WOB-verzoeken: EMA documenten12 december 2022 WOB-verzoeken: EMA documenten Rapporteur’s (SE) Assessment Reports Rapporteur's Rolling Review Report Overview LoQ - COVID-19 mRNA Vaccine BioNTech Rapporteur's Rolling Review Report Quality - COVID-19 mRNA Vaccine BioNTec Rapporteur's Rolling Review Report New Active Substance Status - COVID-19 mRNA Vaccine BioNTec 2020-11-20 Rapporteur's Assessment Report to applicant Comments (Peer Review) Peer Reviewers Comments_NO 23-11-2020 BNT CMC Peer Reviewer Comparability COVID-19 mRNA Vaccine BioNTech - EMA peer review comments Summary of analytical method transfer for BNT162B2 drug product release EudraLink - H0005735 Transfer Plan 11-11-2020 Interim Opinion 30-11-2020 Written procedure for COVID-19.mRNA.Vaccine.BioNTech-5735 – for your comments by 30-11-17 00 CET Eudralink to company - 30-11-2020 COVID-19 mRNA Vaccine BioNTech - CHMP Overview and LoQ COVID-19 mRNA Vaccine BioNTech - CHMP Opinion Applicant Rapports EMA CMC TC 26-11-2020 Annex 1 - Draft 3.2.P.2.2 Drug Product Annex 2 - VAL100130986 + attachment_All approved Annex 3 - BNT162b2 Manufacturing Equipment and Scale Annex 4 - BNT162b2 CMC Data Timelines_for Pre-sub Meeting_PPQ BNT162b2 EMA-Rapp CMC Meeting 26-Nov-2020 M1 20 Nov 2020 FDA Query Responses M3 20 Nov 2020 FDA Query Responses 2020-11-26 BNT162b2 EMAmeeting final 2020-11-30 - Priority OCs to company Priority OCs in quality LoQ - COVID-19 mRNA Vaccine BioNTech 2020-11-26 ETF (vaccines) COVID-19 vaccine (recombinant, adjuvanted) Draft joint report as agreed by Rapps Agenda for ETF meeting on COVID-19 vaccines - 26-11-2020 Summary of the ETF meeting on COVID-19 vaccine - 26 November 2020 COVID-ETF recommendation on the start of rolling review E-mails E-mail 1 E-mail 2 E-mail 3 E-mail 4 E-mail 5 E-mail 6 E-mail 7 E-mail 8 E-mail 9 E-mail 10 E-mail 11 E-mail 12 E-mail 13 E-mail 14 Rolling report MLT rolling report on COVID-19 discussions
