jan/22** 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 Lach, Thank you for your access to documents request, which has been registered under reference ASK-105383. Please note that the EMA is currently operating under business continuity measures to ensure its operational continuity during the COVID-19 pandemic. Whilst every effort is being made to process all access to documents requests as soon as possible, due to these exceptional circumstances and in order to ensure a manageable flow of all access-to-documents requests from all requesters in a fair, timely and consistent way, the following approach is applied: • Each access to documents request cannot exceed 2 documents • A requester/affiliation can have a maximum of 5 access to documents requests in queue. You can find more information about this in the ‘Guidance on unpublished documents’ at our website (https://www.ema.europa.eu/en/documents/other/guide-access-unpublished-documents_en.pdf), specifically Questions 17 and 18. Please note that in the above mentioned Question 18 of the guidance document you will find more detailed information on what is considered as one document. This information should help you identifying the requested documents. Your current request does not meet the above requirements. Please provide us with up to two documents you are interested in. We would appreciate your reply by 01 February 2022 e.o.b. Kind regards,

Dear Mr Lach, I write further to our email of 24 January 2022 in which you were asked to specify which two documents you would like to receive within this request for access to documents. As we have not received any information from you we have been unable to proceed with your request. If you would still like to receive the requested documents, please confirm as soon as possible and provide the necessary information. If we have not received your response by 16 February 2022 we will consider your request to have been withdrawn. You are, of course, very welcome to contact us again in future via our webform<https://www.ema.europa.eu/en/about-us/contact/send-question-european-medicines-agency> should you wish to request access to documents held by the European Medicines Agency. Kind regards,

Dear Mr Lach, We write further to our emails of 24 January and 2 February 2022 in which you were asked to provide clarification in which two documents you are interested in. As we have not received any information from you we have been unable to proceed with your request. If you would still like to receive documents, please confirm as soon as possible and provide information about the documents you would like to receive such as product to which the document(s) refer(s) and specific document. If we have not received your response by 04 March 2022 we will consider your request to have been withdrawn. You are, of course, very welcome to contact us again in future via our webform<https://www.ema.europa.eu/en/about-us...> should you wish to request access to documents held by the European Medicines Agency. Kind regards,

Dear Mr Lach, We write further to our emails of 24 January, 2 February 2022 and 20 February 2022 in which you were asked to provide clarification regarding the scope of the above request for access to documents. As we have not received any information from you we have been unable to proceed with your request. Therefore we consider your request to have been withdrawn. You are, of course, very welcome to contact us again in future via our webform<https://www.ema.europa.eu/en/about-us/contact/send-question-european-medicines-agency> should you wish to request access to documents held by the European Medicines Agency. Kind regards,