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Dear ladies and gentlemen, I just wanted to make sure my preceding email was received by you, as I have not received a response, while my other request from the same day did receive a response (ASK-157379). Sincerely, << Antragsteller:in >> << Antragsteller:in >> Anfragenr: 293383 Antwort an: <<E-Mail-Adresse>> Laden Sie große Dateien zu dieser Anfrage hier hoch: https://fragdenstaat.de/a/293383/ Postanschrift << Antragsteller:in >> << Antragsteller:in >> << Adresse entfernt >>

Dear requester, Can you please confirm the ASK reference number of your query, so we can follow up on your request? Kind regards, European Medicines Agency Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands www.ema.europa.eu Classified as internal/staff & contractors by the European Medicines Agency Classified as confidential by the European Medicines Agency

Guten Tag, the initial request does not have an ASK-number yet, as i received no response. the text of the question was the following: "Please send me the full Pfizer-BioNTech non-clinical studies R-20-0360 and R-20-0054, as referenced in the TGA nonclinical evaluation report*, including all appendices and possible different versions/iterations. *Page 20, Table 2-1. Summary of nonclinical pharmacological studies Assessment of vaccine immunogenicity - BNT162b2 V8 (BALB/c mice) - R-20-0054 In vitro expression of mRNA constructs encoding the SARS-CoV-2 Spike protein variants V8 and V9 - BNT162b2 V8 and V9 (HEK293T cells) - R-20-0360 https://www.tga.gov.au/sites/default/files/foi-2389-06" Mit freundlichen Grüßen << Antragsteller:in >> << Antragsteller:in >> Anfragenr: 293383 Antwort an: <<E-Mail-Adresse>> Laden Sie große Dateien zu dieser Anfrage hier hoch: https://fragdenstaat.de/a/293383/ Postanschrift << Antragsteller:in >> << Antragsteller:in >> << Adresse entfernt >>

Dear requester, Unfortunately your query didn’t reach us. Can you re-send us your initially query, including the date of the correspondence as well as the initial recipient, please? Please note that in order to receive a response, your request has to be in the system. Once it is in the system, you receive the ASK number. We would encourage you to use our webform, which will ensure that your query will be received and acknowledged without any delay. Please find the link to our online form for your convenience. https://www.ema.europa.eu/en/about-us/contacts-european-medicines-agency/send-question-european-medicines-agency Thank you for your cooperation and understanding. Kind regards, Access to Documents Service Documents Access and Publication Department European Medicines Agency Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands www.ema.europa.eu Classified as confidential by the European Medicines Agency

Dear ladies and gentlemen, thank you for your prompt answers. the initial request (all details viewable here: https://fragdenstaat.de/anfrage/r-20-0360-r-20-0054/#nachricht-852835) was sent to "<<E-Mail-Adresse>>" at 19:03 on 25th November, yet received no response and thus no ASK number. ASK-157379 (all details viewable here: https://fragdenstaat.de/anfrage/questions-regarding-the-rapporteurs-rolling-review-assessment-report-of-19-11-2020/) was sent to the same address on the same day at 18:56, hence my question whether this request has been received. The request reads as follows (identically to my previous mail): "Please send me the full Pfizer-BioNTech non-clinical studies R-20-0360 and R-20-0054, as referenced in the TGA nonclinical evaluation report*, including all appendices and possible different versions/iterations. *Page 20, Table 2-1. Summary of nonclinical pharmacological studies Assessment of vaccine immunogenicity - BNT162b2 V8 (BALB/c mice) - R-20-0054 In vitro expression of mRNA constructs encoding the SARS-CoV-2 Spike protein variants V8 and V9 - BNT162b2 V8 and V9 (HEK293T cells) - R-20-0360 https://www.tga.gov.au/sites/default/files/foi-2389-06" Sincerely, << Antragsteller:in >> << Antragsteller:in >> Anfragenr: 293383 Antwort an: <<E-Mail-Adresse>> Laden Sie große Dateien zu dieser Anfrage hier hoch: https://fragdenstaat.de/a/293383/ Postanschrift << Antragsteller:in >> << Antragsteller:in >> << Adresse entfernt >>

Hello, does my request for studies R-20-0360 and R-20-0054 have an ASK number now? Sincerely, << Antragsteller:in >> << Antragsteller:in >> Anfragenr: 293383 Antwort an: <<E-Mail-Adresse>> Laden Sie große Dateien zu dieser Anfrage hier hoch: https://fragdenstaat.de/a/293383/ Postanschrift << Antragsteller:in >> << Antragsteller:in >> << Adresse entfernt >>

Dear requester, Your e-mail sent to the European Medicines Agency on 25 November 2023 has only now reached the Access to document Service as it was sent via e-mail to incorrect recipient. It has been logged to our system today under ASK-158826. We would encourage you to use our webform, which will ensure that your query is logged automatically and it will be received and acknowledged without any delay. Please find the link to our online form for your convenience. https://www.ema.europa.eu/en/about-us/contacts-european-medicines-agency/send-question-european-medicines-agency Thank you for your cooperation and understanding. Kind regards, Documents Access and Publication Service Stakeholders and Communication Division Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands Classified as confidential by the European Medicines Agency

**Re: EMA request reference ASK-158826** Dear Mr << Antragsteller:in >>, Thank you for contacting the European Medicines Agency. We will deal with your request 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 EMA cannot currently process all access-to-documents requests at the same time. This is because their number increased while EMA was operating under a business continuity plan during the COVID-19 pandemic. EMA is making every effort to process all requests as soon as possible. It is dealing with requests in a chronological order, based on time of receipt. You can find out more information about this in our guidance document under Question 16 linked below: https://www.ema.europa.eu/en/documents/other/guide-access-unpublished-documents_en.pdf ( https://www.ema.europa.eu/en/documents/other/guide-access-unpublished-documents_en.pdf ) 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 Access to Documents 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: R-20-0360 & R-20-0054 [#293383] /> Original Description: